Abstract
BackgroundSamples submitted for HIV PCR testing that fail to yield a positive or negative result represent missed diagnostic opportunities. We describe HIV PCR test rejections and indeterminate results, and the associated delay in diagnosis, within South Africa’s early infant diagnosis (EID) program from 2010 to 2015.MethodsHIV PCR test data from January 2010 to December 2015 were extracted from the National Health Laboratory Service Corporate Data Warehouse, a central data repository of all registered test-sets within the public health sector in South Africa, by laboratory number, result, date, facility, and testing laboratory. Samples that failed to yield either a positive or negative result were categorized according to the rejection code on the laboratory information system, and descriptive analysis performed using Microsoft Excel. Delay in diagnosis was calculated for patients who had a missed diagnostic opportunity registered between January 2013 and December 2015 by means of a patient linking-algorithm employing demographic details.ResultsBetween 2010 and 2015, 2 178 582 samples were registered for HIV PCR testing of which 6.2% (n = 134 339) failed to yield either a positive or negative result, decreasing proportionally from 7.0% (n = 20 556) in 2010 to 4.4% (n = 21 388) in 2015 (p<0.001). Amongst 76 972 coded missed diagnostic opportunities, 49 585 (64.4%) were a result of pre-analytical error and 27 387 (35.6%) analytical error. Amongst 49 694 patients searched for follow-up results, 16 895 (34.0%) had at least one subsequent HIV PCR test registered after a median of 29 days (IQR: 13–57), of which 8.4% tested positive compared with 3.6% of all samples submitted for the same period.ConclusionsRoutine laboratory data provides the opportunity for near real-time surveillance and quality improvement within the EID program. Delay in diagnosis and wastage of resources associated with missed diagnostic opportunities must be addressed and infants actively followed-up as South Africa works towards elimination of mother-to-child transmission.
Highlights
In the absence of antiretroviral therapy (ART), HIV infection during infancy is associated with rapid disease progression with more than half of all infected children expected to die before two years of age [1,2]
Between 2010 and 2015, 2 178 582 samples were registered for HIV polymerase chain reaction (PCR) testing of which 6.2% (n = 134 339) failed to yield either a positive or negative result, decreasing proportionally from 7.0% (n = 556) in 2010 to 4.4% (n = 388) in 2015 (p
Amongst 49 694 patients searched for follow-up results, 16 895 (34.0%) had at least one subsequent HIV PCR test registered after a median of 29 days (IQR: 13–57), of which 8.4% tested positive compared with 3.6% of all samples submitted for the same period
Summary
In the absence of antiretroviral therapy (ART), HIV infection during infancy is associated with rapid disease progression with more than half of all infected children expected to die before two years of age [1,2]. With South Africa’s antenatal HIV prevalence remaining around 30% since 2004, the volume of samples submitted within the EID program has increased dramatically over the years, from 13 069 HIV PCR tests registered in 2004, to 294 730 in 2010, and 485 458 in 2015 [13,15]. HIV PCR testing is still performed at centralized facilities, with only nine EID laboratories currently operating within South Africa’s National Health Laboratory Service (NHLS), the only diagnostic laboratory service within the public health sector. Samples submitted for HIV PCR testing that fail to yield a positive or negative result represent missed diagnostic opportunities. We describe HIV PCR test rejections and indeterminate results, and the associated delay in diagnosis, within South Africa’s early infant diagnosis (EID) program from 2010 to 2015
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