Concordance Between Clinical and Laboratory Diagnosis of Abnormal Vaginal Discharge in Chilean Women

Abstract Objective To determine the concordance between the clinical diagnosis of women with abnormal vaginal discharge (AVD) and laboratory results using molecular detection and observation of the vaginal microbiota. Methods Cross-sectional study conducted in 2018 in Temuco, Chile. A total of 25 midwives from 12 health centers participated. A total of 125 women>18 years old, volunteers, were recruited. The sample of the posterior vaginal fornix was obtained by speculoscopy. Characteristics of the discharge and of the external and internal genitalia were observed. Gram staining was used to observe vaginal microbiota, blastoconidia and pseudohyphae, and polymerase chain reaction was used for the detection of Trichomonas vaginalis and Candida albicans. The Cohen kappa coefficient was used in the concordance analysis. Results Out of a total of 125 women with AVD, 85.6% consulted spontaneously and 14.4% were diagnosed clinically during a routine check-up. Absolute concordance was significant (p=0.0012), with an agreement of 13.6%. The relative concordance was significant, but fair for bacterial vaginosis (Kappa=0.21; p=0.003) and candidiasis (Kappa=0.22; p=0.001), and slight for trichomoniasis (Kappa=0.14; p=0.009). The percentage of coincidence of the diagnoses (single or mixed) by laboratory and midwives was: bacterial vaginosis 63.2% (12/19), candidiasis 36.5% (27/74), and trichomoniasis 12.5% (4/32). There was 20% coinfection. A total of 36% of the clinical diagnoses of AVD had negative laboratory tests. Conclusion The vulvovaginitis conditions candidiasis and trichomoniasis appear to be overdiagnosed, and bacterial vaginosis appears to be underdiagnosed by the clinical diagnosis when compared with the laboratory diagnosis. The low concordance obtained shows the importance of complementing the clinical diagnosis with a laboratory study of AVD, particularly in women with failed treatments and/or coinfections with unspecific and varying signs and symptoms.

**摘要 目的** 明确女性异常阴道分泌物（Abnormal Vaginal Discharge, AVD）临床诊断与采用分子检测及阴道菌群观察的实验室检测结果之间的一致性。**方法** 本研究为2018年在智利特木科开展的横断面研究。共计来自12个卫生中心的25名助产士参与本研究，招募了125名年龄≥18岁的女性志愿者。采用阴道窥器检查采集阴道后穹窿样本，观察分泌物及内外生殖器特征。以革兰染色观察阴道菌群、芽生孢子及假菌丝，通过聚合酶链式反应(Polymerase Chain Reaction, PCR)检测阴道毛滴虫（Trichomonas vaginalis）与白色念珠菌（Candida albicans）。采用科恩kappa系数（Cohen Kappa Coefficient）进行一致性分析。**结果** 在共计125名异常阴道分泌物女性中，85.6%为自发就诊，14.4%为常规体检中临床确诊。整体绝对一致性具有统计学意义（p=0.0012），一致率为13.6%。相对一致性同样具有统计学意义，但细菌性阴道病（Kappa=0.21；p=0.003）与念珠菌性阴道炎（Kappa=0.22；p=0.001）的一致性仅为一般水平，滴虫性阴道炎（Kappa=0.14；p=0.009）的一致性仅为轻微水平。实验室与助产士诊断的吻合率（单一或混合感染）分别为：细菌性阴道病63.2%（12/19）、念珠菌性阴道炎36.5%（27/74）、滴虫性阴道炎12.5%（4/32）。合并感染率为20%。共计36%的异常阴道分泌物临床诊断对应的实验室检测结果为阴性。**结论** 与实验室诊断相比，临床诊断存在念珠菌性阴道炎与滴虫性阴道炎过度诊断、细菌性阴道病诊断不足的情况。本次研究得到的低一致性水平表明，对异常阴道分泌物开展实验室辅助检查具有重要意义，尤其是在治疗失败及/或合并感染且存在非特异性、多变体征与症状的女性群体中。