Gous Natasha, Scott Lesley, Potgieter Joachim, Ntabeni Lumka, Enslin Sharon, Newman Ronel, Stevens Wendy
Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
Department of Haematology, Tshwane Academic Division and University of Pretoria, Pretoria, South Africa ; National Health Laboratory Service, Johannesburg, South Africa.
PLoS One. 2013 Dec 20;8(12):e85265. doi: 10.1371/journal.pone.0085265. eCollection 2013.
Point of Care testing (POCT) provides on-site, rapid, accessible results. With current South African anti-retroviral treatment guidelines, up to 4 fingersticks /patient/clinic visit could be required if utilizing POC. We determined the feasibility and accuracy of a nurse performing multiple POCT on multiple fingersticks followed by simplification of the process by performance of multiple POC on a single fingerstick.
Random HIV positive adult patients presenting at a HIV treatment clinic in South Africa, for ART initiation/ monitoring, were approached to participate in the study between April-June 2012. Phase I: n=150 patients approached for multiple POCT on multiple fingersticks. Phase II: n=150 patients approached for multiple POCT on a single fingerstick. The following POC tests were performed by a dedicated nurse: PIMA (CD4), HemoCue (hemoglobin), Reflotron (alanine aminotransferase, creatinine). A venepuncture specimen was taken for predicate laboratory methodology. Normal laboratory ranges and Royal College of Pathologists Australasia (RCPA) allowable differences were used as guidelines for comparison. In 67% of participants, ≥3 tests were requested per visit. All POCT were accurate but ranged in variability. Phase I: Hemoglobin was accurate (3.2%CV) while CD4, alanine aminotransferase and creatinine showed increased variability (16.3%CV; 9.3%CV; 12.9%CV respectively). PIMA generated a misclassification of 12.4%. Phase II: Hemoglobin, alanine aminotransferase and creatinine showed good accuracy (3.2%CV, 8.7%CV, 6.4%CV respectively) with increased variability on CD4 (12.4%CV) but low clinical misclassification (4.1%). No trends were observed for the sequence in which POC was performed on a single fingerstick. Overall, PIMA CD4 generated the highest error rate (16-19%).
Multiple POCT for ART initiation and/or monitoring can be performed practically by a dedicated nurse on multiple fingersticks. The process is as accurate as predicate methodology and can be simplified using a single fingerstick.
即时检验(POCT)可提供现场快速且易于获取的结果。根据当前南非的抗逆转录病毒治疗指南,如果采用即时检验,每位患者每次门诊就诊可能需要多达4次指尖采血。我们确定了护士在多个指尖进行多次即时检验的可行性和准确性,随后通过在单个指尖进行多次即时检验来简化该过程。
2012年4月至6月期间,我们邀请了在南非一家艾滋病毒治疗诊所就诊、准备开始抗逆转录病毒治疗(ART)或接受监测的随机选取的成年艾滋病毒阳性患者参与研究。第一阶段:150名患者接受在多个指尖进行多次即时检验。第二阶段:150名患者接受在单个指尖进行多次即时检验。由一名专门的护士进行以下即时检验:PIMA(CD4)、HemoCue(血红蛋白)、Reflotron(丙氨酸转氨酶、肌酐)。采集静脉穿刺样本用于对照实验室方法检测。以正常实验室范围和澳大利亚皇家病理学家学院(RCPA)允许的差异作为比较指南。67%的参与者每次就诊要求进行≥3项检验。所有即时检验结果均准确,但变异性有所不同。第一阶段:血红蛋白结果准确(变异系数为3.2%),而CD4、丙氨酸转氨酶和肌酐的变异性增加(分别为16.3%CV;9.3%CV;12.9%CV)。PIMA产生了高达12.4%的错误分类。第二阶段:血红蛋白、丙氨酸转氨酶和肌酐显示出良好的准确性(分别为3.2%CV、8.7%CV、6.4%CV),CD4的变异性增加(12.4%CV),但临床错误分类较低(4.1%)。在单个指尖进行即时检验的顺序未观察到任何趋势。总体而言,PIMA CD4产生的错误率最高(16 - 19%)。
专门的护士可以实际操作在多个指尖进行多次用于启动抗逆转录病毒治疗和/或监测的即时检验。该过程与对照方法一样准确,并且可以通过在单个指尖进行检验来简化。