Evaluation of quantitative biosensor for glucose-6-phosphate dehydrogenase activity detection
Pairat Pengboon1, Areenuch Thamwarokun2, Khaimuk Changsri3
1Graduate Program in Medical Technology, Faculty of Allied Health Sciences, Thammasat University, Pathumtani, Thailand.
Insights
Screening for Glucose-6-Phosphate Dehydrogenase (G-6-PD) deficiency in newborns is crucial. The careSTARTTM G6PD biosensor offers a reliable, point-of-care quantitative method for diagnosing G-6-PD deficiency, aiding in preventing severe jaundice.
Area of Science:
- Biochemistry
- Neonatal Medicine
- Diagnostic Technology
Background:
- Neonatal jaundice is a severe risk for premature infants with Glucose-6-Phosphate Dehydrogenase (G-6-PD) deficiency.
- The World Health Organization (WHO) recommends G-6-PD deficiency screening in newborns for early intervention.
- Accurate and timely diagnosis is essential to prevent severe outcomes like acute hemolysis.
Purpose of the Study:
- To evaluate the careSTARTTM G6PD biosensor as a quantitative point-of-care diagnostic tool for G-6-PD deficiency.
- To assess factors influencing G-6-PD enzyme activity measurements.
- To compare the biosensor's performance against established diagnostic methods.
Main Methods:
- Investigated factors affecting G-6-PD enzyme activity in 40 adults (anticoagulant, hematocrit, storage).
- Evaluated the careSTARTTM G6PD biosensor's analytical performance in 216 newborns.
- Compared biosensor results with fluorescent spot test (FST) and standard quantitative G-6-PD assay (SGT).
Main Results:
- G-6-PD activity was stable at 4°C for 3 days and showed strong correlation (r=0.82, ICC=0.90) with SGT.
- The biosensor demonstrated high sensitivity (100%) and specificity (96%) at 30% residual activity.
- Diagnostic accuracy was 88% when stratified by gender, with 78% sensitivity and 89% specificity.
Conclusions:
- The careSTARTTM G6PD biosensor is a viable point-of-care quantitative method for G-6-PD activity detection.
- Quantifying G-6-PD enzyme activity is critical for managing G-6-PD deficiency in newborns.
- This method aids in preventing severe jaundice and acute hemolysis in affected infants.
Abstract:
Neonatal jaundice is a common and severe disease in premature infants with Glucose-6-Phosphate Dehydrogenase (G-6-PD) deficiency. The World Health Organization (WHO) has recommended screening for G-6-PD deficiency in newborns for early recognition as well as to prevent unwanted outcomes in a timely manner. The present study aimed to assess a point-of-care, careSTARTTM G6PD biosensor as a quantitative method for the diagnosis of G-6-PD deficiency. Factors influencing the evaluation of G-6-PD enzyme activity were examined in 40 adults, including ethylenediaminetetraacetic acid (EDTA) anticoagulant, hematocrit concentration, storage temperature and time. Analytic performance of the careSTARTTM G6PD biosensor was evaluated in 216 newborns and compared with fluorescent spot test (FST) and standard quantitative G-6-PD enzyme activity (SGT) assay. The results of factors affecting the G-6-PD enzyme activity showed that the activity determined from finger-prick was not statistically different from venous blood (p = 0.152). The G-6-PD value was highly dependent on the hematocrit and rose with increasing hematocrit concentration. Its activity was stable at 4°C for 3 days. Reliability analysis between the careSTARTTM G6PD biosensor and SGT assay showed a strong correlation with a Pearson's correlation coefficient of 0.82 and perfect agreement by intraclass correlation coefficient (ICC) of 0.90. Analysis of the area under the Receiver Operating Curve (AUC) illustrated that the careSTARTTM G6PD biosensor had 100% sensitivity, 96% specificity, 73% positive predictive value (PPV), 100% negative predictive value (NPV) and 97% accuracy at 30% of residual activity. While the diagnostic ability for identifying G-6-PD deficiency had 78% sensitivity, 89% specificity, 56% positive predictive value (PPV), 96% negative predictive value (NPV) and 88% accuracy when stratified by gender. The careSTARTTM G6PD biosensor is an attractive option as a point-of-care quantitative method for G-6-PD activity detection. Quantification of G-6-PD enzyme activity in newborns is the most effective approach for the management of G-6-PD deficiency to prevent severe jaundice and acute hemolysis.
