HIV serologically indeterminate individuals: Future HIV status and risk factors.

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.

Risks of requiring a dedicated molecular specimen for HIV diagnosis and a potential strategy for mitigation.

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.

Repeated false reactive ADVIA centaur® and bio-rad Geenius™ HIV tests in a patient self-administering anabolic steroids.

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.

Enhancing Routine HIV Testing in Primary Care With a Continuing Education Intervention.

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.].

Comparison of Detection Limits of Fourth- and Fifth-Generation Combination HIV Antigen-Antibody, p24 Antigen, and Viral Load Assays on Diverse HIV Isolates.

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.

Audit of HIV counselling and testing services among primary healthcare facilities in Cameroon: a protocol for a multicentre national cross-sectional study.

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.

A prospective multicentre study of healthcare provider preference in rapid HIV testing kits: Determine versus INSTI.

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.

Contamination with HIV antibody may be responsible for false positive results in specimens tested on automated platforms running HIV 4th generation assays in a region of high HIV prevalence.

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.

Health facility factors and quality of services to prevent mother-to-child HIV transmission in Côte d'Ivoire, Kenya, and Mozambique.

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.

Can the Heterosexual HIV Epidemic be Eliminated in South Africa Using Combination Prevention? A Modeling Analysis.

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.

Performance of Determine Combo and other point-of-care HIV tests among Seattle MSM.

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.

Trends in HIV Testing Among U.S. Older Adults Prior to and Since Release of CDC's Routine HIV Testing Recommendations: National Findings from the BRFSS.

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.

What Counselors Tell Low-Risk Clients About HIV Test Performance.

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.

Nucleic acid testing by public health referral laboratories for public health laboratories using the U.S. HIV diagnostic testing algorithm.

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.

An intersectionality-based policy analysis framework: critical reflections on a methodology for advancing equity.

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.

2014 European Guideline on HIV testing.

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.

Estudo de homogeneidade dos soros utilizados em controle de qualidade interno de testes imunodiagnósticos de HIV/Aids / AidsHomogeneity study of the internal quality control sera for immunodiagnosis of HIV/AIDS

Introduction: The present study reports the data from the first homogeneity assessment of samples composing the serum panels produced at the Immunology Center of Instituto Adolfo Lutz, São Paulo. These samples have been distributed to the public laboratories and those partaking in the Brazilian Unified Health System, and to the participants in the Internal Quality Control Program for human immunodeficiency virus (HIV) antibody (Ab) testing. Objective: To assess the homogeneity of serum samples in panels from different lots for HIV/acquired immunodeficiency syndrome (AIDS) immunodiagnosis by using the statistical method to ensure quality of the reference material. Method: Sera homogeneity was evaluated by means of enzyme-linked immunoassay/enzyme immunoassay (ELISA/EIA) for detection of HIV Ab, and the one-way analysis of variance was employed for analyzing the data. No statistically significant differences were found among the several serum vials. Conclusion: The sera dispensed in the vials were homogeneous in the respective lots...

Introdução: No presente estudo estão descritos os resultados das primeiras análises feitas sobre a avaliação da homogeneidade das amostras componentes de painéis de soros produzidos no Centro de Imunologia do Instituto Adolfo Lutz e distribuídos aos laboratórios públicos e conveniados ao Sistema Único de Saúde e participantes do Programa de Controle de Qualidade Interno para imunodiagnóstico de vírus da imunodeficiência humana/síndrome da imunodeficiência adquirida (HIV/AIDS). Objetivo: Avaliar a homogeneidade das amostras de soro componentes de painéis de diferentes lotes para imunodiagnóstico de HIV/Aids por meio de método estatístico para garantir a qualidade do material de referência. Material e método: A homogeneidade das amostras de soro foi avaliada por meio de enzyme-linked immunoassay/enzyme immunoassay (ELISA/EIA) para detecção de anticorpos anti-HIV, e os resultados foram submetidos à análise de variância fator único. Não foram encontradas diferenças significativas entre os resultados obtidos para os diversos frascos de soro. Conclusão: As amostras distribuídas nos frascos foram homogêneas entre si nos respectivos lotes...

Perspectives on the ethical concerns and justifications of the 2006 Centers for Disease Control and Prevention HIV testing: HIV screening policy changes.

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.

Automatic oral fluid-based HIV testing in HIV screening programmes: automatic for the people.

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.