Ultimately, it is the responsibility of the laboratory director to determine the appropriate verification protocol to follow. However, if it becomes necessary to verify the performance of a loaner or repaired instrument, the following protocol may serve as a guideline:
- Select a few samples and/or proficiency samples (any combination of positives and negatives) previously tested on the BioFire® FilmArray® System. The laboratory director should determine the appropriate number of samples to test. Two to six samples may be sufficient. Proficiency samples should not be pooled or diluted.
- Test the selected specimens/samples on the loaner or repaired instrument and document the results.