thevaccinereaction--2020-06-27--Rapid Tests for Coronavirus Raise Concerns Over Accuracy

On Mar .
27 , 2020 , the U.S. Food and Drug Administration ( FDA ) issued Emergency Use Authorization ( EUA ) to pharmaceutical and medical devices company Abbott Laboratories , Inc. of Abbott Park , Illinois for a rapid diagnostic test for the SARS-CoV-2 virus known as ID NOW.1 2 3 “ We know how important it is to get point-of-care tests out in the field quickly .
These tests that can give results quickly can be a game changer in diagnosing COVID-19 , ” FDA commissioner Steve Hahn said.1 Abbott ’ s ID NOW test is a @ @ @ @ @ @ @ is about the size of a toaster .
At the time it was granted the EUA , Abbott had approximately 18,000 ID NOW devices in the United States and the company said it planned to manufacture more so that it could provide 50,000 tests per day .
According to Abbott , ID NOW can deliver “ positive results in as little as five minutes and negative results in 13 minutes.
” 1 2 3 “ The COVID-19 pandemic will be fought on multiple fronts , and a portable molecular test that offers results @ @ @ @ @ @ @ of diagnostic solutions needed to combat this virus , ” Abbott president and CEO Robert Ford said .
“ With rapid testing on ID NOW , healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots.
” 2 3 The FDA also granted SARS-CoV-2 rapid test EUAs to Cepheid , Inc. of Sunnyvale , California for its Xpert Xpress test and Mesa Biotech , Inc. of San Diego , CA for its Accula test .1 2 4 5 6 The idea behind the increased reliance @ @ @ @ @ @ @ more coronavirus testing of the population .
Not only do these tests allow results to be available within half an hour , they can be administered in a wider variety of health care settings , including doctor ’ s offices .
The more traditional tests for SARS-CoV-2 that are sent off to labs for evaluation take between 24 to 48 hours to obtain results.7 The rapid tests are faster and more convenient .
Joe Petrosino , PhD , chair of molecular virology and microbiology at Baylor College of Medicine , compares to going @ @ @ @ @ @ @ chain ” or a “ gourmet restaurant.
” 7 The problem with the rapid tests , however , is that they ’ re not nearly as reliable as the tests sent to labs for processing .
While most of the PCR ( polymerase chain reaction ) lab tests that take a couple of days to evaluate are more than 90 percent accurate , the rapid tests can be less than 80 percent accurate.7 The relative inaccuracy of the rapid tests means that these tests may be giving people who get them a false @ @ @ @ @ @ @ t think there ’ s a lot of awareness about the differences between rapid tests and the more traditional lab , send it out , 24 to 48 hour results type tests .
It ’ s very important to know the difference .
If you go to a rapid clinic and come out with a negative result , you think you ’ re okay and you could be exposing and putting a lot of individuals at risk.7 “ There ’ s no way I would be comfortable missing two out of 10 patients @ @ @ @ @ @ @ , director of clinical microbiology at NewYork-Presbyterian/Columbia University Medical Center.8 On May 14 , 2020 , the FDA issued a warning to the public regarding the inaccuracy of Abbott ’ s ID NOW test .
The warning began : “ Today , the U.S. Food and Drug Administration is alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19 .
Specifically , the test may return false negative results.
” 9 10 “ We are still evaluating the information about inaccurate @ @ @ @ @ @ @ Abbott about this important issue .
We will continue to study the data available and are working with the company to create additional mechanisms for studying the test , ” said Tim Stenzel , MD , PhD of the FDA ’ s Center for Devices and Radiological Health.9 10 In a study conducted by researchers at New York University , the ID NOW test missed more than 48 percent of the SARS-CoV-2 samples found to be positive by Cepheid ’ s Xpert Xpress test .
Based on this finding , ID NOW may @ @ @ @ @ @ @ cases of the virus.11 A total of 3.7 million ID NOW tests have reportedly been delivered to all 50 states in the country.12