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)...

These data suggest, as have other studies, that women with vaginitis symptoms may be at risk for an STI. Molecular testing could provide broad diagnostic coverage for symptomatic women and improve patient management, regardless of the type of clinic in which patients are treated.

Chlamydia trachomatis (CT) infections remain highly prevalent. CT reinfection occurs frequently within months after treatment, likely contributing to sustaining the high CT infection prevalence. Sparse studies have suggested CT reinfection is associated with a lower organism load, but it is unclear whether CT load at the time of treatment influences CT reinfection risk. In this study, women presenting for treatment of a positive CT screening test were enrolled, treated and returned for 3- and 6-month follow-up visits. CT organism loads were quantified at each visit. We evaluated for an association of CT bacterial load at initial infection with reinfection risk and investigated factors influencing the CT load at baseline and follow-up in those with CT reinfection. We found no association of initial CT load with reinfection risk. We found a significant decrease in the median log10 CT load from baseline to follow-up in those with reinfection (5.6 CT/ml vs. 4.5 CT/ml; P = 0.015). Upon stratification of reinfected subjects based upon presence or absence of a history of CT infections prior to their infection at the baseline visit, we found a significant decline in the CT load from baseline to follow-up (5.7 CT/ml vs. 4.3 CT/ml; P = 0.021) exclusively in patients with a history of CT infections prior to our study. Our findings suggest repeated CT infections may lead to possible development of partial immunity against CT.

Limited information is available concerning the effects of obesity on the functional outcomes of patients requiring major lower limb amputation because of peripheral arterial disease (PAD). The purpose of this study was to examine the predictive ability of body mass index (BMI) to determine functional outcome in the dysvascular amputee. To do this, 434 consecutive patients (mean age, 65.8 ± 13.3, 59% male, 71.4% diabetic) undergoing major limb amputation (225 below-knee amputation, 27 through-knee amputation, 132 above-knee amputation, and 50 bilateral) as a complication of PAD from January 1998 through May 2004 were analyzed according to preoperative BMI. BMI was classified according to the four-group Center for Disease Control system: underweight, 0 to 18.4 kg/m2; normal, 18.5 to 24.9 kg/m2; overweight, 25 to 29.9 kg/m2; and obese, ≥30 kg/m2. Outcome parameters measured included prosthetic usage, maintenance of ambulation, survival, and maintenance of independent living status. The χ2 test for association was used to examine prosthesis wear. Kaplan-Meier curves were constructed to assess maintenance of ambulation, survival, and maintenance of independent living status. Multivariate analysis using the multiple logistic regression model and a Cox proportional hazards model were used to predict variables independently associated with prosthetic use and ambulation, survival, and independence, respectively. Overall prosthetic usage and 36-month ambulation, survival, and independent living status for the entire cohort was 48.6 per cent, 42.8 per cent, 48.1 per cent, 72.3 per cent, and for patients with normal BMI was 41.5 per cent, 37.4 per cent, 45.6 per cent, and 69.5 per cent, respectively. There was no statistically significant difference in outcomes for overweight patients (59.2%, 50.7%, 52.5%, and 75%) or obese patients (51.8%, 46.2%, 49.7%, and 75%) when compared with normal patients. Although there were significantly poorer outcomes for underweight patients for the parameters of prosthetic usage when compared with the remaining cohort (25%, P = 0.001) and maintenance of ambulation when compared with overweight patients (20.8%, P = 0.026), multivariate analysis adjusting for medical comorbidities and level of amputation showed that BMI was not a significant independent predictor of failure for any outcome parameter measured. In conclusion, BMI failed to correlate with functional outcome and, specifically, obesity did not predict a poorer prognosis.