Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Department of Life Science, Imperial College London, London, UK.
Malar J. 2018 Jun 22;17(1):243. doi: 10.1186/s12936-018-2390-6.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most common enzymopathy worldwide. Primaquine is the only licensed drug that effectively removes Plasmodium vivax hypnozoites from the human host and prevents relapse. While well tolerated by most recipients, primaquine can cause haemolysis in G6PD deficient individuals and is, therefore, underused. Rapid diagnostic tests (RDTs) could permit ascertainment of G6PD status outside of laboratory settings and hence safe treatment in remote areas. The performance of the fluorescent spot test (Trinity, Ireland; FST) and a G6PD RDT (Carestart, USA) against spectrophotometry were assessed.
Participants were enrolled during cross-sectional surveys in Laos and by purposive sampling in Cambodia. FST and RDT were performed during village surveys and 3 mL of venous blood was collected for subsequent G6PD measurement by spectrophotometry.
A total of 757 participants were enrolled in Laos and 505 in Cambodia. FST and RDT performed best at 30% cut-off activity and performed significantly better in Laos than in Cambodia. When defining intermediate results as G6PD deficient, the FST had a sensitivity of 100% (95%CI 90-100) and specificity of 90% (95%CI 87.7-92.2) in Laos and sensitivity of 98% (94.1-99.6) and specificity of 71% (95%CI 66-76) in Cambodia (p < 0.001). The RDT had sensitivity and specificity of 100% (95%CI 90-100) and 99% (95%CI 97-99) in Laos and sensitivity and specificity of 91% (86-96) and 93% (90-95) in Cambodia (p < 0.001). The RDT performed significantly better (all p < 0.05) than the FST when intermediate FST results were defined as G6PD deficient.
The interpretation of RDT results requires some training but is a good alternative to the FST. Trial registration clinicaltrials.gov; NCT01872702; 06/27/2013; https://clinicaltrials.gov/ct2/show/NCT01872702.
葡萄糖-6-磷酸脱氢酶(G6PD)缺乏症是全世界最常见的酶病。伯氨喹啉是唯一一种有效清除人体疟原虫休眠子并预防复发的已许可药物。尽管大多数接受者都能很好地耐受伯氨喹啉,但它会导致 G6PD 缺乏症个体发生溶血,因此使用不足。快速诊断检测(RDT)可以在实验室环境之外确定 G6PD 状态,从而在偏远地区进行安全治疗。评估了荧光斑点检测(爱尔兰三一;FST)和 G6PD RDT(美国 Carestart)与分光光度法的性能。
参与者是在老挝的横断面调查中和在柬埔寨的有针对性抽样中招募的。在村庄调查期间进行 FST 和 RDT 检测,并采集 3 毫升静脉血,随后通过分光光度法检测 G6PD。
共有 757 名参与者在老挝和 505 名参与者在柬埔寨入组。在 30%的活性截断值下,FST 和 RDT 表现最佳,在老挝的表现明显优于柬埔寨。当将中间结果定义为 G6PD 缺乏症时,FST 在老挝的灵敏度为 100%(95%CI 90-100),特异性为 90%(95%CI 87.7-92.2),在柬埔寨的灵敏度为 98%(94.1-99.6),特异性为 71%(95%CI 66-76)(p<0.001)。RDT 在老挝的灵敏度和特异性分别为 100%(95%CI 90-100)和 99%(95%CI 97-99),在柬埔寨的灵敏度和特异性分别为 91%(86-96)和 93%(90-95)(p<0.001)。当将中间 FST 结果定义为 G6PD 缺乏症时,RDT 的性能明显优于 FST(均 p<0.05)。
RDT 结果的解释需要一些培训,但它是 FST 的良好替代品。
clinicaltrials.gov;NCT01872702;06/27/2013;https://clinicaltrials.gov/ct2/show/NCT01872702。