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Elecsys® SARS-CoV-2 Antigen

Immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS‑CoV-2)

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Immunoassay for the qualitative detection of the SARS-CoV-2 nucleocapsid antigen

The Elecsys® SARS-CoV-2 Antigen assay uses monoclonal antibodies directed against the SARS-CoV-2 N protein in a double-antibody sandwich assay format for the qualitative detection of SARS-CoV-2 in upper respiratory tract specimens.31

Elecsys® SARS-CoV-2 Antigen Factsheet

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

SARS-CoV-2, the causative agent of COVID-19, is an enveloped, single-stranded RNA Betacoronavirus.1-3 7 coronaviruses have been identified as agents of human infection, causing disease ranging from mild common cold to severe respiratory failure.4 Coronaviruses share the 4 structural proteins spike (S), envelope (E), membrane (M), and nucleocapsid (N), the latter being the most abundant.5-8

SARS-CoV-2 is transmitted primarily from person-to-person through respiratory droplets and aerosols.9,10 The incubation period from infection to detectable viral load in the host commonly ranges from 2 to 14 days.11,12 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.13-15 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.16-18

An effective strategy for controlling the COVID-19 pandemic is to develop highly accurate methods for the identification and isolation of SARS-CoV-2 infected patients.19 Diagnostic confirmation of acute SARS-CoV-2 infection can be based on the detection of unique sequences in the viral RNA or detection of viral proteins in respiratory tract samples from infected individuals.20 Viral antigens are only expressed when the virus is actively replicating, thus making antigen tests clinically useful for identification of acute or early infection.21,22 Current research suggests active replication of SARS-CoV-2 in the throat with high viral shedding in the first 5 days of infection, and infectious virus could be isolated from respiratory samples up to the first 7 – 9 days post symptom onset, indicating potential feasibility of antigen detection using throat swabs.23-25 This time period also coincides with the time when the highest viral load is generally observed in infected individuals.14,26-28 Therefore, the best performance of antigen tests is seen around symptom onset in symptomatic individuals and the initial phase of infection.20 Testing of mildly symptomatic or asymptomatic individuals can be considered in the assessment of contacts of confirmed infected persons.20 Antigen tests can also become part of regular testing regimens for identifying, isolating, and thus filtering out currently infected persons, including those who are asymptomatic.29,30

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Structure of SARS-CoV-2

 

  • Nucleocapsid protein (N)
  • Envelope protein (E)
  • Spike protein (S)
  • Membrane protein (M)
  • RNA
Coronavirus illustration

Elecsys® SARS-CoV-2 Antigen assay characteristics31

  • Systems

    cobas e 411 analyzer, cobas e 601 / cobas e 602 module, cobas e 402 / cobas e 801 analytical unit

     

  • Testing time

    18 minutes

  • Test principle

    One-step double antibody sandwich assay

  • Calibration

    2-point

     

     

     

  • Interpretation

    COI <1.0 = non-reactive, COI ≥1 = reactive

     

     

     

  • Specimen types

    Nasopharyngeal, oropharyngeal and nasal specimens, collected using flocked or polyester-tipped swabs, placed in 3 mL Copan Universal Transport Medium (UTM-RT™), BD™ Universal Viral Transport (UVT), Viral Transport Media (VTM)*, or sterile saline (0.9 % NaCl)

  • Sample volume

    50 μL cobas e 411 analyzer, cobas e 601/602 module
    30 μL cobas e 402 / cobas e 801 analytical unit

  • Sample extraction

    Dry swabs: SARS-CoV-2 Extraction Solution; swabs in UTM/VTM: SARS-CoV-2 Extraction Solution C

  • Onboard stability

    cobas e 411 analyzer, cobas e 601/602 module: 8 weeks
    cobas e 402 / cobas e 801 analytical unit: 16 weeks

  • Intermediate** precision in positive samples

    cobas e 411 analyzer: CV# 2.2 – 5.8 %
    cobas e 601 / 602 module: CV 1.9 – 3.5 %
    cobas e 402 / cobas e 801 analytical unit: CV 1.7 – 5.7 %

* prepared according to CDC SOP DSR-052-05; ** between runs; # coefficient of variation

Detection limit31

The detection limit in different transport media was determined by limiting dilution studies using an inactivated viral lysate (USA-WA1/2020). LoD is defined as the lowest detectable concentration of SARS-CoV-2 at which a minimum of 19 from 20 replicates per concentration generate a reactive test result (≥1.0 COI), and expressed as TCID50*/mL.

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Transport Medium TCID50/mL
COPAN Universal Transport Medium (UTM-RT) 22.5
CDC Viral Transport Medium 22.5
Sterile Saline (0.9 % NaCl) 37.5
SARS-CoV-2 Extraction Solution 22.5
* Median Tissue Culture Infectious Dose
Relative sensitivity31

Relative sensitivity was evaluated using

A) 442 positive naso- and oropharyngeal swab specimens, collected from individuals with signs and symptoms suggestive of COVID-19, with known or suspected exposure to SARS-CoV-2, and from individuals undergoing pre-admission screening before hospitalization for surgical intervention unrelated to an infectious disease. 

B) 116 nasal swab specimens, collected from individuals with signs and symptoms suggestive of COVID-19.

All subjects included in the analysis were tested positive in the cobas® SARS-CoV-2 RT-PCR test32. RT-PCR-positive samples were further stratified using Target 2 (structural protein envelope E-gene/ pan-Sarbecovirus detection) cycle threshold (Ct) values.

The figures below correlate the performance of the Elecsys® SARS-CoV-2 Antigen assay in all RT-PCR-positive naso-/oropharyngeal swab samples (A) or nasal swab samples (B), respectively, to the cobas® SARS-CoV-2 Ct values.

A) Naso- and oropharyngeal swab samples
Relative sensitivity

* structural protein envelope E-gene/pan-Sarbecovirus detection; ** N (cumulative): reactive in the Elecsys® SARS-CoV-2 Antigen assay/total

B) Nasal swab samples
Relative sensitivity

The table below shows additional analyses based on days post-symptom onset (DPSO) and stratification by a cobas® SARS-CoV-2 Ct value of 30. 
(A) The resulting overall relative sensitivity in naso-/oropharyngeal swab samples from symptomatic individuals with a cobas® SARS-CoV-2 Target 2 Ct value <30 was 94.5 % (95 % CI, two-sided: 90.4 – 97.2 % [189/200]).
B) The resulting relative sensitivity in nasal swab samples from symptomatic individuals at 5 DPSO with a cobas® SARS-CoV-2 Target 2 Ct value <30 was 96.8 % (95 % CI, two-sided: 88.8 - 99.6 % [60/62]).

A) Naso- and oropharyngeal swab sample
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Cohort cobas® SARS-CoV-2 Ct <30
  N Non-reactive Sensitivity (95 % CI*)
Symptomatic;
≤5 DPSO		 119 3 97.5 %
(92.8 – 99.5 %)
Symptomatic;
≤10 DPSO		 158 8 94.9 %
(90.3 – 97.8 %)
Symptomatic;
>10 DPSO		 4 1 75.0 %
(19.4 – 99.4 %)
Symptomatic;
unknown DPSO
 38 2 94.7 %
(82.3 – 99.4 %)
Known or
suspected exposure		 27 3 88.9 %
(70.8 – 97.6 %)
Screening 21 4 81.0 %
(58.1 – 94.6 %)
B) Nasal swab samples
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Cohort cobas® SARS-CoV-2 Ct <30
  N Non-reactive Sensitivity (95 % CI*)
≤1 DPSO 2 0 100 %
(15.8 – 100 %)
≤2 DPSO 9 0 100 %
(66.4 – 100 %)


≤3 DPSO		 27 0 100 %
(87.2 – 100 %)
≤4 DPSO 61 2 96.7 %
(88.7 – 99.6 %)
≤5 DPSO 62 2 96.8 %
(88.8 – 99.6 %)

* confidence interval

Relative specificity31

 

Relative specificity of the Elecsys® SARS-CoV-2 Antigen assay was evaluated using 2,747 RT-PCR negative naso-/oropharyngeal swab specimens, collected from individuals with signs and symptoms suggestive of COVID-19, with known or suspected exposure to SARS-CoV-2, and from individuals undergoing pre-admission screening before hospitalization for surgical intervention unrelated to an infectious disease.

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Cohort N Reactive Specificity (95 % CI)
Symptomatic 548* 0 100% (99.3 - 100%)
Known/suspected exposure and screening 2199** 4 99.8% (99.5 - 100%)
Overall 2747 4 99.9% (99.6 - 100%)
* 3; **12 samples invalid with cobas® SARS-CoV-2 RT-PCR, but negative with another SARS-CoV-2 RT-PCR test
Estimated course of markers in SARS-CoV-2 infection27,30
Estimated course of markers in SARS-CoV-2 infections
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    31. Elecsys® SARS-CoV-2 Antigen, Material Number 09345272190, Method Sheet 2022-09 V2.0; Material Number 09345299190 2021-10 V2.0.
    32. cobas® SARS-CoV-2 Qualitative. Method Sheet 2022-01 V2.0.