HIV misdiagnosis: A root cause analysis leading to improvements in HIV diagnosis and patient care

摘要

Highlights ? Despite improvements in HIV testing and diagnostic algorithms there remains a small possibility of false positive result. ? The diagnosis of “elite controller” may mask a misdiagnosis and requires detailed confirmatory testing. ? Heterophilic antibodies have been implicated as a factor leading to false positive reactive screening results. ? Communication between clinic and laboratory is crucial for unusual results. Abstract Background Standard diagnostic testing for HIV infection has traditionally relied on a high sensitivity HIV antibody screening test using an enzyme-linked immunosorbent assay (ELISA) followed by a high specificity antibody confirmatory test such as a Western Blot. Recently several of the screening assays have been enhanced with an ability to identify p24 antigen thereby narrowing the diagnostic window. Objectives To explore the implications of enhanced HIV screening methods that may be leading to HIV misdiagnoses. Study design A patient deemed to be an HIV infected ‘elite controller’ was found to be misdiagnosed when undergoing detailed investigations prior to initiating antiretroviral therapy. A root cause analysis was performed to identify the causative factors of this misdiagnosis. A retrospective review of all “elite controllers” in Alberta, Canada revealed challenges of current HIV testing algorithms. Results Technical and human factors were identified as being causative in this HIV misdiagnosis including (i) high rates of false reactive results on the Abbott ARCHITECT HIV-1&2 COMBO EIA, (ii) human error in reading the initial Western blot, (iii) HIV algorithmic directives in which confirmatory (Western blot) testing was not performed on a repeatedly reactive screen test. The outcome of this analysis identified opportunities for improvement, including implementation of a newly approved (automated) confirmatory assay and improved communication between the clinician and laboratory. Conclusions HIV testing remains problematic despite significant advances in HIV test performance and algorithm development, presenting new and unexpected issues. Ensuring a high-quality management system including implementation of the latest HIV technologies and algorithms along with human resources and policies are required to minimize the impact of false positive diagnoses, especially in the era of universal screening and ‘test and treat’ recommendations.