Comparative Evaluation of the STANDARD F Influenza A/B FIA Test with the Sofia Influenza A+B FIA and SD BIOLINE Influenza Ag A/B/A(H1N1) tests for Influenza A Virus Detection
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Background: This study aimed to evaluate the diagnostic performance of the STANDARD F Influenza A/B FIA test (SD Biosensor Inc., Korea) for the rapid detection of influenza A virus in comparison with the Sofia Influenza A+B FIA (Quidel Corp., USA) and SD BIOLINE Influenza Ag A/B/A(H1N1) (Standard Diagnostic, Inc., Korea) tests. Methods: A total of 227 non-duplicated nasopharyngeal aspirates submitted for real-time RT-PCR analysis were included in the study. We used the three commercial tests in remnant samples from routine assays, according to the manufacturer’s instructions. We analyzed the diagnostic performance, including sensitivity and specificity, of the three tests. Results: Real-time RT-PCR analysis showed that 67 (29.5%) samples were positive and 160 (70.5%) were negative for influenza A virus, and that all the specimens were negative for influenza B. The overall sensitivity and specificity for influenza A virus detection were 50.7% and 100% for the STANDARD F, 50.7% and 100% for the Sofia, and 29.9% and 100% for the SD BIOLINE tests, respectively. The STANDARD F and SD BIOLINE tests showed negative results for influenza B virus in all specimens, whereas the Sofia test showed two false-positive results. Conclusion: The STANDARD F Influenza A/B test showed a good diagnostic performance and may be useful for the rapid diagnosis of influenza A.
Abstract
Background: This study aimed to evaluate the diagnostic performance of the STANDARD F Influenza A/B FIA test (SD Biosensor Inc., Korea) for the rapid detection of influenza A virus in comparison with the Sofia Influenza A+B FIA (Quidel Corp., USA) and SD BIOLINE Influenza Ag A/B/A(H1N1) (Standard Diagnostic, Inc., Korea) tests. Methods: A total of 227 non-duplicated nasopharyngeal aspirates submitted for real-time RT-PCR analysis were included in the study. We used the three commercial tests in remnant samples from routine assays, according to the manufacturer’s instructions. We analyzed the diagnostic performance, including sensitivity and specificity, of the three tests. Results: Real-time RT-PCR analysis showed that 67 (29.5%) samples were positive and 160 (70.5%) were negative for influenza A virus, and that all the specimens were negative for influenza B. The overall sensitivity and specificity for influenza A virus detection were 50.7% and 100% for the STANDARD F, 50.7% and 100% for the Sofia, and 29.9% and 100% for the SD BIOLINE tests, respectively. The STANDARD F and SD BIOLINE tests showed negative results for influenza B virus in all specimens, whereas the Sofia test showed two false-positive results. Conclusion: The STANDARD F Influenza A/B test showed a good diagnostic performance and may be useful for the rapid diagnosis of influenza A.
참고문헌 (16)
- "Vaccines against influenza WHO position paper - November", Wkly Epidemiol Rec, 87, pp.461~476 (2012)
- Uyeki TM, "Influenza diagnosis and treatment in children : a review of studies on clinically useful tests and antiviral treatment for influenza", Pediatr Infect Dis J, 22, pp.164~177 (2003)
- Steed LL, "Identification of influenza A virus by shell vial culture and two commercially available antigen detection methods", Clin Diagn Virol, 2, pp.261~269 (1994)
- 고대현, "Comparison of the Luminex xTAG Respiratory Viral Panel Fast v2 Assay With Anyplex II RV16 Detection Kit and AdvanSure RV Real-Time RT-PCR Assay for the Detection of Respiratory Viruses", Annals of Laboratory Medicine, 37(5), pp.408~414 (2017), 대한진단검사의학회
- 이재현, "Evaluation of Allplex Respiratory Panel 1", 2, Annals of Laboratory Medicine, pp.2018, 38(1)[DOI]
- Vemula SV, "Current approaches for diagnosis of influenza virus infections in humans", Viruses, 8, pp.96~ (2016)
- Lee CK, "Evaluation of Sofia fluorescent immunoassay analyzer for influenza A", B virus, 2012, pp.55, 239~243
- Chartrand C, "Accuracy of rapid influenza diagnostic tests : a meta-analysis", Ann Intern Med, 156, pp.500~511 (2012)
- Sutter DE, "Performance of five FDA-approved rapid antigen tests in the detection of 2009 H1N1influenza A virus", J Med Virol, 84, pp.1699~1702 (2012)
- Centers for Disease Control and Prevention, "Evaluation of rapid influenza diagnostic tests for detection of novel influenza A (H1N1) virus - United States", Morb Mortal Wkly Rep, 58, pp.826~829 (2009)
- Uyeki TM, "Low sensitivity of rapid diagnostic test for influenza", Clin Infect Dis, 48, pp.e89~92 (2009)
- Lewandrowski K, "Detection of influenza A and B viruses with the Sofia analyzer: a novel, rapid immunofluorescence-based in vitro diagnostic device", Am J Clin Pathol, 139, pp.684~689 (2013)
- Hazelton B, "Evaluation of the Sofia Influenza A+B fluorescent immunoassay for the rapid diagnosis of influenza A and B", J Med Virol, 87, pp.35~38 (2015)
- Baas C, "A comparison of rapid point-of-care tests for the detection of avian influenza A (H7N9) virus", Eurosurveillance, 18, pp.20487~ (2013)
- Yang JH, "Diagnostic performance of the Sofia® Influenza A+B fluorescent immunoassay in adult outpatients in Northern Taiwan", J Med Virol, 90, pp.1010~1018 (2018)
- Dunn J, "Prompt detection of influenza A and B viruses using the BD Veritor System Flu A+B, Quidel® Sofia® Influenza A+B FIA, and Alere BinaxNOW® Influenza A&B compared to real-time reverse transcription-polymerase chain reaction (RT-PCR)", Diagn Microbiol Infect Dis, 79, pp.10~13 (2014)