Tests for Chlamydia trachomatis and Neisseria gonorrhoeae, which can provide results rapidly to guide therapeutic decision-making, offer patient care advantages over laboratory-based tests that require several days to provide results. We compared results from the Cepheid GeneXpert CT/NG (Xpert) assay to results from two currently approved nucleic acid amplification assays in 1,722 female and 1,387 male volunteers. Results for chlamydia in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 97.4%, 98.7%, and 97.6%, respectively, and for urine samples from males, a sensitivity of 97.5%, with all specificity estimates being >99.4%. Results for gonorrhea in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 100.0%, 100.0%, and 95.6%, respectively, and for urine samples from males, a sensitivity of 98.0%, with all estimates of specificity being >99.8%. These results indicate that this short-turnaround-time test can be used to accurately test patients and to possibly do so at the site of care, thus potentially improving chlamydia and gonorrhea control efforts. Chlamydia trachomatis and Neisseria gonorrhoeae are the agents of the two most prevalent bacterial sexually transmitted infections (STIs) reported to the Centers for Disease Control and Prevention (CDC), accounting for Ͼ1.6 million reported infections in the United States in 2010 (1). The CDC estimates that STIs cost the health care system $1.5 billion annually. Since these infections, especially chlamydia, are most often asymptomatic, the CDC recommends yearly screening for chlamydia in all sexually active women aged 16 to 25 years. Further, since coinfections are common, most diagnostic test platforms assay for both organisms. Nucleic acid amplification tests (NAATs) are now recommended by the CDC (2) as the tests of choice; however, current NAATs are classified as being of high or moderate complexity and might take 1 to 2 days for results to become available. New assays and new platforms that provide results at the time of patient visits are urgently needed, since many patients do not return for their results when laboratory-based tests that require several days for their results are performed (3, 4).The Cepheid GeneXpert CT/NG (Xpert) assay is a rapid (Ͻ2 h to results) NAAT assay that can be performed in on-site laboratories. The assay detects the DNA of C. trachomatis and N. gonorrhoeae from endocervical, vaginal, and urine specimens of females, as well as from urine specimens of males, from both symptomatic and asymptomatic individuals. The Xpert test is performed using a modular cartridge-based platform for testing each specimen by nucleic acid amplification, and it can process from 1 to 96 specimens in Ͻ2 h with easy-to-use cartridges that minimize processing steps and contamination. This study compares the clinical performance (as measured by sensitivity, specificity, positive predictive value [PPV] and negative predictive value [NPV]) of the Xpert assay to the patient infection status (PIS)...

Summary We conducted a cross-sectional study with 208 HIV-uninfected and 188 HIV-infected women in Uganda and Zimbabwe to investigate differences in median CD4 counts. Absolute CD4 counts were determined by flow cytometry. Multivariate analyses were used to examine the association of country and HIV-infection status on CD4 counts. Median CD4 counts were significantly lower in Zimbabwe than in Uganda overall (649 and 783 cells/mm3, P = 0.009) and among HIV-infected women (470 and 614 cells/mm3, P = 0.003). In separate multivariable models, CD4 counts were significantly lower in Zimbabwe in HIV-uninfected (P = 0.014) and infected (P < 0.001) women, controlling for age, contraceptive method, education and living with partner status. In a model combining HIV-uninfected and infected women, there was no significant interaction between country and HIV infection status (P = 0.344), suggesting that the relationship between country and CD4 count was not significantly modified by HIV infection status. This study reinforces the importance of establishing country-specific reference CD4 levels as CD4 count continues to be used as a key biomarker in clinical decision-making for HIV-infected individuals in sub-Saharan Africa.

We evaluated the acceptability of a community-based herpes simplex virus type 2 (HSV-2) screening programme for at-risk women and assessed factors related to uptake of point of care HSV-2 testing. One hundred recently arrested women (median age 34 years) were recruited from a community court handling lower-level misdemeanour cases in Indianapolis, Indiana. Individuals completed a survey assessing factors related to HSV-2 screening intentions and were offered point of care HSV-2 testing. Rates of HSV-2 infection in this population are high; 61.1% of women tested were positive. The majority (81%) accepted a prescription for suppressive therapy. Women in this sample indicated that HSV-2 screening is an important component of health care but were unwilling to pay the US$10 it cost to be tested. To encourage this and other high-risk populations to be screened for HSV-2, public health resources will be needed to help individuals overcome cost-related barriers to care.

Results We confirm the initially reported specificity and further narrow down its confidence interval (specificity 99.5%, 95% CI 99.4-99.6%), and show that this high specificity is valid across diverse patient categories. Here we demonstrate that differences in positive predictive values between patient categories reflect the prevalence of syphilis in these categories, and are not due to differences in specificity. In addition, in a sensitivity analysis we show that these conclusions are robust for several assumptions. Conclusion Our analysis shows that the high specificity found in the initial study, stands up after implementation in a population with a low syphilis prevalence (0.9%). Using a selected serum sample collection is therefore a valid manner in the evaluation of syphilis serological diagnostic assays. Confirmatory syphilis testing remains mandatory in low prevalence populations, even when the screening test has a very high specificity. Background Although syphilis and HIV are primarily transmitted through sexual intercourse, they can also be transmitted from mother to child during pregnancy or at delivery. Testing pregnant women for syphilis and HIV is an important public health measure to prevent vertical transmission. Several countries have included screening of pregnant women using rapid HIV testing, and recently also rapid syphilis testing. Screening pregnant women for both diseases with one test is not only desirable but could also be very convenient. We present the results of the laboratory-based evaluation of a new test: the SD Bioline HIV/Syphilis Duo. Methods We used archived serum specimens characterised as positive or negative for HIV and/or Syphilis. The gold standard positive for HIV was EIA (Vironostika ® HIV Uni-Form II Ag/Ab, bioMéri-eux) with confirmation using Western blot. The reference standard positive for syphilis was the Rapid Plasma Reagin test (RPR, bioMérieux) with confirmation using the Treponema pallidum Particle Agglutination (TPPA) assay (Fujireibio, Japan). Reference standard negatives were EIA negative and RPR negative for HIV and syphilis respectively. For Syphilis we used a total of 665 samples, including 198 positives, and for HIV we used 662 samples including 91 positives. There were 42 samples positive for both HIV and syphilis. The samples were tested with the SD Bioline HIV/Syphilis Duo by a laboratory technician blinded to the gold standard results. Results For Syphilis we observed a sensitivity of 100% (198/198) and a specificity of 99.57% (465/467). The two RPR negative/Bioline positive samples were negative for TPPA. For HIV, both the sensitivity and specificity were 100% (91/91 and 571/571 respectively). Conclusions The SD Bioline HIV/Syphilis Duo test has a good performance in archived sera. Its high sensitivity suggests that this dual test would be of use in screening programmes for syphilis and HIV. Background Assays for the detection of Trichomonas vaginalis (TV) are available on certain commercial platforms. The objective of this study was to assess ...

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