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Abbott ID Now Not So Ideal

Abbott ID Now, developed by Abbott Laboratories, was highly touted by President Trump and the White House COVID19 Task Force to be an accurate 13-minute test for SARS-CoV-2. Abbott has shipped more than 600,000 tests since being granted Emergency Use Authorization, (EUA), which included both direct testing of a nasopharyngeal swabs and testing of swabs placed in viral transport media.

According to Stat News, clinical laboratories have begun to express concerns about false negative rates in patients with lower viral loads. Abbott has attributed this problem to dilution of virus when swabs are placed in viral transport media. Abbott has now concluded that only dry swabs should be tested and has stated it will work with the FDA to amend its package insert by the week of April 20.

Abbott has also stated that the ID Now platform was designed for use in urgent care clinics, physician offices, emergency departments, and retail settings, where direct testing is performed, and viral transport media is not needed.

Researchers in the Department of Pathology at University Hospitals Cleveland Medical Center and Case Western Reserve University recently published results which confirmed the Stat news report. They compared the positive percent agreement of Abbott ID Now with a modified CDC assay, served as the reference method. Nasopharyngeal swabs were transported in universal transport media. Abbott ID Now failed to detect 6 of 96 positive specimens, giving a false negative rate of 6%.

Because of its higher false negative rate, health care systems are having second thoughts about using Abbott ID Now to rule out whether patients are carrying SARS-Cov-2.


Harper M. Rapid coronavirus test, commonly used in U.S., may miss infections in some situations., April 16, 2020

Rhoads, DD, et al. Comparison of Abbott ID Now, Diasorin Simplexa, and CDC FDA EUA methods for detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from individuals diagnosed with COVID-19, J Clin Microbiol posted online April 17, 2020, doi:10.1128/JCM.00760-20

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