Abstract
Biotin >20ng/mL may interfere with the Elecsys® Troponin T-high sensitive assay (cTnT-hs; Roche Diagnostics International Ltd). We evaluated the performance of an updated assay, cTnT-hs*, which was designed to reduce biotin interference. cTnT-hs* assay performance was assessed using up to two applications (18min/9min) on three analyzers (cobas e 411/cobas e 601/cobas e 801). Biotin interference was determined by measuring recovery in an 11-sample series dilution with biotin ranging from 0-3600ng/mL. Repeatability/reproducibility were evaluated in five serum sample pools (n=75 each). Method comparisons tested: cTnT-hs* vs. cTnT-hs (18min/cobas e 601); cTnT-hs* assay 18 vs. 9min (cobas e 601); cTnT-hs* (18min) on cobas e 601 vs. cobas e 411 and cobas e 601 vs. cobas e 801. Concordance at the 99th percentile decision limit between cTnT-hs* and cTnT-hs (9min/cobas e 601) was calculated using 300 lithium-heparin plasma samples and a 14ng/L assay cutoff. cTnT-hs* assay (18min/cobas e 601) recovery was≥96% for biotin≤1250ng/mL. Across all applications/analyzers, coefficients of variation for repeatability/reproducibility with the cTnT-hs* assay were <5% in most serum sample pools (mean cardiac troponin T: 8.528-9484ng/L). High correlation (Pearson's r=1.000) was demonstrated for all method comparisons. Concordance at the 99th percentile decision limit was high between the cTnT-hs* and cTnT-hs assays. The updated cTnT-hs* assay may provide greater tolerance to biotin interference, and shows good analytical and clinical agreement/concordance with the previous cTnT-hs assay.
Highlights
Biotin-streptavidin coupling is one of the strongest noncovalent interactions innatureand has beenusedfordecades by manufacturers of in vitro diagnostic devices to immobilize biotinylated proteins [1,2,3]
We evaluated the performance of an update for the Elecsys cTnT-hs assay, referred to here as cTnT-hs*, which was designed to reduce biotin interference
We demonstrated that the updated cTnT-hs* assay provides substantially greater tolerance to biotin interference vs. the previous cTnT-hs assay: recovery with the cTnT-hs* assay was ≥99% for biotin concentrations up to 500 ng/mL and 96% for a biotin concentration of 1250 ng/mL
Summary
Biotin-streptavidin coupling is one of the strongest noncovalent interactions innatureand has beenusedfordecades by manufacturers of in vitro diagnostic devices to immobilize biotinylated proteins [1,2,3]. All immunoassays based on biotin-streptavidin technology are potentially susceptible to interference with biotin in the blood sample. The Elecsys® Troponin T-high sensitive assay (cTnT-hs; Roche Diagnostics International Ltd, Rotkreuz, Switzerland) is a biotin-streptavidin-based immunoassay, which provides a high negative predictive value (NPV) of 99.8% for ruling out a diagnosis of acute myocardial infarction (AMI) at 1 h after presentation using the 0/1 h algorithm [4]. All immunoassays that utilize biotin-streptavidin coupling are potentially susceptible to biotin interference, the impact on test results differs depending on the assay’s mechanism of action [5]. In non-competitive (or sandwich) immunoassays, such as the cTnT-hs assay, the target analyte is ‘sandwiched’ between the signal and biotinylated antibodies, of which the latter links the antibodyanalyte complex to a streptavidin-coated solid phase; the signal increases as the target analyte concentration increases.
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