Espino Fe Esperanza, Bibit Jo-Anne, Sornillo Johanna Beulah, Tan Alvin, von Seidlein Lorenz, Ley Benedikt
Department of Parasitology, Research Institute for Tropical Medicine, Department of Health, Alabang, Muntinlupa City, Philippines.
Department of Epidemiology and Biostatistics, Research Institute for Tropical Medicine, Department of Health, Alabang, Muntinlupa City, Philippines.
PLoS One. 2016 Feb 5;11(2):e0148172. doi: 10.1371/journal.pone.0148172. eCollection 2016.
We evaluated a battery of Glucose-6-Phosphate Dehydrogenase diagnostic point-of-care tests (PoC) to assess the most suitable product in terms of performance and operational characteristics for remote areas.
Samples were collected in Puerto Princesa City, Palawan, Philippines and tested for G6PD deficiency with a fluorescent spot test (FST; Procedure 203, Trinity Biotech, Ireland), the semiquantitative WST8/1-methoxy PMS (WST; Dojindo, Japan) and the Carestart G6PD Rapid Diagnostic Test (CSG; AccessBio, USA). Results were compared to spectrophotometry (Procedure 345, Trinity Biotech, Ireland). Sensitivity and specificity were calculated for each test with cut-off activities of 10%, 20%, 30% and 60% of the adjusted male median.
The adjusted male median was 270.5 IU/10(12) RBC. FST and WST were tested on 621 capillary blood samples, the CSG was tested on venous and capillary blood on 302 samples. At 30% G6PD activity, sensitivity for the FST was between 87.7% (95%CI: 76.8% to 93.9%) and 96.5% (95%CI: 87.9% to 99.5%) depending on definition of intermediate results; the WST was 84.2% (95%CI: 72.1% to 92.5%); and the CSG was between 68.8% (95%CI: 41.3% to 89.0%) and 93.8% (95%CI: 69.8% to 99.8%) when the test was performed on capillary or venous blood respectively. Sensitivity of FST and CSG (tested with venous blood) were comparable (p>0.05). The analysis of venous blood samples by the CSG yielded significantly higher results than FST and CSG performed on capillary blood (p<0.05). Sensitivity of the CSG varied depending on source of blood used (p<0.05).
The operational characteristics of the CSG were superior to all other test formats. Performance and operational characteristics of the CSG performed on venous blood suggest the test to be a good alternative to the FST.
我们评估了一系列葡萄糖-6-磷酸脱氢酶即时诊断检测（PoC），以根据偏远地区的性能和操作特性评估最合适的产品。
在菲律宾巴拉望省公主港市采集样本，并用荧光斑点试验（FST；程序203，Trinity Biotech，爱尔兰）、半定量WST8/1-甲氧基吩嗪硫酸甲酯（WST；同仁化学研究所，日本）和Carestart G6PD快速诊断检测（CSG；AccessBio，美国）检测葡萄糖-6-磷酸脱氢酶缺乏症。将结果与分光光度法（程序345，Trinity Biotech，爱尔兰）进行比较。计算每个检测在调整后男性中位数的10%、20%、30%和60%的临界活性下的敏感性和特异性。
调整后男性中位数为270.5 IU/10¹²红细胞。FST和WST在621份毛细血管血样本上进行检测，CSG在302份样本的静脉血和毛细血管血上进行检测。在30%的葡萄糖-6-磷酸脱氢酶活性下，根据中间结果的定义，FST的敏感性在87.7%（95%CI：76.8%至93.9%）和96.5%（95%CI：87.9%至99.5%）之间；WST为84.2%（95%CI：72.1%至92.5%）；当CSG分别在毛细血管血或静脉血上进行检测时，其敏感性在68.8%（95%CI：41.3%至89.0%）和93.8%（95%CI：69.8%至99.8%）之间。FST和CSG（用静脉血检测）的敏感性相当（p>0.05）。CSG对静脉血样本的分析结果明显高于对毛细血管血进行的FST和CSG检测结果（p<0.05）。CSG的敏感性因所用血液来源而异（p<0.05）。
CSG的操作特性优于所有其他检测形式。CSG在静脉血上的性能和操作特性表明该检测是FST的良好替代方法。
