Objective To evaluate the feasibility and accuracy of existing point-of-care (POC) HIV tests performed by an untrained patient compared to the routinely used HIV POC test offered to patients in two urban emergency departments (ED). Methods From April 2008 through December 2009, patients, who had completed a standard HIV oral fluid test performed by a trained healthcare professional and who were unaware of their results, were recruited to perform a rapid POC HIV test. Patients were given a choice of the oral fluid or the finger-stick blood POC. Evaluation of acceptability to perform the mechanics of the test was accessed by questionnaire. For the “self-test,” the participant obtained his/her own sample and performed the test. The patient’s results were compared to standard oral fluid results obtained by the health care professional. Results Overall, 478 of 564 (85%) patients receiving a standard oral fluid HIV test volunteered, with a mean age of 38–39 years. Ninety-one percent of participants chose oral fluid and 9% chose blood (p<0.05). Self-test results were 99.6% concordant with health care professionals’ test results. For the self-testers, 94% of oral fluid testers and 84.4% of blood testers reported trusting the self-administered test result “very much.” Furthermore, 95.6% of oral fluid group and 93.3% of the blood group would “probably” or “definitely” perform a test at home, if available. Conclusions This study demonstrated that a significant proportion of patients offered a self-HIV POC volunteered and preferred using oral fluid. Patients’ results agreed with standard HIV POC results. The majority of participants trusted their results and would perform a POC HIV test at home, given the opportunity.
Use of self-obtained vaginal specimens processed by nucleic acid amplification tests (NAATs) has significantly increased the utilization of nontraditional locations for Chlamydia trachomatis and Neisseria gonorrhoeae screening programs. One important emerging source of such venues includes home-based self-sampling kits available via the Internet. The objective of our study was to evaluate the performance of three commercially available NAATs (Becton-Dickinson ProbeTec SDA, Gen-Probe Aptima Combo2 TMA, and Roche Amplicor PCR) for detection of C. trachomatis and N. gonorrhoeae in vaginal samples obtained via an Internet-based screening program. From July 2004 to August 2005, 500 self-collected vaginal swabs were tested for C. trachomatis and N. gonorrhoeae by using all three NAATs. Another 500 samples were collected between August 2005 and November 2007 and tested by ProbeTec and Combo2; PCR testing was discontinued due to low specificity for N. gonorrhoeae. All tests were conducted according to the manufacturers' procedures; the "gold standard" for an infected C. trachomatis or N. gonorrhoeae patient was defined as >2 positive NAAT results. Of the first 500 swabs submitted, 46 were C. trachomatis infected (9.2%) and 5 were N. gonorrhoeae infected (1.0%), and 3 of these were coinfected (0.6%). All C. trachomatis and N. gonorrhoeae Combo2-positive/ProbeTec-negative samples were confirmed as true positives by an alternative NAAT. For C. trachomatis, ProbeTec, Combo2, and PCR had sensitivities of 82.6%, 100%, and 100%, with specificities of 100%, 100%, and 99.3%, respectively. For N. gonorrhoeae, ProbeTec, Combo2, and PCR had sensitivities of 80%, 100%, and 100%, with specificities of 100%, 100%, and 98.8%, respectively. Of the total 1,000 swabs submitted, 92 were C. trachomatis infected (9.2%) and 15 were N. gonorrhoeae infected (1.5%), and 7 of these were coinfected (0.7%). There were no ProbeTecpositive/Combo2-negative samples. For C. trachomatis, ProbeTec and Combo2 had sensitivities of 81.5% and 100%, with specificities of 100% and 100%, respectively. For N. gonorrhoeae, ProbeTec and Combo2 had sensitivities of 80% and 100%, with specificities of 100% and 100%, respectively. Overall, ProbeTec had 17 C. trachomatis false-negative results (1.7%) and 3 N. gonorrhoeae false-negative results (0.3%), while Combo2 had none. Our results were consistent with the sensitivities and specificities stated by the manufacturers. NAATs perform well for detection of chlamydia and gonorrhea with self-obtained vaginal swabs shipped in a dry state to a laboratory. For 1,000 self-collected vaginal swabs tested by NAATs, the sensitivities for C. trachomatis and N. gonorrhoeae for Combo2 were 100% and 100%, while they were 81.5% and 80%, respectively, for ProbeTec. For 500 PCR samples, the C. trachomatis sensitivity was 100% and the N. gonorrhoeae sensitivity was 100%, with specificities of 99.3% and 98.8%, respectively.
The internet STI testing sites were difficult to contact and demonstrated unwillingness to answer consumer-specific questions. Test accuracy varied, with home tests having poor accuracy and mail-in specimens demonstrating high accuracy.
HIV-infected patients in southeast India have poor knowledge of TB and the methods by which it is spread. Scale-up of patient-directed educational programs is necessary to help control TB in India.
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