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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.)

With universal access to effective combination antiretroviral therapy (ART), people in need can gain effective treatment but are only able to benefit from these advances if they are aware of their serostatus and have effectively accessed testing services. Despite the expectation that ART would lead individuals to seek earlier testing, this trend has not been observed in practice, with stable or even increasing rates of late diagnosis in Europe being witnessed. Ahead of a gathering of key European stakeholders in Brussels in November 2007, we reviewed testing strategies across European countries. We show differences in policy and practices. Moreover, HIV testing strategies are changing, in line with new global guidelines issued by World Health Organization headquarters, and a number of countries are promoting an expansion of routine and opt-out testing. However, gaps in our understanding of effective testing strategies remain and, as a consequence, national policies across Europe remain incoherent and often lack an evidence base. This is likely to have serious public health implications.

The articles in this supplement were developed from a recent pan-European conference entitled 'HIV in Europe 2007: Working together for optimal testing and earlier care', which took place on 26-27 November in Brussels, Belgium. The conference, organized by a multidisciplinary group of experts representing advocacy, clinical and policy areas of the HIV field, was convened in an effort to gain a common understanding on the role of HIV testing and counselling in optimizing diagnosis and the need for earlier care. Key topics discussed at the conference and described in the following articles include: current barriers to HIV testing across Europe, trends in the epidemiology of HIV in the region, problems associated with undiagnosed infection and the psychosocial barriers impacting on testing. The supplement also provides a summary of the World Health Organization's recommendations for HIV testing in Europe and an outline of an indicator disease-guided approach to HIV testing proposed by a committee of experts from the European AIDS Clinical Society (EACS). We hope that consideration of the issues discussed in this supplement will help to shift the HIV field closer towards our ultimate goal: provision of optimal HIV testing and earlier care across the whole of the European region.

In September 2006, the Centers for Disease Control and Prevention released its revised recommendations for human immunodeficiency virus (HIV) testing. Prominent among these were the recommendations that emergency departments should perform routine screening for HIV infection. This report outlines the steps needed to set up an emergency department-based HIV screening program based on these guidelines. It contains the lessons that were learned when such a program was initiated at an academic emergency department. Consideration of these steps will help streamline the establishment of the program, but there should be careful consideration of the program's costs and sustainability before embarking on the process.

Matched-pair design is often used in clinical trials to increase the efficiency of treatment comparison. We consider the problem of equivalence test with a relative risk endpoint in matched-pair studies with binary outcomes, and develop several score and Wald-type statistics for testing a hypothesis of non-unity relative risk. Examples from an assessment of HIV screening test and a cross-over clinical trial of soft contact lenses are used to illustrate the proposed methods. Through simulations we compare the empirical performance of these tests with the test proposed by Lachenbruch and Lynch. We show that a score test based on a reparameterized multinomial model by Tango performs best in the sense that the test satisfactorily controls the type I error rate and its empirical type I error rates are generally much closer to the prespecified nominal significance level than those of the other tests., (Copyright 2003 John Wiley & Sons, Ltd.)

Objective: To describe HIV-infected people's experience of the HIV test procedure in Europe., Methods: Between August 1996 and September 1997, anonymous self-administered questionnaires were distributed to HIV-infected people in 11 European countries., Results: A total of 1366 people completed the questionnaire (50% response rate). Of these, 194 (16%) had more than five negative HIV tests before being diagnosed as HIV positive, 179 (14%) were tested without consent and 192 (15%) were informed about the HIV positive test result by mail or by telephone. Of the 963 people who received a positive test result during a consultation, 247 (26%) reported that this visit lasted less than 10 min, 336 (35%) between 10 and 20 min, and 289 (30%) more than 20 min. Over half the total respondents (591, 54%) felt they did not receive adequate support when they were informed about being HIV positive, with 249 (19%) experiencing feelings of rejection. People who were diagnosed as HIV positive after 1994 reported more frequently receiving adequate support, information and understanding when the positive test result was revealed compared with those diagnosed before 1990., Conclusion: A large number of our study participants did not endorse the way HIV tests were conducted and positive test results revealed. Although there was an improvement over time in the way HIV tests were conducted, they often did not conform to international guidelines.