The test is licensed for the near-patient detection of HIV on whole blood, finger-prick blood and oral fluid transudate. The FDA approved the test for home use with oral fluid in the USA in July 2012 [5]. In the UK and Europe, the test is presently licensed for medical personnel use only. The manufacturer’s specificity claim is 100%

[95% confidence interval (CI) 99.7–100%] for whole blood and 99.8% (95% CI 99.6–99.9%) for oral fluid [6]. The test has been widely used in developed and resource-poor settings. From 2009 to 2010, the Department of Health-funded HIV Testing in Non-traditional Settings (HINTS) study investigated the feasibility and acceptability of routine HIV testing in general medical settings in areas of high community HIV seroprevalence in London,

UK. More than 4100 HIV tests were conducted [7]. In three of the four clinical areas studied (an emergency Selleckchem Gemcitabine department, a dermatology out-patient clinic and a primary care centre), patients would not necessarily undergo venepuncture for other indications and it was feared that blood sampling may act as a disincentive to accept an HIV test; thus, oral fluid was felt to be an appropriate specimen for HIV testing. Concerns were learn more raised in each of the participating clinical areas that the use of an oral fluid POCT might have negative implications. In the emergency department, the use of a POCT with a turnaround time of 30 min did not sit well with patient pathways and strict time targets. In all clinical areas, concerns regarding the specialist training required to perform and read POCTs were cited, as was the requirement for access to specialist services 24 hours a day, in Protein kinase N1 the event of reactive tests. Pre-study patient surveys suggested that potential participants in the nonspecialist areas did not have a strong

preference for POCTs over laboratory tests. In light of the issues raised above, we resolved to develop an oral fluid-based HIV testing methodology utilizing the field collection of oral fluid specimens which were then passed on to a central laboratory for testing. Patients would be afforded the benefits of an oral fluid methodology, and participating centres need be concerned only with the safe collection of specimens in the field, obviating the need for specialist training and 24-hour referral pathways. The methodology needed to be robust, with good performance characteristics for the detection of HIV infection in low-prevalence settings, and able to handle large volume throughput. The turn-around time needed to be less than 7 days, to ensure prompt delivery of results to patients. All patients would receive their result by text message or telephone call. This paper sets out to describe our experiences of developing such a test. The development of the oral fluid HIV test falls into three phases: (1)  pre-automation oral fluid testing; In the initial phase of the HINTS study, a manual methodology was developed.