Abstract
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.
Highlights
Following early outbreaks in North America in April 2009, influenza A/H1N1 spread fast around the world by person to person contact prompting the World Health Organization (WHO) to declare a pandemic[1]
We developed a rapid fluorescent immunochromatographic strip test (FICT) employing Europium nanoparticles (Eu NP) to improve the sensitivity of point of care testing (POCT) for influenza A
75 μL of the specimen was added on to the sample pad followed by 75 μL of lysis buffer to expose antigen from virus and complete the lateral flow reaction
Summary
Following early outbreaks in North America in April 2009, influenza A/H1N1 spread fast around the world by person to person contact prompting the World Health Organization (WHO) to declare a pandemic[1]. Appropriate treatment of patients with respiratory illness depends on the accurate and timely diagnosis[5]. Because antiviral drug should be administrated as early as possible after the onset of symptoms to be efficacious, rapid diagnosis of influenza infection is essential to help minimize the individual and economical loss[10]. Development of influenza rapid diagnostic tests (RDTs) would be important in controlling viral infection[10]. For the diagnosis of seasonal influenza infections, RDTs have demonstrated variable performance with sensitivities ranging between 10%–70%, with up to 90% specificity compared to standard RT-PCR-based assays[13]. A meta-analysis reported pooled sensitivities for detecting influenza A as 54.4% for RDTs and 91.6% for rapid nucleic acid amplification tests (NAATs)[14]
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