6533b82cfe1ef96bd128ffc8
RESEARCH PRODUCT
Head-to-head comparison of plasma cTnI concentration values measured with three high-sensitivity methods in a large Italian population of healthy volunteers and patients admitted to emergency department with acute coronary syndrome: A multi-center study
Cinzia CarrozzaMario PlebaniSara RizzardiRuggero DittadiMartina ZaninottoRosalia AloeAldo ClericoTommaso FasanoCristina GuiottoMarco Alfonso PerroneSilvia MasottiMarco MigliardiDaniela RiggioConcetta PronteraAntonio De SantisMarcello CiaccioVeronica MusettiSergio BernardiniAndrea Ripolisubject
Male0301 basic medicineprincipal component analysisvery elderlyClinical BiochemistryheparinizationBiochemistryPatient Admission0302 clinical medicineReference ValuesLimit of Detectionblood analysisTroponin IHealthy volunteers80 and overMyocardial infarctionAcute coronary syndrome; Cardiac troponins; High-sensitivity methods; Myocardial infarction; Reference population values; Acute Coronary Syndrome; Adolescent; Adult; Aged; Aged 80 and over; Blood Chemical Analysis; Female; Humans; Italy; Male; Middle Aged; Myocardium; Patient Admission; Reference Values; Troponin I; Young Adult; Emergency Service Hospital; Healthy Volunteers; Limit of DetectionReference population valuescomparative studyHigh-sensitivity methodsAged 80 and overemergency wardEmergency Servicehospital emergency servicetroponin I acute coronary syndromeSettore BIO/12clinical trialGeneral Medicinecardiac troponin 1 CLIAMiddle AgedHealthy Volunteerspriority journalItaly030220 oncology & carcinogenesisCardiac troponinFemaleAcute coronary syndromeEmergency Service HospitalAdultmedicine.medical_specialtyAcute coronary syndromecardiac muscleAdolescentHead to headheart infarctionArticleYoung AdultHospital03 medical and health sciencesbloodInternal medicinemedicinesexHumanscontrolled studyADVIA Centaurdiagnostic test accuracy studyhumannormal humanproceduresAgedbusiness.industryMyocardiumTroponin IBiochemistry (medical)reference valueEmergency departmentmedicine.diseasemajor clinical studyhospital admissionyoung adult Acute Coronary SyndromeHigh-sensitivity methodMyocardial infarctionmulticenter study030104 developmental biologySettore BIO/12 - Biochimica Clinica E Biologia Molecolare Clinicaageprotein blood levelReference valuesCardiac troponinsbusinessmetabolismBlood Chemical Analysisdescription
Abstract Background The study aim is to compare cTnI values measured with three high-sensitivity (hs) methods in apparently healthy volunteers and patients admitted to emergency department (ED) with acute coronary syndrome enrolled in a large multicentre study. Methods Heparinized plasma samples were collected from 1511 apparently healthy subjects from 8 Italian clinical institutions (mean age: 51.5 years, SD: 14.1 years, range: 18–65 years, F/M ratio:0.95). All volunteers denied chronic or acute diseases and had normal values of routine laboratory tests. Moreover, 1322 heparinized plasma sample were also collected by 9 Italian clinical institutions from patients admitted to ED with clinical symptoms typical of acute coronary syndrome. The reference study laboratory assayed all plasma samples with three hs-methods: Architect hs-cTnI, Access hs-cTnI and ADVIA Centaur XPT methods. Principal Component Analysis (PCA) was also used to analyze the between-method differences among hs-cTnI assays. Results On average, a between-method difference of 31.2% CV was found among the results of hs-cTnI immunoassays. ADVIA Centaur XPT method measured higher cTnI values than Architect and Access methods. Moreover, 99th percentile URL values depended not only on age and sex of reference population, but also on the statistical approach used for calculation (robust non-parametric vs bootstrap). Conclusions Due to differences in concentrations and reference values, clinicians should be advised that plasma samples of the same patient should be measured for cTnI assay in the same laboratory. Specific clinical studies are needed to establish the most appropriate statistical approach to calculate the 99th percentile URL values for hs-cTnI methods.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2019-01-01 |