Coronavirus testing ramps up: What does an antibody reveal?

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As officials cautiously begin discussing potential steps to take in order to safely reopen the country without creating another spike in new coronavirus cases, antibody or serology testing has become an increasingly hot topic.

New York Gov. Andrew Cuomo announced on Wednesday that the state’s health department had developed its own antibody test and would begin the process later this week, and several others are likely to follow suit. He said testing would be offered to first responders health care workers, and essential workers first.

But what is an antibody test, and what does it prove?

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On April 1, the Food and Drug Administration (FDA) issued its first approval for qSARS-CoV-2 IgG/IgM rapid test made by Cellex Inc. The test seeks to detect IgM and IgG antibodies against SARS-CoV-2 in serum, plasma or venipuncture whole blood from individuals who are suspected to have had COVID-19.

IgG and IgM are antibodies that the body’s immune system produces in response to a virus, and are detectable as soon as several days after initial infection, according to the FDA.

“Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection,” according to the agency.

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However, the agency cautions that it’s also possible a serology test can produce a negative test result in patients if the antibodies have not yet developed, or a false positive in patients who have developed antibodies to another coronavirus separate from COVID-19.

Knowing who has the antibodies in their blood could give officials a better understanding of how widespread the virus is, while also giving researches a better understanding of how sick it makes most people, and what happens if people who have had it are exposed for a second time.

Knowing who has the antibodies combined with other relevant health information may also help officials determine who can safely return to work once the stay-at-home orders are lifted, as well as who should be considered for blood plasma donation to help those who are critically ill.

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As of Thursday, the FDA had not approved any at-home antibody testing, nor has it approved any at-home testing kits for COVID-19.

The FDA has, however, granted emergency authorization to dozens of companies for COVID-19 testing, and has worked with more than 230 developers who are in the process of or are expected to apply for such approval. Separately, a handful of states have relied on their own health departments to develop COVID-19 testing in a bid to cut delays in results and federal red tape.

There is a major difference in how the COVID-19 test and the serology test is conducted, as the antibodies are detected through a blood sample while the coronavirus test relies on a molecular sample taken from the suspected patient’s respiratory system. Suspected COVID-19 patients who are tested are given Nucleic acid amplification tests, or NAAT tests, which detects the virus’ genetic material on a molecular level, according to the FDA.

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Doing so involves taking a sample from the back of the throat with a cotton swab, and the sample is then sent off to a lab for testing. The lab will conduct a polymerase chain reaction test, which identifies two specific genes from the virus. If the results only detect one of the genes, the results are deemed inconclusive, according to Medical News Today.

Similar to how the serology test cannot determine current COVID-19 tests, the NAAT test cannot determine whether a person has developed antibodies.

A full list of companies granted emergency use authorization for either COVID-19 or antibody testing can be found here and include:

Maccura Biotechnology (USA) LLC

Mount Siani Laboratory

Chembio Diagnostic System, Inc

Ortho Clinical Diagnostics, Inc.

Atila BioSystems, Inc.

DiaCarta, Inc

Becton, Dickinson & Company

InBios International, Inc

Gnomegen LLC

Co-Diagnostics, Inc.

ScienCell Research Laboratories

Luminex Corporation

Becton, Dickinson & Company (BD)

Ipsum Diagnostics, LLC

Cellex Inc.

Qiagen GmBH

Luminex Molecular Diagnostics, Inc.

Abbott Diagnostics Scarborough, Inc.

BGI Genomics CO. Ltd

Avellino Lab USA, Inc.

PerkinElmer, Inc.

Mesa Biotech Inc.

BioFire Defense, LLC

Cepheid

Primerdesign Ltd.

GenMark Diagnostics, Inc.

Diasorin Molecular LLC

Abbott Molecular

Quest Diagnostics Infectious Disease, Inc.

Quidel Corporation

Laboratory Corporation of America (LabCorp)

Hologic, Inc.

Thermo Fisher Scientific, Inc.

Roche Molecular Systems, Inc (RMS)

Wadsowrth Center, New York State Department of Public Health’s (CDC)

Centers for Disease Control and Prevention’s (CDC).

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