Two Point-of-Care Cardiac Troponin I Immunoassays Have Acceptable Analytical Performance for the Detection of Measurands of Cardiac Troponin I Cardiac Muscle Homogenates From Southern-Central Black Rhinoceros (Diceros bicornis minor) and Southern White Rhinoceros (Ceratotherium simum simum)

Abstract

Background 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.

Objectives 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.

Methods 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 (TEa) performance goals. Commercial quality control material (QCM) data were used to calculate bias and imprecision for QC validation.

Results 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 13s 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.

Conclusions Both cTnI POCAs are suitable for use in African rhinoceros, and analytical performance goals for low cTnI concentrations in hs-cTnI assays were met.