Abstract
Background: Abbott Diagnostics have developed a new highly sensitive troponin I (hs-TnI) assay. We have assessed its analytical characteristics and applied the assay to a population of apparently cardio-healthy persons.
Methods: We assessed imprecision, bias compared to the previous generation assay, matrix effects, and interferences and applied the assay to an apparently healthy population, deriving the 99th percentile limit of the distribution of values in reference populations for men and women separately.
Results: The dynamic range of the assay was ranged from 0.5–50,000 ng/L (pg/mL). The 10% CV was at a concentration of 3.9 ng/L, and the 20% CV was at a concentration of 1.8 ng/L. The new and current version of the TnI assay were highly correlated [slope: 0.98 (95%CI:0.88–1.07), y-intercept:1.20 (95%CI:-2.35–4.75) r2=0.99]. The 99th percentile limit of the distribution of values in a reference population was different for males and females: for males 14.0 ng/L and for females 11.1 ng/L and at these concentrations the assay CV was 5.0%. TnI was detectable in nearly all patient samples from the healthy reference population (98.6%).
Conclusions: This new hs-TnI assay is able to measure to an order of magnitude lower than the current generation TnI assay from the same manufacturer. With TnI being detectable in nearly all apparently healthy subject samples this suggests that TnI presence does not always indicate cardiomyocyte necrosis.
©2012 by Walter de Gruyter Berlin Boston
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- Masthead
- Masthead
- Editorials
- Reference values and the journal: why the past is now present
- Other-than-annual variations in morning determinations of uric acid
- Reviews
- Blood biochemical markers of bone turnover: pre-analytical and technical aspects of sample collection and handling
- A comprehensive review of upper reference limits reported for (high-)sensitivity cardiac troponin assays: the challenges that lie ahead
- Mini Review
- Reference change values
- Opinion Papers
- Obtaining reference intervals traceable to reference measurement systems: is it possible, who is responsible, what is the strategy?
- Analytical performance, reference values and decision limits. A need to differentiate between reference intervals and decision limits and to define analytical quality specifications
- A pragmatic proposal for permissible limits in external quality assessment schemes with a compromise between biological variation and the state of the art
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- Age dependence of within-subject biological variation of nine common clinical chemistry analytes
- Population-based pediatric reference intervals for general clinical chemistry analytes on the Abbott Architect ci8200 instrument
- Uric acid biorhythm, a feature of long-term variation in a clinical laboratory database
- Age-related changes in serum amino acids concentrations in healthy individuals
- Characterisation of a highly sensitive troponin I assay and its application to a cardio-healthy population
- Are the currently used reference intervals for creatine kinase (CK) reflecting the general population? The Tromsø Study
- Age-specific thyroid hormone and thyrotropin reference intervals for a pediatric and adolescent population
- Serum thyroglobulin reference values according to NACB criteria in healthy subjects with normal thyroid ultrasound
- Thyroid volume influences serum calcitonin levels in a thyroid-healthy population: results of a 3-assay, 519 subjects study
- Impact of the reference values on the clinically-relevant cut-offs. The example of cortisol testing in children
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- The concentration of adiponectin in breast milk is related to maternal hormonal and inflammatory status during 6 months of lactation
- Age- and sex-specific reference limits for creatinine, cystatin C and the estimated glomerular filtration rate
- Determination of the biological variation of S100β and lactate dehydrogenase in disease-free patients with malignant melanoma
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- Letters to the Editor
- Disadvantages of using biological variation data for reference change values
- Reference change values may need some improvement but are invaluable tools in laboratory medicine
- Insulin-like growth factor 1 reference intervals for a chemiluminescent enzyme immunometric assay (Immulite 2000®) in an adult Mediterranean population
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- Congress Abstracts
- Swiss MedLab 2012 Congress of the Swiss Union of Laboratory Medicine (SULM)
Articles in the same Issue
- Masthead
- Masthead
- Editorials
- Reference values and the journal: why the past is now present
- Other-than-annual variations in morning determinations of uric acid
- Reviews
- Blood biochemical markers of bone turnover: pre-analytical and technical aspects of sample collection and handling
- A comprehensive review of upper reference limits reported for (high-)sensitivity cardiac troponin assays: the challenges that lie ahead
- Mini Review
- Reference change values
- Opinion Papers
- Obtaining reference intervals traceable to reference measurement systems: is it possible, who is responsible, what is the strategy?
- Analytical performance, reference values and decision limits. A need to differentiate between reference intervals and decision limits and to define analytical quality specifications
- A pragmatic proposal for permissible limits in external quality assessment schemes with a compromise between biological variation and the state of the art
- Original Articles
- Age dependence of within-subject biological variation of nine common clinical chemistry analytes
- Population-based pediatric reference intervals for general clinical chemistry analytes on the Abbott Architect ci8200 instrument
- Uric acid biorhythm, a feature of long-term variation in a clinical laboratory database
- Age-related changes in serum amino acids concentrations in healthy individuals
- Characterisation of a highly sensitive troponin I assay and its application to a cardio-healthy population
- Are the currently used reference intervals for creatine kinase (CK) reflecting the general population? The Tromsø Study
- Age-specific thyroid hormone and thyrotropin reference intervals for a pediatric and adolescent population
- Serum thyroglobulin reference values according to NACB criteria in healthy subjects with normal thyroid ultrasound
- Thyroid volume influences serum calcitonin levels in a thyroid-healthy population: results of a 3-assay, 519 subjects study
- Impact of the reference values on the clinically-relevant cut-offs. The example of cortisol testing in children
- Trimester-specific reference intervals for haemoglobin A1c (HbA1c) in pregnancy
- The concentration of adiponectin in breast milk is related to maternal hormonal and inflammatory status during 6 months of lactation
- Age- and sex-specific reference limits for creatinine, cystatin C and the estimated glomerular filtration rate
- Determination of the biological variation of S100β and lactate dehydrogenase in disease-free patients with malignant melanoma
- Reference intervals and biological variation for kallikrein 6: influence of age and renal failure
- Faecal haemoglobin concentrations by gender and age: implications for population-based screening for colorectal cancer
- Reference intervals of extended erythrocyte and reticulocyte parameters
- Haematological and iron metabolism parameters in professional cyclists during the Giro d’Italia 3-weeks stage race
- Reference change values for lens culinaris agglutinin-reactive α-fetoprotein and des-γ-carboxy prothrombin in patients with chronic hepatitis C
- Letters to the Editor
- Disadvantages of using biological variation data for reference change values
- Reference change values may need some improvement but are invaluable tools in laboratory medicine
- Insulin-like growth factor 1 reference intervals for a chemiluminescent enzyme immunometric assay (Immulite 2000®) in an adult Mediterranean population
- Reference values for new red blood cell and platelet parameters on the Abbott Diagnostics Cell-Dyn Sapphire
- Congress Abstracts
- Swiss MedLab 2012 Congress of the Swiss Union of Laboratory Medicine (SULM)