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

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, AUCTMA/AUCTotal [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 AUCTMA/AUCTotal ratios correlated neither with AUCPUT/AUCTotal nor AUCCAD/AUCTotal 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 AUCTMA/AUCTotal with AUCPUT/AUCTotal (p < 0.05) and AUCCAD/AUCTotal (p < 0.001). The test shows 83 % sensitivity and 92 % specificity at a cut-off of AUCTMA/AUCTotal = 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.

A novel method for the diagnosis of bacterial contamination in the anterior vagina of sows based on measurement of biogenic amines by ion mobility spectrometry: A field trial.

To determine if postpartum subclinical infection occurs in sows, a novel device was used to diagnose such bacterial contamination of the vagina. The device was based on the measurement of biogenic amines by ion mobility spectrometry (IMS). The device is portable and results are obtained within 1 min. Vaginal swabs were taken from 449 sows before first-estrus insemination and 133 (29.6%) had elevated biogenic amines and were considered positives. Sixty-one percent of the sows became pregnant following post-weaning first estrus insemination. Positive scores had no apparent effect on fertility rate which was 64%. Of the sows that became pregnant, 197 (69.1%) were diagnosed as "negative" and 88 (30.9%) were "positive", of which 37 received treatment with antibiotics and were termed "positive treated". The average live-born piglets litter size of the "positives" was 10.02 which was significantly lower (P = 0.031) than the "negative" sows (11.06) while "positive treated" sow average litter size was close to the "negative" (10.56). In conclusion, it was demonstrated that subclinical anterior-vaginal bacterial contamination in lactating sows about 2 wks postpartum is a condition that affects sow litter number and could be determined by the measurement of vaginal biogenic amines with IMS.