False negative results caused by erroneous automated result interpretation algorithm on the FilmArray 2.0 instrument

What is it about?

We report a series of false-negative results from the FilmArray 2.0 instrument during a verification study to evaluate the diagnostic performance of the FDA-approved FilmArray meningitis/encephalitis (ME) syndromic panel (adapted on the sample-to-result FilmArray 2.0 instrument, BioFire Diagnostics LLC, Salt Lake City, UT) and subsequent routine clinical testing. To investigate the possible root-cause of the discrepant results, we manually inspected and analysed the melt signals for all the runs from the verification exercise. After examining the melt curves for each of the targets, we were able to identify patterns that were indicative of a poor analytical run, which was falsely accepted by the instrument software, leading to erroneous test results.

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