The COVID-19 Testing Toolkit
Tests in the diagnosis of current infection:
- Rapid antigen testing at the point of care can be performed anywhere that fast diagnosis of COVID-19 is needed, for patients with or without COVID-19 symptoms. Nasal specimens can be collected by a healthcare provider or self-collected under the supervision of a healthcare professional. No laboratory personnel or equipment are required. Rapid antigen tests can also be used for self-testing at home in some countries.
- Laboratory-based antigen testing can be used to identify currently infected individuals quickly with improved workflow from swab to result in less than one hour. These tests enable community testing with fast, high-volume laboratory equipment and can deliver automated results, making reporting to public health authorities more streamlined.
- 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 identifies antibodies that may be present in a patient’s blood. These antibodies indicate whether an individual has generated an immune response to the virus. This testing is critical to determine the full scope of COVID-19 disease, combating the pandemic, and rebuilding public confidence. Our tests have been and continue to be engineered with the utmost focus on science – with many providing specificity above 99% and delivering low false positive rates. And with one of the largest installed bases of laboratory equipment worldwide, we’re able to provide access to high-quality testing to hundreds of thousands of patients. These tests are also key to enabling an effective vaccination strategy and helping in the pursuit to better understand immunity.
COVID-19 testing, explained
Testing at scale
As we look 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.
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.
Distributed by Siemens Healthineers. CLINITEST Rapid COVID-19 Antigen Test: Not available for sale in the U.S. Product availability may vary by country.
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
Some claims are not available in all countries. The SARS-CoV-2 IgG assays are for semiquantitative use in the U.S. The semiquantitation claim for the SARS-CoV-2 Total assays is not available. The fingerstick claim is not available in the U.S. Claims for detection of neutralizing antibodies and correlation to PRNT are not available in the U.S. and are under development for the COV2T assays. Not available for sale in the U.S. Product availability may vary from country to country and is 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.
Mahase, E. Covid-19: Where are we on vaccines and variants? BMJ 2021;372:n597 http://dx.doi.org/10.1136/bmj.n597
Karim SA et al. New SARS-CoV-2 Variants — Clinical, Public Health, and Vaccine Implications. NEJM. March 24, 2021. DOI: 10.1056/NEJMc2100362
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