Analytical performance evaluation of the biofire SPOTFIRE respiratory and sore throat panel

IF 1.8 4区医学 Q3 INFECTIOUS DISEASES

Diagnostic microbiology and infectious disease Pub Date : 2026-03-01 Epub Date: 2025-11-25 DOI:10.1016/j.diagmicrobio.2025.117207

Kerstin Locher , Miriam Torchinsky , Corrie Belanger , Billie Velapatino , Jonathan Gubay , Claudine Desruisseaux , Heather Glassman , Suefay H. Liu , Jasmine Ahmed-Bentley , Anthony Lieu , Jennifer Tat , Aruna Uma Chandran , Conor Broderick , Marthe K. Charles

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引用次数: 0

Abstract

The new SPOTFIRE Respiratory/Sore Throat (R/ST) Panel, approved as a Point of Care Test (POCT), enables the detection of 15 respiratory pathogens from nasopharyngeal swabs (NPS) or throat swabs (TS) within 17 min. This study aimed to verify the performance of the assay.

A total of 28 NPS specimens (23 positive for 1 or 2 targets; 5 negative) and 37 TS (20 culture positive for Streptococcus pyogenes or Streptococcus dysgalactiae; 17 culture negative) were analyzed. Results were compared to the BioFire respiratory panel 2.1 (RP2.1) for NPS and S. pyogenes and S. dysgalactiae culture for TS. Contrived TS were created to assess the detection of influenza A/B and SARS-CoV-2, as well as the limit of detection (LoD) of the Streptococcus targets.

For NPS, the SPOTFIRE R menu demonstrated 100 % positive percent agreement (PPA) with reference results for all targets included, and 92-100 % negative percent agreement (NPA). The PPA and NPA for the detection of S. pyogenes and S. dysgalactiae from TS and culture were 100 %. All TS replicates at concentrations around the LoD for S. pyogenes and S. dysgalactiae yielded positive results. Data from this study suggest that influenza A/B, RSV and SARS-CoV-2 are effectively detected from TS by the SPOTFIRE.

In conclusion, the SPOTFIRE R/ST Panel demonstrated high agreement with the reference methods for the detection of viral and bacterial targets from NPS and the detection of S. pyogenes and S. dysgalactiae from TS Additionally, prospective studies will be required to establish the clinical impact of ultra-rapid POCT.

查看原文本刊更多论文

biofire SPOTFIRE呼吸和咽喉痛面板的分析性能评估。

新的SPOTFIRE呼吸/喉咙痛（R/ST）面板被批准为护理点检测（POCT），可在17分钟内从鼻咽拭子（NPS）或咽拭子（TS）中检测出15种呼吸道病原体。本研究旨在验证该方法的性能。共分析28份NPS标本（1或2个靶点23份阳性，5份阴性）和37份TS标本（20份化脓性链球菌或乳糖不良链球菌培养阳性，17份培养阴性）。结果与BioFire呼吸小组2.1 （RP2.1）的NPS和S. pyogenes和S. dysgalactiae培养的TS进行比较，建立人工TS来评估流感A/B和SARS-CoV-2的检测，以及链球菌靶点的检测限（LoD）。对于NPS， SPOTFIRE R菜单显示所有目标的参考结果100%正一致性（PPA），以及92% - 100%负一致性（NPA）。从TS和培养物中检测化脓性链球菌和泌乳不良链球菌的PPA和NPA均为100%。在LoD附近的浓度下，所有TS对化脓性链球菌和泌乳不良链球菌的重复结果均为阳性。本研究数据表明，SPOTFIRE可以有效地从TS中检测出A/B流感、RSV和SARS-CoV-2。总之，SPOTFIRE R/ST Panel与NPS中检测病毒和细菌靶点以及TS中检测化脓性链球菌和乳糖障碍链球菌的参考方法高度一致。此外，还需要进行前瞻性研究来确定超快速POCT的临床影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diagnostic microbiology and infectious disease 医学-传染病学

CiteScore

5.30

自引率

3.40%

发文量

149

审稿时长

56 days

期刊介绍： Diagnostic Microbiology and Infectious Disease keeps you informed of the latest developments in clinical microbiology and the diagnosis and treatment of infectious diseases. Packed with rigorously peer-reviewed articles and studies in bacteriology, immunology, immunoserology, infectious diseases, mycology, parasitology, and virology, the journal examines new procedures, unusual cases, controversial issues, and important new literature. Diagnostic Microbiology and Infectious Disease distinguished independent editorial board, consisting of experts from many medical specialties, ensures you extensive and authoritative coverage.