Clinical Performance of the BD Respiratory Viral Panel for BD MAX™ System in Detecting SARS-CoV-2, Influenza A and B, and Respiratory Syncytial Virus.
Diagn Microbiol Infect Dis
; 110(3): 116482, 2024 Nov.
Article
in En
| MEDLINE
| ID: mdl-39142094
ABSTRACT
Using a nasopharyngeal (NP) or anterior nasal (NS) swab from prospectively collected or retrospective specimens, we assessed the clinical performance of the BD Respiratory Viral Panel (BD RVP) for BD MAX System against FDA-cleared or authorized comparators. Across prospective and retrospective specimens, positive percent agreement (PPA) was ≥ 98.4% for SARS-CoV-2, ≥ 96.7% for influenza (flu) A, ≥ 91.7% for respiratory syncytial virus (RSV), and 100% for flu B (retrospective only) while negative percent agreement (NPA) was ≥ 97.7% across all targets, leading to the assay FDA clearance. A head-to-head comparison of NS versus NP results with BD RVP was also performed; PPA was ≥ 90% and NPA ≥ 98.2% for SARS-CoV-2, flu A and RSV. These findings confirm that the BD MAX RVP assay performs well for detection and differentiation of the three viruses in NP and NS specimens, with strong interrater agreements for NS versus NP comparisons.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Influenza A virus
/
Influenza B virus
/
Nasopharynx
/
Respiratory Syncytial Virus Infections
/
Influenza, Human
/
SARS-CoV-2
/
COVID-19
Limits:
Adolescent
/
Adult
/
Aged
/
Child
/
Female
/
Humans
/
Middle aged
Language:
En
Journal:
Diagn Microbiol Infect Dis
/
Diagn. microbiol. infect. dis
/
Diagnostic microbiology and infectious disease
Year:
2024
Document type:
Article
Country of publication:
Estados Unidos