Rautenbach Yolandi, Meyer Leith C R, Goddard Amelia, Buss Peter E, Hooijberg Emma H
Department of Companion Animal Clinical Studies, Faculty of Veterinary Science, University of Pretoria, Pretoria, Onderstepoort, South Africa.
Centre for Veterinary Wildlife Research, Faculty of Veterinary Science, University of Pretoria, Pretoria, Onderstepoort, South Africa.
Vet Clin Pathol. 2025 Jun;54(2):142-153. doi: 10.1111/vcp.70016. Epub 2025 Jun 4.
Skeletal and possible cardiac muscle damage has been reported in chemically immobilized and transported African rhinoceros during conservation-related activities. The extent of cardiac muscle injury in these rhinoceros is unknown due to a lack of validated cardiac troponin I (cTnI) assays. However, recently, five human cTnI assays were deemed suitable for analytical validation in African rhinoceros based on cTnI sequencing results.
The first objective was to validate two cTnI immunoassay point-of-care analyzers (POCAs) in African rhinoceros and, secondly, to perform quality control (QC) validation for the POCAs.
Analytical validation of the Stratus CS Acute Care Troponin I cTnI immunoassay and Atellica VTLi high sensitivity cTnI (hs-cTnI) assay was performed using rhinoceros serum samples and species-specific cardiac muscle homogenate. Experiments included precision studies, reportable range, hemoglobin interference studies, recovery studies, and detection limit studies, with results assessed against prescribed total allowable error (TE) performance goals. Commercial quality control material (QCM) data were used to calculate bias and imprecision for QC validation.
Imprecision was acceptable (1.9%-10.3%) and met low cTnI concentration performance goals. Reportable ranges were similar to the manufacturer's specifications. High hemoglobin concentrations in white rhinoceros resulted in a positive bias in the Stratus CS. A simple 1 QC rule using two levels of QCM and a TEa of 70% could be used in both analyzers, except at very low cTnI concentrations in the Atellica VTLi.
Both cTnI POCAs are suitable for use in African rhinoceros, and analytical performance goals for low cTnI concentrations in hs-cTnI assays were met.
在与保护相关的活动中,化学固定和运输的非洲犀牛出现了骨骼及可能的心肌损伤。由于缺乏经过验证的心肌肌钙蛋白I(cTnI)检测方法,这些犀牛的心肌损伤程度尚不清楚。然而,最近基于cTnI测序结果,五种人类cTnI检测方法被认为适用于非洲犀牛的分析验证。
第一个目标是在非洲犀牛中验证两种cTnI免疫分析即时检验分析仪(POCA),第二个目标是对POCA进行质量控制(QC)验证。
使用犀牛血清样本和物种特异性心肌匀浆对Stratus CS急性护理肌钙蛋白I cTnI免疫分析和Atellica VTLi高灵敏度cTnI(hs-cTnI)分析进行分析验证。实验包括精密度研究、可报告范围、血红蛋白干扰研究、回收率研究和检测限研究,结果根据规定的总允许误差(TE)性能目标进行评估。使用商业质量控制材料(QCM)数据计算偏差和不精密度以进行QC验证。
不精密度可接受(1.9%-10.3%),符合低cTnI浓度性能目标。可报告范围与制造商的规格相似。白犀牛中高血红蛋白浓度导致Stratus CS出现正偏差。除了Atellica VTLi中cTnI浓度非常低的情况外,两种分析仪均可使用包含两个水平QCM和70% TEa的简单1 QC规则。
两种cTnI POCA均适用于非洲犀牛,并且满足了hs-cTnI分析中低cTnI浓度的分析性能目标。