Investigation of False Positive Results with an Oral Fluid Rapid HIV-1/2 Antibody Test

BACKGROUND: In March 2004, the OraQuick® rapid HIV antibody test became the first rapid HIV test approved by the US Food and Drug Administration for use on oral fluid specimens. Test results are available in 20 minutes, and the oral fluid test is non-invasive. From August 2004–June 2005, we investigated a sudden increase in false-positive results occurring in a performance study of OraQuick® oral-fluid rapid HIV tests in Minnesota. METHODOLOGY/PRINCIPAL FINDINGS: In a field investigation, we reviewed performance study data on oral-fluid and whole-blood OraQuick® rapid HIV test device lots and expiration dates and assessed test performance and interpretation with oral-fluid and whole-blood specimens by operators who reported false-positive results. We used multivariate logistic regression to evaluate client demographic and risk characteristics associated with false-positive results. Next, we conducted an incidence study of false-positive OraQuick rapid HIV tests in nine US cities and tested both oral-fluid and finger-stick whole-blood specimens from clients; reactive tests were confirmed with Western blot. Sixteen (4.1%) false-positive oral-fluid results occurred in the performance study from April 15, 2004 through August 31, 2004 with unexpired devices from six test lots among 388 HIV-uninfected clients (specificity, 95.9%; 95% CI: 93.4–97.6). Three test operators who had reported false-positive results performed and interpreted the test according to package-insert instructions. In multivariate analysis, only older age was significantly associated with false-positive results (adjusted odds ratio = 4.5, 95% CI: 1.2–25.7). In the incidence study, all valid oral-fluid and whole-blood results from 2,268 clients were concordant and no false-positive results occurred (100% specificity). CONCLUSIONS/SIGNIFICANCE: The field investigation did not identify a cause for the increase in false-positive oral-fluid results, and the incidence study detected no false-positive results. The findings suggest this was an isolated cluster; the test's overall performance was as specified by the manufacturer

Enrollment in HIV Care Two Years after HIV Diagnosis in the Kingdom of Swaziland: An Evaluation of a National Program of New Linkage Procedures

To improve early enrollment in HIV care, the Swaziland Ministry of Health implemented new linkage procedures for persons HIV diagnosed during the Soka Uncobe male circumcision campaign (SOKA, 2011–2012) and the Swaziland HIV Incidence Measurement Survey (SHIMS, 2011). Abstraction of clinical records and telephone interviews of a retrospective cohort of HIV-diagnosed SOKA and SHIMS clients were conducted in 2013–2014 to evaluate compliance with new linkage procedures and enrollment in HIV care at 92 facilities throughout Swaziland. Of 1,105 clients evaluated, within 3, 12, and 24 months of diagnosis, an estimated 14.0%, 24.3%, and 37.0% enrolled in HIV care, respectively, after adjusting for lost to follow-up and non-response. Kaplan-Meier functions indicated lower enrollment probability among clients 14–24 (P = 0.0001) and 25–29 (P = 0.001) years of age compared with clients > 35 years of age. At 69 facilities to which clients were referred for HIV care, compliance with new linkage procedures was low: referral forms were located for less than half (46.8%) of the clients, and few (9.6%) were recorded in the appointment register or called either before (0.3%) or after (4.9%) their appointment. Of over one thousand clients newly HIV diagnosed in Swaziland in 2011 and 2012, few received linkage services in accordance with national procedures and most had not enrolled in HIV care two years after their diagnosis. Our findings are a call to action to improve linkage services and early enrollment in HIV care in Swaziland

Implementing the package of CDC and WHO recommended linkage services: Methods, outcomes, and costs of the Bukoba Tanzania Combination Prevention Evaluation peer-delivered, linkage case management program, 2014-2017

Although several studies have evaluated one or more linkage services to improve early enrollment in HIV care in Tanzania, none have evaluated the package of linkage services recommended by the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). We describe the uptake of each component of the CDC/WHO recommended package of linkage services, and early enrollment in HIV care and antiretroviral therapy (ART) initiation among persons with HIV who participated in a peer-delivered, linkage case management (LCM) program implemented in Bukoba, Tanzania, October 2014 –May 2017. Of 4206 participants (88% newly HIV diagnosed), most received recommended services including counseling on the importance of early enrollment in care and ART (100%); escort by foot or car to an HIV care and treatment clinic (CTC) (83%); treatment navigation at a CTC (94%); telephone support and appointment reminders (77% among clients with cellphones); and counseling on HIV-status disclosure and partner/family testing (77%), and on barriers to care (69%). During three periods with different ART-eligibility thresholds [CD4<350 (Oct 2014 –Dec 2015, n = 2233), CD4≤500 (Jan 2016 –Sept 2016, n = 1221), and Test & Start (Oct 2016 –May 2017, n = 752)], 90%, 96%, and 97% of clients enrolled in HIV care, and 47%, 67%, and 86% of clients initiated ART, respectively, within three months of diagnosis. Of 463 LCM clients who participated in the last three months of the rollout of Test & Start, 91% initiated ART. Estimated per-client cost was $44 United States dollars (USD) for delivering LCM services in communities and facilities overall, and$18 USD for a facility-only model with task shifting. Well accepted by persons with HIV, peer-delivered LCM services recommended by CDC and WHO can achieve near universal early ART initiation in the Test & Start era at modest cost and should be considered for implementation in facilities and communities experiencing <90% early enrollment in ART care

Trends in Prevalence of Advanced HIV Disease at Antiretroviral Therapy Enrollment - 10 Countries, 2004-2015.

Monitoring prevalence of advanced human immunodeficiency virus (HIV) disease (i.e., CD4+ T-cell count <200 cells/μL) among persons starting antiretroviral therapy (ART) is important to understand ART program outcomes, inform HIV prevention strategy, and forecast need for adjunctive therapies.*,†,§ To assess trends in prevalence of advanced disease at ART initiation in 10 high-burden countries during 2004-2015, records of 694,138 ART enrollees aged ≥15 years from 797 ART facilities were analyzed. Availability of national electronic medical record systems allowed up-to-date evaluation of trends in Haiti (2004-2015), Mozambique (2004-2014), and Namibia (2004-2012), where prevalence of advanced disease at ART initiation declined from 75% to 34% (p<0.001), 73% to 37% (p<0.001), and 80% to 41% (p<0.001), respectively. Significant declines in prevalence of advanced disease during 2004-2011 were observed in Nigeria, Swaziland, Uganda, Vietnam, and Zimbabwe. The encouraging declines in prevalence of advanced disease at ART enrollment are likely due to scale-up of testing and treatment services and ART-eligibility guidelines encouraging earlier ART initiation. However, in 2015, approximately a third of new ART patients still initiated ART with advanced HIV disease. To reduce prevalence of advanced disease at ART initiation, adoption of World Health Organization (WHO)-recommended "treat-all" guidelines and strategies to facilitate earlier HIV testing and treatment are needed to reduce HIV-related mortality and HIV incidence

The Australian emigrant's guide, or, A few practical observations and directions for the guidance of emigrants proceeding to that colony /

2nd ed. Ferguson, J.A. Australia, 2793; Also available online http://nla.gov.au/nla.aus-vn2246582; Condition yellow paper at FRM F2793 (NL copy)

Rapid Human Immunodeficiency Virus Test Quality Assurance Practices and Outcomes among Testing Sites Affiliated with 17 Public Health Departments ▿

Rapid human immunodeficiency virus testing is often conducted in nonclinical settings by staff with limited training, so quality assurance (QA) monitoring is critical to ensure accuracy of test results. Rapid tests (n = 86,749) were generally conducted according to manufacturers' instructions, but ongoing testing competency assessments and on-site QA monitoring were not uniformly conducted

Repeat confirmatory testing for persons with discordant whole blood and oral fluid rapid HIV test results: findings from post marketing surveillance.

BACKGROUND: Reactive oral fluid and whole blood rapid HIV tests must be followed with a confirmatory test (Western blot (WB), immunofluorescent assay (IFA) or approved nucleic acid amplification test (NAAT)). When the confirmatory result is negative or indeterminate (i.e. discordant with rapid result), repeat confirmatory testing should be conducted using a follow-up specimen. Previous reports have not described whether repeat testing adequately resolves the HIV-infection status of persons with discordant results. METHODOLOGY: Post-marketing surveillance was conducted in 368 testing sites affiliated with 14 state and 2 city health departments from August 11, 2004 to June 30, 2005 and one health department through December 31, 2005. For persons with discordant results, data were collected on demographics, risk behaviors, HIV test results and specimen types. Persons with repeat confirmatory results were classified as HIV-infected or uninfected. Regression models were created to assess risk factors for not having repeat testing. PRINCIPAL FINDINGS: Of 167,371 rapid tests conducted, 2589 (1.6%) were reactive: of these, 2417 (93%) had positive WB/IFA, 172 (7%) had negative or indeterminate WB/IFA. Of 89/172 (52%) persons with a repeat confirmatory test: 17 (19%) were HIV-infected, including 3 with indeterminate WB and positive NAAT; 72 (81%) were uninfected, including 12 with repeat indeterminate WB. Factors associated with HIV-infection included having an initial indeterminate WB/IFA (vs. negative) (p<0.001) and having an initial oral fluid WB (vs. serum) (p<0.001). Persons who had male-female sex (vs. male-male sex) were at increased risk for not having a repeat test [adjusted OR 2.6, 95% CI (1.3, 4.9)]. CONCLUSIONS: Though only half of persons with discordant results had repeat confirmatory testing, of those who did, nearly one in five were HIV-infected. These findings underscore the need for rapid HIV testing programs to increase repeat confirmatory testing for persons with discordant results. Because of the lower sensitivity of oral fluid WBs, confirmatory testing following a reactive rapid test should be conducted using serum or plasma, when possible

Exposure to HIV partner counseling and referral services and notification of sexual partners among persons recently diagnosed with HIV.

ObjectiveAmong HIV-infected persons, we evaluated use of client partner notification (CPN) and health-department partner notification strategies to inform sex partners of possible HIV exposure, and prior exposure to partner counseling and referral services.MethodsWe conducted a cross-sectional, observational study of 590 persons diagnosed with HIV in the prior 6 months at 51 HIV test, medical, and research providers in Chicago and Los Angeles in 2003 and 2004. Logistic regression was used to identify independent correlates of using CPN to notify all locatable partners.ResultsParticipants reported a total of 5091 sex partners in the 6 months preceding HIV diagnosis; 1253 (24.6%) partners were locatable and not known to be HIV-positive. Of 439 participants with ≥1 locatable partners, 332 (75.6%) reported notifying 696 (55.5%) partners by CPN (585, 84.1%), health-department partner notification (94, 13.5%), or other means (17, 2.4%); 208 (47.4%) used CPN to notify all locatable partners. Independent correlates of CPN included having fewer locatable partners and discussing the need to notify partners with an HIV medical-care provider (black and Hispanic participants only). Many participants reported that their HIV test or medical-care provider did not discuss the need to notify partners (48.8%, 33.7%, respectively) and did not offer health-department partner-notification services (60.8%, 52.8%).ConclusionMany locatable sex partners who might benefit from being notified of potential HIV exposure are not notified. In accordance with national policies, HIV test and medical-care providers should routinely provide partner counseling and referral services to HIV-infected clients so that all locatable partners are notified and provided an opportunity to learn their HIV status