Unit of Evidence and Deliberation for Decision Making UNED, Medical Research Institute, School of Medicine, University of Antioquia, Medellin, Colombia.
Centre for Medical Parasitology, Department for Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Malar J. 2024 Nov 2;23(1):327. doi: 10.1186/s12936-024-05144-1.
Glucose-6-Phosphate Dehydrogenase deficiency (G6PDd) is a common genetic enzymopathy that can induce haemolysis triggered by various factors, including some anti-malarial drugs. Although many Point-of-Care (PoC) tests, such as Standard G6PD™ are available to detect G6PDd, its pooled diagnostic test accuracy (DTA) remains unknown.
To estimate the DTA of StandG6PD-BS at various thresholds of G6PDd, a systematic review with a DTA meta-analysis were conducted, searching EMBASE, MEDLINE, and SciELO databases up to April 4, 2024.The included studies were those that measured G6PD activity using StandG6PD-BS (reference test) and spectrophotometry (gold standard) in patients suspected of having G6PDd. The risk of bias (RoB) of the studies was assessed using the QUADAS-2 tool and the certainty of evidence (CoE) with the GRADE approach. For the estimation of within-study DTA, a random-effect bivariate meta-analysis was performed to determine the pooled sensitivity and specificity for 30%, 70%, and 80% enzyme levels' thresholds, and a graphical analysis of the heterogeneity using crosshair and Confidence Regions on receiver operating characteristic (ROC) space plots.
After screening 2496 reports, four studies were included with 7864 participants covering all thresholds. Two studies had high RoB in QUADAS-2 domains 2 and 3, and the others had low RoB, with low, moderate, and high heterogeneity at the 30%, 70%, and 80% thresholds, respectively. The pooled sensitivity was 99.1%, 95.7%, and 90% for 30%, 70%, and 80% thresholds, respectively. The pooled specificity was 97.4%; 92.9%; and 89.0% for 30%, 70%, and 80% thresholds, respectively.
StandG6PD-BS is a PoC test with high sensitivity and specificity to detect G6PDd at different thresholds.
葡萄糖-6-磷酸脱氢酶缺乏症（G6PDd）是一种常见的遗传性酶病，可由多种因素引起溶血，包括一些抗疟药物。虽然有许多即时检测（PoC）试验，如 Standard G6PD™，可用于检测 G6PDd，但它的汇总诊断检测准确性（DTA）仍然未知。
为了估计 StandG6PD-BS 在不同 G6PDd 阈值下的 DTA，我们进行了系统评价和 DTA 荟萃分析，检索了 EMBASE、MEDLINE 和 SciELO 数据库，截至 2024 年 4 月 4 日。纳入的研究是那些使用 StandG6PD-BS（参考测试）和分光光度法（金标准）测量疑似 G6PDd 患者的 G6PD 活性的研究。使用 QUADAS-2 工具评估研究的偏倚风险（RoB），并使用 GRADE 方法评估证据的确定性（CoE）。为了估计研究内的 DTA，我们进行了随机效应双变量荟萃分析，以确定 30%、70%和 80%酶水平阈值的汇总敏感性和特异性，并使用十字准线和置信区间在接收器操作特征（ROC）空间图上进行异质性的图形分析。
经过筛选 2496 份报告，有 4 项研究纳入了 7864 名参与者，涵盖了所有阈值。有两项研究在 QUADAS-2 领域 2 和 3 中有较高的 RoB，其他两项研究的 RoB 较低，在 30%、70%和 80%的阈值下分别具有低、中、高异质性。汇总的敏感性分别为 30%、70%和 80%阈值的 99.1%、95.7%和 90%。汇总的特异性分别为 30%、70%和 80%阈值的 97.4%、92.9%和 89.0%。
StandG6PD-BS 是一种 PoC 检测试验，具有高敏感性和特异性，可在不同阈值下检测 G6PDd。
