FDA Authorizes SARS-CoV-2 Neutralizing Antibody Kit. What Is It?

Diazyme Laboratories received Emergency Use Authorization (EUA) from the FDA last Tuesday, Dec. 6, 2022, for their SARS-CoV-2 Neutralizing Antibody CLIA Kit.

Diazyme Laboratories is located in Poway, Calif., primarily using its proprietary enzyme technologies to develop diagnostic reagents imposed on most automated chemistry analyzers in simple formats. Some of their products range in test kits for diagnosis of cardiovascular disease, liver disease, cancer markers, renal disease, diabetes, and electrolytes.

The antibody test designed by Diazyme assesses antibodies to the virus that causes COVID-19. Antibody tests are not designed to show if you have COVID-19, if signs of COVID-19 appear, be sure to take a COVID-19 test that may determine if you contain the virus.

SARS-CoV-2 causes COVID-19, a new virus in humans causing a contagious respiratory illness. COVID-19 can present with a mild to severe illness with symptoms including loss of taste, and smell, difficulty breathing, fever, or cough.

Risks of the Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit according to the FDA include possible discomfort or complications during sample collection and the possible incorrect test result. It can take one to three weeks for COVID-19 antibodies to appear in the body after contracting the virus.

A positive result from the Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit may indicate a previous episode of COVID-19, or may occur after receiving a COVID-19 vaccination — research has not concluded why positive tests occur after some cases of vaccination.

If found negative for COVID-19 antibodies, the practice of the test may have occurred too early on in the illness to detect antibodies. Also, COVID-19 may have never been present.

The FDA highlights tests’ effectiveness like the Diazyme kit is inconsistent.

“There is also a chance that this test can give a positive result that is wrong (a false positive result). Even a high-performing antibody test when used in a population without many cases of COVID-19 may produce as many or more false results as true results because the likelihood of finding someone who has been infected is very small.”

Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit is not yet FDA-approved and is only under EUA. The FDA emphasizes the EUA is supported by the Secretary of Health and Human Services (HHS) decree that circumstances exist to justify the emergency use of in vitro diagnostics to detect or diagnose COVID-19.

COVID-19 has first declared a U.S. Public Health Emergency on Jan. 31, 2020, with its most recent renewal as a still ongoing health emergency on Oct. 13, 2022.

Do COVID-19 antibodies make you immune to the virus?

No concrete evidence suggests antibodies prevent COVID-19 from occurring. The Centers for Disease Control (CDC) does not recommend antibody tests for determining immunity to COVID-19. However, produced research has found COVID-19 antibodies successful in fighting-off COVID-19 infections.

Their goal was to investigate evidence of SARS-CoV-2 infection based on a diagnostic nucleic acid amplification test (NAAT) within patients containing positive or negative test results of antibodies.

The study’s conclusion:

“In this cohort study, patients with positive antibody test results were initially more likely to have positive NAAT results, consistent with prolonged RNA shedding, but became markedly less likely to have positive NAAT results over time, suggesting that seropositivity is associated with protection from infection.”

Other research from Texas has sought the length of COVID-19 antibodies among vaccinated and unvaccinated individuals within the state. This study featured a large diverse sample size of 4,558 people ranging from grown adults to k-12 students, with 55% of the sample remaining unvaccinated and the median age existing at 49.7 years.

The Texas investigation found COVID-19 antibodies may remain further than 500 days after infection with the virus. Determining factors of how long antibodies to COVID-19 remain in the body include age, body mass index, smoking or vaping use, and disease severity.

The CDC still recommends all individuals stay up-dated on their vaccinations for all age groups. If you have contracted COVID-19, the CDC recommends waiting three months before receiving a booster for the virus.

Current approved COVID-19 vaccines in the U.S. include Pfizer-BioNTech, Moderna, Novavax, and Johnson & Johnson’s Janssen which the CDC highlights safety concerns.

COVID-19 has evolved with time, making it important to stay in touch with booster technology. Updated boosters titled “bivalent” protect against the original form of the virus along with the Omicron BA.4 and BA.5 variants. Older boosters known as “monovalent” were crafted to protect against the virus’ original form along with offering slight protection to Omicron.

There have been 99,241,649 cases of COVID-19 in the U.S. and over one million deaths. Currently, 69.4% of Americans are reported to be vaccinated against the virus as of Monday, Dec. 12, 2022.

The CDC website found a 49.6% increase in covid cases last week compared to previous seven-day averages, meaning the virus is on the rise as colder temperatures and in-door huddling increase.


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