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“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. Oral fluid was collected from 143 patients (56 selleck inhibitor 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. For oral fluid, the level selleck chemicals 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. 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, Paclitaxel 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. Since 2007, a change in the HIV testing paradigm in the UK has been proposed to reduce both undiagnosed and late-stage diagnosed HIV infection. Guidance from the National Institute for Health and Clinical Excellence follows that from the British Association for Sexual Health and HIV, and the British HIV Association, in calling for more widespread testing, including routine HIV testing in general medical settings in areas where HIV prevalence exceeds 0.2% [1-4]. Expansion of HIV testing has driven the development and appraisal of new HIV testing technologies, such as near-patient point-of-care tests (POCTs) and the use of various biological specimens to diagnose HIV infection, including whole blood, serum, capillary blood, dried blood spots and oral fluid. Oral fluid testing has several advantages over blood-based techniques: it is less invasive and less painful, the specimen collection can be performed by the patient without direct supervision, and oral fluid sampling is likely to be less hazardous to health care personnel. To date, the only licensed oral fluid-based HIV test is the OraQuick® ADVANCE Rapid HIV-1/2 Antibody test (OraSure Technologies, Inc.