sequelae and their relationship to increased HIV transmission. CDC guidelines advocate testing MSM at least annually for these infections, but surveys of medical providers suggest that adherence to these guidelines is minimal. Because providers cite limited time and staff as common reasons for not following the guidelines, we evaluated the feasibility and accuracy of performing self-administered testing for GC and CT. Methods 286 clients who attended Whitman-Walker Clinic in Washington, DC for HIV/STI testing participated in the study. Enrolled clients had a mean age of 36611, represented a variety of racial/ethnic backgrounds with 52.8% identifying as Caucasian, and had an average of two male partners in the last 30 days. Clients performed screening using the GenProbe APTIMA 2 Combo (AC2) kit after viewing written and pictorial instructions. A trained provider also performed the testing with the order of client vs provider randomised to adjust for any training effect. This provider remained in the room while the client performed screening to observe, but did not provide assistance.Results The overall prevalence of GC and CT in this sample was 8.9% for P-GC, 8.5% for R-GC, 1.77% for P-CT, and 13.3% for R-CT. McNemar tests were performed stratified by type of infection and anatomic site to evaluate concordance of the client vs provider results. Clients were found to be significantly better at identifying P-GC (91.3% vs 94.4%; 8.8% vs 5.6%; p¼0.01) and R-GC (91.5% vs 94.3%; 8.5% vs 5.7%; p¼0.03) and to have results equivalent to providers for P-CT (98.3% vs 98.9%; 1.8% vs 1.1%; p¼0.50) and R-CT (88.7% vs 88.2%; 13.3% vs 11.9%, p¼0.25) detection. Conclusions The positive predictive value of the AC2 test makes it unlikely that clients obtained false positives, and observation of subjects while they performed screening ruled out cross-contamination of samples. Therefore, the higher detection rate among the clients is most likely attributable to a more rigorous swabbing technique that sampled an increased surface area. These results suggest that individuals are capable of performing their own STI screening and that allowing them to do so may increase infection detection rates and treatment.
14e21 days, while 18 (51%) received <14 days and 8 (23%) received more than 21 days. Among 735 others, 701 (95%) had symptoms compatible with HSV infection; these included vesicular lesions in 10 (1%) and seizure in 244 (33%). Overall, 172 (23%) were ever tested for HSV, including 7/10 (70%) with vesicular lesions and 69/ 244 (28%) with seizure. At least 98 (13%) received some acyclovir, including 2/10 (20%) with vesicular lesions and 18/244 (7%) with seizure. Of these, 32 (4%) infants received acyclovir for $7 days. Conclusions Our results reveal variations in clinical care of infants with possible neonatal HSV infection. Among cases, duration of antiviral therapy rarely followed treatment recommendations. Among symptomatic infants, most with vesicular lesions but few with seizures were ever tested for HSV. These variations suggest opportunities for clinical quality improvements. Background To compare the performance characteristics of the BD ProbeTecTM HSV1 Qx Assay* on the BD ViperTM System in Extracted Mode to viral culture and a well-characterised molecular assay for the detection of HSV1. External anogenital lesions were sampled with two different collection devices: a universal viral transport (UVT) kit and a BD Qx swab (QS) kit*. Methods Eleven geographically diverse clinical centers participated in the study, with nine of the sites enrolling participants. The UVT was collected first followed by the QS specimen. A portion of each UVT specimen was transferred to a Qx Diluent tube (diluted UVT) and a cryovial. The remainder of the UVT in the original tube was frozen at À708C and sent to one of two sites for HSV viral culture using the ELVISÒHSV ID and D3 Typing Test System (Diagnostic Hybrids, Inc). The diluted UVT and QS specimens were shipped to one of three sites for HSV testing on the BD Viper. The UVT aliquot in the cryovial was stored at À708C and shipped to the University of Washington for PCR testing for HSV. Results Subjects (n¼508) were enrolled from February to August of 2010 with 312 UVT and 308 QS samples available for comparison to ELVIS culture, and 506 and 502 samples, respectively, for comparison to the PCR assay. Samples positive for HSV2 by viral culture did not have results for HSV1 per the ELVIS package insert and were excluded from further analysis. The sensitivity and specificity of the BD HSV1 Qx Assay as compared to ELVIS culture and the positive (PPA) and negative per cent agreement (NPA) of the assay compared to the HSV PCR assays were determined for both specimen types see Abstract P3-S2.03 table 1. Conclusions The BD HSV1 Qx Assay on the BD Viper System had excellent agreement with viral culture and the lab developed PCR assay, which is currently recognised as one of the best available tests for the detection of HSV1. A commercially available molecular-based assay for the detection of HSV would not only improve detection and reduce turn-around time on results, but may also obviate the need for stringent transport conditions required for HSV culture. *Product not for sale, for i...
showed similar associations with testing positive in CSI (OR 2.4 [95% CI 2.1 to 2.7]) and the STI centres (OR 1.2 [95% CI 1.0 to 1.3]), but the model basing ethnicity on country of birth of a person and his parents had a better fit (higher likelihood). Self-defined ethnicity may allow for more personal input, this however also makes it a dynamic variable: in the second round of CSI, 15% of the immigrants identified themselves by a different ethnicity than in the first round see Abstract P1-S4.02 Figure 1. Conclusions Both self-defined ethnicity and ethnicity based on the country of birth of a person and his parents, can be used to detect young persons at a higher risk of Chlamydia infection. However the definition of ethnicity based on the country of birth explains variation in the Chlamydia data better and is objective and constant, whereas self-defined ethnicity would disregard a large part of the young population at higher risk for Chlamydia infection. Background The Abbott Realtime m2000 system (m2000) is a qualitative real-time PCR assay for the detection of CT and NG that has the capability to provide a relative measure of target DNA. Results from the m2000 were used to determine CT and NG organism load by comparing the delta cycle (DC) value of each specimen to a set of lab developed standards containing known concentrations of each organism. Methods Vaginal swabs and male urine specimens were evaluated. Six standards of each organism were prepared by inoculating collection tubes with lab strains in concentrations ranging from 0 to 43105 organisms. The log10 organism load for each positive specimen was determined by comparing the DC value to the calibration curve. Self-reported symptoms were available for each patient. Results A total of 99 vaginal and 284 urine specimens were available for analysis. There was no statistical difference in DC value of mean organism load by gender. Neither was there a difference based on the presence or absence of symptoms in people infected with CT. For NG, there was a significant difference in mean DC value and organism load by gender (p<0.001 for both DC and organism load) with men having higher loads. In NG positive men the mean DC was 15.2 [95% CI 14.7 to 15.8] and 11.4 [95% CI 9.0 to 13.7] for men with and without symptoms (p¼0.003). This translated in mean log10 organism loads of 6.5 [95% CI 6.3 to 6.6] and 5.4 [95% CI 4.7 to 6.1] for men with and without symptoms (p¼0.005). In NG positive women there was no difference in organism load based on presence or absence of symptoms (p¼0.220). Conclusions Advantages to using this methodology include being able to quantify organism load from specimens obtained for routine diagnostic testing, using standardised test reagents that can be purchased commercially, and using an automated platform. Even in those settings that do not have the capacity for calibration, the DC values may provide useful relative loads. This exploratory study demonstrated the feasibility of using this method to obtain relative quantitation measures. A...
Poster presentations Conclusion Overall, from this limited evaluation, Artus ® CT/NG is analytically highly sensitive and specific for the detection of C. trachomatis and N. gonorrhoeae. Further assessment with clinical samples would need to be done to fully assess the performance of this assay prior to clinical implementation. Evaluation of thrEE DiffErEnt Diagnostic systEms for thE DEtEction of Chlamydia TraChomaTis anD Neisseria GoNorrhoeae from oral sPEcimEns
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