Comparison of three assays for point-of-care testing of influenza A virus antigen
Objective To compare the clinical diagnostic performance of influenza A virus antigen point-of-care testing(POCT)by immunofluorescence assay,latex immunochromatographic assay,and immunochromatographic colloidal gold assay.Methods qRT-PCR was used as the diagnostic standard;the detection limit,analytical specificity,and diagnostic sensitivity and specificity of three influenza A virus antigen POCT methods were compared in clinical samples.Results The detection limits of immunofluorescence assay,latex immunochromatographic assay,and immunochromatographic colloidal gold assay for H1N1pdm09 were 1∶10 000,1∶1 000,and 1:100,respectively,and for seasonal influenza H1N1,H1N1(PR8 strain),H3N2(Aichi strain),avian influenza virus H6N2,and H7N3 were 1∶100 000,1∶10 000,and 1∶1 000,respectively.The detection limits were in the order of immunofluorescence assay,latex immunochromatographic assay,and immunochromatographic colloidal gold assay from low to high.None of the three influenza A virus antigen POCT methods showed cross-reaction with 25 common pathogens of clinical respiratory infections other than influenza.Compared with qRT-PCR,the diagnostic sensitivity of immunofluorescence assay,latex immunochromatographic assay,and immunochromatographic colloidal gold assay were 74.63％,56.72％,and 40.30％,respectively.The diagnostic sensitivity of immunofluorescence assay was significantly higher than that of latex immunochromatographic assay and immunochromatographic colloidal gold assay(x2=46.13,71.94;all P＜0.05),and the diagnostic sensitivity of latex immunochromatographic assay was significantly higher than that of immunochromatographic colloidal gold assay(x2=103.54,P＜0.05).The diagnostic specificity of immunofluorescence assay,latex immunochromatographic assay,and immunochromatographic colloidal gold assay were 96.41％,100.00％,and 100.00％,respectively.The area under the curve(AUC)of receiver operating characteristic curve(ROC)of immunofluorescence assay,latex immunochromatographic assay,and immunochromatographic colloidal gold assay were 0.86,0.78 and 0.70,respectively.Conclusions Immunofluorescence assay showed the best performance among the three influenza A virus antigen POCT methods,with the lowest detection limit,the highest diagnostic sensitivity and AUC,and good analytical specificity and diagnostic specificity.It can meet the clinical demand for rapid detection of influenza A virus antigen.
Influenza A virusPoint-of-care testingImmunofluorescence assayLatex immunochromatographic assay
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