Multiplex CLIA-waived point-of-care tests for SARS-CoV-2, influenza A and B, ± other respiratory pathogens: A systematic review

Abstract

Background: Many multiplex CLIA-waived point of care tests are available in the United States for community pharmacists to incorporate into their practice.

Objective: To characterize the eleven multiplex CLIA-waived point of care tests available for detecting SARS-CoV-2 and influenza A and B ± other respiratory pathogens and summarize their performance characteristics from published studies.

Methods: Food and Drug Administration websites and databases were utilized to identify currently available tests. Literature searches were conducted and most recently updated through July 21, 2023 to identify studies examining the tests' performance. Primary literature was included if it reported positive and negative percent agreement (PPA and NPA, respectively) for SARS-CoV-2 or influenza A or B, had a comparator, and was conducted in a CLIA-waived environment. Relevant study characteristics, including number of samples, sample collection method, age of participants, comparator, PPA/NPA for SARS-CoV-2, influenza A and B, and respiratory syncytial virus (RSV) were extracted. Data extraction was performed by two authors with any discordant data reconciled by a third author.

Results: Twenty-eight studies met inclusion criteria. The PPA for SARS-CoV-2 ranged from 86.7% to 100%, and NPA ranged from 90.4% to 100%. The PPA for influenza A and B ranged from 92.9% to 100% and 95.3% to 100%, respectively, while NPA ranged from 96.6% to 100% and 98.2% to 100%, respectively. Both the Xpert Xpress Plus and SpotFire tests showed similar results for RSV with PPA ranging from 96.3% to 100% and NPA ranging from 98.4% to 100%.

Conclusion: Currently available multiplex POCT for SARS CoV-2 and influenza A and B ± RSV have demonstrated efficacy in detecting multiple pathogens in a single test. Pathogen detection, costs, materials needed to perform the test (eg, readers), and study data (PPA and NPA) should be utilized to help determine which tests should be ordered for a particular practice setting.