四种阴道分泌物检测试剂临床诊断价值分析和比较

发布时间：2018-06-26 00:16

本文选题：细菌性阴道病 + 霉菌性阴道炎　；参考：《浙江大学》2015年硕士论文

【摘要】：背景与目的目前,根据国家食品药品监督管理局(CFDA)官网的统计,我国关于阴道病的国产检测试剂多达21种,检测项目有pH值、过氧化氢(H2O2)、白细胞酯酶(LET)、唾液酸苷(SNA)、脯氨酸氨基肽酶(PIP)、乙酰氨基葡萄糖苷酶(NAG)、β-葡萄糖醛酸酶、凝固酶、多胺(PA)、乳酸及氧化酶。针对现有检测试剂种类多、项目多,但是否对各类阴道病有诊断价值,试剂之间的一致性如何,我们将临床采集阴道分泌物标本进行四种市面上常用的试剂进行比较分析来判断该类检测试剂的临床诊断价值。对象与方法根据需要采集细菌性阴道病、滴虫性阴道炎、霉菌性阴道炎、支原体阴道炎和正常人群五类人群样本,我们采集了2014年12至2015年5月间我院门诊病人的阴道分泌物标本共389例。采用Amsel标准法作为金标准来诊断细菌性阴道病(BV)、支原体培养阳性、滴虫培养阳性和念珠菌培养阳性作为临床诊断支原体阴道炎、滴虫性阴道炎和念珠菌阴道炎的金标准。共采集到BV标本122例、支原体阴道炎80例、滴虫性阴道炎72例、念珠菌阴道炎102例；正常病例为96例。将这389例标本分别同时进行四种阴道病试剂(A、B、C、D)检测,四种阴道病检测试剂的检测项目有pH值、过氧化氢(H202)、白细胞酯酶(LET)、唾液酸苷酶(SNA)、脯氨酸氨基肽酶(PIP)、乙酰氨基葡萄糖苷酶(NAG)、β-葡萄糖醛酸酶、凝固酶、乳酸及氧化酶。通过比较分析四种试剂各类检测项目对四种阴道疾病的灵敏度、特异度、误诊率、漏诊率、总的符合率以及youden指数来评价各检测试剂的诊断价值。同时通过配对样本T检验来比较三种试剂对PH值检测的一致性；Kappa检验来作为试剂之间相同检测项目之间的一致性检验。结果对于诊断细菌性阴道病四种检测试剂唾液酸苷酶(SNA)的灵敏度、特异度以及youden指数分别为试剂A：47.5%、97.4%及44.9%；试剂B：75.4%、35.6%及11.0%；试剂C：73.8%、81.3%及55.1%；试剂D：68.9%、95.5%及64.4%；均值为72.7%、70.8%及43.5%。三种检测试剂脯氨酸氨基肽酶(PIP)的灵敏度、特异度以及youden指数分别为试剂B：30.4%、86.6%及17.0%；试剂C：21.3%、100.0%及21.3%；试剂D：2.5%、100.0%及2.5%,均值为18.1%、95.5%及13.6%。对于诊断霉菌性阴道炎三种检测试剂脯氨酸氨基肽酶(PIP)的灵敏度、特异度以及youden指数分别为试剂B：16.7%、81.2%及-2.1%；试剂C：6.9%、93.4%及0.3%；试剂D：1.0%、100.0%及1.0%,均值为8.2%、91.5%及-0.3%。乙酰氨基葡萄糖苷酶(NAG)的灵敏度、特异度以及youden指数分别为试剂B：69.6%、59.9%及29.5%；试剂C：62.7%、44.6%及7.3%；试剂D：46.1%、68.3%及14.4%,均值为59.5%、57.6%及17.1%。对于诊断滴虫性阴道炎三种检测试剂乙酰氨基葡萄糖苷酶(NAG)的灵敏度、特异度以及youden指数分别为试剂B：63.9%、36.9%及0.8%；试剂C：83.3%、48.6%及31.9%；试剂D：73.6%、73.2%及46.8%,均值为73.6%、52.9%及26.5%。各试剂之间相同检测项目一致性检验。三种试剂(B、C、D)对于PH值的测定有显著差异(P值均0.05)。检测项目H2O2各试剂之间的Kappa值分别为AB0.066、AC0.028、AD0.052、BC0.035、BD0.113、CD0.181.检测项目LET各试剂之间的Kappa值分别为AB0.073、AC 0.083、AD 0.048、BC 0.072、BD 0.225、CD 0.208.检测项目SNA各试剂之间的Kappa值分别为AB0.128、AC 0.071、AD 0.062、BC 0.051、BD 0.016、CD 0.590同时P值0.05。检测项目NAG各试剂之间的Kappa值分别为BC 0.098、BD 0.072、 CD 0.259。检测项目PIP各试剂之间的Kappa值分别为BC0.248、BD 0.004、 CD 0.004。检测项目凝固酶AB的Kappa值分别为0.000。结论1)检测项目SNA对于细菌性阴道病的诊断价值相对较高,平均youden指数均大于其他的检测项目。2)各检测试剂的各类项目之间的一致性均较差(除了试剂CD的SNA检测),Kappa值均0.4。3)本研究发现国内阴道病的各类检测试剂的诊断价值不高,且各检测试剂的诊断价值参差不齐。
[Abstract]:Background and purpose at present, according to the statistics of the national food and Drug Administration (CFDA) official network (CFDA), our country's domestic detection reagents for vaginosis are as many as 21, pH value, hydrogen peroxide (H2O2), leukocyte esterase (LET), sialic acid glycoside (SNA), proline aminopeptidase (PIP), acetylaminoglucosidase (NAG), beta glucuronidase, Coagulase, polyamines (PA), lactic acid and oxidase. There are many kinds of detection reagents and many items, but whether they have diagnostic value for all kinds of vaginosis and the consistency between the reagents, we compare the clinical collection of four kinds of commonly used reagents in clinical collection of vaginal secretions to judge the clinical diagnostic price of this kind of detection reagent. Objective and methods to collect five samples of bacterial vaginosis, trichomonad vaginitis, mycotic vaginitis, Mycoplasma vaginitis, Mycoplasma vaginitis and normal population. We collected 389 cases of vaginal secretions from 12 to May 2015 2014 in our hospital. The Amsel standard method was used as the gold standard for the diagnosis of bacterial vagina. BV, Mycoplasma positive culture, trichomonas culture positive and Candida culture positive as clinical diagnosis of Mycoplasma vaginitis, trichomonas vaginitis and candidal vaginitis, 122 cases of BV specimens, 80 Mycoplasma vaginitis, trichomonas vaginitis, 102 cases of trichomonas vaginitis and 96 normal cases, and 96 cases of normal cases. The 389 cases were marked. Four kinds of vaginosis reagents (A, B, C, D) were carried out at the same time. The detection items of four kinds of vaginal disease detection reagents were pH, H202, leukocyte esterase (LET), sialidase (SNA), proline aminopeptidase (PIP), acetylglucosidase (NAG), beta glucuronidase, coagulase, lactic acid and oxidase. The sensitivity, specificity, misdiagnosis rate, missed diagnosis rate, total coincidence rate, and Youden index were used to evaluate the diagnostic value of the detection reagents for four kinds of vaginal diseases, and the consistency of the three reagents for the detection of pH was compared with the paired sample T test; Kappa test was used as the same test item between the reagents. Results of the consistency test. Results for the sensitivity, specificity and Youden index of the four detection reagent sialidase (SNA) for the diagnosis of bacterial vaginosis were A:47.5%, 97.4% and 44.9%, reagent B:75.4%, 35.6% and 11%; reagent C:73.8%, 81.3% and 55.1%; test agent D:68.9%, 95.5% and 64.4%; the mean value was 72.7%, 70.8%, and The sensitivity, specificity and Youden index of proline aminopeptidase (PIP) of 43.5%. three reagents were B:30.4%, 86.6% and 17%, reagent C:21.3%, 100% and 21.3%, reagent D:2.5%, 100% and 2.5%, mean 18.1%, 95.5%, and 13.6%. for the diagnosis of Mycoplasma vaginitis, the proline aminopeptidase (PIP), three test reagents. Sensitivity, specificity and Youden index are reagent B:16.7%, 81.2% and -2.1%, reagent C:6.9%, 93.4% and 0.3%; reagent D:1.0%, 100% and 1%, the mean value is 8.2%, 91.5% and -0.3%. acetaminophinase (NAG) sensitivity, specificity and Youden index are reagent B:69.6%, 59.9% and 29.5%; reagent C:62.7%, 44.6% And 7.3%; reagents D:46.1%, 68.3% and 14.4%, the mean value of 59.5%, 57.6%, and 17.1%. for the diagnosis of trichomonas vaginitis, the sensitivity, specificity and Youden index of the reagent B:63.9%, 36.9% and 0.8%, reagent C:83.3%, 48.6% and 31.9%, reagent D:73.6%, 73.2% and 46.8%, mean value The same test items were tested for the same test items between 73.6%, 52.9% and 26.5%.. Three reagents (B, C, D) were significantly different for the determination of pH value (P values were all 0.05). The Kappa values between the H2O2 reagents were AB0.066, AC0.028, AD0.052, BC0.035, respectively. 0.083, AD 0.048, BC 0.072, BD 0.225, CD 0.208. test items SNA between the Kappa values are AB0.128, AC 0.071, AD 0.062, BC 0.051, BD 0.016, 0.590 simultaneous values between the reagents are 0.098, 0.072. 0.004, the Kappa value of the CD 0.004. detection project coagulase AB was 0.000. conclusion 1) the detection project SNA was relatively high in the diagnostic value of bacterial vaginosis, the average Youden index was larger than the other detection items.2) the consistency between the various detection reagents of each detection reagent was poor (except for SNA test of the reagent CD), the Kappa value was 0.4.3) It is found that the diagnostic value of various test reagents in domestic vaginal diseases is not high, and the diagnostic value of each reagent is uneven.
【学位授予单位】：浙江大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R446.1

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