Evaluating turnaround times for early infant diagnosis samples in Kenya from 2011-2014: A retrospective analysis of HITSystem program data.

Catherine Wexler,Brad Gautney,Sarah Finocchario-Kessler,Samoel Khamadi,Kathy Goggin,An-Lin Cheng,Sten H Vermund

doi:10.1371/journal.pone.0181005

Abstract

Long turnaround times (TAT) for the processing and posting of results of infant HIV DNA PCR samples can hinder the success of early infant diagnosis (EID) programs. The HITSystem is an eHealth intervention that alerts staff when services are overdue or results are delayed. We conducted a retrospective analysis of 3669 HIV-exposed infants enrolled in 15 Kenya hospital EID programs and three laboratories using the HITSystem from 2011–2014. We assessed mean and median TAT from when a sample was: 1) obtained to when it was shipped to the laboratory, 2) shipped to when it was received at the laboratory, 3) received to when a result was posted, and 4) the total time from obtaining the sample (step 1) to posting the result (step 3). TAT were compared by laboratory, clinic, year, and month of sample collection. 3625 infant samples had results posted by end of 2014. Mean TAT from sample collection to shipping was 5.2 days, from shipping to laboratory receipt was 2.0 days, and from laboratory receipt to result posting was 17.4 days. Altogether, it took an average of 24.7 days from sample collection until result posting. There was significant variation between laboratories, particularly in laboratory processing times (step 3). TAT showed a decreasing trend from 2011–2014, although TAT in December remained higher. Compared with other Kenyan studies, TAT in these HITSystem enrolled settings were shorter. Significant variation between laboratories, however, indicates the need to strengthen protocols and infrastructure to ensure that all laboratories can provide rapid, high-quality services.

Highlights

Identification and initiation of ART for HIV-infected infants can reduce mortality by up to 76% and slow disease progression [1] and are critical goals of early infant diagnosis (EID) programs
The mean turnaround times (TAT) from when a sample was obtained to when it was shipped was 5.2 days, the mean TAT from when a sample was shipped to when it was received at the laboratory was 2.0 days, and the mean TAT from when it was received at the laboratory to when a result was posted was 17.4 days
It took a mean of 24.7 days from when a sample was obtained until the result was available to the clinician. 76% of samples had results posted within days of sample collection, 19% had results posted between and 60 days of sample collection, and 5% had results posted over 60 days after sample collection

Summary

Introduction

Identification and initiation of ART for HIV-infected infants can reduce mortality by up to 76% and slow disease progression [1] and are critical goals of early infant diagnosis (EID) programs. In 2008, Kenya revised its guidelines to advocate for EID services to be provided to all HIV-exposed infants [3]. According to these revised guidelines, polymerase chain reaction (PCR) testing for HIV-exposed infants should occur when the infant is 6 weeks of age or at the first contact thereafter. In Kenya, the shift from using whole blood to using dried blood spots (DBS) in 2006 for infant PCR testing allowed for substantial scale-up of EID and made HIV testing possible even in remote areas [4]. The shift to using DBS, coupled with the new EID guidelines, contributed to a dramatic increase in the number of infants tested annually and resulted in a three-fold increase from 18,848 in 2008 to 59,413 in 2014 [7]

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