ABSTRACT
Background. Limited availability of multiplex molecular tests in the near-patient setting can impact the rapid diagnosis and treatment of patients experiencing symptoms of respiratory tract infections, including pharyngitis. The BioFire Respiratory/ Sore Throat (R/ST) Panel (bioMerieux, Salt Lake City, UT), designed for use with the BioFire SpotFire System, is a PCR-based sample-to-answer diagnostic test that identifies four bacteria and 10 viruses (including SARS-CoV-2) from nasopharyngeal swab (NPS) or throat swab (TS) specimens in about 16 minutes. This study evaluated the performance of an Investigational Use Only (IUO) version of the BioFire R/ST Panel in the near patient setting. Methods. NPS and TS specimens were prospectively enrolled from symptomatic consented/assented volunteers of all ages, or obtained as residual leftover specimens. Enrollment was conducted between December 2020 and September 2021 at five study sites in the US and UK (adult and pediatric emergency departments or urgent care clinics) with testing performed by personnel representative of the intended users (non-laboratory professionals). Several analytes that were not circulating during the COVID-19 pandemic were supplemented with archived specimens of known analyte composition. Performance was determined for both sample types by comparison to FDA cleared multiplex PCR tests or culture and PCR followed by sequencing of isolates (Streptococcus from throat swabs). Results. A total of 1131 NPS and 452 TS prospectively collected specimens and 542 NPS and 128 TS archived specimens were tested with the BioFire R/ST Panel. For NPS specimens (prospective and archived) overall positive percent agreement (PPA) was 98.7% and negative percent agreement (NPA) was 99.1%, and for TS specimens (prospective and archived) overall PPA was 95.9% and NPA was 99.2%. Conclusion. The BioFire R/ST Panel is a sensitive, specific, and robust test for rapid detection of a wide range of organisms in NPS and TS specimens in the nearpatient setting. This test is expected to aid in the timely diagnosis and appropriate management of pharyngitis and other respiratory infections.
ABSTRACT
Background: The BioFire® COVID-19 Test is a qualitative test for use on the FilmArray® 2.0 and Torch systems for the detection of SARS-CoV-2 RNA in nasopharyngeal swabs (NPS) in transport media. This test received Emergency Use Authorization from the FDA. A closed, disposable pouch contains all the necessary reagents for sample preparation, nucleic acid extraction, reverse transcription, polymerase chain reaction (PCR), and amplified nucleic acid detection to identify RNA from SARS-CoV-2 virus in an NPS specimen. Internal controls monitor all stages of the test process. Once an NPS sample (0.3 mL) is loaded into the system disposable pouch (Figure 1), the fully automated test returns results within an hour. As an additional resource, the BioFire® COVID-19 Test External Control Kit (+) includes positive external control material that may be used for quality control and laboratory verification. Methods: The following were evaluated: • Limit of Detection (LoD) • Positive and Negative Percent Agreement (PPA and NPA, respectively) for clinical contrived samples and a limited number of clinical specimens • Exclusivity Results: • LoD The LoD was evaluated using live SARS-CoV-2 virus (cultured from the USA- WA1/2020 strain obtained from World Reference Center for Emerging Viruses and Arboviruses (WRCEVA)). The LoD was determined to be 3.3E+02 GC/mL (2.2E-02 TCID50/mL). • Clinical Contrived Accurate detection of virus in clinical matrix was demonstrated at various LoD levels using thirty contrived individual unique clinical samples (PPA), and 66 individual unique negative clinical specimens (NPA). • Clinical Samples Positive samples were collected from patients presenting with signs or symptoms of COVID-19, and who were previously identified as positive for SARS-CoV-2 by another EUA test. Negative samples were collected in 2018, and therefore presumed negative for SARS-CoV-2. • Exclusivity The potential for cross-reactivity was evaluated for six viruses from the same genetic family as SARS- CoV-2, and for an additional 30 high priority organisms/viruses. No cross-reactivity was observed. Conclusion: The BioFire COVID-19 Test reliably detects SARS-CoV-2 virus RNA in clinically relevant samples. (Table Presented).