KMID : 1142720210240010021
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Annals of Clinical Microbiology 2021 Volume.24 No. 1 p.21 ~ p.26
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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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Yoo Soo-Hun
Kim Si-Hyun Jeon Ga-Won Park Yo-Han Song Sae-Am Shin Jeong-Hwan
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Abstract
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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.
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KEYWORD
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Enzyme immunoassay, Fluorescence immunoassay, Influenza A
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