念珠菌乳胶免疫层析法的性能评价

目的评价念珠菌乳胶免疫层析法检测试剂盒(以下简称念试剂)检测阴道分泌物中念珠菌的性能和种属特异性。方法采用涂片/革兰染色法和念试剂检测354例怀疑为念珠菌阴道炎妇女阴道分泌物和9种属22种阴道常见感染微生物,并与涂片/革兰染色法半定量比较,评价念试剂的临床标本检测性能及种属特异性。结果与涂片/革兰染色法相比,念试剂的灵敏度为93.81%,特异度为99.10%,准确性97.31%,阳性预期值为98.14%,阴性预期值为96.90%;与涂片/革兰染色法半定量相比,该念试剂检测阴道分泌物中的念珠菌在标本中念珠菌浓度较低时仍然具有较高的特异度、可接受的灵敏性;在种属特异度评价,6种念珠菌阳性,其他16种阴道常见感染微生物均为阴性。结论念试剂检测阴道分泌物中念珠菌具有较高的临床和种属特异度、灵敏度、阳性预测值和阴性预测值。

Performance evaluation of Candida spp.latex immunochromatography

Objective To preliminarily evaluate the performance and species specificity of Candida spp.latex immunochromatography kit for detecting Candida spp.in vaginal secretion.Methods The vaginal secretions in 354 cases of suspected vaginitis and 9 genus of 22 species of common vaginal infecting organisms were by adopting the smear/Gram staining and Candida spp.kit.The results were compared with those detected by smear/Gram staining semi-quantitative method.The detection performance and species specificity of Candida spp.kit for detecting clinical specimens were evaluated.Results Compared with the smear/Gram staining method,the sensitivity,specificity,accuracy,positive predictive value and negative predictive value of Candida sp.kit were 93.81%,99.10%,97.31%,98.14% and 96.90%,respectively;compared the smear/Gram staining semiquantitative method,the Candida spp.kit for detecting Candida spp.in vaginal secretion still had higher specificity and acceptable sensitivity when the Candida spp.concentration was lower in specimens;in the speciese specificity evaluation,6 kinds of Candida spp.were positive and other 16 kinds of common vaginal infecting organisms all were negative.Conclusion The Candida spp.kit for detecting Candida spp.in vaginal secretion has higher clinical and species specificity,sensivity,positive prediction value and negative prediction value.