Abbott Laboratories (Abbott), a world-leading medical devices and healthcare company, is one of the leaders in Covid-19 testing with its three diagnostic PCR tests: the ID NOW, m2000, and Alinity m. Abbott has shipped nearly 4.5 million of its point-of-care (POC) ID NOW tests, and nearly 4 million of its molecular lab tests (m2000 and Alinity m) across the US as of July 1. Abbott’s POC ID NOW is the fastest Covid-19 PCR test on the market, turning around a positive result in just five minutes.
On May 12, a study was released from New York University (NYU), indicating that Abbott ID NOW Covid-19 tests are less effective than the Cepheid Xpert Xpress SARS-CoV-2 devices. The authors of this study found that the Abbot ID NOW Covid-19 device missed between 33.3% and 48.4% of positive samples detected by the Cepheid Xpert. Abbott has responded to this report by stating that the NYU investigators did not use their device as intended.
To date, over 60 reports have been made to the FDA Manufacturer and User Facility Device Experience (MAUDE) database, which is where adverse events involving medical devices are submitted. Similar to the NYU study, the reports submitted to MAUDE all cite discrepancies in Abbott’s rate of false negatives. A false negative is when a patient receives a negative test result, but is in fact, positive for the disease. In the case of the Abbott ID NOW Covid-19 test, this means that patients could be receiving the “all clear” when, in fact, they have the disease. False negatives increase the risk that patients will not self-isolate or practice other precautions, such as wearing a mask, since they are given a false sense of security, and will go on to spread the disease.
Overall, evaluations of the Abbott test have been highly controversial with some researchers finding that the test has accuracy problems, but others saying the test still proves useful. The majority of Covid-19 tests in the US are being performed by high-throughput solutions such as those provided by Abbott, Quidel Corp, and Integrated DNA Technologies Inc, which have a lower average selling price per test. However, higher-priced products such as the Abbott ID NOW Covid-19 and Cepheid Xpert Xpress SARS-CoV-2 are appealing due to their shorter turnaround time.