Certain clinical indications and treatments such as the use of rasburicase in cancer therapy and 8-aminoquinolines for Plasmodium vivax malaria treatment would benefit from a point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. Three studies were conducted to evaluate the performance of one such test: the STANDARD™ G6PD Test (SD BIOSENSOR, South Korea). First, biological interference on the test performance was evaluated in specimens with common blood disorders, including high white blood cell (WBC) counts. Second, the test precision on fingerstick specimens was evaluated against five individuals of each, deficient, intermediate, and normal G6PD activity status. Third, clinical performance of the test was evaluated at three point-of-care settings in the United States. The test performed equivalently to the reference assay in specimens with common blood disorders. High WBC count blood samples resulted in overestimation of G6PD activity in both the reference assay and the STANDARD G6PD Test. The STANDARD G6PD Test showed good precision on multiple fingerstick specimens from the same individual. The same G6PD threshold values (U/g Hb) were applied for a semiquantitative interpretation for fingerstick- and venous-derived results. The sensitivity/specificity values (95% confidence intervals) for the test for G6PD deficiency were 100 (92.3-100.0)/97 (95.2-98.2) and 100 (95.7-100.0)/97.4 (95.7-98.5) for venous and capillary specimens, respectively. The same values for females with intermediate (> 30% to ≤ 70%) G6PD activity were 94.1 (71.3-99.9)/88.2 (83.9-91.7) and 82.4 (56.6-96.2)/87.6(83.3-91.2) for venous and capillary specimens, respectively. The STANDARD G6PD Test enables point-of-care testing for G6PD deficiency.

中文翻译：

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G6PD 缺乏症的参考和即时检测：血液紊乱干扰、人为样本和指尖穿刺等效性和精确度。

某些临床适应症和治疗方法，例如在癌症治疗中使用拉布立酶和在间日疟原虫疟疾治疗中使用 8-氨基喹啉，将受益于对葡萄糖 6-磷酸脱氢酶 (G6PD) 缺乏症的即时检测。进行了三项研究来评估一项此类测试的性能：STANDARD™ G6PD 测试（SD BIOSENSOR，韩国）。首先，在具有常见血液疾病的样本中评估了对测试性能的生物干扰，包括高白细胞 (WBC) 计数。其次，针对 G6PD 活性不足、中等和正常状态的五个个体评估了手指刺标本的测试精度。第三，在美国的三个护理点环境中评估了测试的临床性能。在患有常见血液疾病的样本中，该测试与参考测定等效。高 WBC 计数血样导致参考测定和标准 G6PD 测试中 G6PD 活性的高估。STANDARD G6PD 测试在来自同一个人的多个指尖样本上显示出良好的精度。相同的 G6PD 阈值 (U/g Hb) 用于对指尖和静脉衍生结果的半定量解释。对于静脉和毛细血管样本，G6PD 缺乏症测试的敏感性/特异性值（95% 置信区间）分别为 100 (92.3-100.0)/97 (95.2-98.2) 和 100 (95.7-100.0)/97.4 (95.7-98.5) ， 分别。具有中等（> 30% 至 ≤ 70%）G6PD 活性的女性的相同值为 94.1 (71.3-99.9)/88.2 (83.9-91.7) 和 82.4 (56.6-96.2)/87.6(83.3-91)。2) 分别用于静脉和毛细血管标本。STANDARD G6PD 测试能够对 G6PD 缺乏症进行即时检测。