Medical Science Program, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Biomedical Sciences Program, Graduate School, Chulalongkorn University, Bangkok, Thailand.
Int J Lab Hematol. 2019 Apr;41(2):192-199. doi: 10.1111/ijlh.12943. Epub 2018 Nov 1.
A precise and reliable screening assay for glucose 6-phosphate dehydrogenase (G6PD) deficiency would greatly help avoiding unwanted outcomes due to bilirubin neurotoxicity in neonatal jaundice and antimalarial-induced haemolytic anaemia in malaria patients. Currently, available assays are laborious and require sophisticated laboratory expertise. This study aimed to evaluate the performance of a recently introduced automated screening assay for G6PD deficiency by comparing with a routine spectrophotometric assay.
An automated UV-based enzymatic (Mindray, PRC) and spectrophotometric assays were performed simultaneously in parallel to determine G6PD activity in 251 blood samples from the subjects.
The median G6PD activity value from spectrophotometric assay was significantly lower than that of from the automated assay. The mean difference was -2.0 U/g haemoglobin (-7.3 to 3.2; P < 0.0001). The mean activity values of both assays were strongly correlated with Pearson's correlation coefficient of r = 0.8. Cohen's kappa statistics between assays was 0.77 (0.70-0.83). The sensitivity, specificity, positive and negative predictive values of the automated assay were 85.7%, 99.2%, 85.7%, 99.2%, respectively. The sensitivity and positive predictive values of the automated assay for identifying intermediate G6PD activity levels were 40.0% and 25.0%, respectively. Genotyping was performed to confirm G6PD deficient and intermediate samples. The turnaround time for 40 samples was 60 minutes for the automated assay and 300 minutes for spectrophotometric assay.
The automated assay for the detection of G6PD deficiency is comparable to a routine spectrophotometric assay and help reducing sample handling time. However, the assay shows limitation in identifying individuals with G6PD intermediate.
一种精确可靠的葡萄糖-6-磷酸脱氢酶（G6PD）缺乏症筛查检测方法将极大地有助于避免因新生儿黄疸中的胆红素神经毒性和疟疾患者中抗疟药物诱导的溶血性贫血而导致的不良后果。目前，可用的检测方法繁琐且需要复杂的实验室专业知识。本研究旨在通过与常规分光光度法比较，评估一种新引入的自动化 G6PD 缺乏症筛查检测方法的性能。
同时平行进行基于自动 UV 的酶法（迈瑞，中国）和分光光度法，以确定 251 份来自研究对象的血液样本中的 G6PD 活性。
分光光度法的 G6PD 活性中位数显著低于自动检测法。平均差异为-2.0 U/g 血红蛋白（-7.3 至 3.2；P < 0.0001）。两种检测方法的平均活性值均与 Pearson 相关系数 r = 0.8 高度相关。两种检测方法之间的 Cohen's kappa 统计值为 0.77（0.70-0.83）。自动检测法的灵敏度、特异性、阳性和阴性预测值分别为 85.7%、99.2%、85.7%、99.2%。自动检测法识别中间 G6PD 活性水平的灵敏度和阳性预测值分别为 40.0%和 25.0%。进行基因分型以确认 G6PD 缺乏和中间样本。自动检测法对 40 个样本的检测用时为 60 分钟，而分光光度法的检测用时为 300 分钟。
用于检测 G6PD 缺乏症的自动化检测方法与常规分光光度法相当，有助于减少样本处理时间。然而，该检测方法在识别 G6PD 中间型个体方面存在局限性。
