INTRODUCTION: Rapid diagnostic testing has made HIV diagnosis and subsequent 
treatment more accessible. However, multiple factors, including improper 
implementation of testing strategies and clerical errors, have been reported to 
lead to HIV misdiagnosis. The World Health Organization has recommended HIV 
retesting prior to antiretroviral therapy (ART) initiation which has become 
pertinent with scaling up of Early Access to ART for All (EAAA). In this 
analysis, misdiagnosed clients are identified from a subgroup of clients 
enrolled in EAAA implementation study in Swaziland.
METHODS: The subgroup to assess misdiagnosis was identified from enrolled EAAA 
study clients, who had an undetectable viral load prior to ART initiation 
between September 1, 2014 and May 31, 2016. One hundred and five of 2533 (4%) 
clients had an undetectable viral load prior to initiation to ART (pre-ART). The 
HIV status of clients was confirmed using the Determine HIV 1/2 and Uni-Gold HIV 
1/2 rapid tests performed serially as recommended by the national testing 
algorithm. The status of clients on ART was additionally confirmed by 
fourth-generation HIV Ag/Ab combo tests, Architect and Genscreen Ultra.
RESULTS: Fourteen of the 105 (13%) clients were false positive (HIV negative) on 
confirmation testing, of whom five (36%) were still in pre-ART care, while nine 
(64%) were in ART care. Overall, proportion of false positive was 0.6% 
(14/2533). The false-positive clients had a median CD4 of 791 cells/ml 
(interquartile range (IQR): 628, 967) compared to 549 cells/ml (IQR: 387, 791) 
for true positives (HIV positive) (p = 0.0081) and were nearly 20 years older 
(p = 0.0008).
CONCLUSIONS: Overall 0.6% of all enrolled EAAA clients were misdiagnosed, and 
64% of misdiagnosed clients were initiated on ART. With adoption of EAAA 
guidelines by national governments, ART initiation regardless of immunological 
criteria, strengthening of proficiency testing and adoption of retesting prior 
to ART initiation would allow identification of misdiagnosed clients and further 
reduce potential of initiating misdiagnosed clients on ART.