Herpes infections are among the most common sexually transmitted infections (STI), but diagnostic methods for genital herpes have not kept pace with the movement toward molecular testing. Here, we describe an FDA-approved molecular assay that identifies and types herpes simplex virus (HSV) infections for use in routine clinical settings. Paired samples from anogenital lesions were tested using the BD ProbeTec HSV Q(x) (HSVQ(x)) system, HSV culture and, a laboratory-developed PCR assay. Family planning, obstetrics/gynecology (OB/GYN), or sexually transmitted disease (STD) clinics in the United States served as recruitment sites. Sensitivity and specificity estimates, head-to-head comparisons, measures of agreement, and latent-class analyses were performed to provide robust estimates of performance. A total of 508 participants (174 men and 334 women) with anogenital lesions were included; 260 HSV-2 and 73 HSV-1 infections were identified. No differences in test performance based on gender, clinic type, location of the lesion, or type of lesion were observed. The sensitivity of HSV-2 detection ranged from 98.4 to 100% depending on the analytical approach, while the specificity ranged from 80.6%, compared to the less sensitive culture method, to 97.0%, compared to PCR. For HSV-1, the sensitivity and specificity ranges were 96.7 to 100% and 95.1 to 99.4%, respectively. This assay may improve our ability to accurately diagnose anogenital lesions due to herpes infection.

The Roche cobas® CT/NG test (c4800), performed on the cobas 4800 system, is a new diagnostic assay using an automated workstation to isolate nucleic acids from clinical specimens and a real-time instrument for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). This study compared the performance characteristics of the c4800 with the Becton Dickinson ProbeTec™ CT/GC Q(x) assay (Q(x)) and Gen-Probe® Aptima Combo 2 (AC2) assay for the detection of CT and NG in male urine using patient-infected-status (PIS).Urine and urethral swabs were obtained from men attending STD, family planning, or OB/GYN clinics from 11 geographically distinct locations. Aliquot order was randomized for urine specimens between AC2, c4800, and Q(x). Urethral swabs were randomized between AC2 and Q(x). Urethral swabs were only used to define PIS and were not tested on the c4800. A participant was considered infected if the 2 comparator assays with different molecular targets had positive results from either sample type.A total of 790 men were screened, with 768 evaluable for CT and NG. Symptoms were reported in 296 (38.5%) participants. For urine, the overall sensitivity and specificity of the c4800 assay for CT were 97.6% and 99.5%, respectively, when compared with PIS. Sensitivity and specificity for NG were 100% and 99.7%, respectively.The c4800 has excellent sensitivity and specificity for male urine specimens when compared with PIS. Assay performance was similar in symptomatic and asymptomatic men and was equivalent to nucleic acid amplification tests that are currently on the market.

Abstract The current study assessed the impact of individual, interpersonal, and contextual factors on HIV risk perception. A total of 426 female adolescents attending family planning clinics took part in this study. The majority, 60.1% were African-American and 39.9% were Hispanic. The results indicated that the majority of participants perceived themselves to be at no or low risk for contracting HIV. Individual, interpersonal as well as contextual factors correlated with HIV risk perception in the study. Adolescents who perceived themselves to be at no or low risk were more likely to be Hispanic, be married and had children. They also felt that they can control situations where they have to refuse sex or insist on condom use, had more frequent communication with sexual partners about condom use and held perceptions that peer norms support condom use. The findings in this study have important implications for risk reduction education for female adolescents. Risk reduction education should strengthen adolescents' personal skills to help them avoid HIV risk despite the various pressures they experience in their life.

We assessed the acceptance of self-testing for vaginal pH in 344 Ugandan women in different clinical settings. Women tested themselves by insertion of a gloved finger into the vagina to test vaginal pH and provide a smear on a glass slide. None of the tested women found the test very difficult: 8% found it somewhat difficult, 16% rather easy and 76% very easy to do. Of the 20% who found it difficult to read the test result, more women were attending a family planning clinic or had a higher diploma (P = 0.001). Pregnant women were least likely to understand of the meaning of the test, while those visiting family planning clinics had the opposite experience. HIV-infected women were most motivated to accept: 95% would be happy to use the test more often if requested, and another 3.5% felt they might be better motivated to do repeat testing after extra explanation. Self-sampling of vaginal pH is well accepted by Ugandan women. Our new method also allows diagnostic work-up by formal microscopy. Before commencing large-scale population screening, unexpected reactions of different subpopulations should be taken into account.

Discordant results have been reported between treponemal-specific enzyme immunoassays (EIA) screening and confirmatory tests such as the Treponemal pallidum particle agglutination (TPPA) assay. The performance of IgG EIA screening in specific populations, such as pregnant women, is not well defined. We reviewed laboratory results of 34,251 samples from individuals who underwent IgG EIA screening at a large Boston academic medical center, so as to calculate positive concordance of these screening tests with a confirmatory TPPA or subsequent rapid plasma reagin (RPR) test by age, gender, pregnancy, and obstetric or gynecologic (Ob/Gyn) service.We conducted a retrospective, cross-sectional study of the Captia Syph-G EIA serum samples between 2004 and 2007. Binary regression modeling was used to identify independent associations between demographic variables and positive concordance of EIA screening with RPR and confirmatory TPPA tests.Of 34,251 samples, 631 (1.8%) had a positive IgG EIA screen. In all, 79% of samples with a positive EIA had a reactive TPPA, and 48% had a positive RPR. Patients less than 40 years of age, females, and women on an Ob/Gyn clinical service had significantly lower rates of positive concordance between EIA screening and TPPA reactivity when covariate adjusted in regression modeling, whereas women on Ob/Gyn service were significantly associated with lower positive concordance with RPR testing.The relatively low positive concordances between EIA screening and confirmatory studies were more pronounced in low-risk patients, and it is important to define test performance in diverse patient populations.

To determine the utility of re-testing pregnant patients<or=25 years old at 34-36 weeks gestation for Chlamydia trachomatis.After obtaining IRB approval, a chart review was conducted on patients seen at the University Ob/ Gyn office and Cabell OB/Gyn Clinic from May 2005-November 2007. Patients<or=25 years of age who had been tested for Chlamydia trachomatis (CT) at their initial prenatal visit and again at 34-36 weeks gestation were included in the study. Data was gathered regarding patient age and positive or negative results from CT testing at the initial and 34-36 week visits.A total of 181 patients were included in the study. On the initial screen, 175 patients had a negative result and 6 a positive result. Five of these 6 patients had a negative test result when re-tested at 34-36 weeks. Out of the 175 patients who had a negative result on their initial screen, 5 had a positive result on the 34-36 week screen. A chi-squared test of statistical significance was performed on the data. P-value was >0.05 meaning that having a negative initial screen was not predictive of also having a negative result upon re-testing at 34-36 weeks.First trimester Chlamydia trachomatis test results are not predictive of Chlamydia trachomatis status during the third trimester.

This study examined the impact of the Centers for Disease Control and Prevention's (CDC's) One Test. Two Lives.™ (OTTL) campaign on key outcomes related to CDC's revised HIV testing recommendations and the use of the campaign materials. Data from three cross-sectional surveys were used to assess the effect of OTTL on Obstetricians/Gynecologists' (OB/GYN) HIV knowledge and practice. A 2-year combined sample of 500 OB/GYNs completed DocStyles, a Web-based survey for physicians, and 575 American College of Obstetricians and Gynecologists (ACOG) Fellows completed an ACOG survey. The surveys were similar in focus but did not contain the same items. Data were analyzed using cross-tabulations, χ(2) analyses, and logistic regression. There was a 20% recall of exposure to OTTL with DocStyles and 25% with ACOG. DocStyles respondents reporting having seen OTTL materials were significantly more likely to report awareness of CDC's recommendations [χ(2)(1) = 25.43, P < .001] and include HIV testing as a regular screening test for all patients [χ(2)(1) = 4.98, P < .05]. ACOG respondents not using the materials indicated high levels of willingness to use the materials-63.0 to 71.5%, depending on the material. Of the ACOG sample, 68.1% correctly answered the knowledge items regarding the recommendations. However, a significant relationship between correct knowledge and campaign exposure was not found. Overall, results suggest that OTTL is instrumental in raising awareness and implementation of the testing recommendations and plays an important role in facilitating HIV testing practices with obstetric providers and their patients.

The objective of the study was to evaluate whether providing antiretroviral therapy (ART) integrated in antenatal care (ANC) clinics resulted in a greater proportion of treatment-eligible women initiating ART during pregnancy compared with the existing approach of referral to ART. ANALYSIS DESIGN AND METHODS: The evaluation used a stepped-wedge design and included all HIV-infected, ART-eligible pregnant women in eight public sector clinics in Lusaka district, Zambia. Main outcome indicators were the proportion of treatment-eligible pregnant women enrolling into HIV care within 60 days of HIV diagnosis, and of these, the proportion initiating ART during pregnancy. Adjusted odds ratios (AORs) and confidence intervals (CIs) for enrollment and initiation proportions were estimated through a logistic regression model accounting for clinical site cluster and time effects.Between 16 July 2007 and 31 July 2008, 13,917 women started antenatal care more than 60 days before the intervention rollout and constituted the control cohort; 17 619 started antenatal care after ART integrated into ANC and constituted the intervention cohort. Of the 1566 patients found eligible for ART, a greater proportion enrolled while pregnant and within the 60 days of HIV diagnosis in the intervention cohort (376/846, 44.4%) compared with the control cohort (181/716, 25.3%), AOR 2.06, 95% CI (1.27-3.34); and initiated ART while pregnant in the intervention cohort (278/846, 32.9%) compared with the control cohort (103/716, 14.4%), AOR 2.01, 95% CI (1.37-2.95).An integrated ART in ANC strategy doubled the proportion of treatment-eligible women initiating ART while pregnant.

To evaluate the performance of a Conformitée Européenne (CE)-marked home test for Chlamydia trachomatis (CT) that is available over the internet.A total of 231 eligible women attending the Social Hygiene Clinic (SHC) or Obstetrics-Gynecology (OB-GYN) Clinic in Iloilo City, Philippines were recruited to an evaluation of the HandiLab-C Chlamydia home test (HandiLab-C). One vaginal swab was tested with HandiLab-C on-site and the second in Cambridge, UK with two nucleic acid amplification tests (NAAT), the Roche Amplicor and Abbott m2000. The organism load of NAAT-positive swabs was quantified.Concordance between the NAATs was high (kappa agreement: 0.984). Using the Abbott assay as the gold standard, the sensitivity and specificity of the Roche assay were 97.4% and 100%, respectively. CT prevalence by Abbott was 8.0% (8/100) in the OB-GYN Clinic and 23.7% (31/131) at SHC. The sensitivity of HandiLab-C was 12.5% (1/8) and 19.4% (6/31) in OB-GYN and SHC respectively, with specificities of 93.5% (86/92) and 88% (88/100) respectively. Overall positive and negative predictive values of HandiLab-C were 28% and 84.5% respectively. No correlation between HandiLab-C performance and organism load (range: 1.3 x 10(2) to 1.4 x 10(7) bacteria/swab) was observed.The performance of HandiLab-C is very poor, with the test yielding more false-positive (18/193) than true-positive (7/38) results. It remains accessible via the internet under various brand names and has retained its CE mark. This situation raises serious concerns about the regulation of diagnostic products available via the internet and the standards of certain Notified Bodies that issue the CE mark.

Two identically designed studies were conducted to determine the prevalence of herpes simplex virus type 2 (HSV-2) infection and viral shedding among women with no known history of genital herpes or HSV-2 seropositivity, who sought care at a US-based obstetrics/gynaecology clinic because of recurrent signs and symptoms of vaginitis. Samples comprised 50 women of any race (All-Comers Sample; Study 1) and 49 black women (Black Sample; Study 2) diagnosed at the clinic visit with vaginitis on the basis of standard work-up and medical history. In the All-Comers Sample, 15 (30%) women were HSV-2 seropositive and two (4%) were positive for HSV-2 by polymerase chain reaction (PCR); these two patients were also HSV-2 seropositive. Therefore, among patients seropositive for HSV-2, two (13%) were shedding virus at the time of the clinic visit. In the Black Sample, 25 (51%) were HSV-2 seropositive and two (4%) were PCR positive for HSV-2. Factors associated with HSV-2 seropositivity included age >30 years, erythema on pelvic examination, age < or = 15 years at first intercourse and having more than four lifetime sexual partners. The high prevalence of HSV-2 infection in these samples underscores the need to test for HSV-2 infection in women consulting with signs and symptoms of vaginitis.