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Objective The aim of the study was to compare the cost and clinical impact of repeating BioFire FilmArray gastrointestinal (GI) and respiratory (RP) panel assays with 3 vs 4 pathogen targets positive. Method We analyzed 12,027 GI and RP panels to evaluate our retesting policy, which retested panels with 3 or more detected pathogens (3-pathogen protocol) compared with the manufacturer’s 4-pathogen (4-pathogen protocol) recommendation. We compared the retesting results, calculated the cost implications, and reviewed the clinical impact on antibiotic prescriptions and patient outcomes. Results Retesting with our 3-pathogen protocol revealed that 81% (39/48) of GI and 76% (26/34) of RP panels had identical results, whereas 19% (9/48) of GI and 24% (8/34) of RP panels showed discrepancies on retesting. The additional cost incurred by our protocol compared with the manufacturer’s protocol was $9820.32. There was no evidence that our more stringent policy affected antibiotic prescription or clinical outcomes. Conclusion Our more stringent 3-pathogen protocol for retesting panels did not improve patient management compared with the manufacturer’s 4-pathogen protocol but resulted in unnecessary costs and increased the risk of depleting testing kits during supply shortages. Consequently, we adopted the manufacturer’s suggestions, highlighting the need to balance clinical rigor with cost-effectiveness in laboratory testing protocols.
Objective The aim of the study was to compare the cost and clinical impact of repeating BioFire FilmArray gastrointestinal (GI) and respiratory (RP) panel assays with 3 vs 4 pathogen targets positive. Method We analyzed 12,027 GI and RP panels to evaluate our retesting policy, which retested panels with 3 or more detected pathogens (3-pathogen protocol) compared with the manufacturer’s 4-pathogen (4-pathogen protocol) recommendation. We compared the retesting results, calculated the cost implications, and reviewed the clinical impact on antibiotic prescriptions and patient outcomes. Results Retesting with our 3-pathogen protocol revealed that 81% (39/48) of GI and 76% (26/34) of RP panels had identical results, whereas 19% (9/48) of GI and 24% (8/34) of RP panels showed discrepancies on retesting. The additional cost incurred by our protocol compared with the manufacturer’s protocol was $9820.32. There was no evidence that our more stringent policy affected antibiotic prescription or clinical outcomes. Conclusion Our more stringent 3-pathogen protocol for retesting panels did not improve patient management compared with the manufacturer’s 4-pathogen protocol but resulted in unnecessary costs and increased the risk of depleting testing kits during supply shortages. Consequently, we adopted the manufacturer’s suggestions, highlighting the need to balance clinical rigor with cost-effectiveness in laboratory testing protocols.
Diagnosis of Bordetella pertussis is made by using polymerase chain reaction (PCR) to detect insertion sequence 481 (IS 481 ). However, IS 481 is found in both B. pertussis and Bordetella holmesii . In a recent study, Cole et al. (Microbiol Spectr 12:e00783-24. https://doi.org/10.1128/spectrum.00783-24 ) compared the accuracy of assays performed at two different commercial laboratories that used IS 481 as a molecular target against a multiplex PCR assay performed at the Centers for Disease Control and Prevention (CDC) that can differentiate the different Bordetella species. The results demonstrated that the overall agreement among the assays from the commercial laboratories and the CDC was 85%. Only a small percentage (1.4%) of specimens positive for IS 481 were identified as B. holmesii . This study suggests that PCR tests using IS 481 as a target provide reliable diagnosis for pertussis. However, end users should recognize the limitations of PCR testing for pertussis including the inability to differentiate and monitor transmission of non-pertussis Bordetella species.
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