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J Clin Virol. 2017 Nov;96:84-88. doi: 10.1016/j.jcv.2017.10.005. Epub 2017 Oct 9.

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

Author information

Department of Medicine, University of Calgary, Calgary, Canada.
Department of Laboratory Medicine and Pathology University of Alberta, Edmonton, Canada; Provincial Laboratory of Public Health, Edmonton, Canada.
Southern Alberta HIV Clinic, Calgary, Canada.
National HIV Reference Laboratory, National Microbiology Laboratory, Winnipeg, Canada.
Saskatchewan Disease Control Laboratory, Ministry of Health, Regina, Saskatchewan, Canada.
Department of Medicine, University of Calgary, Calgary, Canada; Southern Alberta HIV Clinic, Calgary, Canada. Electronic address:



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.


To explore the implications of enhanced HIV screening methods that may be leading to HIV misdiagnoses.


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.


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.


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.


Abbott ARCHITECT HIV-1&2 COMBO EIA; Canada; Elite controller; HIV/AIDS; Heterophilic antibodies; Misdiagnosis

[Indexed for MEDLINE]

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