Masemola Kagiso M, Kone Ngalulawa, Chikomba Chemedzai, Khoza Siyabonga
Department of Chemical Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Department of Chemical Pathology, National Health Laboratory Service, Johannesburg, South Africa.
Afr J Lab Med. 2025 Jul 8;14(1):2663. doi: 10.4102/ajlm.v14i1.2663. eCollection 2025.
Chronic kidney disease is a global health crisis, and delays in laboratory testing worsen outcomes. Point-of-care testing (POCT) has shown utility in various settings, but its performance at high creatinine levels seen in advanced chronic kidney disease is variable.
We evaluated the analytical and clinical performance of the Nova Stat Profile Prime Plus (SPP+) point-of-care analyser among patients on maintenance haemodialysis.
A prospective study was conducted at Chris Hani Baragwanath Hospital, Johannesburg, South Africa. In phase one (01 June 2023 - 31 July 2023), precision, linearity, and accuracy of SPP+ were assessed using remnant patient samples. Blood gases, electrolytes, and metabolic parameters were compared with the GEM Premier 5000, while urea and creatinine were compared with the Roche cobas c702. In phase two (01 November 2023 - 31 December 2023), SPP+ was clinically validated among adults undergoing haemodialysis. Whole blood was collected pre- and post-dialysis to assess dialysis adequacy and the creatinine index.
In phase one, SPP+ showed acceptable precision (coefficients of variation 0% - 2.7%), linearity, and correlation ( > 0.90). Creatinine showed proportional bias (4.56% [0.33 - 8.80]) at higher concentrations. Among 51 haemodialysis patients (22 women, 29 men; aged 32-51 years), SPP+ showed 88.6% agreement for single pool Kt/V and urea reduction ratio. However, creatinine index agreement was low (34.3%, Cohen's kappa = 0.24, < 0.0001).
Nova SPP+ was comparable to central laboratory analysis, though caution is needed at high creatinine levels, where central laboratory analysis remains the preferred choice.
This study provides the first South African data on POCT in haemodialysis. The analyser has demonstrated potential for monitoring, but performance concerns remain at high creatinine levels. The findings offer practical guidance for integrating POCT into advanced chronic kidney disease care in a resource-limited setting.
慢性肾脏病是一场全球健康危机，实验室检测的延迟会使病情恶化。即时检验（POCT）已在多种场景中展现出效用，但其在晚期慢性肾脏病所见的高肌酐水平下的性能存在差异。
我们评估了诺瓦Stat Profile Prime Plus（SPP+）即时检验分析仪在维持性血液透析患者中的分析性能和临床性能。
在南非约翰内斯堡的克里斯·哈尼·巴拉干纳特医院进行了一项前瞻性研究。在第一阶段（2023年6月1日至2023年7月31日），使用患者剩余样本评估SPP+的精密度、线性和准确性。将血气、电解质和代谢参数与GEM Premier 5000进行比较，而尿素和肌酐则与罗氏cobas c702进行比较。在第二阶段（2023年11月1日至2023年12月31日），在接受血液透析的成人中对SPP+进行临床验证。在透析前和透析后采集全血，以评估透析充分性和肌酐指数。
在第一阶段，SPP+显示出可接受的精密度（变异系数0% - 2.7%）、线性和相关性（>0.90）。肌酐在较高浓度时显示出比例偏差（4.56% [0.33 - 8.80]）。在51名血液透析患者（22名女性，29名男性；年龄32 - 51岁）中，SPP+在单池Kt/V和尿素清除率方面的一致性为88.6%。然而，肌酐指数的一致性较低（34.3%，科恩kappa系数 = 0.24，<0.0001）。
诺瓦SPP+与中心实验室分析具有可比性，不过在高肌酐水平时需要谨慎，此时中心实验室分析仍是首选。
本研究提供了南非关于血液透析中即时检验的首批数据。该分析仪已展现出监测潜力，但在高肌酐水平时性能仍存在问题。这些发现为在资源有限的环境中将即时检验整合到晚期慢性肾脏病护理中提供了实用指导。
