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Tests for vaginal pH and amines performed better than syndromic management protocols for the diagnosis of bacterial vaginosis and were easy to implement in a resource-poor setting. 

Strategies for diagnosis of bacterial vaginosis in a resource-poor setting.
Posner SF, Kerimova J, Aliyeva F, Duerr A.
International Journal of STD & AIDS
2005;16:52-55.
 

Summary:

Question

How well do the Amsel clinical criteria, the FemExam card, and measurement of vaginal pH and amines perform for the diagnosis of bacterial vaginosis (BV) as determined by the Nugent gram stain score? 

Design

This study describes the evaluation in a resource-poor setting of the sensitivity and specificity of the Amsel clinical criteria, the FemExam card, and measurement of vaginal pH and amines for the diagnosis of BV using the Nugent Gram stain score as the gold standard. 

Participants

Two hundred women between 18 and 48 years old attending reproductive health fairs in rural Azerbaijan were tested. Women who were in menopause were not eligible. The mean age was 34 years, 94% were married, and 97% reported one lifetime sex partner. 

Description of Tests and Diagnostic Standard

Participants completed an interviewer-administered survey regarding demographic information and measures of potential risk behaviors associated with reproductive tract infections and had a gynecological examination during which vaginal swabs were taken for the FemExam test (Litmus Concepts Inc., Santa Clara, CA) and a Gram stain. The Gram stains were scored according to the Nugent method by laboratory personnel who were blinded to the patients’ clinical presentations. A score of >7 was considered positive for BV; a score of <3 was negative for BV; and results with scores of 4 to 6 were excluded from the analyses. 

Main Outcome Measures

The sensitivity and specificity of the Amsel clinical criteria, the FemExam card, and measurement of vaginal pH and amines were calculated using the Nugent Gram stain score (>7 = positive, <3 = negative) as the gold standard. 

Main Results

No demographic or behavioral variables were found to be associated with BV when diagnosed by Nugent Gram stain score, Amsel criteria, or the FemExam card. The prevalence of BV as determined by a Nugent score of >7 was 35%. The sensitivity and specificity of the various tests and criteria for the diagnosis of BV are shown in the table. The Amsel criteria were significantly more sensitive than the FemExam card or the measurement of vaginal pH and amines. The FemExam card was significantly more specific than the Amsel criteria or the measurement of vaginal pH and amines. The measurement of vaginal pH and amines was significantly more specific than the Amsel criteria. 


Sensitivity and specificity of tests for bacterial vaginosis compared to a Nugent Gram stain score of >7 among 200 women in rural Azerbaijan

BV diagnostic method Sensitivity (%) Specificity (%)
3 of 4 Amsel clinical criteria 74  65
FemExam positive pH and amine tests 59  92
FemExam positive pH test 94  57
FemExam positive amine test 64 73
Whiff test (amine) positive 67 71
Vaginal pH >4.5 97 48
Both positive whiff test and increased pH 65 78

Authors' Conclusions

None of the strategies had both high sensitivity and specificity compared with the Gram stain. A diagnostic strategy that uses the pH and amine tests is most likely the best solution in resource-poor settings because, although it is not the most sensitive or specific test, it offers a middle ground on sensitivity and specificity compared with more expensive and more technologically demanding techniques and performed better than the syndromic diagnostic algorithm. 

Source of funding: None given

For correspondence: S. F. Posner, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Division of Reproductive Health, 4770 Buford Highway, Mail Stop K-34, Atlanta, GA 30341. E-mail address: shps@cdc.gov

   

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