The U.S. Food and Drug Administration has warned that one of the coronavirus testing systems currently in use in the U.S. may give more false negative results than expected, raising the likelihood that infected people may be unknowingly told they don’t have the disease. The U.S. Food and Drug Administration has warned that Abbott’s ID NOW test may be inaccurate, giving people with COVID-19 a false sense of security.
As early as February, Abbott’s ID NOW testing system was commissioned as part of the FDA’s EUA program. The purpose of the emergency use authorization system is to allow new treatments and diagnostic methods to be put into use as early as possible without approval. Abbott obtained the license on March 27 for molecular testing of the company’s ID NOW molecular platform machines. Part of the appeal is that it detects more than other coronaviruses, giving results in 13 minutes or less, rather than the hours required for many other systems. Over time, however, Abbott has modified the instructions for using the system for COVID-19 diagnostics.
In early May, for example, Abbott warned hospitals and academic laboratories not to use so-called viral transport media on such testing machines. It is a liquid used to store, store and transport virus samples. Basically, the cotton swab taken from the nasal sample is placed in a small bottle of transport fluid and then placed in ID NOW. Mr Abbott said the method would reduce the sensitivity of the test and could lead to false negative results. Instead, the sample swab should be applied directly to the machine.
This week, the FDA issued a warning about Abbott’s system in a spirit of transparency. The FDA said it was still evaluating information about the Abbott testing system and communicating directly with Abbott on this important issue to establish additional mechanisms to study the testing system. Currently, the testing system is still operational and can correctly identify many positive cases within minutes, and negative results may require reconfirmation using a highly sensitive authorized molecular detection system.