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

Abstract

ObjectivesUK 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 laboratorybased 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. MethodsOral 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. ResultsFor 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. ConclusionsLaboratory-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.

HIV testing strategies employed in health care settings in the European Union/European Economic Area (EU/EEA): evidence from a systematic review

“…Novel HIV testing technologies were employed by 40 studies in a wide range of clinical settings to increase testing coverage; the majority utilized rapid testing (n = 36) [18,19,22,24,25,34,36,45,46,[48][49][50]56,57,59,65,75,77,81,83,85,88,89,[99][100][101]107,113,117,129,132,134,137,139,141] while four utilized self-sampling (n = 3) [44,52,102] and self-testing strategies (n = 1) [108]. Two of the four self-sampling studies used oral fluid sampling while the self-test required a blood sample.…”

“…Thirty studies evaluated the impact of a testing intervention by comparing the intervention data with baseline data (n = 24) [20,26,34,44,47,65,72,75,78,80,83,87,95,96,98,102,111,113,125,126,130,133,135,141] or with a control group (n = 6) [22,77,81,82,120,136] (Table 2). Twelve studies employed novel testing (10 rapid testing and two self-sampling) in diverse settings, of which one reported an increase in HIV test coverage from 2% before the intervention to 45% after [65], while others reported increases in HIV diagnoses [77,141], testing [44,75,83,102] and test acceptance [81] and higher positivity rates [34] after the intervention.…”

Update on HIV in Western Europe

“…Access to testing however seems to vary widely across healthcare settings in Europe: although most countries offer HIV tests in HIV clinics, sexual health clinics, hospitals and antenatal settings, tests are less available through general practitioners, prisons and tuberculosis services [28]. HIV testing has also been found to be feasible in emergency departments, community-based centres and through use of laboratory-based testing of oral fluid, where each have their own benefits and difficulties in implementation [30–33, 34•]. A systematic review assessing barriers to testing in Europe found that there are barriers concerning patients, healthcare providers and at the level of institutions, which include perceived low-risk, fear, accessibility, as well as lack of financial and human resources [35].…”

Validation study of a conventional enzyme immunoassay to detect HIV antibodies in oral fluid

“…The major advantages of replacing serum/plasma with OF include easy access to testing and noninvasive collection while maintaining high-level performance (5,6,7). OF tests do not require the presence of experienced healthcare personnel.…”

“…OF tests do not require the presence of experienced healthcare personnel. Nevertheless, the staff should be trained on how to perform their assigned tasks (5,7). In addition, OF-based testing is a key tool for successful implementation of Second Generation Surveillance approaches (8).…”