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The specificity of a G. vaginalis DNA hybridization test compared well with a Gram stain scoring system for the diagnosis of bacterial vaginosis in pregnant women.

DNA hybridization test: rapid diagnostic tool for excluding bacterial vaginosis in pregnant women with symptoms suggestive of infection.
Witt A, Petricevic L, Kaufmann U, Gregor H, Kiss H.
Journal of Clinical Microbiology 2002;40:3057-3059.

 

Summary:

Question
Can a DNA hybridization test be used as an alternative to Gram-stained microscopic slides for diagnosis of bacterial vaginosis?

Design
This study describes a prospective comparison of a DNA hybridization test with Gram stain for the diagnosis of bacterial vaginosis (BV) in pregnant women.

Participants
One thousand seven hundred twenty-five women between the 12th and 36th weeks of gestation attending the outpatient clinic of the Department of Obstetrics and Gynecology at the University of Vienna, who presented with clinical symptoms of increased vaginal discharge combined with pruritus and/or burning, cervical incompetence, lower abdominal pain, preterm labor, or preterm rupture of the membranes were included in the study.

Description of Tests and Diagnostic Standard
Separate vaginal samples collected on Dacron swabs were tested by the Affirm VPIII G. vaginalis DNA hybridization assay (Becton Dickinson, Sparks, MD), according to the manufacturer's protocol, and by the evaluation of a Gram-stained microscopic slide according to the Nugent scoring system, modified to classify into four categories. Grade 0 corresponded to a smear with no microbes, grade 1 to a Nugent score <4, grade 2 to a Nugent score of 4 to 6, and grade 3 to a Nugent score >6. Grade 3 showed the flora typical of bacterial vaginosis.

Main Outcome Measures
The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the DNA hybridization test compared to the Gram stained slide evaluated by a modified Nugent scoring system for the diagnosis of bacterial vaginosis were determined.

Main Results
The results of the Gram stain, presented by grade, versus the hybridization test are shown in the table. When grade 2 cases were included with grade 3 as positive for bacterial vaginosis, the sensitivity, specificity, PPV, and NPV of the DNA hybridization test were 73.2%, 97.1%, 88.7%, and 92.2%, respectively. When grade 2 cases were subtracted from the analysis, and grade 3 cases only were considered positive for BV, the sensitivity, specificity, PPV, and NPV of the DNA hybridization test were 89.5%, 97.1%, 80.1%, and 98.6%, respectively. However, if grade 2 cases are included with grades 0 and 1 as negative for bacterial vaginosis, the sensitivity, specificity, PPV, and NPV of the DNA hybridization test are 89.5%, 88.3%, 45.7%, and 98.7%, respectively.

Gram stain versus hybridization test in the detection of bacterial vaginosis
Gram stain Hybridization test

Grade

Number of smears Negative Positive
0 and 1

1319

1281 38
2 235 91 144
3 171 18 153
Total

1725

1390 335

Authors' Conclusions
The DNA hybridization test can be used as a rapid diagnostic tool to exclude bacterial vaginosis in pregnant women with symptoms.

Source of funding: None given.

For correspondence: Herbert Kiss, Department of Obstetrics and Gynecology, University of Vienna Medical School, Wahringer Gurtel 18-20, A-1090 Vienna, Austria. E-mail address: herbert.kiss@akh-wien.ac.at.


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