PATH, Seattle, Washington, United States of America.
Special Haematology Laboratory, Hammersmith Hospital, London, United Kingdom.
PLoS One. 2021 Sep 20;16(9):e0257560. doi: 10.1371/journal.pone.0257560. eCollection 2021.
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.
某些临床适应症和治疗方法，如癌症治疗中使用拉布立酶和治疗间日疟原虫感染的 8-氨基喹啉，将受益于即时检测葡萄糖-6-磷酸脱氢酶（G6PD）缺乏症的检测方法。有三项研究评估了一种此类检测方法的性能：STANDARD™ G6PD 检测（SD BIOSENSOR，韩国）。首先，在包含常见血液疾病的标本中评估了对检测性能的生物学干扰，包括高白细胞计数。其次，评估了在 5 名个体的指血样本中检测的精密度，他们的 G6PD 活性状态分别为缺乏、中间和正常。第三，在美国三个即时检测点评估了检测的临床性能。在含有常见血液疾病的标本中，该检测与参考方法等效。高白细胞计数血样会导致参考方法和 STANDARD G6PD 检测均高估 G6PD 活性。STANDARD G6PD 检测在来自同一个体的多个指血样本上表现出良好的精密度。对于指血和静脉血来源的结果，应用相同的 G6PD 阈值（每克血红蛋白 U/g）进行半定量解释。对于 G6PD 缺乏症的检测，静脉和毛细血管标本的敏感性/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）。对于 G6PD 活性中间值（> 30%至≤70%）的女性，静脉和毛细血管标本的敏感性/特异性值分别为 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）。STANDARD G6PD 检测能够实现即时检测 G6PD 缺乏症。
