Abbott ID Now rapid coronavirus test misses as many as half of positive COVID-19 cases, NYU Study Says. (33% false positives and 48% false negatives)

In April, we wrote about the coronavirus antibody test developed by pharmaceutical giant Abbott Laboratories. The ID Now rapid test, which was able to perform a coronavirus test in just 5 minutes, was  authorized for emergency use by the The U.S. Food and Drug Administration (FDA). Now, it turns out the test might not be as reliable as many had hoped.

According to a new study conducted by New York University (NYU), the FDA-authorized ID NOW COVID-19 test from Abbott Laboratories, may have missed as many as half of positive cases. The study was published on BioRxiv, a server where researchers post early work before it has been reviewed by other scientists.

The analysis, which has not yet been confirmed or peer reviewed, found that Abbott’s ID NOW missed at least one-third of positive cases detected with a rival test and as much as 48% of the samples were tested positive using Cepheid GeneXpert, a standard reference test sold by Danaher Corp. The coronavirus test data also shows 33% false negatives in assays and 50% false negatives in nasal swabs.

“The need to identify the COVID-19 positive cases quickly and accurately has propelled the release of a variety of assays intended to meet the urgent demand. Several Nucleic Acid Amplification Tests (NAAT) platforms are currently available. Our laboratory currently uses two real time RT-PCR platforms, the Roche Cobas SARS-CoV2 and the Cepheid Xpert Xpress SARS-CoV-2. Both platforms demonstrate comparable performance; however the run times for each assay are 3.5 hours and 45 minutes, respectively,” the authors of the study said.

“Regardless of method of collection and sample type, Abbot ID NOW COVID-19 missed a third of the samples detected positive by Cepheid Xpert Xpress when using NP swabs in VTM and over 48% when using dry nasal swabs,” the study concludes.