The COVID-19 Testing Toolkit
Tests in the diagnosis of current infection:
- High-throughput laboratory-based antigen testing can assess patients with improved workflow from swab to result in less than one hour. Laboratory antigen testing can scale up more efficiently than rapid tests and does not require the time or specialty equipment of PCR testing. In addition, laboratory testing delivers automated results, making reporting to public health agencies easier.
- Molecular PCR testing is critical to understanding an infectious disease outbreak, and our RT-PCR assay is fundamental to detecting SARS-CoV-2 infection. As the pandemic continues, regional flu seasons and other seasonal outbreaks make it increasingly important to be able to understand whether or not the SARS-CoV-2 pathogen is causing a patient’s symptoms.
Tests in the monitoring of immune response:
- Laboratory antibody (serology) testing can help in understanding antibody status after infection, to indicate an initial response and help us understand the duration of that response. Our assays offers semi-quantitative results, spike protein receptor-binding domain (S1 RBD) IgG antibody detection and very high specificity (≥99.5%).
COVID-19 testing, explained
Testing at scale
As we continue to reopening society, how can you scale up testing for larger groups of individuals? Conducting antigen testing using a high-quality laboratory test can be an effective alternative to RT-PCR testing. High-throughput laboratory tests allow you to test large groups of people quickly and safely, isolating positive cases more quickly than RT-PCR, thereby identifying patients that need follow-up sooner. Laboratory tests with high sensitivity and wide clinical reach, such as the Siemens Healthineers SARS-CoV-2 antigen assay,3 can be an effective tool in getting us to what’s next.
Collaborations
Partnership with the CDC and JRC
Our collaboration with the CDC (Centers for Disease Control) and JRC (Joint Research Centre of European Commission) is developing the framework and reference that all antibody test manufacturers would be expected to adopt moving forward. With an international standard established and adopted by manufacturers, clinicians would be positioned to track their patients' antibody concentrations, regardless of the test method or manufacturer used. The second step is understanding what concentration of neutralizing antibodies are needed to confer immunocompetence or immunity to the virus, and we are currently working with both CDC and JRC to determine what is the threshold of these neutralizing antibodies sufficient to confer immunity.
Learning more about how our immune system responds to variants and how we can test for them is an area of needed research.
Test your variant knowledge
There has been much discussion in the media as well as in scientific research articles about the different variants of SARS-CoV-2 and their impact on community spread of the virus, as well as mortality of the virus and the potential for the variants to escape vaccines or our ability to detect them with assays. Variants of concern will continue to emerge, and enhanced surveillance will support earlier identification. How much do you know about variants and their impact on public health programs?
Variant, mutation or strain?
The term “viral variant” can be confusing and is often (and incorrectly) used interchangeably with other terms such as mutations, strains, and lineages. These terms are inter-related but have distinctions.15 Mutations are normal, abundant, and expected, especially with an RNA virus. What is the difference between variants, mutations, and strains?
What is a "variant of concern?"
To better understand the concern for variants able to escape neutralizing antibody, an understanding of the current mutations of concern is required. The identification of “variants of concern” in several parts of the world (including those first identified in the UK, South Africa, Brazil, and the U.S. but now detected in multiple countries) has elevated recognition and prompted investigation.15, 17, 18 More variants continue to be identified globally as countries initiate enhanced sequence surveillance programs. What do you know about each of these "variants of concern?"
How can we help ensure vaccines are effective against variants?
More variants continue to be identified globally as countries initiate enhanced sequence surveillance programs, with the greatest focus on mutations in the spike protein. All currently approved vaccines (and most in development) target the viral spike protein, which contains the receptor-binding domain (RBD) that helps bind the virus to human receptor cells.
Analytical time: time to generate a result on the cartridge or analytical device.
This test has not been reviewed by the FDA. In the U.S., use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing.
Anterior nasal swab only available in the U.S. Product availability may vary by country and is subject to regulatory requirements.
Installed base of ADVIA Centaur XP, ADVIA Centaur XPT, and Atellica Solution analyzers.
IFCC interim guidelines on molecular testing of SARS-CoV-2 infection. https://doi.org/10.1515/cclm-2020-1412, September 18, 2020.
The SARS-CoV-2 molecular and antibody tests have not been FDA-cleared or approved. These tests have been authorized by FDA under an EUA for use by authorized laboratories. The molecular test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The antibody test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. These tests are 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. Product availability may vary from country to country and is subject to varying regulatory requirements.
Turnaround times are calculated based on theoretical analysis with one NUCLISENS EASYMAG and one Thermo Fisher ABI7500; not based on real workflow study. Using more instruments would decrease the total turnaround time.
FTD SARS-CoV-2 Assay (CE-IVD) Instructions for Use 11416283_en Rev. B, 2020-12 and FTD SARS-CoV-2 Assay (EUA) Instructions for Use 11416299_en Rev. C, 2021-01.
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data. Accessed on March 2, 2021.
Data on file at Fast Track Diagnostics, A Siemens Healthineers Company, Luxembourg.
Evaluation of sensitivity and specificity of four commercially available SARS-CoV-2 antibody immunoassays. Public Health England. 2020 Jul. GW-1386
The fingerstick claim has not been reviewed by the FDA and is not available in the U.S. Claims may vary by country and are subject to varying regulatory requirements.
Installed base of ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP, Atellica Solution, Dimension Vista®, and Dimension® EXL™ analyzers.
Lauring, AS and Hodcroft EB. Genetic Variants of SARS-CoV-2—What Do They Mean? JAMA February 9, 2021 Volume 325, Number 6. 529-531. doi:10.1001/jama.2020.27124
https://www.independent.co.uk/news/world/asia/wuhan-covid-variants-december-2019-who-investigation-b1802393.html. Accessed Feb. 15, 2021
Fontanet, A. et al. SARS-CoV-2 variants and ending the COVID-19 pandemic. www.thelancet.com Published online February 11, 2021 https://doi.org/10.1016/S0140-6736(21)00370-6.
JR Mascola et al. SARS-COV-2 Viral variants—Tackling a moving target. JAMA DOI: 10.1001/jama.2021.2088 (2021).
MMWR / January 22, 2021 / Vol. 70 / No. 3. 95-99. https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7003e2-H.pdf
Wu, K. et al. mRNA-1273 vaccine induces neutralizing antibodies against spike mutants from global SARS-CoV-2 variants. bioRxiv 2021.01.25.427948; doi: https://doi.org/10.1101/2021.01.25.427948
Xie, X., Liu, Y., Liu, J. et al. Neutralization of SARS-CoV-2 spike 69/70 deletion, E484K and N501Y variants by BNT162b2 vaccine-elicited sera. Nat Med (2021). https://doi.org/10.1038/s41591-021-01270-4
Challen R, Brooks-Pollock E, Read J M, Dyson L, Tsaneva-Atanasova K, Danon L et al. Risk of mortality in patients infected with SARS-CoV-2 variant of concern 202012/1: matched cohort study. BMJ. 2021;372(579). doi:10.1136/bmj.n579
Galloway SE et al. Emergence of SARS-CoV-2 B.1.1.7 Lineage — United States, December 29, 2020–January 12, 2021. MMWR Morb Mortal Wkly Rep 2021;70:95–99. DOI: http://dx.doi.org/10.15585/mmwr.mm7003e2external icon.
Collier, D.A. et al. SARS-CoV-2 B.1.1.7 escape from mRNA vaccine-elicited neutralizing antibodies. medRxiv 2021.01.19.21249840; doi: https://doi.org/10.1101/2021.01.19.21249840
Wibmer C.K. et al. SARS-CoV-2 501Y.V2 escapes neutralization by South African COVID-19 donor plasma. bioRxiv 2021.01.18.427166; doi: https://doi.org/10.1101/2021.01.18.427166
Johnson & Johnson announces single-shot Janssen covid-19 vaccine candidate met primary endpoints in interim analysis of its phase 3 ENSEMBLE trial. https://www.jnj.com/johnson-johnsonannounces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interimanalysis-of-its-phase-3-ensemble-trial.
https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html
Claims for neutralizing antibody detection and vaccine response for assays offered by Siemens Healthineers have not been reviewed by the FDA and are not available in the U.S.
Piccoli, L. et al. Mapping neutralizing and immunodominant sites on the SARS-CoV-2 spike receptor-binding domain by structure-guided high-resolution serology, Cell (2020), doi: https://doi.org/10.1016/j.cell.2020.09.037.
Premkumar et al. The receptor binding domain of the viral spike protein is an immunodominant and highly specific target of antibodies in SARS-CoV-2 patients. Sci. Immunol. 10.1126/sciimmunol.abc8413 (2020).
Wajnberg, A. et al., Robust neutralizing antibodies to SARS-CoV-2 infection persist for months. Science. 2020 Dec 4;370(6521):1227-1230. doi: 10.1126/science.abd7728. Epub 2020 Oct 28. PMID: 33115920; PMCID: PMC7810037.
https://www.medrxiv.org/content/10.1101/2020.12.09.20245175v1 (same data from Pfizer FDA VRBPAC report)
Wibmer C.K. et al. SARS-CoV-2 501Y.V2 escapes neutralization by South African COVID-19 donor plasma. bioRxiv 2021.01.18.427166; doi: https://doi.org/10.1101/2021.01.18.427166
Gundlapalli, A.V. et al. CDC COVID-19 Response, SARS-CoV-2 Serologic Assay Needs for the Next Phase of the US COVID-19 Pandemic Response, Open Forum Infectious Diseases, Volume 8, Issue 1, January 2021, ofaa555, https://doi.org/10.1093/ofid/ofaa555
Semi-quantitative claims for ADVIA Centaur COV2T have not been reviewed by the FDA and are not available in the US.
