Evaluation of the Diagnostic Accuracy of the CareStart™ Glucose-6-Phosphate Dehydrogenase Deficiency Rapid Diagnostic Test among Chinese Newborns

Previous studies have shown that the CareStart™ G6PD Deficiency rapid diagnostic test has high diagnostic accuracy on G6PD deficiency in Africa and Thailand, but not in China. As there are regional differences of G6PD genotype distribution, we are attending to verify the effectiveness of the kit in...

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Veröffentlicht in:Journal of tropical pediatrics (1980) 2020-10, Vol.66 (5), p.495-503
Hauptverfasser: Yu, Fengting, Zhang, Sufen, Chen, Binhuan, Zhou, Yuqiu, Ma, Chengjie, Yang, Siyuan, Tang, Yunxia, Huang, Dan, Xie, Xiaohui, Xiao, Qizhi, Wang, Linghang
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container_end_page 503
container_issue 5
container_start_page 495
container_title Journal of tropical pediatrics (1980)
container_volume 66
creator Yu, Fengting
Zhang, Sufen
Chen, Binhuan
Zhou, Yuqiu
Ma, Chengjie
Yang, Siyuan
Tang, Yunxia
Huang, Dan
Xie, Xiaohui
Xiao, Qizhi
Wang, Linghang
description Previous studies have shown that the CareStart™ G6PD Deficiency rapid diagnostic test has high diagnostic accuracy on G6PD deficiency in Africa and Thailand, but not in China. As there are regional differences of G6PD genotype distribution, we are attending to verify the effectiveness of the kit in Chinese population. The study cohort included 247 newborns admitted to our hospital for jaundice. The quantitative detection of G6PD enzyme activity and G6PD gene mutations analysis was used to classify the status of G6PD deficiency. The performance of CareStart™ assays was verified by calculating the sensitivity, specificity and area under the receiver operating characteristic curve (AUC) based on the corrected G6PD deficiency status. In male newborns, the sensitivity of the CareStart™ assay was 98.9%, the specificity was 94.2% and the AUC was 0.97. In female newborns, the sensitivity was 58.5% when the cutoff value of residual enzyme activity was 100%; however, the sensitivity was 100% when the cutoff value was 60%. Therefore, the CareStart™ test can effectively screen G6PD deficiency in male newborns and female infants with less than 60% residual enzyme activity, female infants with residual enzyme activities of 60-100% are more likely to be missed diagnosed among Chinese newborns.
doi_str_mv 10.1093/tropej/fmaa003
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As there are regional differences of G6PD genotype distribution, we are attending to verify the effectiveness of the kit in Chinese population. The study cohort included 247 newborns admitted to our hospital for jaundice. The quantitative detection of G6PD enzyme activity and G6PD gene mutations analysis was used to classify the status of G6PD deficiency. The performance of CareStart™ assays was verified by calculating the sensitivity, specificity and area under the receiver operating characteristic curve (AUC) based on the corrected G6PD deficiency status. In male newborns, the sensitivity of the CareStart™ assay was 98.9%, the specificity was 94.2% and the AUC was 0.97. In female newborns, the sensitivity was 58.5% when the cutoff value of residual enzyme activity was 100%; however, the sensitivity was 100% when the cutoff value was 60%. 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subjects Asian Continental Ancestry Group
China - epidemiology
Diagnostic Tests, Routine - methods
Diagnostic Tests, Routine - standards
Female
Glucosephosphate Dehydrogenase - blood
Glucosephosphate Dehydrogenase - genetics
Glucosephosphate Dehydrogenase Deficiency - blood
Glucosephosphate Dehydrogenase Deficiency - diagnosis
Glucosephosphate Dehydrogenase Deficiency - ethnology
Humans
Infant, Newborn
Male
Polymerase Chain Reaction - methods
Predictive Value of Tests
Sensitivity and Specificity
title Evaluation of the Diagnostic Accuracy of the CareStart™ Glucose-6-Phosphate Dehydrogenase Deficiency Rapid Diagnostic Test among Chinese Newborns
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