Home » FDA recommendations based on new study highlighting serial testing with rapid antigen tests

FDA recommendations based on new study highlighting serial testing with rapid antigen tests

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Findings from a brand new research led by UMass Chan Medical College researchers are the premise for a security communication issued by the U.S. Meals and Drug Administration (FDA) Aug. 11 relating to serial use of at-home antigen exams for COVID-19.

The research outcomes present that at-home antigen exams usually tend to detect COVID-19 inside the first week of an infection when an individual with out signs exams 3 times, at 48-hour intervals, and an individual with signs exams twice, in accordance with the research by UMass Chan researchers and companions supported by the Nationwide Institutes of Well being (NIH) Fast Acceleration of Diagnostics (RADx) Tech program. The analysis appeared in medRxiv, a preprint on-line platform, and has not but been peer reviewed.

This research is a fruits of shut collaboration with the FDA and NIH. The UMass Chan workforce has been working for the previous yr to make sure that the most effective proof was generated for efficiency of fast antigen exams in asymptomatic folks, in accordance with Apurv Soni, MD, Ph.D., assistant professor of medication and principal investigator on the research.

The FDA’s security communication recommends folks carry out repeat, or serial, testing following a damaging outcome on any at-home COVID-19 antigen take a look at. If repeat testing will not be carried out after a damaging outcome, an an infection could also be missed and other people could unknowingly unfold the SARS-CoV-2 virus to others, particularly if they aren’t experiencing signs. The FDA recommends repeat testing following a damaging outcome whether or not or not an individual has COVID-19 signs.

“To our data, this is without doubt one of the largest research thus far that examined COVID-19 fast antigen take a look at efficiency serially over two weeks. The outcomes of this research present that fast exams detect the omicron in addition to delta variants and that serial testing with antigen exams stays a helpful approach to detect an infection,” stated co-author Nathaniel Hafer, Ph.D., assistant professor of molecular medication and lead investigator of the RADx Tech Medical Research Core Logistics Group.

The research evaluation checked out 5,609 eligible folks over age 2 throughout the nation, from amongst 7,361 who have been enrolled within the nationwide Check Us At House research, carried out by the RADx Tech Medical Research Core between October 2021 and January 2022. Contributors took an at-home antigen take a look at utilizing certainly one of three retail take a look at kits, which can be found in the USA, and picked up a pattern for a molecular PCR take a look at, utilizing nasal swabs for each sorts of take a look at samples. They examined themselves each 48 hours for 15 days.

Throughout the take a look at interval, 154 contributors examined constructive for SARS-CoV-2 an infection primarily based on molecular PCR assays.

Serial testing with an at-home antigen take a look at twice over 48 hours resulted in detection of greater than 90% of infections when symptomatic folks began testing inside the first week of an infection, the research studies.

Amongst those that didn’t have signs however had an an infection lasting at the very least two days primarily based on PCR testing, serial testing 3 times with an at-home antigen take a look at at 48-hour intervals detected greater than 75% of infections, a rise from roughly 60% sensitivity after testing simply twice.

An implication of findings from this research is that people who find themselves suspected to be contaminated with the SARS-CoV-2 virus however haven’t developed signs ought to train warning, equivalent to sporting masks and avoiding crowded locations, for at the very least six days till three at-home antigen exams taken 48 hours aside have been carried out, in accordance with the research’s authors.

Dr. Hafer added that this large-scale research was made attainable by its novel app-based digital enrollment and reporting options, developed by the UMass Chan Program in Digital Drugs, which is a way more streamlined methodology in contrast with conventional interventions in scientific trials. “This research demonstrates that it is attainable to quickly enroll and conduct scientific analysis with digital methods,” he stated. “We really feel that our contributors had a fairly seamless expertise. Nevertheless, this was the results of an amazing quantity of labor and coordination by our research workforce and our companions equivalent to Quest Diagnostics, CareEvolution, neighborhood well being facilities and fast take a look at producers.”


Examine: At-home COVID-19 antigen exams detect omicron and delta variants equally


Extra info:
Apurv Soni et al, Efficiency of Screening for SARS-CoV-2 utilizing Fast Antigen Checks to Detect Incidence of Symptomatic and Asymptomatic SARS-CoV-2 An infection: findings from the Check Us at House potential cohort research (2022). DOI: 10.1101/2022.08.05.22278466

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College of Massachusetts Medical College

Quotation:
FDA suggestions primarily based on new research highlighting serial testing with fast antigen exams (2022, August 12)
retrieved 14 August 2022
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