PMID- 35054351 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220128 IS - 2075-4418 (Print) IS - 2075-4418 (Electronic) IS - 2075-4418 (Linking) VI - 12 IP - 1 DP - 2022 Jan 13 TI - Aerobic Vaginitis Diagnosis Criteria Combining Gram Stain with Clinical Features: An Establishment and Prospective Validation Study. LID - 10.3390/diagnostics12010185 [doi] LID - 185 AB - Wet-mount microscopy aerobic vaginitis (AV) diagnostic criteria need phase-contrast microscopy and keen microscopists, and the preservation of saline smears is less common in clinical practice. This research work developed new AV diagnostic criteria that combine Gram stain with clinical features. We enrolled 325 AV patients and 325 controls as a study population to develop new AV diagnostic criteria. Then, an independent group, which included 500 women, was used as a validation population. AV-related microscopic findings on Gram-stained and wet-mount smears from the same participants were compared. The accuracy of bacterial indicators from the two methods was verified by bacterial 16S rRNA V4 sequencing (n = 240). Logistic regression was used to analyse AV-related clinical features. The screened clinical features were combined with Gram-stain microscopic indicators to establish new AV diagnostic criteria. There were no significant differences in the leukocyte counts or the parabasal epitheliocytes (PBC) proportion between the Gram-stain and wet-mount methods (400x). Gram stain (1000x) satisfied the ability to identify bacteria as verified by 16S rRNA sequencing but failed to identify toxic leukocytes. The new criteria included: Lactobacillary grades (LBG) and background flora (Gram stain, 1000x), leukocytes count and PBC proportion (Gram stain, 400x), and clinical features (vaginal pH > 4.5, vagina hyperemia, and yellow discharge). These criteria satisfied the accuracy and reliability for AV diagnosis (Se = 86.79%, Sp = 95.97%, and Kendall's W value = 0.899) in perspective validation. In summary, we proposed an alternative and valuable AV diagnostic criteria based on the Gram stain, which can make it possible to diagnose common vaginitis like AV, BV, VVC, and mixed infections on the same smear and can be available for artificial intelligence diagnosis in the future. FAU - Dong, Mengting AU - Dong M AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Wang, Chen AU - Wang C AUID- ORCID: 0000-0003-3995-4242 AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Li, Huiyang AU - Li H AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Yan, Ye AU - Yan Y AUID- ORCID: 0000-0002-7921-0101 AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Ma, Xiaotong AU - Ma X AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Li, Huanrong AU - Li H AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Li, Xingshuo AU - Li X AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Wang, Huihui AU - Wang H AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Zhang, Yixuan AU - Zhang Y AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Qi, Wenhui AU - Qi W AUID- ORCID: 0000-0002-4872-6957 AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Meng, Ke AU - Meng K AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Tian, Wenyan AU - Tian W AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Wang, Yingmei AU - Wang Y AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Fan, Aiping AU - Fan A AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Han, Cha AU - Han C AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. FAU - Donders, Gilbert G G AU - Donders GGG AUID- ORCID: 0000-0001-9890-6254 AD - Department of Obstetrics and Gynecology, University of Antwerp, 2550 Antwerp-Edegem, Belgium. AD - Femicare Clinical Research for Women, 3300 Tienen, Belgium. AD - Department of Obstetrics and Gynecology, Regional Hospital, 3300 Tienen, Belgium. FAU - Xue, Fengxia AU - Xue F AD - Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, 154 Anshan Road, He Ping District, Tianjin 300052, China. AD - Tianjin Key Laboratory of Female Reproductive Health and Eugenics, 154 Anshan Road, He Ping District, Tianjin 300052, China. LA - eng PT - Journal Article DEP - 20220113 PL - Switzerland TA - Diagnostics (Basel) JT - Diagnostics (Basel, Switzerland) JID - 101658402 PMC - PMC8775230 OTO - NOTNLM OT - 16S rRNA gene sequencing OT - Gram stain OT - aerobic vaginitis OT - clinical features OT - diagnostic criteria COIS- All authors declare no conflict of interest. EDAT- 2022/01/22 06:00 MHDA- 2022/01/22 06:01 PMCR- 2022/01/13 CRDT- 2022/01/21 01:08 PHST- 2021/11/13 00:00 [received] PHST- 2022/01/06 00:00 [revised] PHST- 2022/01/10 00:00 [accepted] PHST- 2022/01/21 01:08 [entrez] PHST- 2022/01/22 06:00 [pubmed] PHST- 2022/01/22 06:01 [medline] PHST- 2022/01/13 00:00 [pmc-release] AID - diagnostics12010185 [pii] AID - diagnostics-12-00185 [pii] AID - 10.3390/diagnostics12010185 [doi] PST - epublish SO - Diagnostics (Basel). 2022 Jan 13;12(1):185. doi: 10.3390/diagnostics12010185.