Point-of-care (POC) diagnosis of bacterial vaginosis (BV) using VGTest™ ion mobility spectrometry (IMS) in a routine ambulatory care gynecology clinic - Archives of Gynecology and Obstetrics

Purpose

A new CE-marked portable desktop ion mobility spectrometer (VGTest) was used for detection of malodorous biogenic amines indicative of bacterial vaginosis (BV). This study aimed to assess the performance of this testing method for the first time in a routine ambulatory care clinic and to determine the relative levels of biogenic amines in vaginal fluid of BV.

Methods

Vaginal and cervical swabs (n = 57) were surveyed for infections. Cases of BV (n = 18) confirmed positive according to “Amsel” criteria and normal controls (n = 39) showing no infection under clinical examination and testing negative in wet mount microscopy were included in the IMS analysis.

Results

The trimethylamine (TMA) content in vaginal fluid of the BV-positive cases, AUC_TMA/AUC_Total [mean 0.215 (range 0.15–0.35)] was significantly higher than normal controls [mean 0.06 (range 0.048–0.07)] p < 0.0001. The putrescine (1,4-diaminobutane, PUT) and cadaverine (1,5-diaminopentane, CAD) of BV-positive cases were above controls at borderline significance. The AUC_TMA/AUC_Total ratios correlated neither with AUC_PUT/AUC_Total nor AUC_CAD/AUC_Total among BV-positive patients. In contrast, among normal controls all the biogenic amines were at a low level and the linear regression analysis revealed striking positive correlations of AUC_TMA/AUC_Total with AUC_PUT/AUC_Total (p < 0.05) and AUC_CAD/AUC_Total (p < 0.001). The test shows 83 % sensitivity and 92 % specificity at a cut-off of AUC_TMA/AUC_Total = 0.112 and AUC of receiver operator characteristic = 0.915 (0.81–0.97, 95 % CI).

Conclusions

VGTest-IMS is accurate and feasible for point-of-care testing of BV in the ambulatory care setting. Further evaluations are in progress to assess the utility of VGTest-IMS for differential diagnosis of candidosis, non-BV infection and common inflammatory conditions.

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We thank all the women who kindly consented to participate in this study and the cooperation of nursing staff for the collection and storage of vaginal swabs. We thank Dr. Zeev Karpas for his invaluable assistance throughout the project and critical reading of the manuscript. We thank Moshe Golan CEO 3QBD for his commitment and support with the VGTest device and all supplies necessary to carry out the research.

Conflict of interest

Dr. Simon D. Lytton has received consultancy fees from 3QBD and Mr Elias Atwah was an employee of 3QBD prior to the publication of this manuscript. The authors have no commercial investments in the VGTest device and no conflict of interest to declare.

Authors and Affiliations

1. 1st Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Maistrasse 11, 80337, Munich, Germany

   T. Blankenstein, B. Leidl & I. Mylonas

2. SeraDiaLogistics, 81545, Munich, Germany

   S. D. Lytton & K. Friese

3. 3QBD Ltd, 89092, Arad, Israel

   E. Atweh

Corresponding author

Correspondence to I. Mylonas.

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