Evaluation of a newly developed chemiluminescence immunoassay for detecting cardiac troponin T

Abstract

BackgroundTo evaluate the performance of a chemiluminescence detection kit for cardiac troponin T (cTnT).MethodsAccording to the “Guiding principles on performance analysis of diagnostic reagents in vitro” and the Clinical and Laboratory Standards Institute (CLSI) Guidelines, we assessed the detection limit, linear range, reportable range, accuracy, precision, cross reactivity, interference factors, and matrix effect of the kit, and compared these parameters with that of the commercial electrochemiluminescence detection kit for cTnT (Roche).ResultsThe minimum detection limit of the kit was 0.01 ng/mL. The linear range was 0.01 ng/mL‐25 ng/mL. The reportable range was from 0.01 ng/mL to 100 ng/mL. Precision within the batch was 2.9%‐6.4%, and precision between batches was 6.0%; the accuracy was good and the recovery rate reached 96.2%. The cross‐reaction test demonstrated that there was no reactivity between cTnT and a variety of troponins. Test results deviated by less than ±10% in the presence of hemoglobin ≤1000 μg/mL, bilirubin ≤250 μg/mL, triglycerides ≤11.25 mg/mL, and rheumatoid factor ≤206 U/mL, suggesting that kit results were not significantly interfered with these factors. Results from the matrix‐effect assessment revealed absence of a matrix effect in the tested serum samples. Correlation study revealed that the performance of the kit was very consistent with that of the Roche electrochemiluminescence detection kit (Kappa = 0.900, P < .001) with a high correlation (r = .903, P < .001) and a total matching rate of 95.00%.ConclusionThe performance of the evaluated chemiluminescence immunoquantitation kit for cTnT detection was acceptable in all tested parameters, fulfilling requirements for clinical applications.

Gold Nanoparticle-Based Platforms for Diagnosis and Treatment of Myocardial Infarction

“…The chemiluminescent mechanism can be defined based on the interaction between free radicals produced by reactants and AuNPs, resulting in the generation of emissive intermediate Au complexes. These properties of AuNPs are of great interest in developing new biosensing systems for the detection of biomarkers such as cardiac ones. − Shen et al used N-(aminobutyl)-N-(ethylisoluminol)-modified (ABEI)-AuNPs as a luminescence probe conjugated with secondary Abs. Another type of AuNPs coated with streptavidin (SA-AuNPs) was modified on the electrode for interaction with biotinylated Abs and increasing the electrical signal.…”

“…Among the markers mentioned, Tn is more important due to an elevated level in bloodstream following MI. − Currently, Tn is used as a potential biomarker for MI detection . So far, recognition of cardiac disease biomarkers (CDB) has been done by several methods such as surface plasmon resonance (SPR), , capacitive detection, , immunochromatography, − transistor arrays, − electrochemical biosensors, − chemiluminescence, − and immunoassay. , Recently, sensing of biomarkers employing biosensors (mainly nanobiosensors) has been considered. , Nanomaterial provides several potential characteristics over classical agents, including easy functionalization and profound activity in harsh conditions, fast and low-cost synthesis, and significant flexibility. , Different nanobiosensors have been explored for the recognition of biomarkers in different diseases as tabulated in Table .…”

Development of the Troponin Detection System Based on the Nanostructure

“…Moreover, several EC biosensors were devised to detect a TN with nanostructures including gold nanoparticles, gold nanodumbbells, ZnO nanostructures, and a CNT-based screen-printed electrode [40,41,42,43]. A clinical test was performed on human serum samples, and the results were compared with those of an electrochemiluminescence method [44]. Thus, a nanostructure can provide various platforms for fabricating an EC TN biosensor effectively.…”

Emission Onset Time-Adjustable Chemiluminescent Gold Nanoparticles with Ultrastrong Emission for Smartphone-Based Immunoassay of Severe Acute Respiratory Syndrome Coronavirus 2 Antigen

“…With the advantages of high sensitivity, wide linear range, and simple instrumentation, chemiluminescence (CL) has been widely used in the field of clinical diagnosis, , food safety assessment, , environmental monitoring, , and drug analysis. , At present, CL assay has become the mainstream technology for in vitro diagnosis . However, most of the CL systems are flash-type, with light emission appearing immediately upon the addition of coreactant and generally lasting only a few seconds.…”