Evaluating the diagnostic performance of the STANDARDTM F Influenza A/B FIA
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Abstract
Rapid diagnosis of influenza is crucial for initiating early treatment, and patient isolation to prevent virus spreading within the community. This study evaluated the performance of the STANDARDTM F Influenza A/B FIA digital kit using the automatic fluorescence reading analyzer. We tested the kit with 150 nasopharyngeal swab samples, including 50 influenza A virus-positive samples, 50 influenza B virus-positive samples, and 50 negative samples confirmed by real-time RT-PCR. Results showed that the sensitivity of the Standard F influenza A/B FIA test for flu A and B samples were 92% and 96%, respectively. We further specifically evaluated two common subtypes of influenza A virus including H1N1 and H3N2 and found the sensitivity to be 86.36% and 91.67%, respectively. The specificity for all subtypes also reached 100%. Based on the aforementioned results, the STANDARDTM F Influenza A/B FIA kit demonstrated high sensitivity and specificity in the diagnosis of influenza, thus is applicable for routine practice.
Article Details
Keywords
influenza A virus, influenza B virus, sensitivity, specificiy, STANDARDTM F Influenza A/B FIA
References
2. CDC Việt Nam. Khuyến cáo phòng chống cúm mùa. Accessed October 13, 2024. https://vncdc.gov.vn/khuyen-cao-phong-chong-cum-mua-nd13463.html
3. CDC. Interim Recommendations for Clinical Use of Influenza Diagnostic Tests. Accessed October 13, 2024. https://archive.cdc.gov/www_cdc_gov/h1n1flu/guidance/diagnostic_tests.htm
4. Ryu SW, Lee JH, Kim J, et al. Comparison of two new generation influenza rapid diagnostic tests with instrument-based digital readout systems for influenza virus detection. Br J Biomed Sci. 2016;73(3):115-120. doi:10.1080/09674845.2016.1189026
5. Hướng dẫn sử dụng Thẻ xét nghiệm định tính kháng nguyên vi rút cúm A, cúm B STANDARDTM F Influenza A/B FIA. SD BIosensor, 2012.
6. Bộ Y tế. Quyết định 1847/QĐ-BYT năm 2009 Hướng dẫn kỹ thuật lấy mẫu, bảo quản, vận chuyển mẫu bệnh phẩm cúm A(H1N1). Accessed October 27, 2024. https://luatvietnam.vn/y-te/quyet-dinh-1847-qd-byt-bo-y-te-42458-d1.html
7. Nguyễn Minh Hằng. Bệnh cúm. Sổ tay xét nghiệm bệnh truyền nhiễm. Bộ y tế, Cục Y tế Dự Phòng. Hà Nội. 2016;1-16.
8. Khamsorn S, Kaewnaphan B, Horthongkham N, et al. Comparison of Rapid Influenza Diagnostic Tests With Digital Readout Systems and Conventional Rapid Influenza Diagnostic Test for Influenza Virus Detection. Malaysian Journal of Medicine and Health Sciences. 2022;18(3):59-65. Published online 2022.
9. Chong YM, Tan XH, Hooi PS, et al. Evaluation of rapid influenza diagnostic tests for influenza A and B in the tropics. J Med Virol. 2019;91(8):1562-1565. doi:10.1002/jmv.25495
10. Yeager K. LibGuides: SPSS Tutorials: Pearson Correlation. Accessed October 28, 2024. https://libguides.library.kent.edu/SPSS/PearsonCorr
11. Kim JJ, Cho Y, Lee SG. Evaluating the Diagnostic Performance of Two Rapid Influenza Diagnostic Tests. Lab Med Online. 2020;10(2):160-164. doi:10.3343/lmo.2020.10. 2.160