BACKGROUND: Since cardiac troponins assay technology should comply with the recommendations of scientific societies (i.e. imprecision (10%) at the 99th percentile value observed in healthy subjects being the analytical qualifying aspect), the aim of the present study was to evaluate whether an improved troponin assay (Vitros Troponin I ES) provides data that meet the "guideline acceptable"criteria recently defined in a proposed scorecard. METHODS: Vitros Troponin I ES, an enhanced chemiluminescence immunoassay, was evaluated in a multicenter study considering: limit of blank (LOB, 60 replicates of 0 calibrators), limit of detection (LOD, 12 measurements for each of 5 serum pools), precision, linearity using control materials and serum plasma pool; matrix samples study matching serum and lithium-heparin plasma (n=107 hospitalized patients); the 99th percentile limit in serum samples from 500 healthy Caucasian donors. RESULTS: LOB and LOD, 0.0029 μg/L and 0.0030 μg/L respectively; coefficients of variation (total CV%), obtained by running 3 levels of control materials and 10 serum pools, from 15.2% (x(-)=0.014 μg/L) to 2.0% (x(-)=5.324 μg/L); method, linear up to 70 μg/L. No significant differences were found between serum and lithium-heparin matched sample (p=0.48) values; 99th percentile limit of cTnI distribution in healthy donors, 0.021 μg/L. CONCLUSION: Since its analytical reliability meets the proposed performance and scorecard requirements, the Vitros TropI method can be considered "contemporary" and "guideline acceptable".
Assay performance improved, but which "scorecard" designation for Vitros Troponin I?
ZANINOTTO, MARTINA;PLEBANI, MARIO
2012
Abstract
BACKGROUND: Since cardiac troponins assay technology should comply with the recommendations of scientific societies (i.e. imprecision (10%) at the 99th percentile value observed in healthy subjects being the analytical qualifying aspect), the aim of the present study was to evaluate whether an improved troponin assay (Vitros Troponin I ES) provides data that meet the "guideline acceptable"criteria recently defined in a proposed scorecard. METHODS: Vitros Troponin I ES, an enhanced chemiluminescence immunoassay, was evaluated in a multicenter study considering: limit of blank (LOB, 60 replicates of 0 calibrators), limit of detection (LOD, 12 measurements for each of 5 serum pools), precision, linearity using control materials and serum plasma pool; matrix samples study matching serum and lithium-heparin plasma (n=107 hospitalized patients); the 99th percentile limit in serum samples from 500 healthy Caucasian donors. RESULTS: LOB and LOD, 0.0029 μg/L and 0.0030 μg/L respectively; coefficients of variation (total CV%), obtained by running 3 levels of control materials and 10 serum pools, from 15.2% (x(-)=0.014 μg/L) to 2.0% (x(-)=5.324 μg/L); method, linear up to 70 μg/L. No significant differences were found between serum and lithium-heparin matched sample (p=0.48) values; 99th percentile limit of cTnI distribution in healthy donors, 0.021 μg/L. CONCLUSION: Since its analytical reliability meets the proposed performance and scorecard requirements, the Vitros TropI method can be considered "contemporary" and "guideline acceptable".
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