Search

Background: Glucose 6 phosphate dehydrogenase (G6PD) deficiency is an inherited enzymopathy that is associated with hemolytic anemia. Objective: To evaluate the diagnostic accuracy of G6PD biosensor analyzer used at study site for the quantitative measurement of total G6PD enzyme activity in whole blood using Trinity biotech quantitative assay as gold standard. Study type, settings and duration: This cross-sectional study was conducted in the Department of Haematology, Armed Forces Institute of Pathology, Rawalpindi from April 2018 to September 2018. Methodology: One hundred and thirty seven patients having unexplained hemolytic anemia and suspected to have G6PD deficiency were included in the study using non-probability consecutive sampling technique. Detailed history, including drug history and transfusion history was taken and a complete physical examination was done. Each eligible patient was analyzed by G6PD biosensor analyzer for the quantitative measurement of total G6PD enzyme activity while Trinity biotech quantitative assay was used as gold standard. Results: A total of 137 individuals with unexplained haemolytic anaemia suspected of having G6PD deficiency were enrolled in our study. On statistical analysis, G6PD Biosensor Analyzer was found to be 96.08% (95% CI: 86.54-99.52%) sensitive and 89.53% (95% CI:81.06-95.10%) specific as compared to our gold standard method Trinity Biotech. The positive likelihood ratio was 9.18 (95% CI:4.94-17.08) while the negative likelihood ratio was 0.04 (95% CI:0.01-0.17) with a positive predictive value and a negative predictive value of 84.48% (95% CI: 74.53-91.01%) and 97.47% (95% CI:90.81-99.34%), respectively. The accuracy of our test determined to be 91.97% (95% CI:86.09-95.92%). Conclusion: G6PD Biosensor Analyzer is a rapid and cost-effective method for diagnosis of G6PD deficiency. [ABSTRACT FROM AUTHOR]