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"ID": "2497", "BrandName": "cobas e 801" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

Elecsys Anti‑SARS‑CoV‑2 S for use on the cobas e analyzers is an electrochemiluminescence immunoassay intended for qualitative and semi-quantitative detection of antibodies to SARS‑CoV‑2 in human serum and plasma (lithium heparin, dipotassium-EDTA, tripotassium-EDTA, and sodium citrate). The Elecsys Anti‑SARS‑CoV‑2 S assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Elecsys Anti‑SARS‑CoV‑2 S assay should not be used to diagnose or exclude acute SARS‑CoV‑2 infection.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.

Results are for the detection of SARS‑CoV‑2 antibodies. Antibodies to SARS‑CoV‑2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. The sensitivity of the Elecsys Anti‑SARS‑CoV‑2 S assay early after infection is unknown. Negative results do not preclude acute SARS‑CoV‑2 infection. If acute infection is suspected, direct testing for SARS‑CoV‑2 is necessary.

False positive results for Elecsys Anti‑SARS‑CoV‑2 S assay may occur due to cross-reactivity from pre‑existing antibodies or other possible causes.

The Elecsys Anti‑SARS‑CoV‑2 S assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Double-antigen sandwich principle. The antigens within the reagent capture predominantly anti‑SARS‑CoV‑2 IgG, but also anti‑SARS‑CoV‑2 IgA and IgM. Total duration of assay: 18 minutes.

  • 1st incubation: 20 µL of sample (cobas e 411, cobas e 601, and cobas e 602 analyzers) or 12 µL of sample (cobas e 801 analyzer), biotinylated SARS‑CoV‑2 S‑RBD‑specific recombinant antigen and SARS‑CoV‑2 S‑RBD‑specific recombinant antigen labeled with a ruthenium complex

    FREFTris(2,2’-bipyridyl)ruthenium(II)-complex (Ru(bpy))
    form a sandwich complex.

2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.

  • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell/ProCell M/ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.

Results are determined via a calibration curve which is instrument-specifically generated by 2‑point calibration and a master curve provided via the reagent barcode or e‑barcode.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Analytical measuring interval

The analytical measuring interval is 0.40‑250 U/mL. Numeric values are interpreted as \"negative\" (< 0.8 U/mL) and as \"positive\" (≥ 0.80 U/mL). Please see Interpretation of the results section. When sample results exceed the upper limit of the analytical measuring interval, refer to the Dilution section below. Values above the measuring range are reported as > 250 U/mL (or up to 2500 U/mL for 10‑fold diluted samples).

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank = 0.30 U/mL

Limit of Detection = 0.35 U/mL

Limit of Quantitation = 0.40 U/mL

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank corresponds to the highest measurement result that is likely to be observed for analyte-free samples with a probability of 95 %. The Limit of Blank was estimated as the 95th percentile value from n ≥ 60 measurements of analyte-free samples over several independent series. The Limit of Blank is 0.30 U/mL.

The Limit of Detection is the lowest concentration of antibodies to SARS‑CoV‑2 in a sample that can be detected with a probability of 95 %. The Limit of Detection was calculated based on the Limit of Blank and the standard deviation of low concentration samples. The Limit of Detection is 0.35 U/mL.

The Limit of Quantitation is defined as the lowest amount of analyte in a sample that can be accurately quantified with a CV ≤ 20 %. It has been determined using low concentration of anti‑SARS‑CoV‑2‑S samples. The Limit of Quantitation is 0.40 U/mL.

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Limitations

  • Drug interferences are measured based on recommendations given in CLSI (Clinical and Laboratory Standards Institute) guidelines EP07 and EP37 and other published literature. Effects of concentrations exceeding these recommendations have not been characterized.

  • In rare cases, interference due to extremely high titers of antibodies to analyte‑specific antibodies, streptavidin or ruthenium can occur. These effects are minimized by suitable test design.

  • Results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

  • This device should not be used to diagnose or exclude acute SARS‑CoV‑2 infection. Direct testing for SARS‑CoV‑2 with a molecular assay should be performed to evaluate acute infection in symptomatic individuals.

  • The clinical applicability of semi‑quantitative results is currently unknown and cannot be interpreted as an indication or degree of immunity nor protection from reinfection, nor compared to other SARS‑CoV‑2 antibody assays.

  • Results obtained with this assay may not be used interchangeably with values obtained with different manufacturers’ test methods.

  • A positive result may not indicate previous SARS‑CoV‑2 infection. Consider other information including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response.

  • A negative result for an individual subject indicates the absence of detectable anti‑SARS‑CoV‑2 antibodies. Negative results do not preclude SARS‑CoV‑2 infection and should not be used as the sole basis for patient management decisions. A negative result can occur if the quantity of the anti‑SARS‑CoV‑2 antibodies that are detected and are not present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.

  • It is not known at this time if the presence of antibodies to SARS‑CoV‑2 confers immunity to re-infection.

  • Not to be used to determine SARS‑CoV‑2 infection in donated blood units. This test should not be used for blood donor screening.

  • The performance of this test has not been established in individuals that have received a COVID‑19 vaccine. The clinical significance of a positive or negative antibody result following COVID‑19 vaccination has not been established, and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination.

  • The performance of this test was established based on the evaluation of a limited number of clinical specimens. Samples used to establish positive clinical agreement were collected between March and July 2020 in Switzerland, Germany, and Ukraine. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS‑CoV‑2 and their prevalence, which change over time.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (Immuno Reagents) + Sum

09289267190

09289267501

200

cobas e 411

cobas e 601

cobas e 602

09289275190

09289275501

300

cobas e 801

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

For cobas e 411 analyzer: test number 2550
For cobas e 601 and cobas e 602 analyzers: Application Code Number 71
For cobas e 801 analyzer: Application Code Number 10230

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Reagent handling

The reagents in the kit have been assembled into a ready‑for‑use unit that cannot be separated.

cobas e 411, cobas e 601, and cobas e 602 analyzers:

All information required for correct operation is read in from the respective reagent barcodes.

cobas e 801 analyzer:

All information required for correct operation is available via the cobas link.

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Storage and stability

Store at 2‑8 °C.

Do not freeze.

Store the Elecsys reagent kit / cobas e pack upright in order to ensure complete availability of the microparticles during automatic mixing prior to use.

Stability of the reagent rackpack:

unopened at 2‑8 °C

up to the stated expiration date

after opening at 2‑8 °C

12 weeks

on the cobas e 411, cobas e 601 and cobas e 602 analyzers

28 days

Stability of the cobas e pack:

unopened at 2‑8 °C

up to the stated expiration date

on the cobas e 801 analyzer

16 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Traceability: This method has been standardized against the internal Roche standard for anti‑SARS‑CoV‑2‑S. This standard consists of an equimolar mixture of 2 monoclonal antibodies that bind Spike‑1 RBD at 2 different epitopes. 1 nM of these antibodies correspond to 20 U/mL of the Elecsys Anti‑SARS‑CoV‑2 S assay. No international standard is currently available for anti‑SARS‑CoV‑2‑S.

Note: The defined unit is specific for the Elecsys Anti‑SARS‑CoV‑2 S assay and must not be used interchangeably with units of other assays.

Every Elecsys reagent set has a barcoded label containing specific information for calibration of the particular reagent lot. The predefined master curve is adapted to the analyzer using the relevant CalSet.

Calibration frequency: Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the same reagent kit was registered on the analyzer).

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Renewed calibration is recommended as follows:

  • after 31 days when using the same reagent lot on the cobas e 411, cobas e 601 and cobas e 602 analyzers

  • after 42 days when using the same reagent lot on the cobas e 801 analyzer

  • after 14 days when using the same reagent kit or cobas e pack on the analyzer

  • as required: e.g. quality control findings outside the defined limits

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Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using Elecsys reagents, samples and controls in a protocol (EP05‑A3) of the CLSI: 1 run per day with 5 replicates of each sample for 5 days. The following results were obtained:


Repeatability and Intermediate precision

cobas e 411 analyzer

Repeatability

Intermediate precision

FREFIntermediate precision includes repeatability and between-day/run components.

Sample
N = 25

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.483

0.014

2.8

0.016

3.4

Human plasma 2

0.826

0.023

2.8

0.023

2.8

Human plasma 3

5.74

0.131

2.3

0.150

2.6

Human plasma 4

12.3

0.266

2.2

0.304

2.5

Human plasma 5

54.6

1.58

2.9

1.58

2.9

Human plasma 6

77.9

1.78

2.3

2.07

2.7

Human plasma 7

190

3.03

1.6

3.69

1.9

PC

FREFPC = PreciControl
ACOV2S 1
FREFPC ACOV2S 1 is free of analyte and therefore consistently resulted below the measuring range (< 0.40 U/mL) throughout the experiment, standard deviation and coefficient of variance could therefore not be determined (‑).

< 0.40

PC ACOV2S 2

10.8

0.207

1.9

0.230

2.1

cobas e 601 and cobas e 602 analyzers

Repeatability

Intermediate precision

FREFIntermediate precision includes repeatability and between-day/run components.

Sample
N = 25

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.441

0.007

1.6

0.016

3.7

Human plasma 2

0.933

0.014

1.5

0.022

2.3

Human plasma 3

5.60

0.102

1.8

0.181

3.2

Human plasma 4

12.0

0.189

1.6

0.334

2.8

Human plasma 5

53.2

0.761

1.4

1.46

2.7

Human plasma 6

75.5

1.55

2.1

2.70

3.6

Human plasma 7

183

3.31

1.8

5.13

2.8

PC ACOV2S 1

FREFPC ACOV2S 1 is free of analyte and therefore consistently resulted below the measuring range (< 0.40 U/mL) throughout the experiment, standard deviation and coefficient of variance could therefore not be determined (‑).

< 0.40

PC ACOV2S 2

10.5

0.118

1.1

0.341

3.3

cobas e 801 analyzer

Repeatability

Intermediate precision

FREFIntermediate precision includes repeatability and between-day/run components.

Sample
N = 25

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.483

0.014

2.9

0.014

2.9

Human plasma 2

0.826

0.015

1.9

0.015

1.9

Human plasma 3

5.69

0.121

2.1

0.136

2.4

Human plasma 4

12.0

0.159

1.3

0.191

1.6

Human plasma 5

54.8

0.743

1.4

0.770

1.4

Human plasma 6

77.3

1.23

1.6

1.54

2.0

Human plasma 7

184

1.69

0.90

2.63

1.4

PC

FREFPC = PreciControl
ACOV2S 1
FREFPC ACOV2S 1 is free of analyte and therefore consistently resulted below the measuring range (< 0.40 U/mL) throughout the experiment, standard deviation and coefficient of variance could therefore not be determined (‑).

< 0.40

PC ACOV2S 2

10.4

0.139

1.3

0.206

2.0

Precision study for evaluation of Lot-to-lot and Between-platform variability

An additional precision study for the estimation of lot-to-lot precision component was conducted with the design similar to the single-site precision study and with 2 additional lots.


Lot-to-lot precision

Lot-to-lot variability was evaluated for the cobas e 801 analyzer with 3 lots.

cobas e 801 analyzer

Repeatability

Between-day

Sample
N = 75

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.474

0.015

3.2

0.004

0.8

Human plasma 2a

0.824

0.018

2.2

0.003

0.4

Human plasma 2b

0.940

0.015

1.6

0.007

0.8

Human plasma 3

5.49

0.112

2.0

0.053

1.0

Human plasma 4

11.8

0.192

1.6

0.106

0.9

Human plasma 5

53.4

0.838

1.6

0.000

0.0

Human plasma 6

73.2

1.20

1.6

0.785

1.1

Human plasma 7

183

2.05

1.1

1.45

0.8

Human plasma 8

253

2.97

1.2

2.09

0.8

cobas e 801 analyzer

Between-lot

Reproducibility

Sample
N = 75

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.474

0.023

4.9

0.028

5.9

Human plasma 2a

0.824

0.052

6.3

0.055

6.7

Human plasma 2b

0.940

0.025

2.7

0.030

3.2

Human plasma 3

5.49

0.209

3.8

0.244

4.4

Human plasma 4

11.8

0.555

4.7

0.596

5.0

Human plasma 5

53.4

1.83

3.4

2.02

3.8

Human plasma 6

73.2

3.90

5.3

4.15

5.7

Human plasma 7

183

3.06

1.7

3.96

2.2

Human plasma 8

253

0.842

0.3

3.73

1.5


Between‑platform precision

Between-platform precision was evaluated as between different platform variability (1 cobas e 411, 1 cobas e 601, and 1 cobas e 801 analyzer).

cobas e 411, cobas e 601 and cobas e 801 analyzers

Repeatability

Between-day

Sample
N = 75

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.469

0.012

2.6

0.010

2.1

Human plasma 2a

0.812

0.020

2.4

0.017

2.1

Human plasma 2b

0.960

0.019

2.0

0.013

1.3

Human plasma 3

5.68

0.119

2.1

0.103

1.8

Human plasma 4

12.1

0.229

1.9

0.183

1.5

Human plasma 5

54.2

1.10

2.0

0.673

1.2

Human plasma 6

76.9

1.54

2.0

1.51

2.0

Human plasma 7

186

3.03

1.6

3.04

1.6

Human plasma 8

256

4.73

1.8

0.220

1.6

cobas e 411, cobas e 601 and cobas e 801 analyzers

Between-platform

Reproducibility

Sample
N = 75

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.469

0.024

5.1

0.028

6.0

Human plasma 2a

0.812

0.025

3.1

0.036

4.4

Human plasma 2b

0.960

0.023

2.4

0.032

3.4

Human plasma 3

5.68

0.050

0.9

0.165

2.9

Human plasma 4

12.1

0.124

1.0

0.319

2.6

Human plasma 5

54.2

0.777

1.4

1.51

2.8

Human plasma 6

76.9

0.970

1.3

2.36

3.1

Human plasma 7

186

3.16

1.7

5.33

2.9

Human plasma 8

256

2.71

1.1

6.89

2.7


Reproducibility including Lot-to-lot and Between-platform variability

cobas e 411, cobas e 601 and cobas e 801 analyzers

Repeatbility

Between-day

Between-lot

Sample
N = 225

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.465

0.014

3.0

0.015

3.2

0.013

2.9

Human plasma 2a

0.818

0.018

2.2

0.022

2.7

0.039

4.7

Human plasma 2b

0.940

0.018

1.9

0.017

1.7

0.014

1.5

Human plasma 3

5.57

0.106

1.9

0.110

2.0

0.178

3.2

Human plasma 4

12.0

0.249

2.1

0.229

1.9

0.539

4.5

Human plasma 5

53.6

1.11

2.1

0.846

1.6

1.83

3.4

Human plasma 6

73.9

1.55

2.1

1.62

2.2

3.36

4.5

Human plasma 7

186

3.00

1.6

3.09

1.7

5.15

2.8

Human plasma 8

257

4.72

1.8

4.67

1.8

2.12

0.8

cobas e 411, cobas e 601 and cobas e 801 analyzers

Between-platform

Reproducibility

Sample
N = 225

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.465

0.016

3.4

0.029

6.3

Human plasma 2a

0.818

0.018

2.1

0.051

6.3

Human plasma 2b

0.940

0.021

2.2

0.035

3.7

Human plasma 3

5.57

0.102

1.8

0.256

4.6

Human plasma 4

12.0

0.246

2.0

0.682

5.7

Human plasma 5

53.6

0.900

1.7

2.47

4.6

Human plasma 6

73.9

1.62

2.2

4.35

5.9

Human plasma 7

186

5.02

2.7

8.38

4.5

Human plasma 8

257

4.91

1.9

8.52

3.3

", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

SARS‑CoV‑2, the causative agent of Coronavirus Disease 2019 (COVID‑19), is an enveloped, single-stranded RNA Betacoronavirus. 7 coronaviruses have been identified as agents of human infection, causing disease ranging from mild common cold to severe respiratory failure.

LREFYe Z-W, Yuan S, Yuen K-S, et al. Zoonotic origins of human coronaviruses. Int J Biol Sci 2020 Mar 15;16(10):1686-1697.

SARS‑CoV‑2 is transmitted primarily from person-to-person through respiratory droplets and aerosols.

LREFTransmission of SARS-CoV-2: implications for infection prevention precautions [Internet]. 2020 [cited 2020 Jul 14]. Available from: https://www.who.int/news-room/commentaries/detail/transmission-of-sars-cov-2-implications-for-infection-prevention-precautions
,
LREFZhu N, Zhang D, Wang W, et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med 2020 20;382(8):727-733.
The incubation period from infection to detectable viral load in the host commonly ranges from 2 to 14 days.
LREFChan JF-W, Yuan S, Kok K-H, et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet 2020 15;395(10223):514-523.
,
LREFLauer SA, Grantz KH, Bi Q, et al. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med 2020 Mar 10.
Detection of viral load can be associated with the onset of clinical signs and symptoms, although a considerable proportion of individuals remains asymptomatic or mildly symptomatic.
LREFZhou R, Li F, Chen F, et al. Viral dynamics in asymptomatic patients with COVID-19. International Journal of Infectious Diseases 2020 Jul 1;96:288-290.
,
LREFHe X, Lau EHY, Wu P, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nature Medicine 2020 May;26(5):672-675.
,
LREFMizumoto K, Kagaya K, Zarebski A, et al. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill 2020 Mar 12;25(10).
The interval during which an individual with COVID‑19 is infectious has not yet been clearly established, however, transmission from symptomatic, asymptomatic, and pre-symptomatic individuals has been well described.
LREFGao M, Yang L, Chen X, et al. A study on infectivity of asymptomatic SARS-CoV-2 carriers. Respir Med 2020 Aug;169:106026.
,
LREFYu P, Zhu J, Zhang Z, et al. A Familial Cluster of Infection Associated With the 2019 Novel Coronavirus Indicating Possible Person-to-Person Transmission During the Incubation Period. J Infect Dis 2020 11;221(11):1757-1761.
,
LREFLiu Z, Chu R, Gong L, et al. The assessment of transmission efficiency and latent infection period on asymptomatic carriers of SARS-CoV-2 infection. International Journal of Infectious Diseases 2020 Jun 13.

Coronavirus genomes encode 4 main structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N). The S protein is a very large transmembrane protein that assembles into trimers to form the distinctive surface spikes of coronaviruses. Each S monomer consists of an N‑terminal S1 domain and a membrane-proximal S2 domain. The virus gains entry to the host cell through binding of the S protein to the angiotensin-converting enzyme 2 (ACE2), which is enzymatically active on the surface of numerous cell types including the alveolar type II cells of the lung and epithelial cells of the oral mucosa.

LREFLetko M, Marzi A, Munster V. Functional assessment of cell entry and receptor usage for SARS-CoV-2 and other lineage B betacoronaviruses. Nat Microbiol 2020;5(4):562-569.
,
LREFXu H, Zhong L, Deng J, et al. High expression of ACE2 receptor of 2019-nCoV on the epithelial cells of oral mucosa. Int J Oral Sci 2020 Feb 24;12(1):1-5.
Mechanistically, ACE2 is engaged by the receptor-binding domain (RBD) on the S1 subunit.
LREFWrapp D, Wang N, Corbett KS, et al. Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation. Science 2020 13;367(6483):1260-1263.
,
LREFHoffmann M, Kleine-Weber H, Schroeder S, et al. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell 2020 16;181(2):271-280.e8.

Upon infection with SARS‑CoV‑2, the host mounts an immune response against the virus, typically including production of specific antibodies against viral antigens. IgM and IgG antibodies to SARS‑CoV‑2 appear to arise nearly simultaneously in blood.

LREFCenters for Disease Control and Prevention. Interim Guidelines for COVID-19 Antibody Testing [Internet]. Centers for Disease Control and Prevention. 2020 [cited 2020 Jun 4]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html
There is significant inter-individual difference in the levels and chronological appearance of antibodies in COVID‑19 patients, but median seroconversion has been observed at approximately 2 weeks.
LREFLong Q-X, Liu B-Z, Deng H-J, et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med 2020 Apr 29.
,
LREFLou B, Li T-D, Zheng S-F, et al. Serology characteristics of SARS-CoV-2 infection since exposure and post symptom onset. Eur Respir J 2020 May 19;2000763.
,
LREFZhao J, Yuan Q, Wang H, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis 2020 Mar 28.
,
LREFTuaillon E, Bolloré K, Pisoni A, et al. Detection of SARS-CoV-2 antibodies using commercial assays and seroconversion patterns in hospitalized patients. Journal of Infection 2020 Jun 3.

Serologic assays can play an important role in understanding viral epidemiology in the general population. The Elecsys Anti‑SARS‑CoV‑2 S assay uses a recombinant protein representing the RBD of the spike antigen in a double‑antigen sandwich assay format. The Elecsys Anti‑SARS‑CoV‑2 S assay detects antibodies to SARS‑CoV‑2 spike protein RBD.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

cobas e 411, cobas e 601, and cobas e 602 analyzers:

The reagent rackpack is labeled as ACOV2S.

M

Streptavidin-coated microparticles (transparent cap), 1 bottle, 12.0 mL:
Streptavidin-coated microparticles 0.72 mg/mL; preservative.

R1

SARS‑CoV‑2 S‑Ag~biotin (gray cap), 1 bottle, 16 mL:
Biotinylated RBD domain of SARS‑CoV‑2 S as recombinant antigen < 0.4 mg/L; HEPES

FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
buffer 50 mmol/L, pH 7.4; preservative.

R2

SARS‑CoV‑2 S‑Ag~Ru(bpy) (black cap), 1 bottle, 16 mL:
RBD domain of SARS‑CoV‑2 S as recombinant antigen labeled with ruthenium complex < 0.4 mg/L; HEPES

FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
buffer 50 mmol/L, pH 7.4; preservative.

cobas e 801 analyzer:

The cobas e pack is labeled as ACOV2S.

M

Streptavidin-coated microparticles, 1 bottle, 16 mL:
Streptavidin-coated microparticles 0.72 mg/mL; preservative.

R1

SARS‑CoV‑2 S‑Ag~biotin, 1 bottle, 18.8 mL:
Biotinylated RBD domain of SARS‑CoV‑2 S as recombinant antigen < 0.4 mg/L; HEPES

FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
buffer 50 mmol/L, pH 7.4; preservative.

R2

SARS‑CoV‑2 S‑Ag~Ru(bpy), 1 bottle, 18.8 mL:
RBD domain of SARS‑CoV‑2 S as recombinant antigen labeled with ruthenium complex < 0.4 mg/L; HEPES

FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
buffer 50 mmol/L, pH 7.4; preservative.

Calibrators are available separately. See Materials required (but not provided) section of this Method Sheet.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For use under Emergency Use Authorization only.
This test has not been FDA-cleared or ‑approved; this test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories; by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform high complexity tests.
This test has been authorized only for detecting antibodies against SARS‑CoV‑2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID‑19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C § 360bbb‑3(b)(1), unless the authorization is terminated or revoked sooner.

For in vitro diagnostic use.
Do not use reagents beyond the labeled expiration date.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H317

May cause an allergic skin reaction.

Prevention:

P261

Avoid breathing dust/fume/gas/mist/vapours/spray.

P272

Contaminated work clothing should not be allowed out of the workplace.

P280

Wear protective gloves.

Response:

P333 + P313

If skin irritation or rash occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Disposal:

P501

Dispose of contents/container to an approved waste disposal plant.

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

Avoid foam formation in all reagents and sample types (specimens, calibrators and controls).

", "Language": "en" }, { "Name": "Caution", "Value": "

Warning

Warning

  • For use under Emergency Use Authorization only.

  • For prescription use only.

  • For in vitro diagnostic use.

  • The results of this semi‑quantitative test should not be interpreted as an indication or degree of immunity or protection from reinfection.

", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use PreciControl Anti‑SARS‑CoV‑2 S. Please refer to the PreciControl Method Sheet for instructions for use, including description of the controls and the expected results.

In addition, other commercially available quality control material can be used that covers at least two levels of analyte.

Controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit / cobas e pack, and following each calibration.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Follow your laboratory’s quality control procedures if the results obtained do not fall within the acceptable limits. Please refer to PreciControl instructions for use. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

If necessary, repeat the measurement of the samples concerned.

Follow the applicable government regulations and local and accrediting group guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

Only the specimens listed below were tested and found acceptable.

Serum collected using standard sampling tubes or tubes containing separating gel.

Li‑heparin, dipotassium EDTA (K2‑EDTA), tripotassium EDTA (K3‑EDTA), and sodium citrate plasma.

Plasma tubes containing separating gel can be used.

Criterion: Slope 1.00 ± 0.10 + bias at 0.8 U/mL ± 20 %.

For native samples collected in sodium citrated plasma: Slope 0.84 ± 0.10.

Results with sample materials other than serum were compared to serum results. Linear regression was performed for results obtained with the different sample materials, comparison of slope and bias verified comparability to serum results.

Sampling devices containing liquid anticoagulants have a dilution effect resulting in lower values (U/mL) for individual patient specimens. In order to minimize dilution effects it is essential that respective sampling devices are filled completely according to manufacturer’s instructions. For citrated plasma (1 part citrate solution + 9 parts blood), the dilution effect must be taken into account.

Stable for 14 days at 15‑25 °C, 14 days at 2‑8 °C, 3 months at ‑20 °C (± 5 °C). The samples may be frozen 3 times.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Specimens should not be subsequently altered with additives (e.g. biocides, anti-oxidants or substances that could possibly change the pH or ionic strength of the sample) in order to avoid erroneous findings.

Centrifuge samples containing precipitates and thawed samples before performing the assay.

Do not use heat‑inactivated samples.

Ensure the samples and calibrators are at 20‑25 °C prior to measurement.

Due to possible evaporation effects, samples and calibrators on the analyzers should be analyzed/measured within 2 hours.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "09289275501", "ProductName": "Elecsys Anti-SARS-CoV-2 S", "ProductLongName": "", "Language": "en", "DocumentVersion": "1", "DocumentObjectID": "FF000000046E970E", "DocumentOriginID": "FF000000046E960E", "MaterialNumbers": [ "09289275190" ], "InstrumentReferences": [ { "ID": "2497", "BrandName": "cobas e 801" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

Elecsys Anti‑SARS‑CoV‑2 S for use on the cobas e analyzers is an electrochemiluminescence immunoassay intended for qualitative and semi-quantitative detection of antibodies to SARS‑CoV‑2 spike (S) protein receptor binding domain (RBD) in human serum and plasma (lithium heparin, dipotassium-EDTA, tripotassium-EDTA, and sodium citrate). The Elecsys Anti‑SARS‑CoV‑2 S assay is intended as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Elecsys Anti‑SARS‑CoV‑2 S assay should not be used to diagnose acute SARS‑CoV‑2 infection.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.

Results are for the detection of SARS‑CoV‑2 antibodies. Antibodies to SARS‑CoV‑2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. The sensitivity of the Elecsys Anti‑SARS‑CoV‑2 S assay early after infection is unknown. Negative results do not preclude acute SARS‑CoV‑2 infection. If acute infection is suspected, direct testing for SARS‑CoV‑2 is necessary.

False positive results for Elecsys Anti‑SARS‑CoV‑2 S assay may occur due to cross-reactivity from pre‑existing antibodies or other possible causes.

The Elecsys Anti‑SARS‑CoV‑2 S assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Double-antigen sandwich principle. The antigens within the reagent captures predominantly anti‑SARS‑CoV‑2 IgG, but also anti‑SARS‑CoV‑2 IgA and IgM. Total duration of assay: 18 minutes.

  • 1st incubation: 20 µL of sample (cobas e 411, cobas e 601, and cobas e 602 analyzers) or 12 µL of sample (cobas e 801 analyzer), biotinylated SARS‑CoV‑2 S‑RBD‑specific recombinant antigen and SARS‑CoV‑2 S‑RBD‑specific recombinant antigen labeled with a ruthenium complex

    FREFTris(2,2’-bipyridyl)ruthenium(II)-complex (Ru(bpy))
    form a sandwich complex.

2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.

  • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell/ProCell M/ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.

Results are determined via a calibration curve which is instrument-specifically generated by 2‑point calibration and a master curve provided via the reagent barcode or e‑barcode.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Analytical measuring interval

The analytical measuring interval is 0.40‑250 U/mL. Numeric values are interpreted as \"negative\" (< 0.8 U/mL) and as \"positive\" (≥ 0.80 U/mL). Please see Interpretation of the results section. When sample results exceed the upper limit of the analytical measuring interval, refer to the Dilution section below. Values above the measuring range are reported as > 250 U/mL (or up to 2500 U/mL for 10‑fold diluted samples).

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank = 0.30 U/mL

Limit of Detection = 0.35 U/mL

Limit of Quantitation = 0.40 U/mL

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank corresponds to the highest measurement result that is likely to be observed for analyte-free samples with a probability of 95 %. The Limit of Blank was estimated as the 95th percentile value from n ≥ 60 measurements of analyte-free samples over several independent series. The Limit of Blank is 0.30 U/mL.

The Limit of Detection is the lowest concentration of antibodies to SARS‑CoV‑2 in a sample that can be detected with a probability of 95 %. The Limit of Detection was calculated based on the Limit of Blank and the standard deviation of low concentration samples. The Limit of Detection is 0.35 U/mL.

The Limit of Quantitation is defined as the lowest amount of analyte in a sample that can be accurately quantified with a CV ≤ 20 %. It has been determined using low concentration of anti‑SARS‑CoV‑2‑S samples. The Limit of Quantitation is 0.40 U/mL.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations

  • Drug interferences are measured based on recommendations given in CLSI (Clinical and Laboratory Standards Institute) guidelines EP07 and EP37 and other published literature. Effects of concentrations exceeding these recommendations have not been characterized.

  • In rare cases, interference due to extremely high titers of antibodies to analyte‑specific antibodies, streptavidin or ruthenium can occur. These effects are minimized by suitable test design.

  • Results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

  • This device should not be used to diagnose or exclude acute SARS‑CoV‑2 infection. Direct testing for SARS‑CoV‑2 with a molecular assay should be performed to evaluate acute infection in symptomatic individuals.

  • The clinical applicability of semi‑quantitative results is currently unknown and cannot be interpreted as an indication or degree of immunity nor protection from reinfection, nor compared to other SARS‑CoV‑2 antibody assays.

  • Results obtained with this assay may not be used interchangeably with values obtained with different manufacturers’ test methods.

  • A positive result may not indicate previous SARS‑CoV‑2 infection. Consider other information including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response.

  • A negative result for an individual subject indicates the absence of detectable anti‑SARS‑CoV‑2 antibodies. Negative results do not preclude SARS‑CoV‑2 infection and should not be used as the sole basis for patient management decisions. A negative result can occur if the quantity of the anti‑SARS‑CoV‑2 antibodies that are detected and are not present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.

  • It is not known at this time if the presence of antibodies to SARS‑CoV‑2 confers immunity to re-infection.

  • Not to be used to determine SARS‑CoV‑2 infection in donated blood units. This test should not be used for blood donor screening.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (Immuno Reagents) + Sum

09289267190

09289267501

200

cobas e 411

cobas e 601

cobas e 602

09289275190

09289275501

300

cobas e 801

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

For cobas e 411 analyzer: test number 2550
For cobas e 601 and cobas e 602 analyzers: Application Code Number 71
For cobas e 801 analyzer: Application Code Number 10230

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

The reagents in the kit have been assembled into a ready‑for‑use unit that cannot be separated.

cobas e 411, cobas e 601, and cobas e 602 analyzers:

All information required for correct operation is read in from the respective reagent barcodes.

cobas e 801 analyzer:

All information required for correct operation is available via the cobas link.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Store at 2‑8 °C.

Do not freeze.

Store the Elecsys reagent kit / cobas e pack upright in order to ensure complete availability of the microparticles during automatic mixing prior to use.

Stability of the reagent rackpack:

unopened at 2‑8 °C

up to the stated expiration date

after opening at 2‑8 °C

28 days (4 weeks)

on the cobas e 411, cobas e 601 and cobas e 602 analyzers

14 days

Stability of the cobas e pack:

unopened at 2‑8 °C

up to the stated expiration date

on the cobas e 801 analyzer

14 days

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Traceability: This method has been standardized against the internal Roche standard for anti‑SARS‑CoV‑2‑S. This standard consists of an equimolar mixture of 2 monoclonal antibodies that bind Spike‑1 RBD at 2 different epitopes. 1 nM of these antibodies correspond to 20 U/mL of the Elecsys Anti‑SARS‑CoV‑2 S assay. No international standard is currently available for anti‑SARS‑CoV‑2‑S.

Note: The defined unit is specific for the Elecsys Anti‑SARS‑CoV‑2 S assay and must not be used interchangeably with units of other assays.

Every Elecsys reagent set has a barcoded label containing specific information for calibration of the particular reagent lot. The predefined master curve is adapted to the analyzer using the relevant CalSet.

Calibration frequency: Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the same reagent kit was registered on the analyzer).

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Renewed calibration is recommended as follows:

  • after 31 days when using the same reagent lot on the cobas e 411, cobas e 601 and cobas e 602 analyzers

  • after 42 days when using the same reagent lot on the cobas e 801 analyzer

  • after 14 days when using the same reagent kit or cobas e pack on the analyzer

  • as required: e.g. quality control findings outside the defined limits

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using Elecsys reagents, samples and controls in a protocol (EP05‑A3) of the CLSI: 1 run per day with 5 replicates of each sample for 5 days. The following results were obtained:


Repeatability and Intermediate precision

cobas e 411 analyzer

Repeatability

Intermediate precision

FREFIntermediate precision includes repeatability and between-day/run components.

Sample
N = 25

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.483

0.014

2.8

0.016

3.4

Human plasma 2

0.826

0.023

2.8

0.023

2.8

Human plasma 3

5.74

0.131

2.3

0.150

2.6

Human plasma 4

12.3

0.266

2.2

0.304

2.5

Human plasma 5

54.6

1.58

2.9

1.58

2.9

Human plasma 6

77.9

1.78

2.3

2.07

2.7

Human plasma 7

190

3.03

1.6

3.69

1.9

PC

FREFPC = PreciControl
ACOV2S 1
FREFPC ACOV2S 1 is free of analyte and therefore consistently resulted below the measuring range (< 0.40 U/mL) throughout the experiment, standard deviation and coefficient of variance could therefore not be determined (‑).

< 0.40

PC ACOV2S 2

10.8

0.207

1.9

0.230

2.1

cobas e 601 and cobas e 602 analyzers

Repeatability

Intermediate precision

FREFIntermediate precision includes repeatability and between-day/run components.

Sample
N = 25

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.441

0.007

1.6

0.016

3.7

Human plasma 2

0.933

0.014

1.5

0.022

2.3

Human plasma 3

5.60

0.102

1.8

0.181

3.2

Human plasma 4

12.0

0.189

1.6

0.334

2.8

Human plasma 5

53.2

0.761

1.4

1.46

2.7

Human plasma 6

75.5

1.55

2.1

2.70

3.6

Human plasma 7

183

3.31

1.8

5.13

2.8

PC ACOV2S 1

FREFPC ACOV2S 1 is free of analyte and therefore consistently resulted below the measuring range (< 0.40 U/mL) throughout the experiment, standard deviation and coefficient of variance could therefore not be determined (‑).

< 0.40

PC ACOV2S 2

10.5

0.118

1.1

0.341

3.3

cobas e 801 analyzer

Repeatability

Intermediate precision

FREFIntermediate precision includes repeatability and between-day/run components.

Sample
N = 25

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.483

0.014

2.9

0.014

2.9

Human plasma 2

0.826

0.015

1.9

0.015

1.9

Human plasma 3

5.69

0.121

2.1

0.136

2.4

Human plasma 4

12.0

0.159

1.3

0.191

1.6

Human plasma 5

54.8

0.743

1.4

0.770

1.4

Human plasma 6

77.3

1.23

1.6

1.54

2.0

Human plasma 7

184

1.69

0.90

2.63

1.4

PC

FREFPC = PreciControl
ACOV2S 1
FREFPC ACOV2S 1 is free of analyte and therefore consistently resulted below the measuring range (< 0.40 U/mL) throughout the experiment, standard deviation and coefficient of variance could therefore not be determined (‑).

< 0.40

PC ACOV2S 2

10.4

0.139

1.3

0.206

2.0

Precision study for evaluation of Lot-to-lot and Between-platform variability

An additional precision study for the estimation of lot-to-lot precision component was conducted with the design similar to the single-site precision study and with 2 additional lots.


Lot-to-lot precision

Lot-to-lot variability was evaluated for the cobas e 801 analyzer with 3 lots.

cobas e 801 analyzer

Repeatability

Between-day

Sample
N = 75

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.474

0.015

3.2

0.004

0.8

Human plasma 2a

0.824

0.018

2.2

0.003

0.4

Human plasma 2b

0.940

0.015

1.6

0.007

0.8

Human plasma 3

5.49

0.112

2.0

0.053

1.0

Human plasma 4

11.8

0.192

1.6

0.106

0.9

Human plasma 5

53.4

0.838

1.6

0.000

0.0

Human plasma 6

73.2

1.20

1.6

0.785

1.1

Human plasma 7

183

2.05

1.1

1.45

0.8

Human plasma 8

253

2.97

1.2

2.09

0.8

cobas e 801 analyzer

Between-lot

Reproducibility

Sample
N = 75

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.474

0.023

4.9

0.028

5.9

Human plasma 2a

0.824

0.052

6.3

0.055

6.7

Human plasma 2b

0.940

0.025

2.7

0.030

3.2

Human plasma 3

5.49

0.209

3.8

0.244

4.4

Human plasma 4

11.8

0.555

4.7

0.596

5.0

Human plasma 5

53.4

1.83

3.4

2.02

3.8

Human plasma 6

73.2

3.90

5.3

4.15

5.7

Human plasma 7

183

3.06

1.7

3.96

2.2

Human plasma 8

253

0.842

0.3

3.73

1.5


Between‑platform precision

Between-platform precision was evaluated as between different platform variability (1 cobas e 411, 1 cobas e 601, and 1 cobas e 801 analyzer).

cobas e 411, cobas e 601 and cobas e 801 analyzers

Repeatability

Between-day

Sample
N = 75

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.469

0.012

2.6

0.010

2.1

Human plasma 2a

0.812

0.020

2.4

0.017

2.1

Human plasma 2b

0.960

0.019

2.0

0.013

1.3

Human plasma 3

5.68

0.119

2.1

0.103

1.8

Human plasma 4

12.1

0.229

1.9

0.183

1.5

Human plasma 5

54.2

1.10

2.0

0.673

1.2

Human plasma 6

76.9

1.54

2.0

1.51

2.0

Human plasma 7

186

3.03

1.6

3.04

1.6

Human plasma 8

256

4.73

1.8

0.220

1.6

cobas e 411, cobas e 601 and cobas e 801 analyzers

Between-platform

Reproducibility

Sample
N = 75

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.469

0.024

5.1

0.028

6.0

Human plasma 2a

0.812

0.025

3.1

0.036

4.4

Human plasma 2b

0.960

0.023

2.4

0.032

3.4

Human plasma 3

5.68

0.050

0.9

0.165

2.9

Human plasma 4

12.1

0.124

1.0

0.319

2.6

Human plasma 5

54.2

0.777

1.4

1.51

2.8

Human plasma 6

76.9

0.970

1.3

2.36

3.1

Human plasma 7

186

3.16

1.7

5.33

2.9

Human plasma 8

256

2.71

1.1

6.89

2.7


Reproducibility including Lot-to-lot and Between-platform variability

cobas e 411, cobas e 601 and cobas e 801 analyzers

Repeatbility

Between-day

Between-lot

Sample
N = 225

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.465

0.014

3.0

0.015

3.2

0.013

2.9

Human plasma 2a

0.818

0.018

2.2

0.022

2.7

0.039

4.7

Human plasma 2b

0.940

0.018

1.9

0.017

1.7

0.014

1.5

Human plasma 3

5.57

0.106

1.9

0.110

2.0

0.178

3.2

Human plasma 4

12.0

0.249

2.1

0.229

1.9

0.539

4.5

Human plasma 5

53.6

1.11

2.1

0.846

1.6

1.83

3.4

Human plasma 6

73.9

1.55

2.1

1.62

2.2

3.36

4.5

Human plasma 7

186

3.00

1.6

3.09

1.7

5.15

2.8

Human plasma 8

257

4.72

1.8

4.67

1.8

2.12

0.8

cobas e 411, cobas e 601 and cobas e 801 analyzers

Between-platform

Reproducibility

Sample
N = 225

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.465

0.016

3.4

0.029

6.3

Human plasma 2a

0.818

0.018

2.1

0.051

6.3

Human plasma 2b

0.940

0.021

2.2

0.035

3.7

Human plasma 3

5.57

0.102

1.8

0.256

4.6

Human plasma 4

12.0

0.246

2.0

0.682

5.7

Human plasma 5

53.6

0.900

1.7

2.47

4.6

Human plasma 6

73.9

1.62

2.2

4.35

5.9

Human plasma 7

186

5.02

2.7

8.38

4.5

Human plasma 8

257

4.91

1.9

8.52

3.3

", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

SARS‑CoV‑2, the causative agent of Coronavirus Disease 2019 (COVID‑19), is an enveloped, single-stranded RNA Betacoronavirus. 7 coronaviruses have been identified as agents of human infection, causing disease ranging from mild common cold to severe respiratory failure.

LREFYe Z-W, Yuan S, Yuen K-S, et al. Zoonotic origins of human coronaviruses. Int J Biol Sci 2020 Mar 15;16(10):1686-1697.

SARS‑CoV‑2 is transmitted primarily from person-to-person through respiratory droplets and aerosols.

LREFTransmission of SARS-CoV-2: implications for infection prevention precautions [Internet]. 2020 [cited 2020 Jul 14]. Available from: https://www.who.int/news-room/commentaries/detail/transmission-of-sars-cov-2-implications-for-infection-prevention-precautions
,
LREFZhu N, Zhang D, Wang W, et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med 2020 20;382(8):727-733.
The incubation period from infection to detectable viral load in the host commonly ranges from 2 to 14 days.
LREFChan JF-W, Yuan S, Kok K-H, et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet 2020 15;395(10223):514-523.
,
LREFLauer SA, Grantz KH, Bi Q, et al. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med 2020 Mar 10.
Detection of viral load can be associated with the onset of clinical signs and symptoms, although a considerable proportion of individuals remains asymptomatic or mildly symptomatic.
LREFZhou R, Li F, Chen F, et al. Viral dynamics in asymptomatic patients with COVID-19. International Journal of Infectious Diseases 2020 Jul 1;96:288-290.
,
LREFHe X, Lau EHY, Wu P, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nature Medicine 2020 May;26(5):672-675.
,
LREFMizumoto K, Kagaya K, Zarebski A, et al. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill 2020 Mar 12;25(10).
The interval during which an individual with COVID‑19 is infectious has not yet been clearly established, however, transmission from symptomatic, asymptomatic, and pre-symptomatic individuals has been well described.
LREFGao M, Yang L, Chen X, et al. A study on infectivity of asymptomatic SARS-CoV-2 carriers. Respir Med 2020 Aug;169:106026.
,
LREFYu P, Zhu J, Zhang Z, et al. A Familial Cluster of Infection Associated With the 2019 Novel Coronavirus Indicating Possible Person-to-Person Transmission During the Incubation Period. J Infect Dis 2020 11;221(11):1757-1761.
,
LREFLiu Z, Chu R, Gong L, et al. The assessment of transmission efficiency and latent infection period on asymptomatic carriers of SARS-CoV-2 infection. International Journal of Infectious Diseases 2020 Jun 13.

Coronavirus genomes encode 4 main structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N). The S protein is a very large transmembrane protein that assembles into trimers to form the distinctive surface spikes of coronaviruses. Each S monomer consists of an N‑terminal S1 domain and a membrane-proximal S2 domain. The virus gains entry to the host cell through binding of the S protein to the angiotensin-converting enzyme 2 (ACE2), which is enzymatically active on the surface of numerous cell types including the alveolar type II cells of the lung and epithelial cells of the oral mucosa.

LREFLetko M, Marzi A, Munster V. Functional assessment of cell entry and receptor usage for SARS-CoV-2 and other lineage B betacoronaviruses. Nat Microbiol 2020;5(4):562-569.
,
LREFXu H, Zhong L, Deng J, et al. High expression of ACE2 receptor of 2019-nCoV on the epithelial cells of oral mucosa. Int J Oral Sci 2020 Feb 24;12(1):1-5.
Mechanistically, ACE2 is engaged by the receptor-binding domain (RBD) on the S1 subunit.
LREFWrapp D, Wang N, Corbett KS, et al. Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation. Science 2020 13;367(6483):1260-1263.
,
LREFHoffmann M, Kleine-Weber H, Schroeder S, et al. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell 2020 16;181(2):271-280.e8.

Upon infection with SARS‑CoV‑2, the host mounts an immune response against the virus, typically including production of specific antibodies against viral antigens. IgM and IgG antibodies to SARS‑CoV‑2 appear to arise nearly simultaneously in blood.

LREFCenters for Disease Control and Prevention. Interim Guidelines for COVID-19 Antibody Testing [Internet]. Centers for Disease Control and Prevention. 2020 [cited 2020 Jun 4]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html
There is significant inter-individual difference in the levels and chronological appearance of antibodies in COVID‑19 patients, but median seroconversion has been observed at approximately 2 weeks.
LREFLong Q-X, Liu B-Z, Deng H-J, et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med 2020 Apr 29.
,
LREFLou B, Li T-D, Zheng S-F, et al. Serology characteristics of SARS-CoV-2 infection since exposure and post symptom onset. Eur Respir J 2020 May 19;2000763.
,
LREFZhao J, Yuan Q, Wang H, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis 2020 Mar 28.
,
LREFTuaillon E, Bolloré K, Pisoni A, et al. Detection of SARS-CoV-2 antibodies using commercial assays and seroconversion patterns in hospitalized patients. Journal of Infection 2020 Jun 3.

Serologic assays can play an important role in understanding viral epidemiology in the general population. The Elecsys Anti‑SARS‑CoV‑2 S assay uses a recombinant protein representing the RBD of the S antigen in a double‑antigen sandwich assay format.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

cobas e 411, cobas e 601, and cobas e 602 analyzers:

The reagent rackpack is labeled as ACOV2S.

M

Streptavidin-coated microparticles (transparent cap), 1 bottle, 12.0 mL:
Streptavidin-coated microparticles 0.72 mg/mL; preservative.

R1

SARS‑CoV‑2 S‑Ag~biotin (gray cap), 1 bottle, 16 mL:
Biotinylated RBD domain of SARS‑CoV‑2 S as recombinant antigen < 0.4 mg/L; HEPES

FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
buffer 50 mmol/L, pH 7.4; preservative.

R2

SARS‑CoV‑2 S‑Ag~Ru(bpy) (black cap), 1 bottle, 16 mL:
RBD domain of SARS‑CoV‑2 S as recombinant antigen labeled with ruthenium complex < 0.4 mg/L; HEPES

FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
buffer 50 mmol/L, pH 7.4; preservative.

cobas e 801 analyzer:

The cobas e pack is labeled as ACOV2S.

M

Streptavidin-coated microparticles, 1 bottle, 16 mL:
Streptavidin-coated microparticles 0.72 mg/mL; preservative.

R1

SARS‑CoV‑2 S‑Ag~biotin, 1 bottle, 18.8 mL:
Biotinylated RBD domain of SARS‑CoV‑2 S as recombinant antigen < 0.4 mg/L; HEPES

FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
buffer 50 mmol/L, pH 7.4; preservative.

R2

SARS‑CoV‑2 S‑Ag~Ru(bpy), 1 bottle, 18.8 mL:
RBD domain of SARS‑CoV‑2 S as recombinant antigen labeled with ruthenium complex < 0.4 mg/L; HEPES

FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
buffer 50 mmol/L, pH 7.4; preservative.

Calibrators are available separately. See Materials required (but not provided) section of this Method Sheet.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For use under Emergency Use Authorization only.
This test has not been FDA-cleared or ‑approved; this test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform high complexity tests.
This test has been authorized only for detecting antibodies against SARS‑CoV‑2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID‑19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C § 360bbb‑3(b)(1), unless the authorization is terminated or revoked sooner.

For in vitro diagnostic use.
Do not use reagents beyond the labeled expiration date.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H317

May cause an allergic skin reaction.

Prevention:

P261

Avoid breathing dust/fume/gas/mist/vapours/spray.

P272

Contaminated work clothing should not be allowed out of the workplace.

P280

Wear protective gloves.

Response:

P333 + P313

If skin irritation or rash occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Disposal:

P501

Dispose of contents/container to an approved waste disposal plant.

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

Avoid foam formation in all reagents and sample types (specimens, calibrators and controls).

", "Language": "en" }, { "Name": "Caution", "Value": "

Warning

Warning

  • For use under Emergency Use Authorization only.

  • For prescription use only.

  • For in vitro diagnostic use.

  • The results of this semi‑quantitative test should not be interpreted as an indication or degree of immunity or protection from reinfection.

", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use PreciControl Anti‑SARS‑CoV‑2 S. Please refer to the PreciControl Method Sheet for instructions for use, including description of the controls and the expected results.

In addition, other commercially available quality control material can be used that covers at least two levels of analyte.

Controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit / cobas e pack, and following each calibration.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Follow your laboratory’s quality control procedures if the results obtained do not fall within the acceptable limits. Please refer to PreciControl instructions for use. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

If necessary, repeat the measurement of the samples concerned.

Follow the applicable government regulations and local and accrediting group guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

Only the specimens listed below were tested and found acceptable.

Serum collected using standard sampling tubes or tubes containing separating gel.

Li‑heparin, dipotassium EDTA (K2‑EDTA), tripotassium EDTA (K3‑EDTA), and sodium citrate plasma.

Plasma tubes containing separating gel can be used.

Criterion: Slope 1.00 ± 0.10 + bias at 0.8 U/mL ± 20 %.

For native samples collected in sodium citrated plasma: Slope 0.84 ± 0.10.

Results with sample materials other than serum were compared to serum results. Linear regression was performed for results obtained with the different sample materials, comparison of slope and bias verified comparability to serum results.

Sampling devices containing liquid anticoagulants have a dilution effect resulting in lower values (U/mL) for individual patient specimens. In order to minimize dilution effects it is essential that respective sampling devices are filled completely according to manufacturer’s instructions. For citrated plasma (1 part citrate solution + 9 parts blood), the dilution effect must be taken into account.

Stable for 3 days at 15‑25 °C, 7 days at 2‑8 °C, 28 days at ‑20 °C (± 5 °C). The samples may be frozen once.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Specimens should not be subsequently altered with additives (e.g. biocides, anti-oxidants or substances that could possibly change the pH or ionic strength of the sample) in order to avoid erroneous findings.

Centrifuge samples containing precipitates and thawed samples before performing the assay.

Do not use heat‑inactivated samples.

Ensure the samples and calibrators are at 20‑25 °C prior to measurement.

Due to possible evaporation effects, samples and calibrators on the analyzers should be analyzed/measured within 2 hours.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

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Intended use

Elecsys Anti‑SARS‑CoV‑2 S for use on the cobas e analyzers is an electrochemiluminescence immunoassay intended for qualitative and semi-quantitative detection of antibodies to SARS‑CoV‑2 in human serum and plasma (lithium heparin, dipotassium-EDTA, tripotassium-EDTA, and sodium citrate). The Elecsys Anti‑SARS‑CoV‑2 S assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Elecsys Anti‑SARS‑CoV‑2 S assay should not be used to diagnose or exclude acute SARS‑CoV‑2 infection.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.

Results are for the detection of SARS‑CoV‑2 antibodies. Antibodies to SARS‑CoV‑2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. The sensitivity of the Elecsys Anti‑SARS‑CoV‑2 S assay early after infection is unknown. Negative results do not preclude acute SARS‑CoV‑2 infection. If acute infection is suspected, direct testing for SARS‑CoV‑2 is necessary.

False positive results for Elecsys Anti‑SARS‑CoV‑2 S assay may occur due to cross-reactivity from pre‑existing antibodies or other possible causes.

The Elecsys Anti‑SARS‑CoV‑2 S assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Double-antigen sandwich principle. The antigens within the reagent capture predominantly anti‑SARS‑CoV‑2 IgG, but also anti‑SARS‑CoV‑2 IgA and IgM. Total duration of assay: 18 minutes.

  • 1st incubation: 20 µL of sample (cobas e 411, cobas e 601, and cobas e 602 analyzers) or 12 µL of sample (cobas e 801 analyzer), biotinylated SARS‑CoV‑2 S‑RBD‑specific recombinant antigen and SARS‑CoV‑2 S‑RBD‑specific recombinant antigen labeled with a ruthenium complex

    FREFTris(2,2’-bipyridyl)ruthenium(II)-complex (Ru(bpy))
    form a sandwich complex.

2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.

  • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell/ProCell M/ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.

Results are determined via a calibration curve which is instrument-specifically generated by 2‑point calibration and a master curve provided via the reagent barcode or e‑barcode.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Analytical measuring interval

The analytical measuring interval is 0.40‑250 U/mL. Numeric values are interpreted as \"negative\" (< 0.8 U/mL) and as \"positive\" (≥ 0.80 U/mL). Please see Interpretation of the results section. When sample results exceed the upper limit of the analytical measuring interval, refer to the Dilution section below. Values above the measuring range are reported as > 250 U/mL (or up to 2500 U/mL for 10‑fold diluted samples).

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank = 0.30 U/mL

Limit of Detection = 0.35 U/mL

Limit of Quantitation = 0.40 U/mL

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank corresponds to the highest measurement result that is likely to be observed for analyte-free samples with a probability of 95 %. The Limit of Blank was estimated as the 95th percentile value from n ≥ 60 measurements of analyte-free samples over several independent series. The Limit of Blank is 0.30 U/mL.

The Limit of Detection is the lowest concentration of antibodies to SARS‑CoV‑2 in a sample that can be detected with a probability of 95 %. The Limit of Detection was calculated based on the Limit of Blank and the standard deviation of low concentration samples. The Limit of Detection is 0.35 U/mL.

The Limit of Quantitation is defined as the lowest amount of analyte in a sample that can be accurately quantified with a CV ≤ 20 %. It has been determined using low concentration of anti‑SARS‑CoV‑2‑S samples. The Limit of Quantitation is 0.40 U/mL.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations

  • Drug interferences are measured based on recommendations given in CLSI (Clinical and Laboratory Standards Institute) guidelines EP07 and EP37 and other published literature. Effects of concentrations exceeding these recommendations have not been characterized.

  • In rare cases, interference due to extremely high titers of antibodies to analyte‑specific antibodies, streptavidin or ruthenium can occur. These effects are minimized by suitable test design.

  • Results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

  • This device should not be used to diagnose or exclude acute SARS‑CoV‑2 infection. Direct testing for SARS‑CoV‑2 with a molecular assay should be performed to evaluate acute infection in symptomatic individuals.

  • The clinical applicability of semi‑quantitative results is currently unknown and cannot be interpreted as an indication or degree of immunity nor protection from reinfection, nor compared to other SARS‑CoV‑2 antibody assays.

  • Results obtained with this assay may not be used interchangeably with values obtained with different manufacturers’ test methods.

  • A positive result may not indicate previous SARS‑CoV‑2 infection. Consider other information including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response.

  • A negative result for an individual subject indicates the absence of detectable anti‑SARS‑CoV‑2 antibodies. Negative results do not preclude SARS‑CoV‑2 infection and should not be used as the sole basis for patient management decisions. A negative result can occur if the quantity of the anti‑SARS‑CoV‑2 antibodies that are detected and are not present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.

  • It is not known at this time if the presence of antibodies to SARS‑CoV‑2 confers immunity to re-infection.

  • Not to be used to determine SARS‑CoV‑2 infection in donated blood units. This test should not be used for blood donor screening.

  • The performance of this test has not been established in individuals that have received a COVID‑19 vaccine. The clinical significance of a positive or negative antibody result following COVID‑19 vaccination has not been established, and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination.

  • The performance of this test was established based on the evaluation of a limited number of clinical specimens. Samples used to establish positive clinical agreement were collected between March and July 2020 in Switzerland, Germany, and Ukraine. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS‑CoV‑2 and their prevalence, which change over time.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (Immuno Reagents) + Sum

09289267190

09289267501

200

cobas e 411

cobas e 601

cobas e 602

09289275190

09289275501

300

cobas e 801

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

For cobas e 411 analyzer: test number 2550
For cobas e 601 and cobas e 602 analyzers: Application Code Number 71
For cobas e 801 analyzer: Application Code Number 10230

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

The reagents in the kit have been assembled into a ready‑for‑use unit that cannot be separated.

cobas e 411, cobas e 601, and cobas e 602 analyzers:

All information required for correct operation is read in from the respective reagent barcodes.

cobas e 801 analyzer:

All information required for correct operation is available via the cobas link.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Store at 2‑8 °C.

Do not freeze.

Store the Elecsys reagent kit / cobas e pack upright in order to ensure complete availability of the microparticles during automatic mixing prior to use.

Stability of the reagent rackpack:

unopened at 2‑8 °C

up to the stated expiration date

after opening at 2‑8 °C

12 weeks

on the cobas e 411, cobas e 601 and cobas e 602 analyzers

28 days

Stability of the cobas e pack:

unopened at 2‑8 °C

up to the stated expiration date

on the cobas e 801 analyzer

16 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Traceability: This method has been standardized against the internal Roche standard for anti‑SARS‑CoV‑2‑S. This standard consists of an equimolar mixture of 2 monoclonal antibodies that bind Spike‑1 RBD at 2 different epitopes. 1 nM of these antibodies correspond to 20 U/mL of the Elecsys Anti‑SARS‑CoV‑2 S assay. No international standard is currently available for anti‑SARS‑CoV‑2‑S.

Note: The defined unit is specific for the Elecsys Anti‑SARS‑CoV‑2 S assay and must not be used interchangeably with units of other assays.

Every Elecsys reagent set has a barcoded label containing specific information for calibration of the particular reagent lot. The predefined master curve is adapted to the analyzer using the relevant CalSet.

Calibration frequency: Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the same reagent kit was registered on the analyzer).

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Renewed calibration is recommended as follows:

  • after 31 days when using the same reagent lot on the cobas e 411, cobas e 601 and cobas e 602 analyzers

  • after 42 days when using the same reagent lot on the cobas e 801 analyzer

  • after 14 days when using the same reagent kit or cobas e pack on the analyzer

  • as required: e.g. quality control findings outside the defined limits

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using Elecsys reagents, samples and controls in a protocol (EP05‑A3) of the CLSI: 1 run per day with 5 replicates of each sample for 5 days. The following results were obtained:


Repeatability and Intermediate precision

cobas e 411 analyzer

Repeatability

Intermediate precision

FREFIntermediate precision includes repeatability and between-day/run components.

Sample
N = 25

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.483

0.014

2.8

0.016

3.4

Human plasma 2

0.826

0.023

2.8

0.023

2.8

Human plasma 3

5.74

0.131

2.3

0.150

2.6

Human plasma 4

12.3

0.266

2.2

0.304

2.5

Human plasma 5

54.6

1.58

2.9

1.58

2.9

Human plasma 6

77.9

1.78

2.3

2.07

2.7

Human plasma 7

190

3.03

1.6

3.69

1.9

PC

FREFPC = PreciControl
ACOV2S 1
FREFPC ACOV2S 1 is free of analyte and therefore consistently resulted below the measuring range (< 0.40 U/mL) throughout the experiment, standard deviation and coefficient of variance could therefore not be determined (‑).

< 0.40

PC ACOV2S 2

10.8

0.207

1.9

0.230

2.1

cobas e 601 and cobas e 602 analyzers

Repeatability

Intermediate precision

FREFIntermediate precision includes repeatability and between-day/run components.

Sample
N = 25

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.441

0.007

1.6

0.016

3.7

Human plasma 2

0.933

0.014

1.5

0.022

2.3

Human plasma 3

5.60

0.102

1.8

0.181

3.2

Human plasma 4

12.0

0.189

1.6

0.334

2.8

Human plasma 5

53.2

0.761

1.4

1.46

2.7

Human plasma 6

75.5

1.55

2.1

2.70

3.6

Human plasma 7

183

3.31

1.8

5.13

2.8

PC ACOV2S 1

FREFPC ACOV2S 1 is free of analyte and therefore consistently resulted below the measuring range (< 0.40 U/mL) throughout the experiment, standard deviation and coefficient of variance could therefore not be determined (‑).

< 0.40

PC ACOV2S 2

10.5

0.118

1.1

0.341

3.3

cobas e 801 analyzer

Repeatability

Intermediate precision

FREFIntermediate precision includes repeatability and between-day/run components.

Sample
N = 25

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.483

0.014

2.9

0.014

2.9

Human plasma 2

0.826

0.015

1.9

0.015

1.9

Human plasma 3

5.69

0.121

2.1

0.136

2.4

Human plasma 4

12.0

0.159

1.3

0.191

1.6

Human plasma 5

54.8

0.743

1.4

0.770

1.4

Human plasma 6

77.3

1.23

1.6

1.54

2.0

Human plasma 7

184

1.69

0.90

2.63

1.4

PC

FREFPC = PreciControl
ACOV2S 1
FREFPC ACOV2S 1 is free of analyte and therefore consistently resulted below the measuring range (< 0.40 U/mL) throughout the experiment, standard deviation and coefficient of variance could therefore not be determined (‑).

< 0.40

PC ACOV2S 2

10.4

0.139

1.3

0.206

2.0

Precision study for evaluation of Lot-to-lot and Between-platform variability

An additional precision study for the estimation of lot-to-lot precision component was conducted with the design similar to the single-site precision study and with 2 additional lots.


Lot-to-lot precision

Lot-to-lot variability was evaluated for the cobas e 801 analyzer with 3 lots.

cobas e 801 analyzer

Repeatability

Between-day

Sample
N = 75

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.474

0.015

3.2

0.004

0.8

Human plasma 2a

0.824

0.018

2.2

0.003

0.4

Human plasma 2b

0.940

0.015

1.6

0.007

0.8

Human plasma 3

5.49

0.112

2.0

0.053

1.0

Human plasma 4

11.8

0.192

1.6

0.106

0.9

Human plasma 5

53.4

0.838

1.6

0.000

0.0

Human plasma 6

73.2

1.20

1.6

0.785

1.1

Human plasma 7

183

2.05

1.1

1.45

0.8

Human plasma 8

253

2.97

1.2

2.09

0.8

cobas e 801 analyzer

Between-lot

Reproducibility

Sample
N = 75

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.474

0.023

4.9

0.028

5.9

Human plasma 2a

0.824

0.052

6.3

0.055

6.7

Human plasma 2b

0.940

0.025

2.7

0.030

3.2

Human plasma 3

5.49

0.209

3.8

0.244

4.4

Human plasma 4

11.8

0.555

4.7

0.596

5.0

Human plasma 5

53.4

1.83

3.4

2.02

3.8

Human plasma 6

73.2

3.90

5.3

4.15

5.7

Human plasma 7

183

3.06

1.7

3.96

2.2

Human plasma 8

253

0.842

0.3

3.73

1.5


Between‑platform precision

Between-platform precision was evaluated as between different platform variability (1 cobas e 411, 1 cobas e 601, and 1 cobas e 801 analyzer).

cobas e 411, cobas e 601 and cobas e 801 analyzers

Repeatability

Between-day

Sample
N = 75

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.469

0.012

2.6

0.010

2.1

Human plasma 2a

0.812

0.020

2.4

0.017

2.1

Human plasma 2b

0.960

0.019

2.0

0.013

1.3

Human plasma 3

5.68

0.119

2.1

0.103

1.8

Human plasma 4

12.1

0.229

1.9

0.183

1.5

Human plasma 5

54.2

1.10

2.0

0.673

1.2

Human plasma 6

76.9

1.54

2.0

1.51

2.0

Human plasma 7

186

3.03

1.6

3.04

1.6

Human plasma 8

256

4.73

1.8

0.220

1.6

cobas e 411, cobas e 601 and cobas e 801 analyzers

Between-platform

Reproducibility

Sample
N = 75

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.469

0.024

5.1

0.028

6.0

Human plasma 2a

0.812

0.025

3.1

0.036

4.4

Human plasma 2b

0.960

0.023

2.4

0.032

3.4

Human plasma 3

5.68

0.050

0.9

0.165

2.9

Human plasma 4

12.1

0.124

1.0

0.319

2.6

Human plasma 5

54.2

0.777

1.4

1.51

2.8

Human plasma 6

76.9

0.970

1.3

2.36

3.1

Human plasma 7

186

3.16

1.7

5.33

2.9

Human plasma 8

256

2.71

1.1

6.89

2.7


Reproducibility including Lot-to-lot and Between-platform variability

cobas e 411, cobas e 601 and cobas e 801 analyzers

Repeatbility

Between-day

Between-lot

Sample
N = 225

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.465

0.014

3.0

0.015

3.2

0.013

2.9

Human plasma 2a

0.818

0.018

2.2

0.022

2.7

0.039

4.7

Human plasma 2b

0.940

0.018

1.9

0.017

1.7

0.014

1.5

Human plasma 3

5.57

0.106

1.9

0.110

2.0

0.178

3.2

Human plasma 4

12.0

0.249

2.1

0.229

1.9

0.539

4.5

Human plasma 5

53.6

1.11

2.1

0.846

1.6

1.83

3.4

Human plasma 6

73.9

1.55

2.1

1.62

2.2

3.36

4.5

Human plasma 7

186

3.00

1.6

3.09

1.7

5.15

2.8

Human plasma 8

257

4.72

1.8

4.67

1.8

2.12

0.8

cobas e 411, cobas e 601 and cobas e 801 analyzers

Between-platform

Reproducibility

Sample
N = 225

Mean
U/mL

SD
U/mL

CV
%

SD
U/mL

CV
%

Human plasma 1

0.465

0.016

3.4

0.029

6.3

Human plasma 2a

0.818

0.018

2.1

0.051

6.3

Human plasma 2b

0.940

0.021

2.2

0.035

3.7

Human plasma 3

5.57

0.102

1.8

0.256

4.6

Human plasma 4

12.0

0.246

2.0

0.682

5.7

Human plasma 5

53.6

0.900

1.7

2.47

4.6

Human plasma 6

73.9

1.62

2.2

4.35

5.9

Human plasma 7

186

5.02

2.7

8.38

4.5

Human plasma 8

257

4.91

1.9

8.52

3.3

", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

SARS‑CoV‑2, the causative agent of Coronavirus Disease 2019 (COVID‑19), is an enveloped, single-stranded RNA Betacoronavirus. 7 coronaviruses have been identified as agents of human infection, causing disease ranging from mild common cold to severe respiratory failure.

LREFYe Z-W, Yuan S, Yuen K-S, et al. Zoonotic origins of human coronaviruses. Int J Biol Sci 2020 Mar 15;16(10):1686-1697.

SARS‑CoV‑2 is transmitted primarily from person-to-person through respiratory droplets and aerosols.

LREFTransmission of SARS-CoV-2: implications for infection prevention precautions [Internet]. 2020 [cited 2020 Jul 14]. Available from: https://www.who.int/news-room/commentaries/detail/transmission-of-sars-cov-2-implications-for-infection-prevention-precautions
,
LREFZhu N, Zhang D, Wang W, et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med 2020 20;382(8):727-733.
The incubation period from infection to detectable viral load in the host commonly ranges from 2 to 14 days.
LREFChan JF-W, Yuan S, Kok K-H, et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet 2020 15;395(10223):514-523.
,
LREFLauer SA, Grantz KH, Bi Q, et al. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med 2020 Mar 10.
Detection of viral load can be associated with the onset of clinical signs and symptoms, although a considerable proportion of individuals remains asymptomatic or mildly symptomatic.
LREFZhou R, Li F, Chen F, et al. Viral dynamics in asymptomatic patients with COVID-19. International Journal of Infectious Diseases 2020 Jul 1;96:288-290.
,
LREFHe X, Lau EHY, Wu P, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nature Medicine 2020 May;26(5):672-675.
,
LREFMizumoto K, Kagaya K, Zarebski A, et al. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill 2020 Mar 12;25(10).
The interval during which an individual with COVID‑19 is infectious has not yet been clearly established, however, transmission from symptomatic, asymptomatic, and pre-symptomatic individuals has been well described.
LREFGao M, Yang L, Chen X, et al. A study on infectivity of asymptomatic SARS-CoV-2 carriers. Respir Med 2020 Aug;169:106026.
,
LREFYu P, Zhu J, Zhang Z, et al. A Familial Cluster of Infection Associated With the 2019 Novel Coronavirus Indicating Possible Person-to-Person Transmission During the Incubation Period. J Infect Dis 2020 11;221(11):1757-1761.
,
LREFLiu Z, Chu R, Gong L, et al. The assessment of transmission efficiency and latent infection period on asymptomatic carriers of SARS-CoV-2 infection. International Journal of Infectious Diseases 2020 Jun 13.

Coronavirus genomes encode 4 main structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N). The S protein is a very large transmembrane protein that assembles into trimers to form the distinctive surface spikes of coronaviruses. Each S monomer consists of an N‑terminal S1 domain and a membrane-proximal S2 domain. The virus gains entry to the host cell through binding of the S protein to the angiotensin-converting enzyme 2 (ACE2), which is enzymatically active on the surface of numerous cell types including the alveolar type II cells of the lung and epithelial cells of the oral mucosa.

LREFLetko M, Marzi A, Munster V. Functional assessment of cell entry and receptor usage for SARS-CoV-2 and other lineage B betacoronaviruses. Nat Microbiol 2020;5(4):562-569.
,
LREFXu H, Zhong L, Deng J, et al. High expression of ACE2 receptor of 2019-nCoV on the epithelial cells of oral mucosa. Int J Oral Sci 2020 Feb 24;12(1):1-5.
Mechanistically, ACE2 is engaged by the receptor-binding domain (RBD) on the S1 subunit.
LREFWrapp D, Wang N, Corbett KS, et al. Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation. Science 2020 13;367(6483):1260-1263.
,
LREFHoffmann M, Kleine-Weber H, Schroeder S, et al. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell 2020 16;181(2):271-280.e8.

Upon infection with SARS‑CoV‑2, the host mounts an immune response against the virus, typically including production of specific antibodies against viral antigens. IgM and IgG antibodies to SARS‑CoV‑2 appear to arise nearly simultaneously in blood.

LREFCenters for Disease Control and Prevention. Interim Guidelines for COVID-19 Antibody Testing [Internet]. Centers for Disease Control and Prevention. 2020 [cited 2020 Jun 4]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html
There is significant inter-individual difference in the levels and chronological appearance of antibodies in COVID‑19 patients, but median seroconversion has been observed at approximately 2 weeks.
LREFLong Q-X, Liu B-Z, Deng H-J, et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med 2020 Apr 29.
,
LREFLou B, Li T-D, Zheng S-F, et al. Serology characteristics of SARS-CoV-2 infection since exposure and post symptom onset. Eur Respir J 2020 May 19;2000763.
,
LREFZhao J, Yuan Q, Wang H, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis 2020 Mar 28.
,
LREFTuaillon E, Bolloré K, Pisoni A, et al. Detection of SARS-CoV-2 antibodies using commercial assays and seroconversion patterns in hospitalized patients. Journal of Infection 2020 Jun 3.

Serologic assays can play an important role in understanding viral epidemiology in the general population. The Elecsys Anti‑SARS‑CoV‑2 S assay uses a recombinant protein representing the RBD of the spike antigen in a double‑antigen sandwich assay format. The Elecsys Anti‑SARS‑CoV‑2 S assay detects antibodies to SARS‑CoV‑2 spike protein RBD.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

cobas e 411, cobas e 601, and cobas e 602 analyzers:

The reagent rackpack is labeled as ACOV2S.

M

Streptavidin-coated microparticles (transparent cap), 1 bottle, 12.0 mL:
Streptavidin-coated microparticles 0.72 mg/mL; preservative.

R1

SARS‑CoV‑2 S‑Ag~biotin (gray cap), 1 bottle, 16 mL:
Biotinylated RBD domain of SARS‑CoV‑2 S as recombinant antigen < 0.4 mg/L; HEPES

FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
buffer 50 mmol/L, pH 7.4; preservative.

R2

SARS‑CoV‑2 S‑Ag~Ru(bpy) (black cap), 1 bottle, 16 mL:
RBD domain of SARS‑CoV‑2 S as recombinant antigen labeled with ruthenium complex < 0.4 mg/L; HEPES

FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
buffer 50 mmol/L, pH 7.4; preservative.

cobas e 801 analyzer:

The cobas e pack is labeled as ACOV2S.

M

Streptavidin-coated microparticles, 1 bottle, 16 mL:
Streptavidin-coated microparticles 0.72 mg/mL; preservative.

R1

SARS‑CoV‑2 S‑Ag~biotin, 1 bottle, 18.8 mL:
Biotinylated RBD domain of SARS‑CoV‑2 S as recombinant antigen < 0.4 mg/L; HEPES

FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
buffer 50 mmol/L, pH 7.4; preservative.

R2

SARS‑CoV‑2 S‑Ag~Ru(bpy), 1 bottle, 18.8 mL:
RBD domain of SARS‑CoV‑2 S as recombinant antigen labeled with ruthenium complex < 0.4 mg/L; HEPES

FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid
buffer 50 mmol/L, pH 7.4; preservative.

Calibrators are available separately. See Materials required (but not provided) section of this Method Sheet.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For use under Emergency Use Authorization only.
This test has not been FDA-cleared or ‑approved; this test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories; by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform high complexity tests.
This test has been authorized only for detecting antibodies against SARS‑CoV‑2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID‑19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C § 360bbb‑3(b)(1), unless the authorization is terminated or revoked sooner.

For in vitro diagnostic use.
Do not use reagents beyond the labeled expiration date.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H317

May cause an allergic skin reaction.

Prevention:

P261

Avoid breathing dust/fume/gas/mist/vapours/spray.

P272

Contaminated work clothing should not be allowed out of the workplace.

P280

Wear protective gloves.

Response:

P333 + P313

If skin irritation or rash occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Disposal:

P501

Dispose of contents/container to an approved waste disposal plant.

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

Avoid foam formation in all reagents and sample types (specimens, calibrators and controls).

", "Language": "en" }, { "Name": "Caution", "Value": "

Warning

Warning

  • For use under Emergency Use Authorization only.

  • For prescription use only.

  • For in vitro diagnostic use.

  • The results of this semi‑quantitative test should not be interpreted as an indication or degree of immunity or protection from reinfection.

", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use PreciControl Anti‑SARS‑CoV‑2 S. Please refer to the PreciControl Method Sheet for instructions for use, including description of the controls and the expected results.

In addition, other commercially available quality control material can be used that covers at least two levels of analyte.

Controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit / cobas e pack, and following each calibration.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Follow your laboratory’s quality control procedures if the results obtained do not fall within the acceptable limits. Please refer to PreciControl instructions for use. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

If necessary, repeat the measurement of the samples concerned.

Follow the applicable government regulations and local and accrediting group guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

Only the specimens listed below were tested and found acceptable.

Serum collected using standard sampling tubes or tubes containing separating gel.

Li‑heparin, dipotassium EDTA (K2‑EDTA), tripotassium EDTA (K3‑EDTA), and sodium citrate plasma.

Plasma tubes containing separating gel can be used.

Criterion: Slope 1.00 ± 0.10 + bias at 0.8 U/mL ± 20 %.

For native samples collected in sodium citrated plasma: Slope 0.84 ± 0.10.

Results with sample materials other than serum were compared to serum results. Linear regression was performed for results obtained with the different sample materials, comparison of slope and bias verified comparability to serum results.

Sampling devices containing liquid anticoagulants have a dilution effect resulting in lower values (U/mL) for individual patient specimens. In order to minimize dilution effects it is essential that respective sampling devices are filled completely according to manufacturer’s instructions. For citrated plasma (1 part citrate solution + 9 parts blood), the dilution effect must be taken into account.

Stable for 14 days at 15‑25 °C, 14 days at 2‑8 °C, 3 months at ‑20 °C (± 5 °C). The samples may be frozen 3 times.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Specimens should not be subsequently altered with additives (e.g. biocides, anti-oxidants or substances that could possibly change the pH or ionic strength of the sample) in order to avoid erroneous findings.

Centrifuge samples containing precipitates and thawed samples before performing the assay.

Do not use heat‑inactivated samples.

Ensure the samples and calibrators are at 20‑25 °C prior to measurement.

Due to possible evaporation effects, samples and calibrators on the analyzers should be analyzed/measured within 2 hours.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } } ] }

Elecsys® Anti-SARS-CoV-2 S

Immunoassay for the qualitative and semi-quantitative determination of antibodies to the SARS-CoV-2 spike protein. For use under the Emergency Use Authorization (EUA) only.

IVD For in vitro diagnostic use.
Elecsys Anti-SARS-CoV-2 S
Immunoassay for the semi-quantitative determination of antibodies to the SARS-CoV-2 spike protein

Elecsys® Anti‑SARS‑CoV‑2 S for use on the cobas e analyzers is an electrochemiluminescence immunoassay intended for qualitative and semi-quantitative detection of antibodies to SARS‑CoV‑2 spike (S) protein receptor binding domain (RBD) in human serum and plasma (lithium heparin, dipotassium-EDTA, tripotassium-EDTA, and sodium citrate). The Elecsys Anti‑SARS‑CoV‑2 S assay is intended as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection. The Elecsys Anti‑SARS‑CoV‑2 S assay should not be used to diagnose or exclude acute SARS‑CoV‑2 infection.

SARS-CoV-2: An overview of virus structure, transmission and detection

SARS-CoV-2, the causative agent of Coronavirus Disease 2019 (COVID-19), is an enveloped, single-stranded RNA Betacoronavirus. Seven coronaviruses have been identified as agents of human infection, causing disease ranging from mild common cold to severe respiratory failure.1

SARS-CoV-2 is transmitted primarily from person-to-person through respiratory droplets and aerosols.2,3 The incubation period from infection to detectable viral load in the host commonly ranges from two to 14 days.4,5 Detection of viral load can be associated with the onset of clinical signs and symptoms, although a considerable proportion of individuals remain asymptomatic or mildly symptomatic.6-8 The interval during which an individual with COVID-19 is infectious has not yet been clearly established, however, transmission from symptomatic, asymptomatic, and pre-symptomatic individuals has been well described.9-11

Coronavirus genomes encode 4 main structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N). The S protein is a very large transmembrane protein that assembles into trimers to form the distinctive surface spikes of coronaviruses. Each S monomer consists of an N-terminal S1 subunit and a membrane-proximal S2 subunit. The virus gains entry to the host cell through binding of the S protein to the angiotensin-converting enzyme 2 (ACE2) receptor, which is present on the surface of numerous cell types including the alveolar type II cells of the lung and epithelial cells of the oral mucosa.12,13 Mechanistically, ACE2 is engaged by the receptor-binding domain (RBD) on the S1 subunit.14,15

Upon infection with SARS-CoV-2, the host usually mounts an immune response against the virus, typically including production of specific antibodies against viral antigens. IgM and IgG antibodies against SARS-CoV-2 appear to arise nearly simultaneously in blood.16 There is significant inter-individual difference in the levels and chronological appearance of antibodies in COVID-19 patients, but median seroconversion has been observed at approximately two weeks.17-20

After infection or vaccination, the binding strength of antibodies to antigens increases over time - a process called affinity maturation21. High‑affinity antibodies can elicit neutralization by recognizing and binding specific viral epitopes22,23. Antibodies against SARS‑CoV‑2 with strong neutralizing capacity, especially potent if directed against the RBD, have been identified.24-27 Numerous vaccines for COVID-19 are in development, many of which focus on eliciting an immune response to the RBD.28-30

Would you like to know more about Elecsys® Anti-SARS-CoV-2 S?

Please submit your information in the following form to be contacted by a Roche representative with more details about Elecsys® Anti-SARS-CoV-2 S.

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Structure of the SARS-CoV-2 spike protein and binding to host receptor

Illustration of the structure of the spike protein

Positive Percent Agreement

View Full Table

Positive Percent Agreement

A total of 1485 samples from 331 symptomatic patients (including 172 samples from 172 hospitalized patients) with a PCR confirmed SARS‑CoV‑2 infection were tested with the Elecsys Anti‑SARS‑CoV‑2 S assay. 1 or more sequential samples from these patients were collected at various time points after PCR confirmation. Positive percent agreement (PPA) was correlated with days post PCR specimen collection, and the results are shown for the first bleed per time bin.

First bleed

233 of the tested samples had a sampling date of 15 days or later after diagnosis with PCR. 225 of these 233 samples were determined with ≥ 0.8 U/mL in the Elecsys Anti‑SARS‑CoV‑2 S assay and hence considered positive, resulting in a PPA of 96.6 % (95 % CI: 93.35‑98.51 %) in this sample cohort.

A total of 1485 samples from 331 symptomatic patients (including 172 samples from 172 hospitalized patients) with a PCR confirmed SARS‑CoV‑2 infection were tested with the Elecsys Anti‑SARS‑CoV‑2 S assay. 1 or more sequential samples from these patients were collected at various time points after PCR confirmation. Positive percent agreement (PPA) was correlated with days post PCR specimen collection, and the results are shown for the first bleed per time bin.

First bleed

233 of the tested samples had a sampling date of 15 days or later after diagnosis with PCR. 225 of these 233 samples were determined with ≥ 0.8 U/mL in the Elecsys Anti‑SARS‑CoV‑2 S assay and hence considered positive, resulting in a PPA of 96.6 % (95 % CI: 93.35‑98.51 %) in this sample cohort.

 

Days after PCR positive result Number tested Pos Neg PPA (%) 95 % CI* (%)
0-7 32 29 3 90.6 (74.9 - 98.0)
8-14 77 67 10 87.0 (77.4 - 93.5)
≥ 15 233 225 8 96.6 (93.3 - 98.5)
* = confidence interval

Analytical specificity 31

View Full Table

Analytical specificity 31

A total of 1,468 potentially cross-reactive samples collected before October 2019, including anti-MERS-CoV positive samples, samples from individuals with common cold symptoms, and samples from individuals confirmed to be infected with one of the four common cold coronaviruses were tested with the Elecsys® Anti-SARS-CoV-2 S assay. Overall specificity in this cohort of potentially cross-reactive samples was 100 % (95 % CI: 99.7 – 100 %).

A total of 1,468 potentially cross-reactive samples collected before October 2019, including anti-MERS-CoV positive samples, samples from individuals with common cold symptoms, and samples from individuals confirmed to be infected with one of the four common cold coronaviruses were tested with the Elecsys® Anti-SARS-CoV-2 S assay. Overall specificity in this cohort of potentially cross-reactive samples was 100 % (95 % CI: 99.7 – 100 %).

Cohort N Reactive Specificity (95% CI)
MERS-CoV* 51 0 100 %
Common cold panel** 21 0 100 %
Common Coronavirus panel*** 151 0 100 %
Other potentially cross-reactive samples****   978 0 100 %
Overall 1,468   0 100 %  
* positive for IgG antibodies against the Middle East respiratory syndrome-related coronavirus (MERS-CoV) spike protein subunit S1
** 40 samples from individuals with common cold symptoms, collected before October 2019
*** from individuals with past infection with coronavirus HKU1, NL63, 229E, or OC43, confirmed by antigen testing
**** pre-pandemic samples with reactivity for various other indications, which could have an elevated potential for unspecific interference

Negative Percent Agreement 31

View Full Table

Negative Percent Agreement 31

A total of 5,991 samples from diagnostic routine and blood donors drawn before October 2019 were tested with the Elecsys® Anti-SARSCoV-2 S assay. Overall Negative Percent Agreement (NPA) in this cohort of pre-pandemic samples was 99.98 % (95 % CI: 99.91 – 100 %).

A total of 5,991 samples from diagnostic routine and blood donors drawn before October 2019 were tested with the Elecsys® Anti-SARSCoV-2 S assay. Overall Negative Percent Agreement (NPA) in this cohort of pre-pandemic samples was 99.98 % (95 % CI: 99.91 – 100 %).

Cohort N Reactive NPA (95 % CI)
Diagnostic routine  2,528  0 100 % (99.8 – 100 %)
US blood donors 2,713 1 99.9 % (99.7 – 100 %)
African blood donors 750 0 100 % (99.5 – 100 %)
Overall 5,991 1 99.9 % (99.9 – 100 %) 
Estimated course of markers in SARS-CoV-2 infection33
cps-elecsys-anti-sars-cov-2-estimated-course-of-markers-in-SARS-CoV-2-infection

Estimated course of markers in SARS-CoV-2 infection47

Assay specifications

  • Testing time

    18 minutes

  • Test principle

    One-step double antigen sandwich assay

  • Traceability

    Internal Roche standard for anti-SARS-CoV-2-S consisting of monoclonal antibodies. 1 nM of these antibodies correspond to 20 U/mL of the Elecsys® Anti-SARS-CoV-2 S assay

  • Linear range

    0.4 to 250 U/mL

  • Calibration

    2-point (separate CalSet)

  • Interpretation

    <0.8 U/mL = negative, ≥0.8 U/mL = positive

  • Specimen types

    Serum collected using standard sampling tubes; Li-heparin, K2-EDTA-, K3-EDTA-, and sodium citrate plasma

  • Sample volume

    20 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules
    12 μL cobas e 801 module

  • Onboard stability

    cobas e 411/601/602: 28 days
    cobas e 801: 16 weeks

  • Intermediate precision in positive samples

    cobas e 411 analyzer: CV* 1.9 – 2.9 %
    cobas e 601 / cobas e 602 modules: CV 2.7 – 3.6 
    cobas e 801 module: CV 1.4 – 2.4 %

WARNING:

For use under Emergency Use Authorization only. This test has not been FDA-cleared or ‑approved; this test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories; by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform high complexity tests. This test has been authorized only for detecting antibodies against SARS‑CoV‑2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID‑19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C § 360bbb‑3(b)(1), unless the authorization is terminated or revoked sooner.

References

  1. Ye, Z.-W. (2020). Int J Biol Sci. 16(10), 1686-97.
  2. Word Health Organization (2020). Available from: https://www.who.int/news-room/commentaries/detail/transmission-of-sars-cov-2-implications-for-infection-prevention-precautions.
  3. Zhu, N. et al. (2020). N Engl J Med. 20, 382(8), 727-33.
  4. Chan, J.F.-W. et al. (2020). Lancet. 15, 395(10223), 514-23.
  5. Lauer, S.A. et al. (2020). Ann Intern Med. 172(9), 577-582.
  6. Zhou, R. et al. (2020). Int J Inf Dis. 96, 288-90.
  7. He, X. et al. (2020). Nat Med. 26(5), 672-5.
  8. Mizumoto, K. et al. (2020). Euro Surveill. 25(10), pii=2000180.
  9. Gao, M. et al. (2020). Respir Med. 169, 106026.
  10. Yu, P. et al. (2020). J Infect Dis. 221(11), 1757-61.
  11. Liu, Z. et al. (2020). Int J Inf Dis. https://doi.org/10.1016/j.ijid.2020.06.036.
  12. Letko, M. et al. (2020). Nat Microbiol. 5(4), 562-9.
  13. Xu, H. et al. (2020). Int J Oral Sci. 24, 12(1), 1-5.
  14. Wrapp, D. et al. (2020). Science. 13, 367(6483), 1260-3.
  15. Hoffmann, M. et al. (2020). Cell. 16, 181(2), 271-280.e8.
  16. Centers for Disease Control and Prevention (2020). Available from: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html.
  17. Long, Q. et al. (2020). medRxiv. https://doi.org/10.1101/2020.03.18.20038018.
  18. Lou, B. et al. (2020). Eur Respir J. 19, 2000763.
  19. Zhao, J. et al. Clin Infect Dis. ciaa344. https://doi.org/10.1093/cid/ciaa344.
  20. Tuaillon, E. et al. (2020). J Inf. 81(2), e39-e45.
  21. Klasse, P.J. (2016). Expert Rev Vaccines 15(3), 295-311.
  22. Payne, S. (2017). Viruses: Chapter 6 – Immunity and Resistance to Viruses, Editor(s): Susan Payne, Academic Press, Pages 61-71, ISBN 9780128031094.
  23. Iwasaki, A. and Yang, Y. (2020). Nat Rev Immunol. https://doi.org/10.1038/s41577-020-0321-6.
  24. Salazar, E. et al. (2020). bioRxiv 2020.06.08.138990; https://doi.org/10.1101/2020.06.08.138990.
  25. Klasse, P. and Moore, J.P. (2020). Elife. 2020, 9:e57877. doi:10.7554/eLife.57877.
  26. Premkumar, L. et al. (2020). Sci Immunol. 11, 5(48).
  27. Luchsinger, L.L. et al. (2020). medRxiv. https://doi.org/10.1101/2020.06.08.20124792
  28. Mukherjee, R. (2020). J Biosci. 45, 68. https://doi.org/10.1007/s12038-020-00040-7.
  29. Graham, B.S. (2020). Science. 368(6494), 945-6.
  30. Hotez, P.J. et al. (2020). Nat Rev Immunol. 20(6), 347-8.
  31. Elecsys Anti-SARS-CoV-2 S. Package Insert 2022-03, V3.0; Material Numbers 09289267190 and 09289275190.
  32. Meyer, B. et al. medRxiv. https://doi.org/10.1101/2020.05.02.20080879.
  33. Sethuraman, N. et al. (2020). JAMA. Published online May 06, 2020. doi:10.1001/jama.2020.8259.
  34. To, K. et al. (2020). Lancet Infect Dis. 20(5), 565-74.
  35. Xiang, F. et al. (2020). Clin Infect Dis. pii: ciaa46. https://doi.org/10.1093/cid/ciaa461.

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