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Evaluation of a point-of-care assay for cardiac markers for patients suspected of acute myocardial infarction.
Clin Chim Acta. 2004 Aug 16; 346(2):211-9.CC

Abstract

BACKGROUND

Creatine kinase MB (CK-MB), and cardiac troponin I (cTnI) are important biomarkers for the diagnosis and rule-out of acute myocardial infarction (AMI) of patients who presented to the emergency department (ED) with chest pain. With new rapid ED assessment protocols, there is increasing pressure to produce results with a short turnaround time (TAT), and point-of-care (POC) testing is one alternative for providing fast results.

METHODS

In a multicenter study, we evaluated the analytical precision, sensitivity and specificity of the RAMP (Response Biomedical) CK-MB and cTnI POC assays and compared results against the Triage (Biosite) POC and the Dimension RxL (Dade Behring) central-laboratory assays on 365 subjects, including 185 patients suspected of AMI, and determined the normal range on 180 healthy individuals. At one site, the clinical sensitivity and specificity were estimated in 121 patients and healthy subjects with AMI using the European Society of Cardiology (ESC)/American College of Cardiology (ACC) definition of AMI. Results from healthy individuals and those with ST elevation and non-ST elevation AMI were included in a receiver operating characteristic (ROC) curve analysis.

RESULTS

Intra- and total imprecision ranged from 7.2% to 11.4% for cTnI at 0.22, 1 and 5 ng/ml and 4.8% to 8.6% for CK-MB at 7, 14 and 25 ng/ml. The upper limit of linearity was 32 ng/ml with an average recovery of 105% for cTnI and 80 ng/ml with a 106% recovery for CK-MB. The lower limit of detection was 0.03 ng/ml (10% coefficient of variance [CV] = 0.21 ng/ml) for cTnI and 0.32 ng/ml for CK-MB. The upper reference limit (normal range) was < 0.03 ng/ml for cTnI and 0-3.7 ng/ml for CK-MB. Analytical correlation against Dimension RxL were RAMP=(0.456 x RxL) + 0.11 (r = 0.988, n = 364) for cTnI and RAMP=(0.966 x RxL) + 0.60 (r = 0.986, n = 363) for CK-MB and against Triage, RAMP=(0.626 x Triage) + 0.164 (r = 0.969, n = 364) for cTnI and RAMP=(0.845 x RxL) - 0.495 (r = 0.952, n = 363) for CK-MB. On 39 AMI and 67 non-AMI patients, the clinical sensitivity, specificity and diagnostic efficiency of the cTnI and CK-MB RAMP assays were not significantly different from predicate assays.

CONCLUSIONS

The RAMP cardiac marker assays are alternatives to other FDA-cleared central laboratory and POC testing devices.

Authors+Show Affiliations

Department of Pathology and Laboratory Medicine, Hartford Hospital, 80 Seymour St., Hartford, CT 06102, USA. awu@harthosp.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

15256323

Citation

Wu, Alan H B., et al. "Evaluation of a Point-of-care Assay for Cardiac Markers for Patients Suspected of Acute Myocardial Infarction." Clinica Chimica Acta; International Journal of Clinical Chemistry, vol. 346, no. 2, 2004, pp. 211-9.
Wu AH, Smith A, Christenson RH, et al. Evaluation of a point-of-care assay for cardiac markers for patients suspected of acute myocardial infarction. Clin Chim Acta. 2004;346(2):211-9.
Wu, A. H., Smith, A., Christenson, R. H., Murakami, M. M., & Apple, F. S. (2004). Evaluation of a point-of-care assay for cardiac markers for patients suspected of acute myocardial infarction. Clinica Chimica Acta; International Journal of Clinical Chemistry, 346(2), 211-9.
Wu AH, et al. Evaluation of a Point-of-care Assay for Cardiac Markers for Patients Suspected of Acute Myocardial Infarction. Clin Chim Acta. 2004 Aug 16;346(2):211-9. PubMed PMID: 15256323.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of a point-of-care assay for cardiac markers for patients suspected of acute myocardial infarction. AU - Wu,Alan H B, AU - Smith,Andrew, AU - Christenson,Robert H, AU - Murakami,MaryAnn M, AU - Apple,Fred S, PY - 2004/02/09/received PY - 2004/03/20/revised PY - 2004/03/26/accepted PY - 2004/7/17/pubmed PY - 2005/8/13/medline PY - 2004/7/17/entrez SP - 211 EP - 9 JF - Clinica chimica acta; international journal of clinical chemistry JO - Clin Chim Acta VL - 346 IS - 2 N2 - BACKGROUND: Creatine kinase MB (CK-MB), and cardiac troponin I (cTnI) are important biomarkers for the diagnosis and rule-out of acute myocardial infarction (AMI) of patients who presented to the emergency department (ED) with chest pain. With new rapid ED assessment protocols, there is increasing pressure to produce results with a short turnaround time (TAT), and point-of-care (POC) testing is one alternative for providing fast results. METHODS: In a multicenter study, we evaluated the analytical precision, sensitivity and specificity of the RAMP (Response Biomedical) CK-MB and cTnI POC assays and compared results against the Triage (Biosite) POC and the Dimension RxL (Dade Behring) central-laboratory assays on 365 subjects, including 185 patients suspected of AMI, and determined the normal range on 180 healthy individuals. At one site, the clinical sensitivity and specificity were estimated in 121 patients and healthy subjects with AMI using the European Society of Cardiology (ESC)/American College of Cardiology (ACC) definition of AMI. Results from healthy individuals and those with ST elevation and non-ST elevation AMI were included in a receiver operating characteristic (ROC) curve analysis. RESULTS: Intra- and total imprecision ranged from 7.2% to 11.4% for cTnI at 0.22, 1 and 5 ng/ml and 4.8% to 8.6% for CK-MB at 7, 14 and 25 ng/ml. The upper limit of linearity was 32 ng/ml with an average recovery of 105% for cTnI and 80 ng/ml with a 106% recovery for CK-MB. The lower limit of detection was 0.03 ng/ml (10% coefficient of variance [CV] = 0.21 ng/ml) for cTnI and 0.32 ng/ml for CK-MB. The upper reference limit (normal range) was < 0.03 ng/ml for cTnI and 0-3.7 ng/ml for CK-MB. Analytical correlation against Dimension RxL were RAMP=(0.456 x RxL) + 0.11 (r = 0.988, n = 364) for cTnI and RAMP=(0.966 x RxL) + 0.60 (r = 0.986, n = 363) for CK-MB and against Triage, RAMP=(0.626 x Triage) + 0.164 (r = 0.969, n = 364) for cTnI and RAMP=(0.845 x RxL) - 0.495 (r = 0.952, n = 363) for CK-MB. On 39 AMI and 67 non-AMI patients, the clinical sensitivity, specificity and diagnostic efficiency of the cTnI and CK-MB RAMP assays were not significantly different from predicate assays. CONCLUSIONS: The RAMP cardiac marker assays are alternatives to other FDA-cleared central laboratory and POC testing devices. SN - 0009-8981 UR - https://www.unboundmedicine.com/medline/citation/15256323/Evaluation_of_a_point_of_care_assay_for_cardiac_markers_for_patients_suspected_of_acute_myocardial_infarction_ DB - PRIME DP - Unbound Medicine ER -