Elecsys Anti‑SARS‑CoV‑2 is an immunoassay intended for qualitative detection of antibodies to SARS‑CoV‑2 in human serum and plasma (K2‑EDTA, K3‑EDTA, Li‑heparin). The test 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 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.
Samples should only be tested from individuals that are 14 days or more post-symptom onset.
The sensitivity of the Elecsys Anti‑SARS‑CoV‑2 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 the Elecsys Anti‑SARS‑CoV‑2 assay may occur due to cross reactivity from pre-existing antibodies or other possible causes.
The Elecsys Anti‑SARS‑CoV‑2 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.
Sandwich principle. 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‑specific recombinant antigen and SARS‑CoV‑2‑specific recombinant antigen labeled with a ruthenium complex
![](\"http://pim-media.roche.com/Images/Elecsys_2_3new2_804797451_All.jpg\"/)
)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 automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration.
The effect of the following endogenous substances and pharmaceutical compounds on assay performance was tested. Interference was tested up to the listed concentration and no impact on results was observed.
Compound | Concentration tested |
|---|---|
Bilirubin | ≤ 1129 µmol/L or ≤ 66 mg/dL |
Hemoglobin | 1000 mg/dL or 10 g/L |
Intralipid | 2000 mg/dL |
Biotin | ≤ 4912 nmol/L or ≤ 1200 ng/mL |
Rheumatoid factors | 1200 IU/mL |
IgG | 7.0 g/dL or 70 g/L |
IgA | 1.6 g/dL or 16 g/L |
IgM | 1.0 g/dL or 10 g/L |
This assay has no biotin interference in serum concentrations up to 1200 ng/mL. Some studies have shown that serum concentrations of biotin can reach up to 355 ng/mL within the first hour after biotin ingestion for subjects consuming supplements of 20 mg biotin per day
In vitro tests were performed on 17 commonly used pharmaceuticals. No interference with the assay was found.
In addition, the following special drugs were tested. No interference with the assay was found.
Drug | Concentration tested |
|---|---|
Interferon alpha-2a | 21600 IU/mL |
Interferon alpha-2b | 3000 IU/mL |
Zanamivir | 0.006 mg/mL |
Ribavirin | 0.750 mg/mL |
Oseltamivir | 0.090 mg/mL |
Peramivir | 0.360 mg/mL |
Lopinavir | 0.480 mg/mL |
Ritonavir | 0.240 mg/mL |
Remdesivir | 0.120 mg/mL |
Actemra (Tocilizumab) | 0.384 mg/mL |
Levofloxacin | 0.3 mg/mL |
Azithromycin | 0.3 mg/mL |
Ceftriaxone | 2.40 mg/mL |
Meropenem | 3.60 mg/mL |
Tobramycin | 0.360 mg/mL |
Hydroxychloroquine | 0.480 mg/mL |
Drug interferences are measured based on recommendations given in CLSI guidelines EP07 and EP37 and other published literature. Effects of concentrations exceeding these recommendations have not been characterized.
For use under an Emergency Use Authorization Only.
This test should not be used to diagnose or exclude acute SARS‑CoV‑2 infection.
No false negative results due to a high‑dose hook effect were found with the Elecsys Anti‑SARS‑CoV‑2 assay but occurrence of high‑dose hook effect cannot be completely excluded.
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.
The results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.
SARS‑CoV‑2 IgG antibodies may be below detectable levels in patients who have been exhibiting symptoms for less than 15 days.
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.
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 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.
Assay results should not be used for the diagnosis or exclusion of acute novel coronavirus infection. An assay that directly detects the virus should be used to evaluate symptomatic individuals for acute COVID‑19.
It is not known at this time if the presence of antibodies to SARS‑CoV‑2 confers immunity to reinfection.
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 anitbody 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. The samples for the negative agreement study were collected in the United States and Germany prior to December 2019. The samples for the positive percent agreement study were collected in Germany between March 2020 and June 2020. 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.
This test should not be used for screening of donated blood.
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09203095190 | 09203095501 | 200 | cobas e 411 cobas e 601 cobas e 602 |
09203079190 | 09203079501 | 300 | cobas e 801 |
Rx ONLY
For in vitro diagnostic and Laboratory Professional use. For use under the Emergency Use Authorization (EUA) only
For cobas e 411 analyzer: test number 3000
For cobas e 601 and cobas e 602 analyzers: Application Code Number 737
For cobas e 801 analyzer: Application Code Number 10226
The reagents in the kit are ready‑for‑use and are supplied in bottles compatible with the system.
Calibrators:
The calibrators are supplied ready‑for‑use in bottles compatible with the system.
cobas e 411 analyzer: The calibrators should only be left on the analyzer during calibration at 20‑25 °C. After use, close the bottles as soon as possible and store upright at 2‑8 °C.
Due to possible evaporation effects, not more than 4 calibration procedures per calibrator bottle set should be performed.
cobas e 801 analyzer: Store the calibrators at 2‑8 °C for later use.
cobas e 601, cobas e 602 and cobas e 801 analyzers:
Perform only one calibration procedure per bottle.
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 analyzers:
All information required for correct operation is available via the cobas link.
Please note for cobas e 602 analyzers: Both the vial labels contain 2 different barcodes. The barcode between the yellow markers is for cobas 8000 systems only. If using a cobas 8000 system, please turn the vial cap 180° into the correct position so that the barcode between the yellow markers can be read by the system. Place the vial on the analyzer as usual.
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.
Do not use the reagents after their expiration date has passed.
Stability of the reagent rackpack | |
|---|---|
unopened at 2‑8 °C | up to the stated expiration date |
after opening at 2‑8 °C | 21 days |
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 | 14 days |
Stability of the calibrators | |
|---|---|
unopened at 2‑8 °C | up to the stated expiration date |
after opening at 2‑8 °C | 31 days |
on cobas e 411 at 20‑25 °C | up to 3 hours |
on cobas e 601, cobas e 602, and cobas e 801 analyzers at 20‑25 °C | use only once |
Store calibrators upright in order to prevent the calibrator solution from adhering to the snap‑cap.
No international standard is available for Anti‑SARS‑CoV‑2.
Calibration frequency: Calibration must be performed once per reagent lot using ACOV2 Cal1, ACOV2 Cal2 and fresh reagent (i.e., not more than 24 hours since the reagent kit / cobas e pack 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 25 days when using the same reagent lot on the cobas e 411, cobas e 601 and cobas e 602 analyzers
after 11 weeks when using the same reagent lot on the cobas e 801 analyzer
after 7 days when using the same reagent pack on the cobas e 411, cobas e 601 and cobas e 602 analyzers
after 14 days when using the same cobas e pack on the cobas e 801 analyzer
as required: e.g. quality control findings outside the defined limits
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
SARS‑CoV‑2 is an enveloped, single-stranded RNA virus of the family Coronaviridae, genus Betacoronavirus. All coronaviruses share similarities in the organization and expression of their genome, which encodes 16 nonstructural proteins and the 4 structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N). Viruses of this family are of zoonotic origin. They cause disease with symptoms ranging from those of a mild common cold to more severe ones such as the Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) and Coronavirus Disease 2019 (COVID‑19). Other coronaviruses known to infect people include 229E, NL63, OC43 and HKU1. The latter are ubiquitous and infection typically causes common cold or flu-like symptoms.
The Elecsys Anti‑SARS‑CoV-2 assay uses a recombinant protein representing the nucleocapsid (N) antigen for the determination of antibodies against SARS‑CoV‑2.
cobas e 411, cobas e 601, and cobas e 602 analyzers:
The reagent rackpack (M, R1, R2) is labeled as ACOV2.
M | Streptavidin-coated microparticles (transparent cap), 1 bottle, 12 mL: |
R1 | SARS-CoV-2-Ag~biotin, (gray cap), 1 bottle, 16 mL: FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid buffer 50 mmol/L, pH 7.7; preservative. |
R2 | SARS-CoV-2 Ag~Ru(bpy) FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid buffer 50 mmol/L, pH 7.7; preservative. |
ACOV2 Cal1 | Negative calibrator 1 (white cap), 1 bottle of 0.67 mL: |
ACOV2 Cal2 | Positive calibrator 2 (black cap), 1 bottle of 0.67 mL: |
cobas e 801 analyzer:
The cobas e pack (M, R1, R2) is labeled as ACOV2.
M | Streptavidin-coated microparticles, 1 bottle, 16 mL: |
R1 | SARS-CoV-2-Ag~biotin, 1 bottle, 18.8 mL: FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid buffer 50 mmol/L, pH 7.7; preservative. |
R2 | SARS-CoV-2-Ag~Ru(bpy) FREFHEPES = [4-(2-hydroxyethyl)-piperazine]-ethane sulfonic acid buffer 50 mmol/L, pH 7.7; preservative. |
ACOV2 Cal1 | Negative calibrator 1, 1 bottle of 0.67 mL: |
ACOV2 Cal2 | Positive calibrator 2, 1 bottle of 0.67 mL: |
For Emergency Use Authorization only.
For in vitro diagnostic use.
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests.
This product has been authorized only for detecting the presence of antibodies to SARS‑CoV‑2, not for any other viruses or pathogens.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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 declaration is terminated or authorization is revoked sooner.
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:
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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: 1-866-987-6243
All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods used assays approved by the FDA or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.
The serum containing anti-SARS‑CoV‑2 (ACOV2 Cal2) was heat-inactivated for 30 minutes at 56 °C.
However, as no inactivation or testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.
Avoid foam formation in all reagents and sample types (specimens, calibrators and controls).
Warning
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For quality control, use PreciControl Anti‑SARS‑CoV‑2.
In addition, other suitable control material can be used.
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, 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. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.
The open‑vial PreciControl stability is 28 days at 2‑8 °C.
If necessary, repeat the measurement of the samples concerned.
Follow the applicable government regulations and local guidelines for quality control.
Note forcobas e411 and cobas e 601 analyzers:
Note: The controls are not barcode-labeled and therefore have to be run like external controls. All values and ranges have to be entered manually. Please refer to the section “QC” in the operator's manual or to the online help of the instrument software.
Non-barcode labeled controls: Only one target value and range for each control level can be entered in the analyzer. The reagent lot-specific target values have to be re-entered each time a specific reagent lot with different control target values and ranges is used. Two reagent lots with different control target values and ranges cannot be used in parallel in the same run.
The exact lot-specific target values and ranges are printed on the enclosed (or electronically available) value sheet in the reagent kit or PreciControl kit.
Please make sure that the correct values are used.
Alternatively, controls can be prepared as follows:
Negative control: Determine the COI of ACOV2 Cal1 by measuring it as a routine sample. Pool serum samples with a COI result of ≤ 150 % compared to the COI result of ACOV2 Cal1 (pooling of ≥ 5 non-reactive samples in this range is recommended). Mix carefully, avoiding foam formation. Prepare aliquots of at least 250 µL from this sample pool and store frozen at ‑20 °C (± 5 °C) or colder. Use these aliquots to perform regular quality control.
This negative control has a target value range of COI < 0.8 (qualitative assay result “non-reactive”).
Positive control: Determine the COI of ACOV2 Cal2 by measuring it as a routine sample. Pool serum samples with a COI result that is higher than the COI result of ACOV2 Cal2 (pooling of ≥ 3 reactive samples in this range is recommended). Dilute the sample pool by adding pooled negative serum (for pooling criterion see negative control) or Diluent MultiAssay to obtain a COI between 3 and 15. Mix carefully, avoiding foam formation. It is recommended to confirm calculated reactivity after dilution by a measurement. Prepare aliquots of at least 250 µL from this sample pool and store frozen at ‑20 °C (± 5 °C) or colder. Use these aliquots to perform regular quality control. Upon first use of this control, determine the COI of the control by measurement of the control in triplicate and using a freshly opened and calibrated reagent rack pack / cobas e pack.
The obtained median of these measurements serves as target value for this positive control. Subsequent measurements of all aliquots of this control material must match this target value ± 45 % (3SD = 45 %, 1SD = 15 %; qualitative assay result \"reactive\").
The target value of the positive control is lot specific and target value assessment as described above has to be performed for every assay lot.
After measurement, discard aliquots with a remaining volume of 250 µL or less. Aliquots with a remaining volume of more than 250 µL can be re-used if sealed tightly and stored immediately at 2‑8 °C for a maximum of 3 days. In case quality control fails for any reason, thaw a new control aliquot and re-assess the performance of the assay.
Pools of plasma samples with similar reactivity can be used, however fibrin clots frequently occur with plasma after thawing. If this occurs, either discard or centrifuge the aliquot before use. Do not mix serum samples and plasma samples to prepare a sample pool.
The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.
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.
If necessary, repeat the measurement of the samples concerned.
Follow the applicable government regulations and local guidelines for quality control.
Note: The controls should be run like external controls. All values and ranges have to be entered manually. Please refer to the section “QC” in the operator's manual or to the online help of the instrument software. Only one target value and range for each control level can be entered in the analyzer. The reagent lot-specific target values have to be re-entered each time a specific reagent lot with different control target values and ranges is used. Two reagent lots with different control target values and ranges cannot be used in parallel in the same run.
Only the specimens listed below were tested and found acceptable.
Serum collected using standard sampling tubes or tubes containing separating gel.
Li‑heparin, K2‑EDTA and K3‑EDTA plasma.
Plasma tubes containing separating gel can be used.
Criterion: Absolute deviation of negative samples ± 0.3 COI (cutoff index) from serum value; reactive samples: recovery within 70‑130 % of serum value.
Stable for 7 days at 15‑25 °C, 14 days at 2‑8 °C, 28 days 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 or systems 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/collection system 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.
Pooled samples and other artificial material may have different effects on different assays and thus may lead to discrepant findings.
Centrifuge samples containing precipitates and thawed samples before performing the assay.
Do not use heat‑inactivated samples.
Do not use samples and controls stabilized with azide.
Ensure the samples, calibrators and controls are at 20‑25 °C prior to measurement.
Due to possible evaporation effects, samples, calibrators and controls on the analyzers should be analyzed/measured within 2 hours.
The performance of the Elecsys Anti‑SARS‑CoV‑2 assay has not been established with cadaveric samples or body fluids other than serum and plasma.
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.
Immunoassay intended for qualitative detection of antibodies to SARS-CoV-2 in human serum and plasma.
For use under the Emergency Use Authorization (EUA) only.
Elecsys® Anti-SARS-CoV-2 is an immunoassay intended for the qualitative detection of antibodies to SARS-CoV-2 in human serum and plasma. The assay uses a recombinant protein representing the nucleocapsid (N) antigen for the determination of antibodies against SARS-CoV-2. The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.43
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an enveloped, single-stranded RNA virus of the family Coronaviridae. Coronaviruses share structural similarities and are composed of 16 nonstructural proteins and 4 structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N). Coronaviruses cause diseases with symptoms ranging from those of a mild common cold to more severe ones such as Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2 1,2.
SARS-CoV-2 is transmitted from person-to-person primarily via respiratory droplets, while indirect transmission through contaminated surfaces is also possible3-6. The virus accesses host cells via the angiotensin-converting enzyme 2 (ACE2), which is most abundant in the lungs7,8.
The incubation period for COVID-19 ranges from 2 – 14 days following exposure, with most cases showing symptoms approximately 4 – 5 days after exposure3,9,10. The spectrum of symptomatic infection ranges from mild (fever, cough, fatigue, loss of smell and taste, shortness of breath) to critical11,12. While most symptomatic cases are not severe, severe illness occurs predominantly in adults with advanced age or underlying medical comorbidities and requires intensive care. Acute respiratory distress syndrome (ARDS) is a major complication in patients with severe disease. Critical cases are characterized by e.g., respiratory failure, shock and/or multiple organ dysfunction, or failure11,13,14.
Definite COVID-19 diagnosis entails direct detection of SARS-CoV-2 RNA by nucleic acid amplification technology (NAAT)21-23. Serological assays, which detect antibodies against SARS-CoV-2, can contribute to identify individuals, which were previously infected by the virus, and to assess the extent of exposure of a population. They might thereby help to decide on application, enforcement or relaxation of containment measures24.
Upon infection with SARS-CoV-2, the host mounts an immune response against the virus, including production of specific antibodies against viral antigens. Both IgM and IgG have been detected as early as day 5 after symptom onset25,26. Median seroconversion has been observed at day 10 – 13 for IgM and day 12 – 14 for IgG27-29, while maximum levels have been reported at week 2 – 3 for IgM, week 3 – 6 for IgG and week 2 for total antibody25-31. Whereas IgM seems to vanish around week 6 – 732,33, high IgG seropositivity is seen at that time25,32,33. While IgM is typically the major antibody class secreted to blood in the early stages of a primary antibody response, levels and chronological order of IgM and IgG antibody appearance seem to be highly variable for SARS-CoV-2. Anti-SARS-CoV-2 IgM and IgG often appear simultaneously, and some cases have been reported where IgG appears before IgM, limiting its diagnostic utility26,27,29,34,35.
After infection or vaccination, the binding strength of antibodies to antigens increases over time – a process called affinity maturation36. High-affinity antibodies can elicit neutralization by recognizing and binding specific viral epitopes37,38. In SARS-CoV-2 infection, antibodies targeting both the spike and nucleocapsid proteins, which correlate with a strong neutralizing response, are formed as early as day 9 onwards, suggesting seroconversion may lead to protection for at least a limited time34,39-42.
Please submit your information in the following form to be contacted by a Roche representative with more details about Elecsys® Anti-SARS-CoV-2.
* COI: cutoff index
A total of 10,453 samples from diagnostic routine and blood donors obtained before December 2019 were tested with the Elecsys® Anti-SARS-CoV-2 assay.
A total of 10,453 samples from diagnostic routine and blood donors obtained before December 2019 were tested with the Elecsys® Anti-SARS-CoV-2 assay.
| Cohort | N | Reactive | Specificity % (95 % CI) |
| Diagnostic routine | 6305 | 12 | 99.81 % (99.67 – 99.90 %) |
| Blood donors | 4148 | 9 | 99.78 % (99.59 – 99.90 %) |
| Overall | 10453 | 21 | 99.80 % (99.69 – 99.88 %) |
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Overall specificity in a cohort of 792 potentially cross-reactive samples was 99.5 % (95 % CI: 98.63 – 99.85 %).
* 40 samples from individuals with common cold symptoms, collected before Dec 2019
** 40 samples from individuals following an infection with Coronavirus HKU1, NL63, 229E or OC43, confirmed by PCR
*** N=712
Common cold panel*
100 % specificity
Coronavirus panel**
100 % specificity
Other potential cross-reactivity***
99.44 % specificity
A total of 496 samples from 102 symptomatic patients with a PCR confirmed SARS-CoV-2 infection were tested with the Elecsys® Anti-SARS-CoV-2 assay. One or more sequential specimens from these patients were collected after PCR confirmation at various time points.
A total of 496 samples from 102 symptomatic patients with a PCR confirmed SARS-CoV-2 infection were tested with the Elecsys® Anti-SARS-CoV-2 assay. One or more sequential specimens from these patients were collected after PCR confirmation at various time points.
| Days post PCR confirmation | N | Non-reactive | Sensitivity (95 % CI**) |
| 0 – 6 days | 161 | 64 | 60.2 % (52.3 – 67.8 %) |
| 7 – 13 days | 150 | 22 | 85.3 % (78.6 – 90.6 %) |
| ≥14 days | 185 | 1* | 99.5 % (97.0 – 100 %) |
After recovery from infection, confirmed by a negative PCR result, 26 consecutive samples from 5 individuals were tested with the Elecsys® Anti-SARS-CoV-2 assay.
* Day 0 represents initial positive PCR
Part of the cobas 8000 modular analyzer series and cobas pro integrated solutions.
Part of the cobas 8000 modular analyzer series.
Part of the cobas 6000 modular analyzer series.
Part of the cobas 4000 modular analyzer series.
WARNING:
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