The clinical performance of the BioCode Respiratory Pathogen Panel for the detection of viruses and bacteria from nasopharyngeal swabs Journal Article
| Authors: | Zhang, X.; Knoth, C.; Pham, A.; Lima, A.; Dominguez, R.; Ibarra-Flores, I.; Lopez, J. C.; Uy, D.; Silbert, S.; Patel, A.; Aye, M.; Tang, Y. W.; Bard, J. D. |
| Article Title: | The clinical performance of the BioCode Respiratory Pathogen Panel for the detection of viruses and bacteria from nasopharyngeal swabs |
| Abstract: | Early detection ofmicrobial pathogens causing respiratory tract infection plays a crucial role in clinical management. The BioCode Respiratory Pathogen Panel (BioCode RPP) utilizes reverse transcriptase PCR (RT-PCR) in combination with barcoded magnetic beads to amplify, detect, and identify respiratory pathogens. This panel qualitatively detects and identifies 14 viruses, including influenza virus A with H1 pdm09, H1, and H3 subtyping; influenza B; respiratory syncytial virus (RSV); humanmetapneumovirus; parainfluenza virus 1; parainfluenza virus 2; parainfluenza virus 3; parainfluenza virus 4; coronavirus (229E, NL63, OC43, and HKU1); adenovirus; and human rhinovirus/enterovirus, and 3 bacteria, including Chlamydia pneumoniae, Mycoplasma pneumoniae, and Bordetella pertussis. Reproducibility, which was assessed with contrived specimens containing 12 targets at 3 clinical sites, with 2 operators at each site for 5 days, was 99.4% for Flu A H3 and Flu B, 98.9% for RSV, and 100% for the remaining 9 targets assayed. A multicenter clinical trial evaluated the performance of the BioCode RPP with 2,647 nasopharyngeal swab specimens from 5 geographically distinct sites and revealed comparable performance between the BioCode RPP and FilmArray Respiratory Panel (FA-RP). Specifically, the positive percent agreements (PPAs) for various pathogens ranged between 80.8% and 100% compared with the FA-RP (1.7 and 2.0). Negative percent agreement ranged from 98.4% to 100% for BioCode RPP. The BioCode RPP also offers scalable automated testing capability ofupto 96 specimens in a single runwith total sample-to-result time under 5h. The invalid rate of the BioCode RPP on initial testingwas 1.0%(26/2,649). IMPORTANCE Early detection of microbial pathogens causing respiratory tract infection plays a crucial role in clinical management. The BioCode Respiratory Pathogen Panel (BioCode RPP) is a high-throughput test that utilizes RT-PCR in combination with barcoded magnetic beads to amplify, detect, and identify 17 respiratory pathogens, including 14 viruses and 3 bacteria. This study summarizes data generated from a multicenter clinical trial evaluating the performance of the BioCode RPP on 2,647 nasopharyngeal swab specimens from five geographically distinct sites. © 2023 Zhang et al. |
| Keywords: | genetics; clinical trial; reproducibility; reproducibility of results; multicenter study; virus infection; microbiology; virus; respiratory tract infection; virus diseases; bacterium; nasopharynx; bacteria; viruses; respiratory tract infections; multiplex pcr; paramyxoviridae infections; humans; human; human respiratory syncytial virus; respiratory pathogens; syndromic testing; respiratory syncytial virus, human; scalable; paramyxovirus infection |
| Journal Title: | Microbiology Spectrum |
| Volume: | 11 |
| Issue: | 3 |
| ISSN: | 2165-0497 |
| Publisher: | American Society for Microbiology |
| Date Published: | 2023-06-01 |
| Start Page: | e04044-22 |
| Language: | English |
| DOI: | 10.1128/spectrum.04044-22 |
| PUBMED: | 37039708 |
| PROVIDER: | scopus |
| PMCID: | PMC10269715 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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