Date Published: August 10, 2017
Publisher: Public Library of Science
Author(s): Catherine Wexler, An-Lin Cheng, Brad Gautney, Sarah Finocchario-Kessler, Kathy Goggin, Samoel Khamadi, Sten H Vermund.
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.
Early identification and initiation of ART for HIV-infected infants can reduce mortality by up to 76% and slow disease progression  and are critical goals of early infant diagnosis (EID) programs. Prior to 2008, guidelines for infant HIV-testing in Kenya focused on the identification of HIV in infants who presented at pediatric or tuberculosis wards with symptoms . However, in 2008, Kenya revised its guidelines to advocate for EID services to be provided to all HIV-exposed infants . 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. Antibody testing should then occur at 9- and 18- months of age or 6 weeks after cessation of breastfeeding, with confirmatory PCR tests for infants with positive antibody tests .
Of the 3669 infant samples collected, 3625 (98.8%) had results posted by end of 2014. A total of 3407 (94%) samples were negative, 192 (5.3%) were positive, and 26 (0.7%) were indeterminate.
This study provides the most comprehensive description of TAT for EID in Kenya, to date. The mean turnaround time from when a DBS sample was collected from an infant to when a result was posted was 24.7 days. This is faster than the 1.5–2 months reported in other studies in Kenya [10,11]. The TAT in this study was slightly longer than the 2.5 weeks observed in a preliminary analysis of the HITSystem at one hospital and one laboratory (Lab 2) by Gautney et al . This analysis, however; includes 3 laboratories and 15 hospitals, increasing variability of TAT across hospitals and laboratories. While this increases the representativeness of these data it also contributed to the higher TAT reported here, partially due to the lack of consistent practices and capacity among sites. Clinic and laboratory characteristics, including varying levels of HITSystem ownership and varying rates of HITSystem adoption among facilities  and staffing levels and commitment at the different facilities may have contributed to differences in TAT. Furthermore, distance and road conditions between the hospital and the laboratory and the role of outside funding agency and varying EID volume among labs may have contributed to variations in sample shipment and sample processing times, respectively.
This study provides the most comprehensive and up to date description of turnaround time for EID in Kenya. While overall TAT showed modest improvement from 2011 to 2014, investments in infrastructure and laboratory personnel are needed to accelerate TAT, reduce the number of samples with excessive delays, and ensure that all laboratories providing EID diagnostic services are capable of keeping up with the increasing workload. While lack of a control group limits our ability to compare these results from HITSystem facilities to standard of care, this study provide promising evidence that the HITSystem can effectively monitor and manage TAT for EID samples by identifying TAT segments and time periods that need targeted support (i.e. sample processing at laboratories, staggered support during holiday months).