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Background: Indeterminate HIV test results are common, but little is known about the evolution of indeterminate serology and its sociodemographic and behavioral correlates. We assessed future HIV serological outcomes for individuals with indeterminate results and associated factors in Rakai, Uganda., Methods: 115,944 serological results, defined by two enzyme immunoassay (EIAs), among 39,440 individuals aged 15-49 years in the Rakai Community Cohort Study were assessed. Indeterminate results were defined as contradictory EIAs. Modified Poisson regression models with generalized estimating equations were used to assess prevalence ratios (PRs) of subsequent HIV serological outcomes and factors associated with HIV indeterminate results., Results: The prevalence of HIV serologically indeterminate results was 4.9%. Indeterminate results were less likely among women than men (adjPR 0.76, 95% CI 0.71,0.81), in unmarried participants than married participants (adjPR 0.92, 95% CI 0.85,99), and in individuals with primary (adjPR 0.90, 95% CI 0.80,1.02), secondary (adjPR 0.83, 95% CI 0.73,0.96) and post-secondary (adjPR 0.75, 95% CI 0.60,0.94) education, relative to no education. The proportions of persons with indeterminate results progressing to HIV positive, negative or indeterminate results in subsequent visits was 5%, 71% and 24%, respectively., Conclusion: HIV serologically indeterminate results were associated with gender and marital status. HIV surveillance programs should develop a protocol for reporting individuals with mixed or persistently indeterminate HIV results on multiple follow-up visits. Most indeterminate results became HIV-negative over time, but follow-up is still needed to detect positive serologies., Competing Interests: The authors have declared that no competing interests exist.

Background: HIV screening (i.e. antigen/antibody) tests are followed by a supplemental (i.e. antibody-only) if the screen is positive. Discrepant results can result from two scenarios: a false-positive screening test or acute HIV infection. These scenarios can be distinguished by a molecular HIV test, but due to contamination concerns, our laboratory recently implemented a policy requiring a second specimen dedicated for molecular HIV testing. Our objective was to (1) characterize the effect of this policy on the time-to-diagnosis for patients with discrepant screening and supplemental test results, and (2) explore "strength of positivity" as an interim predictor of screening test accuracy while awaiting confirmatory test results., Methods: Data from our laboratory information system, electronic health record, and instrument logs were used to collate data for all HIV testing performed at Barnes-Jewish Hospital (BJH) between January 1, 2014 and October 18, 2017., Results: Requiring a dedicated specimen for molecular testing significantly increased the time-to-diagnosis for patients with discrepant screening and supplemental HIV tests (p = 0.0084). This policy also contributed to loss-to-followup, with 0/35 discrepant cases lost-to-followup prior to policy implementation compared to 2/10 after implementation. However, by optimizing the signal-to-cutoff (S/CO) ratio of the screening test, we were able to more accurately distinguish false-positives from acute-HIV prior to molecular testing (sensitivity of 100%, specificity of 89%)., Conclusions: We propose utilizing quantitative fourth-generation assay results (S/CO) ratios as a predictor of infection true positivity in situations where the screening assay is reactive but the supplemental test is negative and confirmatory molecular results are not immediately available., Competing Interests: The authors have declared that no competing interests exist.

Background: An individual is considered HIV positive when a confirmatory HIV-1/HIV-2 differentiation test returns positive following an initial reactive antigen/antibody combination screen. Falsely reactive HIV screens have been reported in patients with various concomitant infectious and autoimmune conditions. Falsely positive confirmatory HIV differentiation assays are seen less frequently, but have been observed in cases of pregnancy, pulmonary embolism, and malaria., Case Presentation: A healthy 27 year-old man was referred after a reactive ADVIA Centaur® HIV Ag/Ab screen and positive Bio-Rad Geenius™ HIV 1/2 Confirmatory assay, suggesting HIV-1 infection. The patient's HIV viral load was undetectable prior to initiation of antiretroviral therapy, and remained undetectable on subsequent testing after initiation of antiretroviral therapy. Both Centaur® and Geenius™ tests were repeated and returned reactive. As this patient was believed to be at low risk of acquiring HIV infection, samples were additionally run on Genscreen™ HIV-1 Ag assay and Fujirebio Inno-LIA™ HIV-1/2 score, with both returning non-reactive. For confirmation, the patient's proviral HIV DNA testing was negative, confirming the initial results as being falsely positive. The patient disclosed that he had been using a variety of anabolic steroids before and during the time of HIV testing., Discussion and Conclusions: The erroneous diagnosis of HIV can result in decreased quality of life and adverse effects of antiretroviral therapy if initiated, hence the importance of interpreting the results of HIV testing in the context of an individual patient. This reports suggests a potential association between the use of anabolic steroids and falsely-reactive HIV testing.

Objective: This is the first large-scale assessment of the implementation of HIV Rapid Test Quality Improvement Initiative in South Africa., Methods: We used a quasi-experimental one group post-test only design. The intervention implemented starting April 2014 comprised health-care worker training on quality assurance (QA) of HIV rapid testing and enrolment of the facilities in proficiency testing (PT), targeting 2,077 healthcare facilities in 32 high HIV burden districts. Following the intervention, two consecutive rounds of site assessments were undertaken. The first, conducted after a median of 7.5 months following the training, included 1,915 facilities that participated in the QA training, while the second, conducted after a median of one-year following the first-round assessment included 517 (27.0%) of the 1,915 facilities. In both assessments, the Stepwise-Process-for-Improving-the-quality-of-HIV-Rapid-Testing (SPI-RT) checklist was used to score facilities' performance in 7 domains: training, physical facility, safety, pre-testing, testing, post-testing and external quality assessment. Facilities' level of readiness for national certification was assessed., Result: Between 2016 and 2017, there were four PT cycles. PT participation increased from 32.4% (620/1,915) in 2016 to 91.5% (1,753/1,915) in 2017. In each PT cycle, PT results were returned by 76%-87% of facilities and a satisfactory result (>80%) was achieved by ≥95% of facilities. In the SPI-RT assessment, in round-one, 22.3% of facilities were close to or eligible for national certification-this significantly increased to 38.8% in round-two (P-value<0.001). The median SPI-RT score for the domains HIV pre-testing (83.3%) and post-testing (72.2%) remained the same between the two rounds. The median score for the testing domain increased by 5.6% (to 77.8%)., Conclusion: Facilities performance on the domains that are critical for accuracy of diagnosis (i.e. pre-testing, testing and post-testing) remained largely unchanged. This study provided several recommendations to improve QA implementation in South Africa, including the need to improve routine use of internal quality control for corrective actions., Competing Interests: The authors have declared that no competing interests exist.

Severe malaria is an uncommon diagnosis in the United States. However, awareness of signs, symptoms, and treatment options is imperative in order to promptly initiate optimal therapy. False positive human immunodeficiency virus (HIV) results are rare in the setting of acute malaria infection and with the introduction of newer fourth-generation immunoassays. The Centers for Disease Control algorithms assist in confirming true HIV infection (Branson et al. 2014)., (Copyright © 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Screening tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and syphilis infections performed in at-risk population show a higher number of positive tests compared to those carried out in the general population. 'Test & Counselling' Ambulatory of Infectious Disease Clinic (T&C-IDC) and Sexually Transmitted Diseases Ambulatory of Dermatology Unit (STDs-DU) of Modena began collaboration in 2010 and adopted a common diagnostic serological profile since 2013., Objectives: The main objective was to analyse the number of screening tests performed in the T&C-IDC and STDs-DU, comparing the results obtained after the adoption of the shared protocol with the previous period. The secondary aim was to evaluate the linkage to care of newly diagnosed patients., Methods: Consecutive patients referred to the T&C-IDC and STDs-DU from January 2010 to December 2016, with at least one performed screening test for HIV, HBV, HCV and syphilis were enrolled. Referral of patients with a new infection was obtained by capture-recapture methods in hospital databases., Results: During the 7-year observation, we collected 13 117 admittances for 9154 patients. A significant increase in the number of screening tests (P < 0.001) and ratio between tests and admissions (P = 0.002) was observed. A total of 644 (7.0%) people with at least one infection were diagnosed. Among these, the most common was syphilis (41.9%), followed by HBV (25.7%), HCV (21.4%) and HIV (10.9%). Syphilis occurred predominantly in Italians (72.5%) and males (75.7%), as like as HCV, while foreign-born (85.5%) mainly harboured HBV infection. HIV diagnosis was detected more frequently among males (67.1%) with a similar proportion between Italians and foreign-born. Five hundred and forty-three out of 644 (84.3%) patients were linked to care., Conclusion: The collaboration between T&C-IDC and STDs-DU has proven to work well increasing the diagnosis over the time and obtaining good results in linkage to care., (© 2018 European Academy of Dermatology and Venereology.)

Since 2006, the Centers for Disease Control and Prevention (CDC) has recommended routine HIV screening in primary care settings for people ages 13 to 64, regardless of individual risk factors. However, an extensive body of research has identified several barriers to primary care providers' (PCPs) adherence to the CDC recommendations. Employing a pre-postintervention design, this study provided an assessment of barriers among 11 PCPs and implemented an evidence-based continuing education program adapted to the specific individual barriers they identified. The study found that PCPs were initially providing HIV testing using risk-based criteria but that the continuing education program increased intentions to perform routine HIV testing (e.g., during annual wellness examinations and new patient visits). Results of the study inform individual quality improvement projects and legislative or policy actions to increase HIV screening in sites providing primary care. [J Contin Educ Nurs. 2018;49(12):563-574.]., (Copyright 2018, SLACK Incorporated.)

Men who purchase sex (MWPS) have long been considered as one of the population groups at risk of HIV transmission. However, while HIV-related interventions have been targeted towards this group, few studies have directly recruited MWPS to measure the impact of such interventions. This study aimed to fill the gap for Indonesia by identifying the level and predictors of condom use and HIV testing among MWPS, to inform prevention strategies. A cross-sectional study was conducted by surveying 200 MWPS in Bali, Indonesia in 2015. A structured questionnaire was administered to collect the data. Self-reported condom use on the occasion of last paid sex was very high (88.5%), while a history of HIV testing was low (8.1%). None of the variables identified in this study were associated with condom use at last paid sex. Men were more likely to report a history of HIV testing if they: perceived themselves to be at high risk of HIV, had a higher level of HIV-related knowledge, reported a history of genital ulcers or urethral discharge in the past 12 months, or were aware that confidential HIV testing was available. Implications and limitations of this study are discussed.

Detection of acute HIV infection is critical for HIV public health and diagnostics. Clinical fourth-generation antigen (Ag)/antibody (Ab) combination (combo) and p24 Ag immunoassays have enhanced detection of acute infection compared to Ab-alone assays but require ongoing evaluation with currently circulating diverse subtypes. Genetically and geographically diverse HIV clinical isolates were used to assess clinical HIV diagnostic, blood screening, and next-generation assays. Three-hundred-member panels of 20 serially diluted well-characterized antibody-negative HIV isolates for which the researchers were blind to the results (blind panels) were distributed to manufacturers and end-user labs to assess the relative analytic sensitivity of currently approved and preapproved clinical HIV fourth-generation Ag/Ab combo or p24 Ag-alone immunoassays for the detection of diverse subtypes. The limits of detection (LODs) of virus were estimated for different subtypes relative to confirmed viral loads. Analysis of immunoassay sensitivity was benchmarked against confirmed viral load measurements on the blind panel. On the basis of the proportion of positive results on 300 observations, all Ag/Ab combo and standard sensitivity p24 Ag assays performed similarly and within half-log LODs, illustrating the similar breadth of reactivity and diagnostic utility. Ultrasensitive p24 Ag assays achieved dramatically increased sensitivities, while the rapid combo assays performed poorly. The similar performance of the different commercially available fourth-generation assays on diverse subtypes supports their use in broad geographic settings with locally circulating HIV clades and recombinant strains. Next-generation preclinical ultrasensitive p24 Ag assays achieved dramatically improved sensitivity, while rapid fourth-generation assays performed poorly for p24 Ag detection., (Copyright © 2018 American Society for Microbiology.)

Introduction: HIV testing is an invaluable entry point to prevention, care and treatment services for people living with HIV and AIDS. Poor adherence to recommended protocols and guidelines reduces the performance of rapid diagnostic tests, leading to misdiagnosis and poor estimation of HIV seroprevalence. This study seeks to evaluate the adherence of primary healthcare facilities in Cameroon to recommended HIV counselling and testing (HCT) procedures and the impact this may have on the reliability of HIV test results., Methods and Analysis: This will be an analytical cross-sectional study involving primary healthcare facilities from all the 10 regions of Cameroon, selected by a multistaged random sampling of primary care facilities in each region. The study will last for 9 months. A structured questionnaire will be used to collect general information concerning the health facility, laboratory and other departments involved in the HCT process. The investigators will directly observe at least 10 HIV testing processes in each facility and fill out the checklist accordingly., Ethics and Dissemination: Clearance has been obtained from the National Ethical Committee to carry out the study. Informed consent will be sought from the patients to observe the HIV testing process. The final study will be published in a peer-reviewed journal and the findings presented to health policy-makers and the general public., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Rapid HIV testing may circumvent the practical barriers to HIV testing in several settings. User preference of the testing kits available has been relatively underexplored. We examined healthcare provider (HCP) ratings of two validated rapid testing kits in clinical practice. From 1 July to 1 December 2012 we prospectively recruited HCPs (clinic nurses) from three outpatient clinics linked to Lausanne University Hospital, Lausanne, Switzerland. The HCPs had experience in taking blood samples but varying experience in rapid HIV testing. Participating HCPs performed rapid HIV testing using Determine™ Combo (DETE) or INSTI™ (INSTI), according to a predefined randomization sequence, and rated practical aspects of each test using a Likert scale. Seventeen HCPs of 23 approached (74%) were eligible and agreed to participate, performing a total of 336 HIV tests. Globally, the testing procedure was rated as easy or very easy by 97% (DETE) to 99% (INSTI) of tests performed. Among experienced HCPs, DETE was rated easier than INSTI for kit storage (p < 0.001) and blood collection ( P = 0.012) while INSTI was rated easier than DETE for blood application ( P = 0.001) and test interpretation ( P = 0.005). Among less experienced HCPs, both tests performed equally with the exception of test interpretation ( P < 0.001) and overall ease of use ( P = 0.05) in favour of INSTI. Of all HCPs, 94% stated they would recommend INSTI over DETE based on the time to result, ease of test interpretation and overall ease of use. Rapid HIV testing was considered easy to perform, even by inexperienced nursing staff. Whilst both tests were considered easy to use, the HCPs in this study preferred INSTI to DETE overall, due to rapid time to result, ease of test interpretation and general ease of use.

Introduction: In South Africa where the prevalence of HIV infection is very high, 4th generation HIV antibody/p24 antigen combo immunoassays are the tests of choice for laboratory based screening. Testing is usually performed in clinical pathology laboratories on automated analysers. To investigate the cause of false positive results on 4th generation HIV testing platforms in public sector laboratories, the performance of two automated platforms was compared in a clinical pathology setting, firstly on routine diagnostic specimens and secondly on known sero-negative samples., Methods: Firstly, 1181 routine diagnostic specimens were sequentially tested on Siemens and Roche automated 4th generation platforms. HIV viral load, western blot and follow up testing were used to determine the true status of inconclusive specimens. Subsequently, known HIV seronegative samples from a single donor were repeatedly tested on both platforms and an analyser was tested for surface contamination with HIV positive serum to identify how suspected specimen contamination could be occurring., Results: Serial testing of diagnostic specimens yielded 163 weakly positive or discordant results. Only 3 of 163 were conclusively shown to indicate true HIV infection. Specimen contamination with HIV antibody was suspected, based on the following evidence: the proportion of positive specimens increased on repeated passage through the analysers; viral loads were low or undetectable and western blots negative or indeterminate on problem specimens; screen negative, 2nd test positive specimens tested positive when reanalysed on the screening assay; follow up specimens (where available) were negative. Similarly, an increasing number of known negative specimens became (repeatedly) sero-positive on serial passage through one of the analysers. Internal and external analyser surfaces were contaminated with HIV serum, evidence that sample splashes occur during testing., Conclusions: Due to the extreme sensitivity of these assays, contamination with minute amounts of HIV antibody can cause a negative sample to test positive. Better contamination control measures are needed on analysers used in clinical pathology environments, especially in regions where HIV sero-prevalence is high.

This study aimed to identify facility-level characteristics associated with prevention of mother-to-child HIV transmission service quality. This cross-sectional study sampled 60 health facilities in Mozambique, Côte d'Ivoire, and Kenya (20 per country). Performance score - the proportion of pregnant women tested for HIV in first antenatal care visit, multiplied by the proportion of HIV-positive pregnant women who received appropriate antiretroviral medications - was calculated for each facility using routine data from 2012 to 2013. Facility characteristics were ascertained during on-site visits, including workload. Associations between facility characteristics and performance were quantified using generalized linear models with robust standard errors, adjusting for country. Over six months, facilities saw 38,611 first antenatal care visits in total. On-site CD4 testing, Pima CD4 machine, air conditioning, and low or high (but not mid-level) patient volume were each associated with higher performance scores. Each additional first antenatal care visit per nurse per month was associated with a 4% (95% confidence interval: 1%-6%) decline in the odds that an HIV-positive pregnant woman would receive both HIV testing and antiretroviral medications. Physician workload was only modestly associated with performance. Investments in infrastructure and human resources - particularly nurses - may be critical to improve prevent mother-to-child HIV transmission service delivery and protect infants from HIV.

Many people living with human immunodeficiency virus (HIV) do not know that they are infected. It is important for infected persons to get tested for HIV in order to be diagnosed and medically treated. HIV has no known cure, but it can be controlled and sometimes prevented with proper medical care. The social work profession has ideal positioning to be extraordinarily helpful in work that promotes HIV testing, leading to reducing then eliminating new HIV diagnoses. Social marketing interventions, along with audience segmenting are explained. Specific attention is given to two separate subjects-minority health disparities and impulsive and/or sensation seeking sex practices-to showcase the versatility of social marketing in the promotion of HIV testing. Further ideas about how social workers can participate in these interprofessional social marketing campaigns are provided.

Background: Client satisfaction serves as a predictor for acceptance of HIV counselling and testing (HCT) services. Therefore, the study of clients' perception and satisfaction may offer insights on how to improve HCT programmes., Aim and Setting: The aim of this study was to assess clients' satisfaction with HCT as well as describe perceived barriers to and facilitators of HIV testing by HCT clients in South Africa., Methods: A cross-sectional survey was conducted through interviews with 498 clients purposefully selected at the end of an HCT visit at 56 HCT sites throughout the country., Results: All the 498 study participants had tested for HIV with 98.8% receiving their results. Most (88.2%) reported testing for HIV before. The vast majority (75.5%) of clients reported that they had decided to be tested for HIV by themselves. High levels of satisfaction with HCT service (89.8%), low levels (27.7%) of difficulty in making the decision to have an HIV test and high levels of perceived confidentiality (94.6%) of the HIV test results were reported in this study. The most cited perceived barrier to HIV testing was lack of awareness about the HCT service (98%), while staff attitudes (37%), confidentiality (29.6%) and privacy (23.6%) were perceived facilitators. In multivariate logistic regression, staff attitude was significantly associated with client satisfaction (p &lt; 0.05)., Conclusion: High levels of client satisfaction with HCT services were observed. Various barriers to and facilitators of - including staff attitude - HCT were identified which can help guide the improvement of HCT services in South Africa.

Laboratory innovation significantly affects program sustainability of HIV programs in low and middle income countries (LMICs) far beyond its immediate sphere of impact. Innovation in rapid development of diagnostic technologies, improved quality management systems, strengthened laboratory management, affordable external quality assurance and accreditation schemes, and building local capacity have reduced costs, brought quality improvement to point-of-care testing, increased access to testing services, reduced treatment and prevention costs and opened the door to the real possibility of ending the AIDS epidemic. However, for effectively implemented laboratory innovation to contribute to HIV quality program sustainability, it must be implemented within the overall context of the national strategic plan and HIV treatment programs. The high quality of HIV rapid diagnostic test was a breakthrough that made it possible for more persons to learn their HIV status, receive counseling, and if infected to receive treatment. Likewise, the use of dried blood spots made the shipment of samples easier for the assessment of different variables of HIV infection-molecular diagnosis, CD4+ cell counts, HIV antibodies, drug resistance surveillance, and even antiretroviral drug level measurements. Such advancement is critical for to reaching the UNAIDS target of 90-90-90 and for bringing the AIDS epidemic to an end, especially in LMICs.

Little is known about how combining efficacious interventions for human immunodeficiency virus (HIV) prevention could lead to HIV elimination. We used an agent-based simulation model, the HIV calibrated dynamic model, to assess the potential for HIV elimination in South Africa. We examined several scenarios (from continuation of the current status quo to perfect achievement of targets) with differing combinations of male condom use, adult male circumcision, HIV testing, and early antiretroviral therapy (ART). We varied numerous parameters, including the proportion of adult males circumcised, the frequency of condom use during sex acts, acceptance of HIV testing, linkage to health care, criteria for ART initiation, ART viral suppression rates, and loss to follow-up. Maintaining current levels of combination prevention would lead to increasing HIV incidence and prevalence in South Africa, while the perfect combination scenario was projected to eliminate HIV on a 50-year time scale from 2013 to 2063. Perfecting testing and treatment, without changing condom use or circumcision rates, resulted in an 89% reduction in HIV incidence but not elimination. Universal adult male circumcision alone resulted in a 21% incidence reduction within 20 years. Substantial decreases in HIV incidence are possible from sufficient uptake of both primary prevention and ART, but with continuation of the status quo, HIV elimination in South Africa is unlikely within a 50-year time scale., (© The Author 2016. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: Testing for human immunodeficiency virus (HIV) is the key first step in HIV treatment and prevention. In 2006, the Centers for Disease Control and Prevention (CDC) recommended annual HIV testing for people at high risk for HIV infection. We evaluated HIV testing among men with high-risk heterosexual (HRH) contact and sexually active men who have sex with men (MSM) before and after the CDC recommendations., Methods: We used data from the National Survey of Family Growth, 2002 and 2006-2010, to assess proportions of HRH respondents and MSM reporting HIV testing in the prior 12 months, compare rates of testing before and after release of the 2006 CDC HIV testing guidelines, and examine demographic variables and receipt of health-care services as correlates of HIV testing., Results: Among MSM, the proportion tested was 37.2% (95% confidence interval [CI] 28.2, 47.2) in 2002, 38.2% (95% CI 25.9, 52.2) in 2006-2008, and 41.7% (95% CI 29.2, 55.3) in 2008-2010; among HRH respondents, the proportion was 23.7% (95% CI 20.5, 27.3) in 2002, 24.5% (95% CI 20.9, 28.7) in 2006-2008, and 23.9% (95% CI 20.2, 28.1) in 2008-2010. HIV testing was more likely among MSM and HRH respondents who received testing or treatment for sexually transmitted disease in the prior 12 months, received a physical examination in the prior 12 months (MSM only), or were incarcerated in the prior 12 months., Conclusions: The rate of annual HIV testing was low for men with sexual risk for HIV infection, and little improvement took place from 2002 to 2006-2010. Interventions aimed at men at risk, especially MSM, in both nonmedical and health-care settings, likely could increase HIV testing.

Background and Objective: The rapid test study was a real-time comparison of point-of-care (POC) HIV tests to determine their abilities to detect early HIV infection., Study Design: Men and transgender persons reporting sex with men in the prior year were recruited at the Public Health-Seattle & King County STD Clinic, Gay City Health Project, and University of Washington Primary Infection Clinic. Study tests included the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test performed on oral fluids and tests performed on fingerstick whole blood specimens including OraQuick, Uni-Gold Recombigen HIV test, Determine HIV-1/2 Ag/Ab Combo, and INSTI HIV-1 Rapid Antibody Test. Specimens from subjects with negative results were sent for EIA and nucleic acid amplification testing. McNemar's exact tests compared the numbers of HIV-infected subjects detected., Results: Between February 2010 and August 2014, there were 3438 study visits. Twenty-four subjects had discordant POC results with at least one reactive and one non-reactive test, including one subject with a reactive Determine p24 antigen. OraQuick performed on oral fluids identified fewer persons compared to all fingerstick tests. OraQuick performed on fingerstick whole blood detected fewer persons compared to the Determine Combo antibody component (p=.008) and Combo overall (p=.004), and there was a trend when compared to INSTI (p=.06). The Determine Combo specificity was 98.99%., Conclusions: As reported by others, Determine Combo underperforms compared to laboratory-based testing, but it did detect one acute infection. If these results are validated, the specificity of Determine Combo may limit its usefulness in populations with lower HIV incidence., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Novel fourth generation screening and confirmatory human immunodeficiency virus (HIV) assays are now commercially available and incorporated into new diagnostic algorithms. We report two cases involving a total of three patients which highlight the spectrum of false positivity for both the Abbott Architect p24 antigen/antibody assay and the confirmatory Multispot antibody differentiation test. We then discuss the mechanisms for false positivity and the associated clinical conditions or laboratory scenarios that may predispose to inaccurate interpretation.

Objective: This study examined temporal trends in HIV testing among U.S. older adults (50-64 years of age) before and after the release of CDC's routine HIV testing recommendations in 2006., Methods: The sample (n=872,797; 51.4% female) comprised 2003-2010 Behavioral Risk Factor Surveillance System respondents in the oldest categories to which the recommendations apply: 50-54 years (34.5%, n=301,519), 55-59 years (34.1%, n=297,865), and 60-64 years (31.3%, n=273,413). We calculated (1) four-year pooled prevalences of past-year HIV testing before and after 2006, when the recommendations were released; and (2) annual prevalences of HIV testing overall and by age category from 2003-2010. Using weighted, multivariable logistic regression analyses, we examined binary (pre- vs. post-recommendations) and annual changes in testing, controlling for covariates. We stratified the data by recent doctor visits, examined racial/ethnic differences, and tested for linear and quadratic temporal trends., Results: Overall and within age categories, the pooled prevalence of past-year HIV testing decreased following release of the recommendations (p<0.001). The annual prevalence decreased monotonically from 2003 (5.5%) to 2006 (3.6%) (b=-0.16, p<0.001) and then increased immediately after release of the recommendations, but decreased to 3.7% after 2009 (b=0.01, p<0.001). By race/ethnicity, testing increased over time among non-Hispanic black people only. Annual prevalence also increased among respondents with recent doctor visits., Conclusion: CDC's HIV testing recommendations were associated with a reversal in the downward trend in past-year HIV testing among older adults; however, the gains were neither universal nor sustained over time.

Background: Important differences have been demonstrated in laboratory parameters from healthy persons in different geographical regions and populations, mostly driven by a combination of genetic, demographic, nutritional, and environmental factors. Despite this, European and North American derived laboratory reference intervals are used in African countries for patient management, clinical trial eligibility, and toxicity determination; which can result in misclassification of healthy persons as having laboratory abnormalities., Methods: An observational prospective cohort study known as the Kisumu Incidence Cohort Study (KICoS) was conducted to estimate the incidence of HIV seroconversion and identify determinants of successful recruitment and retention in preparation for an HIV vaccine/prevention trial among young adults and adolescents in western Kenya. Laboratory values generated from the KICoS were compared to published region-specific reference intervals and the 2004 NIH DAIDS toxicity tables used for the trial., Results: About 1106 participants were screened for the KICoS between January 2007 and June 2010. Nine hundred and fifty-three participants aged 16 to 34 years, HIV-seronegative, clinically healthy, and non-pregnant were selected for this analysis. Median and 95% reference intervals were calculated for hematological and biochemistry parameters. When compared with both published region-specific reference values and the 2004 NIH DAIDS toxicity table, it was shown that the use of locally established reference intervals would have resulted in fewer participants classified as having abnormal hematological or biochemistry values compared to US derived reference intervals from DAIDS (10% classified as abnormal by local parameters vs. >40% by US DAIDS). Blood urea nitrogen was most often out of range if US based intervals were used: <10% abnormal by local intervals compared to >83% by US based reference intervals., Conclusion: Differences in reference intervals for hematological and biochemical parameters between western and African populations highlight importance of developing local reference intervals for clinical care and trials in Africa.

Background: Many public health laboratories adopting the U.S. HIV laboratory testing algorithm do not have a nucleic acid test (NAT), which is needed when the third- or fourth-generation HIV screening immunoassay is reactive and the antibody-based supplemental test is non-reactive or indeterminate., Objectives: Among public health laboratories utilizing public health referral laboratories for NAT conducted as part of the algorithm, we evaluated the percentage of screening immunoassays needing NAT, the number of specimens not meeting APTIMA (NAT) specifications, time to APTIMA result, the proportion of acute infections (i.e., reactive APTIMA) among total infections, and screening immunoassay specificity., Study Design: From August 2012 to April 2013, 22 laboratories enrolled to receive free APTIMA (NAT) at New York or Florida public health referral laboratories. Data were analyzed for testing conducted until June 2013., Results: Submitting laboratories conducted a median of 4778 screening immunoassays; 0-1.3% (median 0.2%) needed NAT. Of 140 specimens received, 9 (6.4%) did not meet NAT specifications. The median time from specimen collection to reporting the 11 reactive NAT results was ten days, including six days from receipt in the submitting laboratory to shipment to the referral laboratory. Acute infections ranged from 0 to 12.5% (median 0%) of total infections. Third- and fourth-generation immunoassays met package insert specificity values., Conclusions: Public health referral laboratories provide a feasible option for conducting NAT. Reducing the time from specimen collection to submission of specimens for NAT is an important step toward maximizing the public health impact of identifying acute infections., (Published by Elsevier B.V.)

In 1998, Gigerenzer et al. studied how heterosexual men with low-risk behavior were counseled about the accuracy of HIV test results. Most professional counselors conveyed the illusions that false positives do not occur and that a positive HIV test result means that the client is certainly infected. To help improve counseling quality, the authors provided feedback to all counseling centers in Germany. Sixteen years later we assessed whether HIV counseling in Germany has improved by replicating the original study with an expanded sample of 32 randomly selected counseling centers across the country. Since the original research, the positive predictive value (PPV) of HIV testing for a low-risk client has improved from about 50% to 96%. Hence, among every 26 low-risk clients who test positive, we can expect that one is actually not infected. Whereas test performance has improved over the last 16 years, counseling has not. About half of professional counselors communicated the illusion of certainty for sensitivity (15 of 30), specificity (16 of 30), and the PPV (18 of 30). Only one of the 30 counselors could correctly state the PPV. In what follows, we explain how to improve counselors' and clients' understanding of the PPV by representing the information in terms of natural frequencies rather than conditional probabilities. Doing so has been shown to improve the quality of counseling in different medical settings and may enhance future HIV counseling as well.

Introduction: In the field of health, numerous frameworks have emerged that advance understandings of the differential impacts of health policies to produce inclusive and socially just health outcomes. In this paper, we present the development of an important contribution to these efforts - an Intersectionality-Based Policy Analysis (IBPA) Framework., Methods: Developed over the course of two years in consultation with key stakeholders and drawing on best and promising practices of other equity-informed approaches, this participatory and iterative IBPA Framework provides guidance and direction for researchers, civil society, public health professionals and policy actors seeking to address the challenges of health inequities across diverse populations. Importantly, we present the application of the IBPA Framework in seven priority health-related policy case studies., Results: The analysis of each case study is focused on explaining how IBPA: 1) provides an innovative structure for critical policy analysis; 2) captures the different dimensions of policy contexts including history, politics, everyday lived experiences, diverse knowledges and intersecting social locations; and 3) generates transformative insights, knowledge, policy solutions and actions that cannot be gleaned from other equity-focused policy frameworks., Conclusion: The aim of this paper is to inspire a range of policy actors to recognize the potential of IBPA to foreground the complex contexts of health and social problems, and ultimately to transform how policy analysis is undertaken.

Routine HIV testing of all pregnant women in Oman has been introduced without prior knowledge of women's attitudes towards testing or their behaviour in the event of a positive test. This study recruited 1000 Omani pregnant women from antenatal clinics to explore their knowledge of HIV/AIDS, attitudes towards HIV testing and intended behaviours in the event of a positive test. Mother-to-child transmission was recognized by 86.6% of the women but only 21.0% knew that it was preventable and a few acknowledged the important role of antiviral drugs. Half of the women (51.9%) reported having been tested for HIV and 75.8% agreed about routine HIV testing for all pregnant women. A higher level of knowledge was significantly associated with a favourable intended behaviour related to voluntary testing, disclosure and seeking professional assistance in the event of a positive HIV test. The results are discussed in relation to opt-in and opt-out approaches to voluntary testing during pregnancy.

Testing for HIV is one of the cornerstones in the fight against HIV spread. The 2014 European Guideline on HIV Testing provides advice on testing for HIV infection in individuals aged 16 years and older who present to sexually transmitted infection, genito-urinary or dermato-venereology clinics across Europe. It may also be applied in other clinical settings where HIV testing is required, particularly in primary care settings. The aim of the guideline is to provide practical guidance to clinicians and laboratories that within these settings undertake HIV testing, and to indicate standards for best practice., (© The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.)

Introduction: Efforts to implement and take to scale highly efficacious, low-cost interventions to prevent mother-to-child HIV transmission (pMTCT) have been a cornerstone of reproductive health services in sub-Saharan Africa for over a decade. Yet efforts to increase access and utilization of these services remain far from optimal. This study developed and applied an approach to systematically classify pMTCT performance to identify modifiable health system factors associated with pMTCT performance which may be replicated in other pMTCT systems., Methods: Facility-level performance measures were collected at 30 sites over a 12-month period and reviewed for consistency. Five combinations of three indicators (1. HIV testing; 2. CD4 testing; 3. antiretroviral prophylaxis and combined antiretroviral therapy initiation) were compared including a composite of all three, a combination of 1. and 3., and each individually. Approaches were visually assessed to describe facility performance, focusing on rank order consistency across high, medium and low categories. Modifiable and non-modifiable factors were ascertained at each site and ranking process was reviewed to estimate association with facility performance through unadjusted Chi-square tests and logistic regression. After describing factors associated with high versus low performing pMTCT clinics, the effect of inclusion of the 10 middle performers was assessed., Results: The indicator most consistently associated with the reference composite indicator (HIV testing, antiretroviral prophylaxis and combined antiretroviral therapy) was the single measure of antiretroviral prophylaxis and combined antiretroviral therapy. Lower performing pMTCT clinics ranked consistently low across measurement strategies; high and middle performing clinics demonstrated more variability. Association between clinic characteristics and high pMTCT performance varied markedly across ranking strategies. Using the reference composite indicator, larger catchment area, higher number of institutional deliveries, onsite CD4 point-of-care capacity, and higher numbers of nurses and doctors were associated with high clinic performance while clinic location, NGO support, women's support group, community linkages patient-tracking systems and stock-outs were not associated with high performance., Conclusions: Classifying high and low performance provided consistent results across ranking measures, though granularity was improved by aggregating middle performers with either high or low performers. Human resources, catchment size and utilization were positively associated with effective pMTCT service delivery.

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development of revised WHO Recommendations and Guidelines for a number of vaccines, blood products and related substances. Specific discussion areas included the development of WHO guidance on the quality, safety and efficacy of poliomyelitis vaccines; recombinant malaria vaccines; diphtheria vaccines; tetanus vaccines; combined vaccines based on diphtheria and tetanus vaccines; and Japanese encephalitis vaccines. Subsequent sections of the report then provide information on the current status and proposed development of international reference materials in the areas of vaccines and related substances; blood products and related substances; in vitro diagnostic device reagents; biotherapeutics other than blood products; and antibiotics. A series of annexes are then presented which include an updated list of WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1), followed by a series of WHO Recommendations and Guidelines adopted on the advice of the Committee (Annexes 2-7). All additions made during the meeting to the list of International Standards and Reference Reagents for biological substances maintained by WHO are then summarized in Annex 8, and are also available at: http://www. who.int/biologicals.

Objectives: The aim was to summarize national prevention of mother-to-child transmission (PMTCT) guidelines across Europe and to identify differences between these., Methods: A survey was conducted using a structured questionnaire sent to experts in 25 European countries from January to March 2012, requesting a copy of the national guidelines. Responses were received from 23 countries., Results: Twenty-two (96%) countries supported a policy to recommend antenatal HIV screening for all pregnant women (15: opt-out strategy; 8: opt-in strategy). For HIV-positive women in whom the only indication for antiretroviral therapy (ART) was PMTCT, the recommended gestational age for commencing ART varied from 12 to 28 weeks: initiation before 19 weeks gestation was recommended in guidelines from nine countries; in France, the UK and the Netherlands, there was a wide range, from 14 to 24 weeks, whereas the Swiss and Ukrainian guidelines recommended starting at 24-28 weeks and the German/Austrian and Lithuanian at 28 weeks. Six national guidelines recommended inclusion of Zidovudine in antenatal ART regimens, and seven (37%) allowed continuation of Efavirenz for women conceiving on this drug. According to nine guidelines, zidovudine should always be used intrapartum. Eighteen national guidelines stated that HIV-positive women on successful ART can have a vaginal delivery. Viral load thresholds for vaginal delivery were <1000 copies/ml in 5 countries, <400 copies/ml in 3 and <50 copies/ml in 11 countries., Conclusion: There are important differences across Europe in national PMTCT guidelines, with most variation seen where the evidence-base remains limited. Such differences should be considered when interpreting research and surveillance findings.

Background: The 2006 Centers for Disease Control and Prevention (CDC) revised recommendations for HIV testing in clinical settings contained seven specific changes to how health care facilities should provide HIV testing. These seven elements have been both supported and challenged in the lay and medical literature. Our first paper in BMC Medical Ethics presented an analysis of the three HIV testing procedural changes included in the recommendations. In this paper, we address the four remaining elements that concern HIV screening policy changes: (1) nontargeted HIV screening, (2) making HIV screening similar to screening for other treatable conditions, (3) increasing HIV screening without assured additional funding for linkage to care, and (4) making patients bear the costs of increased HIV screening in health care settings., Methods: We interviewed 25 members from the fields of US HIV advocacy, care, policy, and research about the ethical merits and demerits of the four changes to HIV screening policies. We performed a qualitative analysis of the participant responses in the interviews and summarized the major themes., Results: Participants commented that nontargeted HIV screening and making HIV screening similar to screening for other treatable medical conditions was ethical when it broadened the scope of people being tested for HIV. However, they believed it was unethical when it did not respect the exceptional nature of HIV and HIV testing. Some participants favored more testing regardless if there was assured additional funding for linkage to care or if patients might bear the costs of testing because they believed that merely alerting patients of their status was beneficial and would lead to positive consequences. Other participants found ethical flaws with testing without assured linkage to care and patients bearing the costs of testing, as this could discriminate against those who could not pay., Conclusions: Our findings suggest that there are fundamental ethical disagreements that shape views on CDC's recommended HIV testing policies. Differences remain on whether or not HIV remains an exceptional condition that requires it to be treated differently than other treatable conditions. Disagreement also exists on the responsibilities of health care providers and rights of patients in regards to screening in (1) the absence of assured linkage to care after an HIV diagnosis and (2) paying for the costs of HIV screening. Resolution of these disagreements is needed to serve the common goal of using testing to facilitate medical care for those who are HIV infected and for reducing HIV transmission.

Background: External quality assurance (EQA) programmes, which are routinely used in laboratories, have not been widely implemented for point-of- care tests (POCTs). A study was performed in ten health centres in Tanzania, to implement the use of dried blood spots (DBS) as an EQA method for HIV and syphilis (POCTs)., Method: DBS samples were collected for retesting at a reference laboratory and the results compared to the POCT results obtained at the clinic. In total, 2341 DBS samples were collected from 10 rural health facilities over a period of nine months, of which 92.5% were correctly collected and spotted., Results: The EQA method was easily implemented by healthcare workers under routine conditions in Northern Tanzania. For HIV, 967 out of 972 samples (99.5%) were concordant between DBS and POCT results. For syphilis, the sensitivity of syphilis tests varied between clinics with a median of 96% (25th and 75th quartile; 95-98%). The specificity of syphilis POCT was consistent compared to laboratory based test using DBS, with a median of 96% (25th and 75th quartiles; 95-98%)., Conclusion: Overall, the quality of testing varied at clinics and EQA results can be used to identify clinics where healthcare workers require remedial training, suggesting the necessity for stringent quality assurance programmes for POC testing. As Tanzania embarks on scaling up HIV and syphilis testing, DBS can be a useful and robust tool to monitor the quality of testing performed by healthcare workers and trigger corrective action to ensure accuracy of test results.

Objectives: UK guidelines recommend routine HIV testing in general clinical settings when the local HIV prevalence is > 0.2%. During pilot programmes evaluating the guidelines, we used laboratory-based testing of oral fluid from patients accepting tests. Samples (n = 3721) were tested manually using the Bio-Rad Genscreen Ultra HIV Ag-Ab test (Bio-Rad Laboratories Ltd, Hemel Hempstead, UK). This was a methodologically robust method, but handling of samples was labour intensive. We performed a validation study to ascertain whether automation of oral fluid HIV testing using the fourth-generation HIV test on the Abbott Architect (Abbott Diagnostics, Maidenhead, UK) platform was possible., Methods: Oral fluid was collected from 143 patients (56 known HIV-positive volunteers and 87 others having contemporaneous HIV serological tests) using the Oracol+ device (Malvern Medicals, Worcester, UK). Samples were tested concurrently: manually using the Genscreen Ultra test and automatically on the Abbott Architect., Results: For oral fluid, the level of agreement of results between the platforms was 100%. All results agreed with HIV serology. The use of the Oracol+ device produced high-quality samples. Subsequent field use of the test has shown a specificity of 99.97% after nearly 3000 tests., Conclusions: Laboratory-based HIV testing of oral fluid requires less training of local staff, with fewer demands on clinical time and space than near-patient testing. It is acceptable to patients. The validation exercise and subsequent clinical experience support automation, with test performance preserved. Automation reduces laboratory workload and speeds up the release of results. Automated oral fluid testing is thus a viable option for large-scale HIV screening programmes., (© 2013 British HIV Association.)

Early diagnosis of human immunodeficiency virus (HIV) leads to a decreased morbidity and mortality. General practice offers an important window for earlier diagnosis. The British HIV Association produced guidelines in 2008 advocating an increase in HIV testing, with specific references to primary care. This study explores the awareness of, and opinions towards, these guidelines within general practice. An email questionnaire was sent to 191 general practitioners nationwide, in both areas of high and low HIV prevalence. A total of 80 doctors replied, giving a response rate of 42%. In all, 44% of the respondents were unaware of the guidelines and 89% felt comfortable discussing and carrying out an HIV test themselves; of the 11% that did not, all but one were from low prevalence areas (P = 0.037). Respondents felt that main barrier to HIV testing was patient acceptability. Having read the guidelines, 70% believed it would be feasible to follow them in practice. Those who disagreed felt that time implications were the most important reason not to adopt the guidelines. Almost half the respondents were not aware of the guidelines; having read them, the majority felt that implementation is feasible. This demonstrates the necessity for better dissemination of these guidelines. This study found that the main barrier to performing an HIV test was felt to be patient acceptance, a contradiction to findings from recent pilot studies.

How can national AIDS program managers in low- and middle-income countries improve the coverage of HIV testing? In these countries heavily affected by HIV/AIDS, testing for HIV infection remains indeed critically infrequent with regard to its central role for individual care and control of the epidemic. Only 20 per cent of adults and 28 per cent of infants born from HIV-infected mothers are tested in a timely manner. The expansion of HIV testing is a prerequisite for reaching the World Health Organization's objective of universal access to HIV prevention, treatment, care, and support as well as the Millennium Development Goals related to HIV/AIDS and child mortality. The successful Rwandan experience of scaling up early infant HIV diagnosis brings hope for many countries.

Background: Advances in molecular biology and changes in microbial nomenclature may subject diagnostic microbiology to errors. A patient diagnosed with Pneumocystis jiroveci pneumonia and then with AIDS had received a negative "AIDS test"--"negative for antibodies to HTLV 1 and 2." The test requisition showed that the physician had requested HTLV-I/II testing but not an HIV-1/2 test. A root cause analysis was performed to determine if the erroneous testing represented a systemic problem. A study was conducted to identify and address such testing errors., Methods: For the 1,952 HTLV-I/II test requests in a 17-month period in the Southern Alberta region, a random representative sample of 555 requests for HTLV-I/II testing were evaluated for appropriateness. Physicians ordering "inappropriate" tests were surveyed to determine root causes, and the HTLV-I/II check box was subsequently removed from the requisition., Results: Some 318 (94%) of the 340 clinically directed HTLV tests were likely or definitely inappropriate--that is, only an HIV-1/2 test was required. At least 81% (127/156) of the 8% (156/1,948) of the HTLV-I/II tests ordered without an HIV-1/2 test concurrently were ordered inappropriately. In the telephone survey, all 69 physicians suspected to have incorrectly ordered HTLV-I/II tests reported erroneously requesting HTLV for HIV. A root cause analysis identified confusing viral nomenclature, diagnostic testing menu, and form design as contributing factors. A requisition recall and redesign has reduced erroneous laboratory testing., Conclusions: A high proportion of HTLV-I/II tests were ordered erroneously and confused with HIV-1/2. Careful attention to routine test menus and form design, including the exclusion of rare and confusing pathogens, reduces risk of error for practicing physicians.

Background: Adoption of CDC recommendations for routine, voluntary HIV screening of all Americans age 13–64 years has been slow. One method to increase adherence to clinical practice guidelines is through medical school and residency training., Objective: To explore the attitudes, barriers, and behaviors of clinician educators (CEs) regarding advocating routine HIV testing to their trainees., Design/participants: We analyzed CE responses to a 2009 survey of Society of General Internal Medicine members from community, VA, and university-affiliated clinics regarding HIV testing practices., Main Measures: Clinician educators were asked about their outpatient practices, knowledge and attitudes regarding the revised CDC recommendations and whether they encouraged trainees to perform routine HIV testing. Associations between HIV testing knowledge and attitudes and encouraging trainees to perform routine HIV testing were estimated using bivariate and multivariable logistic regression., Results: Of 515 respondents, 367 (71.3%) indicated they supervised trainees in an outpatient general internal medicine clinic. These CEs demonstrated suboptimal knowledge of CDC guidelines and over a third reported continued risk-based testing. Among CEs, 196 (53.4%) reported that they encourage trainees to perform routine HIV testing. Higher knowledge scores (aOR 5.10 (2.16, 12.0)) and more positive attitudes toward testing (aOR 8.83 (4.21, 18.5)) were independently associated with encouraging trainees to screen for HIV. Reasons for not encouraging trainees to screen included perceived low local prevalence (37.2%), competing teaching priorities (34.6%), and a busy clinic environment (34.0%)., Conclusions: Clinician educators have a special role in the dissemination of the CDC recommendations as they impact the knowledge and attitudes of newly practicing physicians. Despite awareness of CDC recommendations, many CEs do not recommend universal HIV testing to trainees. Interventions that improve faculty knowledge of HIV testing recommendations and address barriers in resident clinics may enhance adoption of routine HIV testing.