Analytical evaluation of the novel Mindray high sensitivity cardiac troponin I immunoassay on CL-1200i
Author:
Lippi Giuseppe1ORCID, Pighi Laura1, Paviati Elisa1, Demonte Davide1, De Nitto Simone1, Gelati Matteo1, Montagnana Martina1, Gandini Giorgio2, Henry Brandon M.3, Salvagno Gian Luca1
Affiliation:
1. Section of Clinical Biochemistry , University Hospital of Verona , Verona , Italy 2. Transfusion Center , University Hospital of Verona , Verona , Italy 3. Clinical Laboratory, Division of Nephrology and Hypertension , Cincinnati Children’s Hospital Medical Center , Cincinnati , OH , USA
Abstract
Abstract
Objectives
The current study was designed to evaluate the analytical performance of the new Mindray highly sensitive cardiac troponin I (hs-cTnI) chemiluminescent immunoassay on Mindray CL-1200i, as a thorough validation of novel hs-cTnI methods is required before introduction into clinical practice.
Methods
The evaluation of the analytical performance of this hs-cTnI immunoassay encompassed the calculation of the limit of blank (LOB), limit of detection (LOD), functional sensitivity, imprecision, linearity, 99th percentile upper reference limit (URL) and concordance with another previously validated hs-cTnI chemiluminescent immunoassay.
Results
The LOB and LOD were 0.32 and 0.35 ng/L, whilst the functional sensitivity (expressed as cTnI value with <10 % imprecision), was 0.35 ng/L. The linearity was excellent throughout a wide range of clinically measurable values (r=1.00 between 0.8 and 9,726.9 ng/mL). The intra-assay, inter-assay and total imprecision were 1.1–1.3 %, 5.5–8.1 % and 5.6–8.2 %, respectively. The 99th percentile URL calculated using residual plasma from 246 ostensibly healthy blood donors was 9.2 ng/L (4.3 ng/L in women vs. 12.3 ng/L in men). The Spearman’s correlation between Mindray hs-cTnI and Access hs-TnI was 0.97, with mean bias of 7.2 % (95 % CI, 2.6–11.9 %).
Conclusions
Although we failed to confirm the very optimistic analytical characteristics previously reported for this method, our evaluation of the novel Mindray hs-cTnI immunoassay on CL-1200i demonstrated that the overall performance is comparable to that of other commercially available hs-cTnI techniques, making it a viable alternative to other methods.
Publisher
Walter de Gruyter GmbH
Subject
Biochemistry (medical),Clinical Biochemistry,General Medicine
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