Multiplex PCR assay detects four respiratory viruses with single swab
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Key takeaways:
- The BD MAX Respiratory Viral Panel detected and differentiated between influenza A and B respiratory syncytial virus and SARS-CoV-2.
- The panel requires less than 1.5 minutes hands-on time per sample.
HOUSTON — A multiplex PCR assay was able to detect and differentiate between four respiratory viruses — influenza A and B, respiratory syncytial virus and SARS-CoV-2 — researchers reported at ASM Microbe.
To support an emergency use authorization (EUA) of the BD Respiratory Viral Panel for the BD Max system, Sonia Paradis, clinical project lead at Becton Dickinson and Company (BD), and colleagues assessed the ability of the assay to detect and differentiate between the viruses using a single nasopharyngeal or nasal swab.
For the study, they prospectively collected nasopharyngeal and nasal specimens at six sites in the United States from people with respiratory symptoms during the 2022 respiratory illness season and retrospectively collected nasopharyngeal swabs from two vendors from Dec. 20, 2019, through Jan. 11, 2022.
They tested the specimens on the BD MAX system and determined positive percent agreements (PPA) and negative percent agreements (NPA) with other assays and methods used to test the same specimens. In total they collected and tested 252 nasopharyngeal and 254 nasal specimens.
Among nasopharyngeal specimens, PPA and NPA were 98.8% (95% CI, 93.6-99.8) and 98.2% (95% CI, 94.9-99.4), respectively, for SARS-CoV-2, and 100% (95% CI, 61-100) and 99.6% (95% CI, 97.7-99.9), respectively, for influenza A.
For prospectively collected anterior nasal specimens, PPA and NPA were 98.8% (95% CI, 93.3-99.8) and 98.3 (95% CI, 95.1-99.4) for SARS-CoV-2 and 100% (95% CI, 61-100) and 99.6% (95% CI, 97.8-99.9) for influenza A.
Although they were unable to enroll anyone with a positive influenza B or RSV test, they were able to determine that the NPA for both influenza B and RSV was 100% for nasopharyngeal and nasal specimens.
Among the 240 retrospectively collected nasopharyngeal specimens, PPA was 100% (95% CI, 93.7-100) for influenza A, 100% (95% CI, 93.8-100) for influenza B, and 98.4% (95% CI, 91.5-99.7) for RSV were collected, whereas NPA was 98.9% (95% CI, 96.1-99.7), 98.9% (95% CI, 96.1-99.7) and 100% (95% CI, 97.9-100) for influenza A, influenza B and RSV, respectively.
Paradis said the results show that users of the investigational panel can obtain reliable results for all three respiratory illnesses. Specifically, she said reliable results can be obtained for 24 patients every 2 hours and 15 minutes with less than 1.5 minutes hands-on time per sample, making the test efficient.
“As seasonal outbreaks of SARS-CoV-2, flu A and B, and RSV often coincide and their symptomology are not easily differentiable without laboratory testing, the BD Respiratory Panel for BD MAX System will support accurate and concurrent diagnostic of these viruses,” Paradis concluded.