Annals of Clinical Microbiology, The official Journal of the Korean Society of Clinical Microbiology

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pISSN 2288-0585 eISSN 2288-6850

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

Original article

Annals of Clinical Microbiology (Ann Clin Microbiol) 2021 March, Volume 24, Issue 1, pages 21-26.

https://doi.org/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

Soohun Yoo1*, Si Hyun Kim2*, Ga Won Jeon3, Yo-Han Park4, Sae Am Song5, Jeong Hwan Shin5,6†
1Department of Laboratory Medicine, Busan Medical Center, Busan, 2Department of Clinical Laboratory Science, Semyung University, Jecheon, 3Department of Pediatrics, Inje University College of Medicine, Busan, 4Department of Surgery, Inje University College of Medicine, Busan, 5Department of Laboratory Medicine, Inje University College of Medicine, Busan, 6Paik Institute for Clinical Research, Inje University College of Medicine, Busan, Korea

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.

Keywords

Enzyme immunoassay, Fluorescence immunoassay, Influenza A