南非用于透析的诺瓦Stat Profile Prime Plus即时检验的验证

Validation of Nova Stat Profile Prime Plus point-of-care testing for dialysis in South Africa.

作者信息

Masemola Kagiso M, Kone Ngalulawa, Chikomba Chemedzai, Khoza Siyabonga

机构信息

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.

出版信息

Afr J Lab Med. 2025 Jul 8;14(1):2663. doi: 10.4102/ajlm.v14i1.2663. eCollection 2025.

DOI:10.4102/ajlm.v14i1.2663

PMID:40801005

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12339888/

Abstract

BACKGROUND

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.

OBJECTIVE

We evaluated the analytical and clinical performance of the Nova Stat Profile Prime Plus (SPP+) point-of-care analyser among patients on maintenance haemodialysis.

METHODS

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.

RESULTS

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).

CONCLUSION

Nova SPP+ was comparable to central laboratory analysis, though caution is needed at high creatinine levels, where central laboratory analysis remains the preferred choice.

WHAT THIS STUDY ADDS

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.

摘要

背景

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。

目的

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。

方法

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。

结果

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）。