迪瑞GMD-S600妇科分泌物分析系统显微镜复检规则制订及验证

Establishment and verification of microscopic review rules in Dirui GMD-S600 gynecological secretion analysis system

目的制订并验证迪瑞GMD-S600妇科分泌物分析系统的显微镜复检规则。方法收集阴道分泌物样本2619份,采用迪瑞GMD-S600妇科分泌物分析系统进行有形成分和干化学项目检测。所有样本均采用双盲法进行人工显微镜镜检,分别记录仪器检测结果、仪器检测经人工图片审核后的结果、人工显微镜镜检结果。以人工显微镜镜检结果作为标准,分析仪器检测及仪器检测经人工图片审核后有形成分结果的假阴性率、假阳性率,同时分析仪器检测干化学项目和与其相对应有形成分间的假阴性率、假阳性率,并由此得出复检规则。随后选取344份样本对复检规则有效性进行验证。结果仪器检测白细胞、真菌、滴虫、线索细胞的假阳性率分别为28.77%、14.71%、20.09%、2.30%,假阴性率分别为0.28%、15.06%、4.35%、10.34%;仪器检测结果经人工图片审核修正后,白细胞、真菌、滴虫、线索细胞的假阳性率分别为28.77%、7.06%、8.67%、0.66%,假阴性率分别为0.28%、3.35%、4.35%、10.34%;白细胞酯酶(LE)对白细胞、N-乙酰氨基己糖甘酶(NAG)对真菌、NAG对滴虫、过氧化氢(H 2O 2)对杆菌、乳酸(LA)对杆菌、唾液酸苷酶(SNA)对线索细胞、脯氨酸氨基肽酶(PIP)对线索细胞的假阳性率分别为13.83%、22.47%、24.10%、95.52%、2.52%、12.92%、5.54%,假阴性率分别为28.17%、48.12%、0.00%、23.55%、78.82%、0.00%、74.14%。260例验证样本的假阳性率为1.68%、假阴性率为4.22%、复检率为45.38%。结论迪瑞GMD-S600妇科分泌物分析系统的复检规则为:(1)所有样本均需图片审核,以下规则均基于此条;(2)若白细胞结果呈阳性,需显微镜镜检;(3)若真菌结果呈阳性,需显微镜镜检;(4)若滴虫结果呈阳性,需显微镜镜检;(5)若SNA与线索细胞阴阳性结果不符合,需显微镜镜检。

Objective To establish and verify the microscopic review rules of Dirui GMD-S600 gynecological secretion analysis system.Methods A total of 2619 samples of vaginal secretions were collected and tested for tangible components and dry chemistry items using the Dirui GMD-S600 gynecological secretions analysis system.All samples were subjected to manual microscope examination using a double blind method,and the results of instrument testing,manual image review of instrument testing,and manual microscope examination were recorded separately.Using the results of manual microscope examination as the standard,the false negative rates and the false positive rates of instrument testing results and tangible component results after manual image review of instrument testing were analyzed.At the same time,the false negative rates and the false positive rates of instrument detection dry chemistry items and their corresponding tangible components were analyzed,and the review rules were derived based on this.Subsequently,344 samples were selected to verify the effectiveness of the review rules.Results The false positive rates of white blood cells,fungi,trichomonas and clue cells detected by the instrument were 28.77%,14.71%,20.09%and 2.30%,and the false negative rates were 0.28%,15.06%,4.35%and 10.34%.After manual image review and correction,the false positive rates of white blood cells,fungi,trichomonas and clue cells were 28.77%,7.06%,8.67%,0.66%,and the false negative rates were 0.28%,3.35%,4.35%and 10.34%.The false positive rates of white blood cell esterase(LE)for white blood cells,N-acetylhexylglucosidase(NAG)for fungi,NAG for trichomonas,hydrogen peroxide(H 2O 2)for bacteria,lactic acid(LA)for bacteria,sialidase(SNA)for clue cells,and proline aminopeptidase(PIP)for clue cells were 13.83%,22.47%,24.10%,95.52%,2.52%,12.92%and 5.54%,and the false negative rates were 28.17%,48.12%,0.00%,23.55%,78.82%,0.00%and 74.14%.The false positive rate of 260 validation samples was 1.68%,the false negative rate was 4.22%,and the review rate was 45.38%.Conclusion The review rules of the Dirui GMD-S600 gynecological secretion analysis system are as follows(1)All specimens need to be reviewed with images,and the following rules are based on this rule.(2)When the result of white blood cell shows positive,then the microscopic examination is required.(3)When the result of fungi shows positivity,then the microscopic examination is required.(4)When the result of trichomonas shows positive,then the microscopic examination is required.(5)When the result of SNA does not match the positive result of clue cells,then the microscopic examination is required.