Assessment of CareStartTM G6PD RDT for G6PD deficiency screening in newborns and malaria diagnosed subjects in the Northern Thailand

Abstract

Background: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is an inherited enzymatic disorder associated with severe neonatal hyperbilirubinemia and acute hemolysis after exposure to certain drugs or infections. The most common test for screening G6PD deficiency is fluorescent spot test which is rapid and convenient. However, fluorescent spot test needs tools and skills in diagnosis and interpretation of the results. CareStartTM G6PD Rapid Diagnosis Test (RDT) is an enzyme chromatographic strip test based on reduction of colorless nitro blue tetrazolium into formazan which gives purple color and the results could be read within 10 minutes. Objective: This study aimed to analyze the sensitivity, specificity and accuracy of CareStartTM G6PD RDT for screening of G6PD deficiency in newborn and subjects with malaria diagnosis. Materials and methods: This study was conducted from December 2017 to February 2018. G6PD diagnostic tests including fluorescent spot test and CarestartTM G6PD RDT were performed in 196 newborns aged varied from 1 day to 12 years and 48 subjects with malaria diagnosis. The efficiency of CareStartTM G6PD RDT was analyzed by comparing with the reference method, fluorescent spot test. Results: CareStartTM G6PD RDT demonstrated 100% sensitivity, 100% specificity and 100% accuracy for screening of G6PD deficiency in malarial diagnosed samples. However, it presented invalid results up to 27.04% in newborns. Therefore, sensitivity, specificity and accuracy were not applicable in this group. Conclusion: CareStartTM G6PD RDT could be used for preliminary screening of G6PD deficiency in malarial diagnosed samples. However, it should be improved to reduce the invalid results in newborns.

Keywords

• Accuracy
• CareStartTM G6PD RDT
• Fluorescent spot test
• G6PD deficiency
• Screening