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Abstract：
OBJECTIVE: Vaginal microbiota evaluation is a methodology widely used in China to diagnose various vaginal inflammatory diseases. Although vaginal microbiota evaluation has many advantages, it is time-consuming and requires highly skilled and experienced operators. Here, we investigated a six-index functional test that analyzed pH, hydrogen peroxide (H2O2), leukocyte esterase (LEU), sialidase (SNA), β-glucuronidase (GUS), and acetylglucossidase (NAG), and determined its diagnostic value by comparing it with morphological tests of vaginal microbiota.
METHODS: The research was conducted using data extracted from the Laboratory Information System of Women and Children\'s Hospital. A total of 4902 subjects, ranging in age from 35.4 ± 9.7 years, were analyzed. During the consultation, a minimum of two vaginal swab specimens per patient were collected for both functional and morphological testing. Fisher\'s exact was used to analyze data using SPSS.
RESULTS: Of the 4,902 patients, 2,454 were considered to have normal Lactobacillus morphotypes and 3,334 were considered to have normal dominant microbiota. The sensitivity and specificity of H2O2-indicating Lactobacillus morphotypes were 91.3% and 25.28%, respectively, while those of pH-indicating Lactobacillus morphotypes were 88.09% and 59.52%, respectively. The sensitivity and specificity of H2O2-indicating dominant microbiota were 91.3% and 25.3%, respectively, while those of pH-indicating dominant microbiota were 86.27% and 64.45%, respectively. The sensitivity and specificity of NAG for vulvovaginal candidiasis were 40.64% and 84.8%, respectively. For aerobic vaginitis, GUS sensitivity was low at 0.52%, while its specificity was high at 99.93%; the LEU sensitivity and specificity values were 94.73% and 27.49%, respectively. Finally, SNA sensitivity and specificity for bacterial vaginosis were 80.72% and 96.78%, respectively.
CONCLUSIONS: Functional tests (pH, SNA, H2O2, LEU) showed satisfactory sensitivity for the detection of vaginal inflammatory diseases. However, these tests lacked specificity, making it difficult to accurately identify specific pathologies. By contrast, NAG and GUS showed excellent specificity in identifying vaginal inflammatory diseases, but their sensitivity was limited. Therefore, functional tests alone are not sufficient to diagnose various vaginal inflammatory diseases. When functional and morphological tests are inconsistent, morphological tests are currently considered the preferred reference method.
METHODS: The research was conducted using data extracted from the Laboratory Information System of Women and Children\'s Hospital. A total of 4902 subjects, ranging in age from 35.4 ± 9.7 years, were analyzed. During the consultation, a minimum of two vaginal swab specimens per patient were collected for both functional and morphological testing. Fisher\'s exact was used to analyze data using SPSS.
RESULTS: Of the 4,902 patients, 2,454 were considered to have normal Lactobacillus morphotypes and 3,334 were considered to have normal dominant microbiota. The sensitivity and specificity of H2O2-indicating Lactobacillus morphotypes were 91.3% and 25.28%, respectively, while those of pH-indicating Lactobacillus morphotypes were 88.09% and 59.52%, respectively. The sensitivity and specificity of H2O2-indicating dominant microbiota were 91.3% and 25.3%, respectively, while those of pH-indicating dominant microbiota were 86.27% and 64.45%, respectively. The sensitivity and specificity of NAG for vulvovaginal candidiasis were 40.64% and 84.8%, respectively. For aerobic vaginitis, GUS sensitivity was low at 0.52%, while its specificity was high at 99.93%; the LEU sensitivity and specificity values were 94.73% and 27.49%, respectively. Finally, SNA sensitivity and specificity for bacterial vaginosis were 80.72% and 96.78%, respectively.
CONCLUSIONS: Functional tests (pH, SNA, H2O2, LEU) showed satisfactory sensitivity for the detection of vaginal inflammatory diseases. However, these tests lacked specificity, making it difficult to accurately identify specific pathologies. By contrast, NAG and GUS showed excellent specificity in identifying vaginal inflammatory diseases, but their sensitivity was limited. Therefore, functional tests alone are not sufficient to diagnose various vaginal inflammatory diseases. When functional and morphological tests are inconsistent, morphological tests are currently considered the preferred reference method.
摘要：
目的：阴道菌群评估是一种在中国广泛用于诊断各种阴道炎症性疾病的方法。尽管阴道微生物群评估具有许多优点，这是耗时的，需要高技能和经验丰富的操作员。这里,我们研究了一种六指数功能测试，该测试分析了pH值，过氧化氢(H2O2),白细胞酯酶（LEU），唾液酸酶（SNA），β-葡糖醛酸酶（GUS），和乙酰葡糖苷酶（NAG），并通过与阴道菌群的形态学检查进行比较，确定其诊断价值。
方法：本研究使用从妇女儿童医院实验室信息系统中提取的数据进行。共4902个科目,年龄在35.4±9.7岁之间，进行了分析。在协商期间,每个患者至少收集2份阴道拭子样本进行功能和形态学检测.Fisher的精确数据用于SPSS分析。
结果：在4,902名患者中，2,454被认为具有正常的乳杆菌形态型，3,334被认为具有正常的优势微生物群。H2O2指示型乳杆菌的敏感性和特异性分别为91.3%和25.28%,分别,而pH指示型乳杆菌的形态分别为88.09%和59.52%，分别。H2O2指示优势微生物群的敏感性和特异性分别为91.3%和25.3%,分别,而指示pH的优势微生物群分别为86.27%和64.45%，分别。NAG对外阴阴道念珠菌病的敏感性和特异性分别为40.64%和84.8%,分别。对于需氧性阴道炎，GUS灵敏度低，为0.52%，其特异性高达99.93%;LEU敏感性和特异性分别为94.73%和27.49%,分别。最后,SNA对细菌性阴道病的敏感性和特异性分别为80.72%和96.78%,分别。
结论：功能测试（pH，SNA,H2O2，LEU）对阴道炎性疾病的检测显示出令人满意的敏感性。然而,这些测试缺乏特异性，这使得很难准确识别特定的病理。相比之下,NAG和GUS在鉴别阴道炎性疾病方面表现出极好的特异性,但他们的敏感性有限。因此,仅功能检查不足以诊断各种阴道炎性疾病。当功能和形态学测试不一致时，形态学测试目前被认为是首选的参考方法。
方法：本研究使用从妇女儿童医院实验室信息系统中提取的数据进行。共4902个科目,年龄在35.4±9.7岁之间，进行了分析。在协商期间,每个患者至少收集2份阴道拭子样本进行功能和形态学检测.Fisher的精确数据用于SPSS分析。
结果：在4,902名患者中，2,454被认为具有正常的乳杆菌形态型，3,334被认为具有正常的优势微生物群。H2O2指示型乳杆菌的敏感性和特异性分别为91.3%和25.28%,分别,而pH指示型乳杆菌的形态分别为88.09%和59.52%，分别。H2O2指示优势微生物群的敏感性和特异性分别为91.3%和25.3%,分别,而指示pH的优势微生物群分别为86.27%和64.45%，分别。NAG对外阴阴道念珠菌病的敏感性和特异性分别为40.64%和84.8%,分别。对于需氧性阴道炎，GUS灵敏度低，为0.52%，其特异性高达99.93%;LEU敏感性和特异性分别为94.73%和27.49%,分别。最后,SNA对细菌性阴道病的敏感性和特异性分别为80.72%和96.78%,分别。
结论：功能测试（pH，SNA,H2O2，LEU）对阴道炎性疾病的检测显示出令人满意的敏感性。然而,这些测试缺乏特异性，这使得很难准确识别特定的病理。相比之下,NAG和GUS在鉴别阴道炎性疾病方面表现出极好的特异性,但他们的敏感性有限。因此,仅功能检查不足以诊断各种阴道炎性疾病。当功能和形态学测试不一致时，形态学测试目前被认为是首选的参考方法。
