Diagnostic Accuracy Of CareStartTM G6PD Biosensor, Prevalence And Associated Factors Of G6PD Deficiency Among Newborns Delivered At Kawempe Referral Hospital
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Background: Glucose 6 phosphate Dehydrogenase deficiency (G6PDD), an X linked inherited disorder, is among the most common enzyme deficiency affecting more than 400 million individuals worldwide. Newborns with G6PD deficiency are at high risk of neonatal hyperbilirubinemia that can lead to acute bilirubin encephalopathy, and later severe neurological damage or death. Newborn screening for G6PD deficiency in countries with a prevalence of 35% or more in males is recommended by World Health (WHO). Routine newborn screening is not done, yet it would be helpful in early identification and referral of newborns with hyperbilirubinaemia, for medical evaluation and treatment. Such routine screening requires an easy to use, rapid and affordable method that can be rolled out on a National scale. The aim of this study was to assess the performance of CareStartTM G6PD biosensor, determine the prevalence of G6PDdeficiency, and the factors associated with G6PD deficiency among newborns delivered in Kawempe Referral Hospital. Methods: This was a cross sectional study, carried out on cord blood of newborns, whose mothers delivered at the Kawempe Referral Hospital labor ward, in Kawempe. Test performance was assessed by comparing the CareStartTM G6PD biosensor to the reference essay (spectrophotometry). Information on factors associated was obtained by triangulating responses from a structured questionnaire, clinical examination, and laboratory investigations. Independent and dependent variables were collected using a data checklist, and structured questionnaire. Data was entered using EpiData version 3.1, and statistical data analyzed using STATA College Station TX version 14. Bivariables and multivariables were assessed using Cox Proportional Hazards Regression. A newborn was deemed deficient if the cord blood G6PD enzyme activity was less than 60% of the Adjusted Median Male value. Results: A total of 217 newborns were recruited into the study. The adjusted male median value derived by spectrophotometry was 12.73U/gHb, and 7.08U/gHb by CareStartTM G6PD biosensor. The sensitivity of the CareStartTM G6PD biosensor was 41.2% 95%CI ((24.6 -59.3%), specificity at 79.2%CI (72.6-84.9), negative predictive value of 89.7% CI(81.9-92.4), positive predictive value of 26.9%(15.6 -41) and positive likelihood ratio of 1.98 CI (1.21-3.24) for cut off of mild deficiency of 60% activity. G6PD prevalence was determined using both the spectrophotometry, and the CareStartTM G6PD biosensor. G6PD prevalence was higher by CareStartTM G6PD biosensor (23.9%), than by spectrophotometry, using a <60% threshold (value=0.01). Increased bilirubin levels were found xii to be two and half times more likely in neonates with G6PD deficiency based on UV spectrophotometry. Conclusion and recommendations: The CareStartTM G6PD biosensor performed sub optimally at <60% threshold, with a low sensitivity at 41%, moderately high specificity at 79.2% and low positive likelihood ratio at 1.98. CareStartTM G6PD biosensor needs to be improved before being considered as a point of care diagnostic test for G6PD deficiency. The prevalence of G6PD deficiency is higher than the WHO threshold for screening at 15-24%, therefore routine newborn screening should be considered in Uganda.