Available online 26 April 2023, 115953

Author links open overlay panel, , , , , , , ABSTRACTPurpose

Vaginitis is caused by bacterial vaginosis (BV), Candida vaginitis (CV) and Trichomonas vaginalis (TV). This retrospective study evaluates the performance of the Aptima CV/TV, and BV assays on the automated Panther system.

Methods

242 Multitest swabs were tested on the CV/TV assay and 422 on the BV assay. Positive and negative percent agreement (PPA, NPA) of the Candida glabrata (CG), Candida species group (CSG), TV and BV targets were calculated using a modified gold standard, with review of Gram smear and the usage of the Allplex Vaginitis Screening Assay to resolve discrepancies.

Results

The PPA and NPA were respectively 98.4% and 95.9% for BV, 100.0% and 95.4% for CSG, 100.0% and 99.0% for CG, and 100.0% and 100.0% for TV, and when compared to consensus results.

Conclusion

The CV/TV and BV assays surpassed the acceptance criteria threshold of 95%, and proved to be an excellent alternative to conventional testing.

Section snippetsINTRODUCTION

Vaginitis, characterized by vaginal discharge, odor, irritation, and pruritus, is the most common reason for gynecologic visits to primary care. Bacterial vaginosis (BV) is most common in women of childbearing age, followed by vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV) [1], [2], [3]. BV occurs due to a shift in vaginal microflora, characterized by a loss or sharp decline in the quantity of Lactobacillus species, such as L. crispatus, L. gasseri, L. iners and L. jensenii, with

Study design

This was a retrospective study performed on archived samples from females 14 to 59 years old, including inpatients and outpatients, who had specimens for vaginitis testing submitted to Interior Health laboratories from March to October 2021. Testing was performed at Kelowna General Hospital laboratory, in British Columbia, Canada. Ethics approval was not required as the project was deemed to be a quality improvement project for laboratory capacity.

Specimen collection

Aptima Multitest vaginal swabs (Hologic Inc,

RESULTS

Overall, 664 specimens, including 616 patient specimens and 48 contrived specimens, were tested (Table 1). Four clinical specimens were collected from admitted patients, while 612 specimens were collected from the Emergency department or community clinics. The median age of the population studied was 32 (Interquartile range: 25 to 42).

DISCUSSION

Vaginitis is a common condition, with significant social impact and morbidity, which may remain undiagnosed in a significant proportion of women, using traditional clinical and laboratory based diagnostic schemes [21]. When left undiagnosed or untreated, it can result in absenteeism from work or school, sexual dysfunction and negative self image [22,23]. In our laboratory based, retrospective study, the Aptima assays performed well, with excellent PPA and NPA compared to consensus results.

Author Contributions•

Conceived and designed study: Melissa Caza, Marthe Charles, Kerstin Locher, Amanda Wilmer

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Collected data: Morgan Tucker, Jeremy Mandy;

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Testing: Melissa Caza, Jeremy Mandy, Heather Jewsbury

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Data analysis: Melissa Caza, Amanda Wilmer

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Manuscript writing and editing: All authors

All authors read and approved the final manuscript.

Uncited Floats

Table 2

Funding

Reagents for this study were provided in kind by Hologic Canada and Seegene Canada, although they did not participate in performing the study, analyzing the results or writing this manuscript. Funding for Co-op students were provided in kind by the Colin & Lois Pritchard Foundation.

Data availability

The dataset generated during the current study is not publicly available due to patient privacy policies, but are available from the corresponding author on reasonable request.

Ethics approval

Ethics approval was not required as the project was deemed to be a quality improvement project for laboratory capacity.

Consent to participate

N/A – retrospective study

Consent to publish

N/A – retrospective study

ACKNOWLEDGEMENTS

We would like to thank the Interior Health microbiology technologists for performing all conventional laboratory testing used in the study. We would also like to thank Braden Patterson and Lindsey Eastman for their assistance in organizing study specimens. We would also like to thank Hologic® and Seegene, who provided reagents for this study, although they did not participate in performing the study, analyzing the results or writing this manuscript. Finally, we would like to thank the Colin &

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