Rapid Human Immunodeficiency Virus Test Quality Assurance Practices and Outcomes among Testing Sites Affiliated with 17 Public Health Departments

Abstract

Rapid human immunodeficiency virus testing is often conducted in nonclinical settings by staff with limited training, so quality assurance (QA) monitoring is critical to ensure accuracy of test results. Rapid tests (n ‫؍‬ 86,749) were generally conducted according to manufacturers' instructions, but ongoing testing competency assessments and on-site QA monitoring were not uniformly conducted.In 2003, rapid human immunodeficiency virus (HIV) tests became available that were waived under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and HIV testing began to be conducted in nonclinical settings by nonlaboratory staff (3). Because testing outside of clinical settings may affect result accuracy, monitoring to ensure that rapid testing is conducted in a manner that is consistent with manufacturers' instructions is essential. The Food and Drug Administration requires testing facilities that plan to perform waived rapid HIV testing to develop quality assurance (QA) plans which include site-specific testing procedures, plans for training testing personnel, and development of systems to identify and correct mistakes (3, 4). Mistakes that can occur during the testing process include performing testing outside of recommended temperatures, collecting specimens incorrectly, documentation errors, improper performance of testing, and incorrect interpretation of results (7). Adherence to QA procedures and ongoing test performance monitoring should reduce the number of testing mistakes that occur and increase the accuracy of results (5,6,8,13).The Centers for Disease Control and Prevention (CDC) developed guidelines for the implementation and operation of rapid test QA programs (4). The CDC recommends that testing sites participate in external quality assessments to evaluate how well testing is being performed. Examples include (i) proficiency testing (PT) programs which provide panels of samples with known results; (ii) competency assessments which evaluate the ability of individuals to read test devices, such as interpreting pictures of rapid test devices; and (iii) QA monitoring in which someone outside the organization observes testing (4).To characterize QA practices and outcomes, the CDC conducted postmarketing surveillance in conjunction with 17 state and city health departments

Sensitivity of Five Rapid HIV Tests on Oral Fluid or Finger-Stick Whole Blood: A Real-Time Comparison in a Healthcare Setting

“…This is of particular importance in highly endemic countries where test positivity has a high probability of being truly positive. Whatever the test, the strategy and the clinical setting, quality control remains crucial [35] and these devices are not considered alone sufficient to confirm HIV infection. International guidelines recommend that, whatever the HIV prevalence, a positive rapid test must be confirmed by EIA or at least one other rapid test [18] .…”

Evaluation of an External Quality Assessment Program for HIV Testing in Haiti, 2006–2011

“…2 Errors can occur at any stage of the testing process: in the preanalytical stage (storage outside the recommended temperatures, collecting specimens incorrectly, and expired test kits), in the analytical stage (deviation from testing procedures, misinterpretation of results, and poor test performance), and the postanalytical stage (documentation errors). 3,4 …”

Development of an approach to monitor the manufacturing consistency of HIV rapid diagnostic tests: Panel qualification and potential impact on country programs

“…Although the primary purpose of this work is to routinely monitor RDT quality, there are several other applications of the established set of panels and the implemented criteria. With the importance of external quality assurance and proficiency testing [36][37][38][39][40][41], the panels could be used to establish new smaller scale proficiency programs with other labs or be included within existing proficiency programs for enhanced training and laboratory quality control [42,43]. The use of the digital image analysis may enhance training approaches where line intensities are observed from images of HIV RDTs [44,45].…”