FDA Flags Accuracy Issues With COVID-19 Test Kit And Software

TaqPath Kit was one of the first commercial test kits that the FDA granted an emergency use authorization to in March 2020. Since getting the green light these test kits served as the base of several widely employed diagnostics which includes the at-home sample collection kits that were developed by Rutgers University and P23 Labs, among other COVID-19 assays that have been used with validated modifications. 

The FDA has issued an alert due to the risk of inaccurate results to clinical laboratory staff and healthcare providers that points to insufficient mixing of samples linked to inadequate vortexing and centrifugation of the test’s RT-PCP reaction to plates which can cause false-positive results. The company has updated the instructions to reduce the risk, this affects the test itself and any associated versions that have been used since getting the authorization use back in mid-March of 2020 to present. 

Another issue was traced to the assay’s internal positive controls and the software used to interpret the results on the company’s Applied Biosystems instruments which were also widely employed by other FDA authorized coronavirus test kits dating back to March 2020 to present as well.

Along with urging routine plate level checks to ensure accuracy, in the alert the agency is recommending that staff promptly update the device’s software to a newer version and complete a digital tutorial on the proper use, as well as review the amplification curves for all positive results to determine whether a plate should be requested. The FDA is working with the company to resolve these issues.