Evaluation of quantitative biosensor for glucose-6-phosphate dehydrogenase activity detection

Pairat Pengboon; Areenuch Thamwarokun; Khaimuk Changsri; Chollanot Kaset; Sirinart Chomean

doi:10.1371/journal.pone.0226927

Evaluation of quantitative biosensor for glucose-6-phosphate dehydrogenase activity detection

PLoS One. 2019 Dec 20;14(12):e0226927. doi: 10.1371/journal.pone.0226927. eCollection 2019.

Authors

Pairat Pengboon¹, Areenuch Thamwarokun², Khaimuk Changsri³, Chollanot Kaset³, Sirinart Chomean³

Affiliations

¹ Graduate Program in Medical Technology, Faculty of Allied Health Sciences, Thammasat University, Pathumtani, Thailand.
² Graduate Program in Biomedical Sciences, Faculty of Allied Health Sciences, Thammasat University, Pathumtani, Thailand.
³ Department of Medical Technology, Faculty of Allied Health Sciences, Thammasat University, Pathumtani, Thailand.

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.

Publication types

Comparative Study
Evaluation Study
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Biosensing Techniques / methods*
Blood Donors
Clinical Enzyme Tests / methods*
Data Accuracy
Female
Glucosephosphate Dehydrogenase / analysis*
Glucosephosphate Dehydrogenase Deficiency / complications
Glucosephosphate Dehydrogenase Deficiency / diagnosis*
Hematologic Tests / methods*
Humans
Infant, Newborn
Jaundice, Neonatal / etiology
Male
Neonatal Screening / methods*
Point-of-Care Systems*
Sensitivity and Specificity
Young Adult

Substances

Glucosephosphate Dehydrogenase

Grants and funding

This study was supported by Thammasat University Research Fund (Contract No. TUGG138/2562) which cover the chemical and reagents supply. The careSTARTTM G6PD biosensor was provided by the manufacturer (WELLS BIO, INC., Korea). However, the funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.