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Clinical evaluation of rapid fluorescent diagnostic immunochromatographic test for influenza A virus (H1N1)

tetano

Editor, Senior Moderator
Sci Rep. 2018 Sep 7;8(1):13468. doi: 10.1038/s41598-018-31786-8.
[h=1]Clinical evaluation of rapid fluorescent diagnostic immunochromatographic test for influenza A virus (H1N1).[/h] Yu ST[SUP]1[/SUP], Thi Bui C[SUP]2[/SUP], Kim DTH[SUP]2[/SUP], V T Nguyen A[SUP]2[/SUP], Thi Trinh TT[SUP]2[/SUP], Yeo SJ[SUP]3[/SUP].
[h=3]Author information[/h]

[h=3]Abstract[/h] Rapid diagnostic tests (RDTs) have been developed to detect influenza A virus for the swift diagnosis and management of patients. However, despite the simplicity and convenience, the low sensitivity of RDTs remains a limitation for their use in point of care testing (POCT). In this study, we developed a rapid fluorescent immunochromatographic strip test (FICT) and the performance of FICT was confirmed by the real-time reverse transcription-polymerase chain reaction (rRT-PCR) of H1N1, compared with that of RDT. The limit of detection (LOD) of FICT was improved by 16-fold compared to RDT. FICT showed 85.29% sensitivity (29/34) (95% Confidence Interval [95% CI]: 68.94 to 95.05), 100% specificity (26/26) (95% CI: 86.78 to 100.00), and a strong correlation (kappa; 0. 92) compared with rRT-PCR (20 ≤ Ct ≤ 36). In contrast, RDT (Standard Diagnostics [SD] BIOLINE Influenza Ag A/ B/ A(H1N1) Pandemic) showed 55.88% sensitivity (19/34) (95% CI: 37.87 to 72.82), 100% specificity (26/26) (95% CI: 77.07 to 100), and had a fair correlation with rRT-PCR (kappa; 0. 75). FICT had better sensitivity than RDT (P < 0.01; McNemar's test). Therefore, FICT has the potential to improve the quality of current rapid POCT for the diagnosis of influenza A/H1N1 infection.


PMID: 30194330 PMCID: PMC6128899 DOI: 10.1038/s41598-018-31786-8
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