Evaluation of vaginal secretion routine determination modes and review criteria analysis

doi:10.3969/j.issn.1673-8640.2023.11.016

Abstract

Abstract:

Objective To evaluate the performance of vaginal secretion routine determination modes，and to establish review criteria. Methods A total of 1 334 vaginal swabs were collected from the International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University School of Medicine from February to May 2021，of which 1 064 samples were used to evaluate the sensitivities of different determination modes and establish review criteria，and 270 samples were used to verify the review criteria. Automated composition analyzer，vaginitis examination analysis，AutowoMO dry chemical enzyme instrument，automated composition analyzer combined with AutowoMO dry chemical enzyme instrument，automated composition analyzer combined with vaginitis examination analysis artificial wet smear microscopy and Gram staining microscopy were used. Totally，3 initial review criteria were designed using the results of artificial wet smear microscopy and Gram staining microscopy. The sensitivities，specificities，false positive rates，false negative rates and consistency rates of different determination modes were evaluated. The determination mode with the highest sensitivity and the lowest false negative rate was selected to further optimize the review criteria and verify it. Results Of the 1 064 samples，328（30.83%）samples were positive，and 736（69.17%） samples were negative. The results of artificial wet smear microscopy and Gram staining microscopy showed that bacterial vaginosis（BV） accounted for 18.80%（200 samples），vulvovaginal candidiasis（VVC） 14.10%（150 samples） and trichomonas vaginitis（TV） 1.03%（11 samples）. Among the 5 determination modes，automated composition analyzer combined with AutowoMO dry chemical enzyme instrument had the highest sensitivities to BV，VVC and TV [56.00%（112/200），58.00%（87/150） and 90.91%（10/11），respectively]. Through verifying the review criteria of optimal determination mode，the false negative rates of BV，VVC and TV were 5.56%，5.93% and 0，respectively，and the review rate was 24.81%. Conclusions Automated composition analyzer combined with AutowoMO dry chemical enzyme instrument is suitable for the early screening of BV，VVC and TV，and the optimized review criteria can effectively decrease the false negative rate，and the review rate is acceptable.

Key words: Vaginal secretion, Composition analysis, Dry chemical enzyme method, Microscopy, Review criterion

CLC Number:

R446.11

LU Tingyan, GU Danfeng, WANG Yahong, GE Yafang, YANG Haiou. Evaluation of vaginal secretion routine determination modes and review criteria analysis[J]. Laboratory Medicine, 2023, 38(11): 1091-1097.

Figures/Tables 6

References 25

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湿片镜检	仪器法有形成分分析（白细胞分级）				合计
湿片镜检	0级	1级	2级	3级	合计
0级	371	171	41	6	589
1级	13	77	72	11	173
2级	2	17	38	24	81
3级	0	5	30	186	221
合计	386	270	181	227	1 064

湿片镜检	仪器法有形成分分析（白细胞分级）				合计
湿片镜检	0级	1级	2级	3级	合计
0级	371	171	41	6	589
1级	13	77	72	11	173
2级	2	17	38	24	81
3级	0	5	30	186	221
合计	386	270	181	227	1 064

联合镜检	份数	阴道炎五联检		仪器法干化学酶检测		仪器法有形成分分析		仪器法有形成分分析+阴道炎五联检		仪器法有形成分分析+仪器法干化学酶检测
联合镜检	份数	阳性	阴性	阳性	阴性	阳性	阴性	阳性	阴性	阳性	阴性
BV
阳性	200	36	164	94	106	77	123	83	117	112	88
阴性	864	3	861	23	841	7	857	6	858	17	847
VVC
阳性	150	31	119	53	97	82	68	80	70	87	63
阴性	914	0	914	0	914	5	909	5	909	5	909
TV
阳性	11	9	2	9	2	9	2	9	2	10	1
阴性	1 053	0	1 053	0	1 053	0	1 053	0	1 053	0	1 053

联合镜检	份数	阴道炎五联检		仪器法干化学酶检测		仪器法有形成分分析		仪器法有形成分分析+阴道炎五联检		仪器法有形成分分析+仪器法干化学酶检测
联合镜检	份数	阳性	阴性	阳性	阴性	阳性	阴性	阳性	阴性	阳性	阴性
BV
阳性	200	36	164	94	106	77	123	83	117	112	88
阴性	864	3	861	23	841	7	857	6	858	17	847
VVC
阳性	150	31	119	53	97	82	68	80	70	87	63
阴性	914	0	914	0	914	5	909	5	909	5	909
TV
阳性	11	9	2	9	2	9	2	9	2	10	1
阴性	1 053	0	1 053	0	1 053	0	1 053	0	1 053	0	1 053

项目	阴道炎五联检			仪器法干化学酶检测			仪器法有形成分分析			仪器法有形成分分析+阴道炎五联检			仪器法有形成分分析+仪器法干化学酶检测
项目	敏感性	特异性	总符合率	敏感性	特异性	总符合率	敏感性	特异性	总符合率	敏感性	特异性	总符合率	敏感性	特异性	总符合率
BV	18.00	99.65	84.30	47.00	97.33	87.88	38.50	99.19	87.78	41.50	99.07	88.44	56.00	98.03	90.13
VVC	20.67	100.00	88.82	35.33	100.00	90.88	54.67	99.45	93.14	53.33	99.45	92.95	58.00	99.34	93.61
TV	81.82	100.00	99.81	81.82	100.00	99.81	81.82	100.00	99.81	81.82	100.00	99.81	90.91	100.00	99.91