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Women in Madagascar who seek primary care for genital discharge should be treated syndromically and screened for syphilis.

Laboratory diagnosis of sexually transmitted infections in women with genital discharge in Madagascar: implications for primary care.
Behets FM-TF, Andriamiadana J, Randrianasolo D, Rasamilalao D, Ratsimbazafy N, Dallabetta G, Cohen MS.
Inter J STD AIDS. 2002;13:606-611.

 

Summary:

Question
Which tests and diagnostic approaches are feasible and useful in some settings of Madagascar for the detection of sexually transmitted infections in women with genital discharge?

Design
This study describes a direct comparison of the results of reference assays for the detection of C. trachomatis, N. gonorrhoeae, and T. vaginalis with those of less technical and more readily available laboratory tests for these organisms.

Participants
Women (n=1066) presenting to two STI clinics in Antananarivo, Madagascar, with a new episode of genital discharge, itching, or dysuria, who were at least 18 years old, were tested.

Description of Tests and Diagnostic Standard
A blood sample was collected for syphilis serology using rapid plasma reagin (RPR, Becton Dickinson, Cockeysville, MD). Sera that were RPR positive were tested using microhemagglutination for T. pallidum (TPHA, Fujirebio, Tokyo). Women provided a first-stream urine sample for detection of leukocytes using a dipstick test (LED, Chemstrip LN, Biodynamics, Indianapolis, IN) and for gonococcal and chlamydial testing using ligase chain reaction (LCR, LCx Probe System, Abbott, Laboratories, Abbott Park, IL) following manufacturers' instructions. Wet mounts of vaginal fluid were examined microscopically for the presence of motile trichomonads. Gram-stained smears of cervical swabs were examined for the presence of Gram-negative intracellular diplococci and leukocytes. Cervical swabs were cultured on modified Thayer-Martin medium (Becton Dickinson) and tested for chlamydia antigen using immunofluorescence (IF, Syva MicroTrak Chlamydia trachomatis Direct specimen Test, Behring Diagnostics Inc., Rijswijk, Netherlands). All testing was performed locally except the LCR, which was performed at the University of North Carolina.

Main Outcome Measures
The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of locally performed tests for the detection of gonococcal and chlamydial infections were determined compared with LCR results. LED was evaluated as a marker for gonococcal, chlamydial, and trichomonas infections.

Main Results
The results of laboratory tests are presented in table 1. The performances of selected laboratory results to detect gonococcal and chlamydial infection as defined by the result of the LCR test on urine are shown in table 2. When cervical infection with N. gonorrhoeae or C. trachomatis (determined by LCR) was grouped with trichomoniasis (detected by wet mount), the sensitivity, specificity, PPV, and NPV of the LED test was 64.3, 61.8, 52.6, and 72.5, respectively.

Table 1. Results of laboratory tests
Laboratory test  Number tested  Number (%) positive
RPR 992 71 (7.1)*
LED 1005 489 (48.7)**
Gram stain for diplococci 1056 50 (4.7)
Culture for N. gonorrhoeae  936 69 (7.4)
LCR for N. gonorrhoeae 1058 140 (13.2)
IF for chlamydia antigen 149 38 (25.5)
LCR for C. trachomatis 1058 115 (10.9)
Wet mount for T. vaginalis 1051 260 (24.7)
*60 (89.5%) of 67 RPR-reactive sera had a positive TPHA test result
**228 (22.4%) additional samples were trace reactive
Table 2. Performance by organism of selected laboratory results for detection of gonococcal and chlamydial infections as determined by LCR
Organism Test Number tested Parameter (%)
Sensitivity Specificity PPV NPV
N. gonorrhoeae Gram stain 1049 22.9 98.0 64.0 89.2
Culture 930 56.9 99.7 97.0 94.2
C. trachomatis IF 149 75.0 77.3 15.8 98.2
Both* >20 leukocytes** 1049 27.8 81.4 27.9 81.3
LED positive 1003 58.2 53.9 24.0 83.7
LED trace or positive 1003 81.1 31.2 22.8 86.8
*The prevalence of cervical infection due to gonococcal or chamydial infection was 20.7%.
**Leukocytes were measured per microscopic high power field in Gram-stained cervical smears

Authors' Conclusions
Attempts to identify low-technology laboratory tests that may be used as helpful surrogate markers for gonococcal and chlamydial infections in symptomatic women were unsuccessful. The infections were not associated with either the presence of at least 20 leukocytes per high power field in endocervical smears or reactive LED in urine. Women who seek primary care for genital discharge should be treated syndromically and tested for syphilis.

Source of funding: US Agency for International Development through Futures Group International and Family Health International

For correspondence: Frieda Behets, 2102A McGavran-Greenberg Hall, CB 7435, Chapel Hill, NC 27599-7400. Email address: frieda_behets@unc.edu.

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