彩色乳胶免疫层析法检测单纯疱疹病毒1,2型抗原临床应用分析

Analysis of Clinical Application of Immuno-chromatographic Assay for Detection of HSV

目的探讨彩色乳胶免疫层析法检测单纯疱疹病毒(HSV)1和2型抗原的临床应用价值。方法采用彩色乳胶颗粒免疫层析法检测各种水疱、溃疡和其他皮损中的HSV-1和2型抗原,同时用实时荧光定量PCR法进行对照。结果免疫层析法可检出≥1×106DNA拷贝/mL的HSV-1型混悬液和≥5×105DNA拷贝/mL的HSV-2型混悬液。132例标本中,免疫层析法检出HSV阳性43例,PCR检出HSV阳性50例。以PCR法为金标准,免疫层析法的灵敏度、特异度、阳性预测值和阴性预测值分别为84.00%,98.78%,97.67%和91.01%。结论免疫层析法检测HSV敏感性和特异性高,具有方便、快速和经济的特点,适于有症状患者的及时检测,对疱疹感染早期诊断和及时治疗有重要作用。

Objective To approach the clinical value of dyed latex beads immuno-chromatographic assay （ICA） for de- tection of Herpes simplex virus（HSV） 1 and 2 antigens. Methods The dyed latex beads ICA were used to detect HSV 1 and 2 antigens in blister, ulcer and other cutaneous lesions. The detection of HSV by PCR was taken as a control. Results ICA may detect more than and equal 1 x 106DNA copy/mL of HSV-1 mixture, and more than and equal 5 x 105DNA copy/mL of HSV-2 mixture. In detected 132 cases, 43 cases were positive by ICA, and 50 cases were positive by PCR. When PCR was taken as the golden standard, the sen- sitivity, specificity, positive predictivevalue and negative predictive value were 84.00%, 98.78%, 97.67% and 91.01% respectively. Conclusion The sensitivity and specificity of ICA to detect HSV is high. ICA is convenient, rapid and economical. ICA may detect HSV promptly for symptomatic patients and play an im- portant role in early diagnosis and timely treatment for HSV infection.