18th May 2020 Author: Paul Carton
Abbott Agrees With FDA To Perform Post-Market Study on Questionable COVID-19 Test
Abbott Laboratories has agreed with the US FDA to conduct post-market studies on its ID NOW™ COVID-19 test, due to reports of false-negatives. The FDA has confirmed it will review the study's interim data on an ongoing basis and has alerted the public, via a press release, about "early data that suggest potential inaccurate results" with the test.
The ID Now COVID-19 test was hailed as the fastest RT-PCR test to detect SARS-CoV-2. Abbott claimed it could provide a positive result from sample in 5 minutes, with 15 minutes required for a negative.
However last month, a validation study was carried out by two research teams; The Cleveland Clinic and The University of Pittsburgh, which found false-negative rates of approximately 15% and 50% respectively.
After talks between Abbott and the research teams, Abbott concluded the test was not used correctly, and the reasons for these false-negatives was due to the use of viral transport media that diluted the samples. Abbott stated, that as it is a point-of-care test, nasal, throat and nasopharyngeal specimens should be placed directly into the ID NOW device. Subsequently, the FDA amended the EUA 'Instructions For Use' (IFU) document for the test accordingly, as requested by Abbott.
At present, the FDA has received 15 adverse event reports about the Abbott ID NOW device, which has led to suggest its inaccuracy. There is currently 18,000 ID NOW devices in doctors offices, clinics and hospitals. And so, while this study is being carried out the FDA has informed users that the test can still be used, and can correctly identify many positive cases in minutes, but that negative results may need to be confirmed with a high-sensitivity authorized molecular test.
In tandem with the FDA's alert, Abbot issued the following statement: "While we understand no test is perfect, test outcomes depend on a number of factors including patient selection, specimen type, collection, handling, storage, transport and conformity to the way the test was designed to be run. ID NOW is intended to be used near the patient with a direct swab test method."
The new study, by Abbott and under FDA review, will include at least 150 COVID-19 positive patients in a variety of clinical settings. Abbott has also promised to continue to optimize the test and to clarify product information to provide better guidance to healthcare providers.
Date Published: 18th May 2020