四種陰道分泌物檢測試劑臨床診斷價值分析和比較
發(fā)布時間:2018-06-26 00:16
本文選題:細菌性陰道病 + 霉菌性陰道炎; 參考:《浙江大學》2015年碩士論文
【摘要】:背景與目的目前,根據(jù)國家食品藥品監(jiān)督管理局(CFDA)官網(wǎng)的統(tǒng)計,我國關于陰道病的國產(chǎn)檢測試劑多達21種,檢測項目有pH值、過氧化氫(H2O2)、白細胞酯酶(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。針對現(xiàn)有檢測試劑種類多、項目多,但是否對各類陰道病有診斷價值,試劑之間的一致性如何,我們將臨床采集陰道分泌物標本進行四種市面上常用的試劑進行比較分析來判斷該類檢測試劑的臨床診斷價值。對象與方法根據(jù)需要采集細菌性陰道病、滴蟲性陰道炎、霉菌性陰道炎、支原體陰道炎和正常人群五類人群樣本,我們采集了2014年12至2015年5月間我院門診病人的陰道分泌物標本共389例。采用Amsel標準法作為金標準來診斷細菌性陰道病(BV)、支原體培養(yǎng)陽性、滴蟲培養(yǎng)陽性和念珠菌培養(yǎng)陽性作為臨床診斷支原體陰道炎、滴蟲性陰道炎和念珠菌陰道炎的金標準。共采集到BV標本122例、支原體陰道炎80例、滴蟲性陰道炎72例、念珠菌陰道炎102例;正常病例為96例。將這389例標本分別同時進行四種陰道病試劑(A、B、C、D)檢測,四種陰道病檢測試劑的檢測項目有pH值、過氧化氫(H202)、白細胞酯酶(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。通過比較分析四種試劑各類檢測項目對四種陰道疾病的靈敏度、特異度、誤診率、漏診率、總的符合率以及youden指數(shù)來評價各檢測試劑的診斷價值。同時通過配對樣本T檢驗來比較三種試劑對PH值檢測的一致性;Kappa檢驗來作為試劑之間相同檢測項目之間的一致性檢驗。結果對于診斷細菌性陰道病四種檢測試劑唾液酸苷酶(SNA)的靈敏度、特異度以及youden指數(shù)分別為試劑A:47.5%、97.4%及44.9%;試劑B:75.4%、35.6%及11.0%;試劑C:73.8%、81.3%及55.1%;試劑D:68.9%、95.5%及64.4%;均值為72.7%、70.8%及43.5%。三種檢測試劑脯氨酸氨基肽酶(PIP)的靈敏度、特異度以及youden指數(shù)分別為試劑B:30.4%、86.6%及17.0%;試劑C:21.3%、100.0%及21.3%;試劑D:2.5%、100.0%及2.5%,均值為18.1%、95.5%及13.6%。對于診斷霉菌性陰道炎三種檢測試劑脯氨酸氨基肽酶(PIP)的靈敏度、特異度以及youden指數(shù)分別為試劑B:16.7%、81.2%及-2.1%;試劑C:6.9%、93.4%及0.3%;試劑D:1.0%、100.0%及1.0%,均值為8.2%、91.5%及-0.3%。乙酰氨基葡萄糖苷酶(NAG)的靈敏度、特異度以及youden指數(shù)分別為試劑B:69.6%、59.9%及29.5%;試劑C:62.7%、44.6%及7.3%;試劑D:46.1%、68.3%及14.4%,均值為59.5%、57.6%及17.1%。對于診斷滴蟲性陰道炎三種檢測試劑乙酰氨基葡萄糖苷酶(NAG)的靈敏度、特異度以及youden指數(shù)分別為試劑B:63.9%、36.9%及0.8%;試劑C:83.3%、48.6%及31.9%;試劑D:73.6%、73.2%及46.8%,均值為73.6%、52.9%及26.5%。各試劑之間相同檢測項目一致性檢驗。三種試劑(B、C、D)對于PH值的測定有顯著差異(P值均0.05)。檢測項目H2O2各試劑之間的Kappa值分別為AB0.066、AC0.028、AD0.052、BC0.035、BD0.113、CD0.181.檢測項目LET各試劑之間的Kappa值分別為AB0.073、AC 0.083、AD 0.048、BC 0.072、BD 0.225、CD 0.208.檢測項目SNA各試劑之間的Kappa值分別為AB0.128、AC 0.071、AD 0.062、BC 0.051、BD 0.016、CD 0.590同時P值0.05。檢測項目NAG各試劑之間的Kappa值分別為BC 0.098、BD 0.072、 CD 0.259。檢測項目PIP各試劑之間的Kappa值分別為BC0.248、BD 0.004、 CD 0.004。檢測項目凝固酶AB的Kappa值分別為0.000。結論1)檢測項目SNA對于細菌性陰道病的診斷價值相對較高,平均youden指數(shù)均大于其他的檢測項目。2)各檢測試劑的各類項目之間的一致性均較差(除了試劑CD的SNA檢測),Kappa值均0.4。3)本研究發(fā)現(xiàn)國內(nèi)陰道病的各類檢測試劑的診斷價值不高,且各檢測試劑的診斷價值參差不齊。
[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.
【學位授予單位】:浙江大學
【學位級別】:碩士
【學位授予年份】:2015
【分類號】:R446.1
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