Why the Accuracy of SARS-CoV-2 Antibody Tests Varies So Much

Why the Accuracy of SARS-CoV-2 Antibody Tests Varies So Much

Due to the massive pressure from both policymakers and researchers, the test figures for the COVID-19 patients has skyrocketed in the past few weeks. According to a non-profit organization called Foundation for Innovative New Diagnostics, around 200 serologic test products are either in development or available in the market. Most of these test product manufacturers are based in China and some other countries such as South Korea, India, Germany, the US, and the UK.

Among all these test kit manufacturers only twelve have received emergency use authorization from the United States FDA or Food and Drug Administration. The authorization gives the brand, permission to deploy a specific product without providing any amount of evidence that is required in the typical approval process. In the month of March, the US Food and Drug Administration announced that in order to expedite availability, brands can market these test products all throughout the US without the EUA as long as they are duly conducting their own evolution. As on the 4th of May, the agency made an announcement that it would help in heightening the scrutiny of these test kits, after the flawed test results that became readily available in the markets of the US.

As the policymakers and the researchers rush around the world to use these tests, several questions have been raised about their precision. In some cases, these test kits have turned to be too inaccurate for use over the mass. Just a month back, the British government shelved a rapid COVID-19 antibody test kit, worth $20 million USD, just because the results were incomplete and inadequate.

Accuracy Assessment Of COVID-19 Test Kits

As of now several other groups are conducting independents testing of these faulty coronavirus test kits. According to them, there is really a wide difference in their performance. They further stated that the actual accuracy of these test depends only on the actual test, but can interpret the results depending on factors such as when and how it is performed.

Their results found that the ability to detect antibodies among the people increases over time, rising to almost 100 percent when more than twenty days have elapsed after the first showing of symptoms. According to a bioengineer called Patrick Hsu, this finding actually highlights why longitudinal antibody testing is actually important. It was later identified that the test specificity was actually 97 percent and it only identified antibodies in 37 percent of the samples from approximately two to five days after showing the symptoms. Identically it was 90 percent after twenty days of being infected which was really inconclusive. So, the bottom line is that we need more independent evaluations to know how good these tests are.

While all the countries across the world are facing the coronavirus pandemic with courage, the nurses, doctors, and the medical facility remains to be in the front line of defense. Recent data suggest that there is a big shortage of medical authorities and trained nurses in the United States. In order to fill that shortage, the Centers For Disease Control and Prevention, along with some other American government institutions came up with some great plans and ideas. These plans include several notifications for the Higher education institutes and the nursing schools of the US to fight bravely against this pandemic. Erudite online nursing school came up with an idea to provide online courses including some accelerated nursing programs to further help the nurses fight against the dreaded Coronavirus disease.

Sources-

https://www.cdc.gov/coronavirus/2019-ncov/index.html

https://www.osha.gov/SLTC/covid-19/controlprevention.html#health

https://www.fda.gov/home

https://www.nih.gov/

 

Note: The foregoing article and information contained therein may be copyrighted and may not be reproduced in part or entirety without advance written permission. For permissions or editorial corrections, contact: Ms. Kelsey Hanna, khanna@EruditeNursing.education. All information is provided for informational purposes and deemed to be correct at the time of publication, but may change with or without notice; no guarantees are made as to accuracy and all liability is hereby released as to the same.

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