For in vitro diagnostic use. Others Elecsys Anti-SARS-CoV-2 IVD Elecsys® Anti-SARS-CoV-2 CPS_000273 09 203 095 190 9 203 095 190 09203095190 9203095190 09203095190 Anti-SARS-CoV-2 Elecsys cobas e 200 Elecsys Anti-SARS-CoV-2 07613336179451 Reagents, kits 200 tests cobas e 411/601/602 true 09 203 079 190 9 203 079 190 09203079190 9203079190 09203079190 Anti-SARS-CoV-2 Elecsys E2G 300 Elecsys Anti-SARS-CoV-2 07613336179444 Reagents, kits 300 tests cobas e 402/801 true 09203079501 Elecsys Anti-SARS-CoV-2 en 9 FF00000004DE940E FF000000040E510E 09203079190 2497 cobas e 801 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. Intended useElecsys 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. en

Elecsys^® Anti-SARS-CoV-2

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.

IVD

Immunoassay to qualitatively detect antibodies against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

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

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

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 possible^3-6. The virus accesses host cells via the angiotensin-converting enzyme 2 (ACE2), which is most abundant in the lungs^7,8.

The incubation period for COVID-19 ranges from 2 – 14 days following exposure, with most cases showing symptoms approximately 4 – 5 days after exposure^3,9,10. The spectrum of symptomatic infection ranges from mild (fever, cough, fatigue, loss of smell and taste, shortness of breath) to critical^11,12. 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 failure^11,13,14.

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 onset^25,26. Median seroconversion has been observed at day 10 – 13 for IgM and day 12 – 14 for IgG^27-29, while maximum levels have been reported at week 2 – 3 for IgM, week 3 – 6 for IgG and week 2 for total antibody^25-31. Whereas IgM seems to vanish around week 6 – 7^32,33, high IgG seropositivity is seen at that time^25,32,33. 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 utility^{26,27,29,34,35}.

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 epitopes^37,38. 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 time^34,39-42.

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Structure of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Nucleocapsid protein (N)
Envelope protein (E)
Spike protein (S)
Membrane glycoprotein (M)
RNA

Estimated course of markers in SARS-CoV-2 infection⁴⁴

Elecsys^® Anti-SARS-CoV-2 assay characteristics

Systems

cobas e 411 analyzer, cobas e 601 / cobas e 602 modules, cobas e 801 module
Testing time

18 minutes
Calibration

2-point
Interpretation

COI* < 1.0 = non-reactive
COI ≥ 1.0 = reactive
Sample material

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

Li-heparin, K₂-EDTA and K₃-EDTA plasma as well as plasma tubes containing separating gel.
Sample volume

20 μL cobas e 411 analyzer, cobas e 601 / cobas e 602 modules

12 μL cobas e 801 module
Onboard stability

14 days
Intermediate precision in positive samples

cobas e 411 analyzer: 2.2 - 5.0%
cobas e 601 / cobas e 602 modules: 2.3 - 2.7 %
cobas e 801 module: 2.1 - 2.6 %

* COI: cutoff index

Clinical specificity⁴³

View Full Table

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.

Overall	10453	21	99.80 % (99.69 – 99.88 %)
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 %)

Analytical specificity⁴³

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

Clinical sensitivity⁴³

View Full Table

Clinical sensitivity⁴³

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 %)

* 1 patient was non-reactive at day 14 (0.696 COI) but reactive at day 16 (4.48 COI); ** confidence interval

Seroconversion sensitivity⁴³

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

Testing modules

cobas e 801 module

Throughput of up to 300 tests/hour
48 reagent positions

^{Part of the cobas 8000 modular analyzer series and cobas pro integrated solutions.}

cobas e 602 module

Throughput of up to 170 tests/hour
25 reagent positions

^{Part of the cobas 8000 modular analyzer series.}

cobas e 601 module

Throughput of up to 170 tests/hour
25 reagent positions

^{Part of the cobas 6000 modular analyzer series.}

cobas e 411 analyzer

Up to 86 tests/hour
Benchtop

^{Part of the cobas 4000 modular analyzer series.}

WARNING:

This test has not been FDA cleared or approved.
Not for screening of donated blood.
This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test has been authorized only for detecting the presence of 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 diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

References

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