title: [Performance and clinical utility of a high-sensitivity troponin T assay].
abstract: In the present study, we evaluated the performance and clinical utility of a high-sensitivity troponin T (hs-cTnT) assay. The within- and between-assay variations (coefficients of variation: CV) in the low and high concentrations of troponin T in serum samples were 0.84% to 3.34%, respectively. Analysis of interferents showed that only hemoglobin negatively influenced the assay results. Blank assay was < 0.001 ng/mL, and a limit of quantification (10% CV) was found at 0.005 ng/mL. The correlation coefficient (r) between hs-cTnT and the conventional assay was 0.997 (p < 0.000). The high-sensitivity assay system could detect cTnT in 88% of samples in which the conventional assay could not detect any immunoreactivity. The 99th percentile in healthy subjects, determined using 559 samples from medical checkups, was 0.011 ng/mL. There was a gender difference (hs-cTnT levels were higher in men than in women), and hs-cTnT levels increased with age. Because hs-cTnT level exceeded 0.011 ng/mL approximately 2 hours after the onset of chest pain in patients with acute myocardial infarction, hs-cTnT can serve as a biomarker for early detection of myocardial infarction. There was a positive correlation (r = 0.491, p < 0.001) between hs-cTnT and NT-proBNP, and hs-cTnT levels increased with the progression of the disease state, as assessed using New York Heart Association (NYHA) classification. These findings indicate that the hs-cTnT assay is sensitive enough to diagnose early-stage acute myocardial infarction and congestive heart failure.
authors: Department of Clinical Laboratory, Kansai Medical University Hirakata Hospital, Hirakata 573-1191, Japan.
authors: Hiroe
authors: H
authors: Okura
authors: Reiko
authors: R
authors: Suzuki
authors: Sachiyo
authors: S
authors: Sugibayashi
authors: Masamichi
authors: M
authors: Yoshika
authors: Hakuo
authors: H
authors: Takahashi
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008163:Luminescent Measurements / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood* / Q000175:diagnosis*; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010446:Peptide Fragments / Q000097:blood; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D020107:Troponin T / Q000097:blood*; D055815:Young Adult
chemical_list: D015415:Biomarkers; D010446:Peptide Fragments; D020107:Troponin T; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain