Ann Clin Microbiol.  2021 Mar;24(1):21-26. 10.5145/ACM.2021.24.1.3.

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

• Yoo S
• Kim SH
• Jeon GW
• Park YH
• Song SA
• Shin JH

• KMID: 2514047
• DOI: http://doi.org/10.5145/ACM.2021.24.1.3

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.

Keyword

Enzyme immunoassay; Fluorescence immunoassay; Influenza A

Reference

1. Vaccines against influenza WHO position paper - November 2012. Wkly Epidemiol Rec 2012;87:461-76.

2. 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 2003;22:164-77.

3. Steed LL, Salmon VC, Overall JC Jr. Identification of influenza A virus by shell vial culture and two commercially available antigen detection methods. Clin Diagn Virol 1994;2:261-9.

4. Ko DH, Kim HS, Hyun J, Kim HS, Kim JS, Park KU, et al. 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. Ann Lab Med 2017;37:408-14.

5. Lee J, Lee HS, Cho YG, Choi SI, Kim DS. Evaluation of allplex respiratory panel 1/2/3 multiplex real-time PCR assays for the detection of respiratory viruses with influenza A virus subtyping. Ann Lab Med 2018;38:46-50.

6. Vemula SV, Zhao J, Liu J, Wang X, Biswas S, Hewlett I. Current approaches for diagnosis of influenza virus infections in humans. Viruses 2016;8:96.

7. Lee CK, Cho CH, Woo MK, Nyeck AE, Lim CS, Kim WJ. Evaluation of Sofia fluorescent immunoassay analyzer for influenza A/B virus. J Clin Virol 2012;55:239-43.

8. Chartrand C, Leeflang MM, Minion J, Brewer T, Pai M. Accuracy of rapid influenza diagnostic tests: a meta-analysis. Ann Intern Med 2012;156:500-11.

9. Sutter DE, Worthy SA, Hensley DM, Maranich AM, Dolan DM, Fischer GW, et al. Performance of five FDA-approved rapid antigen tests in the detection of 2009 H1N1 influenza A virus. J Med Virol 2012;84:1699-702.

10. Centers for Disease Control and Prevention. Evaluation of rapid influenza diagnostic tests for detection of novel influenza A (H1N1) virus - United States, 2009. Morb Mortal Wkly Rep 2009;58:826-9.

11. Uyeki TM, Prasad R, Vukotich C, Stebbins S, Rinaldo CR, Ferng YH, et al. Low sensitivity of rapid diagnostic test for influenza. Clin Infect Dis 2009;48:e89-92.

12. Lewandrowski K, Tamerius J, Menegus M, Olivo PD, Lollar R, Lee-Lewandrowski E. Detection of influenza A and B viruses with the Sofia analyzer: a novel, rapid immunofluorescence-based in vitro diagnostic device. Am J Clin Pathol 2013;139:684-9.

13. Hazelton B, Nedeljkovic G, Ratnamohan VM, Dwyer DE, Kok J. Evaluation of the Sofia Influenza A+B fluorescent immunoassay for the rapid diagnosis of influenza A and B. J Med Virol 2015;87:35-8.

14. Baas C, Barr I, Fouchier R, Kelso A, Hurt A. A comparison of rapid point-of-care tests for the detection of avian influenza A (H7N9) virus, 2013. Eurosurveillance 2013;18:20487.

15. Yang JH, Huang PY, Shie SS, Yang S, Tsao KC, Wu TL, et al. Diagnostic performance of the Sofia® Influenza A+B fluorescent immunoassay in adult outpatients in Northern Taiwan. J Med Virol 2018;90:1010-8.

16. Dunn J, Obuekwe J, Baun T, Rogers J, Patel T, Snow L. 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 2014;79:10-3.