Performance of self-collected penile-meatal swabs compared to clinician-collected urethral swabs for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium by nucleic acid amplification assays.

Men were enrolled in a study to assess the performance and acceptability of self-collected penile meatal swabs as compared to clinician-collected urethral swabs for sexually transmitted infections (STIs). We expected penile-meatal swabs to perform favorably to urethral swabs for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) detection by nucleic acid amplification assays (NAATs). Of 203 swab pairs tested; for CT, penile-meatal swab sensitivity was 96.8% and specificity was 98.8%. NG sensitivity and specificity were 100% and 98.9%, respectively. For TV, sensitivity was 85.0% and specificity was 96.7%. For MG sensitivity and specificity were 79.3% and 99.4%, respectively. No significant statistical differences between sample type accuracy (CT: P=0.625; NG: P=0.248; TV: P=0.344; and MG: P=0.070) existed. Most men, 90.1%, reported self-collection of penile-meatal swabs as "Very Easy" or "Easy". Self-collected penile-meatal swabs appeared acceptable for NAAT STI detection and an acceptable collection method by men.

QuantiFERON-TB gold in-tube implementation for latent tuberculosis diagnosis in a public health clinic: a cost-effectiveness analysis.

BACKGROUND: The tuberculin skin test (TST) has limitations for latent tuberculosis infection (LTBI) diagnosis in low-prevalence settings. Previously, all TST-positive individuals referred from the community to Baltimore City Health Department (BCHD) were offered LTBI treatment, after active TB was excluded. In 2010, BCHD introduced adjunctive QuantiFERON-TB Gold In-Tube (QFT-GIT) testing for TST-positive referrals. We evaluated costs and cost-effectiveness of this new diagnostic algorithm. METHODS: A decision-analysis model compared the strategy of treating all TST-positive referrals versus only those with positive results on adjunctive QFT-GIT testing. Costs were collected at BCHD, and Incremental Cost-Effectiveness Ratios (ICERs) were utilized to report on cost-effectiveness. RESULTS: QFT-GIT testing at BCHD cost $43.51 per test. Implementation of QFT-GIT testing was associated with an ICER of $1,202 per quality-adjusted life-year gained and was considered highly cost-effective. In sensitivity analysis, the QFT-GIT strategy became cost-saving if QFT-GIT sensitivity increased above 92% or if less than 3.5% of individuals with LTBI progress to active TB disease. CONCLUSIONS: LTBI screening with TST in low-prevalence settings may lead to overtreatment and increased expenditures. In this public health clinic, additional QFT-GIT testing of individuals referred for a positive TST was cost-effective.

Programmatic impact of QuantiFERON-TB Gold In-Tube implementation on latent tuberculosis diagnosis and treatment in a public health clinic.

BACKGROUND: QuantiFERON-TB Gold In-Tube (QFT-GIT) is considered an alternative to the tuberculin skin test (TST) for the diagnosis of tuberculosis (TB) infection, but the programmatic impact of QFT-GIT implementation is largely unknown. In March, 2010, the Baltimore City Health Department (BCHD) introduced routine QFT-GIT testing for individuals referred to the TB program for suspected latent TB infection (LTBI). DESIGN: Retrospective study comparing LTBI diagnosis and treatment during the 13 months before and after QFT-GIT implementation at the BCHD TB clinic. RESULTS: 607 and 750 individuals were referred by community-providers for suspected LTBI in the pre- and post-QFT-GIT periods, respectively. Most individuals in the pre- and post-QFT-GIT periods were referred on the basis of a positive TST (597/607 [98%] vs. 690/750 [92%], respectively) and were foreign-born (363/607[59%] vs. 507/750[68%], respectively). BCHD performed QFT-GIT testing for 375/543 (69%) eligible individuals in the post-QFT-GIT period, of which 185 (49%) were positive, 178 (47%) were negative, 1 (0.25%) was indeterminate, and 11 (3%) did not yield results. Concordance of QFT-GIT with TST was low (183/352[52%]). Foreign-born individuals had higher proportions of QFT-GIT positivity (57%) than US-born individuals (36%; AOR 3.3 [95%CI 1.7-6.2]). Significantly fewer individuals received a final diagnosis of LTBI in the post-QFT-GIT period (397/567 [70%]) compared to the pre-QFT-GIT period (445/452 [98%], p<0.001). In the post-QFT-GIT period, only 230/399 (58%) of those receiving QFT-GIT testing had a final diagnosis of LTBI, while 167/168 (99%) of those without QFT-GIT testing were diagnosed with LTBI (p<0.001). There was no difference in treatment initiation between those with and without QFT-GIT testing (175/230 [76%]) vs. 133/167 [80%], respectively) in the post-QFT-GIT period. CONCLUSION: QFT-GIT implementation for LTBI evaluation in a public health clinic significantly reduced the proportion of referred individuals in whom LTBI was diagnosed. QFT-GIT testing had no impact on treatment initiation or completion among those diagnosed with LTBI.

Screening for acute human immunodeficiency virus infection in Baltimore public testing sites.

BACKGROUND: Human immunodeficiency virus (HIV) RNA testing of pooled HIV antibody-negative specimens can identify acute HIV infection (AHI) and trigger interventions to reduce transmission during this highly infectious period. METHODS: A Baltimore, MD program serving sexually transmitted disease clinics and other high-risk sites combined HIV testing by third-generation enzyme immunoassay (EIA) with RNA testing of pooled antibody-negative specimens. Laboratory and Disease Intervention Specialists' records were reviewed for program evaluation. A cost analysis was performed. RESULTS: In 22 months, we tested 60,695 specimens for HIV. Of these, 1766 (2.9%) tested positive by EIA. Pooled HIV RNA testing of 58,925 EIA-negative specimens detected 7 cases of AHI (0.01%). Reflex HIV RNA testing of EIA-reactive, Western blot-indeterminate specimens confirmed 4 additional AHI cases (total AHI, 0.02%). Contact tracing detected no additional previously unknown cases of HIV infection. CONCLUSIONS: The utility of pooled HIV RNA testing may be limited by advances in HIV testing technology that reduce the seronegative window period and by characteristics of the local HIV epidemic.

Gonorrhea reinfection among sexually transmitted disease clinic attendees in Baltimore, Maryland.

OBJECTIVES: We hypothesized that an active follow-up program to assess for reinfection after gonorrhea treatment could be a useful disease control strategy. GOAL: We evaluated an active follow-up and repeat testing program for all Baltimore sexually transmitted disease clinic patients diagnosed with gonorrhea. STUDY DESIGN: From September 2003 to May 2004, all clients with a treated gonorrhea infection were advised to return 3 months later for repeat testing. If clients did not return as scheduled, field outreach was attempted. At follow-up visits, urine was tested for gonorrhea and consenting participants completed a behavioral survey. In addition, we reviewed morbidity records for any intercurrent gonorrhea infections reported during the project period. RESULTS: Of the 667 participants diagnosed with gonorrhea at baseline, 54 had a gonorrhea reinfection diagnosed for an incidence of 13.8 per 100 person-years. One hundred seventy-eight (27%) either presented for a follow-up visit or were located through field efforts, and of these, 5 (2.8%) had gonorrhea detected on follow-up urine testing. No measured factors had predictive value in identifying gonorrhea reinfection. CONCLUSIONS: Although reinfection rates were high, we found that field staff intervention to increase follow-up testing rates did not identify a significant amount of repeat infections compared with passive surveillance.