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

Findings from a brand new research led by UMass Chan Medical Faculty 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 throughout 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 line 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 staff has been working for the previous yr to make sure that the very best proof was generated for efficiency of speedy antigen exams in asymptomatic individuals, in line with Apurv Soni, MD, Ph.D., assistant professor of medication and principal investigator on the research.

The FDA’s security communication recommends individuals carry out repeat, or serial, testing following a unfavourable consequence on any at-home COVID-19 antigen take a look at. If repeat testing just isn’t carried out after a unfavourable consequence, 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 unfavourable consequence 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 speedy antigen take a look at efficiency serially over two weeks. The outcomes of this research present that speedy exams detect the omicron in addition to delta variants and that serial testing with antigen exams stays a helpful option to detect an infection,” stated co-author Nathaniel Hafer, Ph.D., assistant professor of molecular drugs and lead investigator of the RADx Tech Scientific Research Core Logistics Workforce.

The research evaluation checked out 5,609 eligible individuals over age 2 throughout the nation, from amongst 7,361 who had been enrolled within the nationwide Take a look at Us At Residence research, performed by the RADx Tech Scientific Research Core between October 2021 and January 2022. Members took an at-home antigen take a look at utilizing one in all three retail take a look at kits, which can be found in the US, 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.

Through the take a look at interval, 154 individuals examined optimistic for SARS-CoV-2 an infection based mostly 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 individuals began testing throughout the first week of an infection, the research reviews.

Amongst those that didn’t have signs however had an an infection lasting a minimum of two days based mostly 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, corresponding to sporting masks and avoiding crowded locations, for a minimum of six days till three at-home antigen exams taken 48 hours aside have been carried out, in line with the research’s authors.

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