Integration between point-of-care cardiac markers in an emergency/cardiology department and the central laboratory: methodological and preliminary clinical evaluation

References

1 Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined – a Consensus Document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction. J Am Coll Cardiol 2000; 36: 959–69. Eur Heart J 2000;21:1502–13. Search in Google Scholar

2 Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, et al. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non–ST-segment elevation myocardial infarction: executive summary and recommendations. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients with Unstable Angina). Circulation 2000; 102: 1193–209. 10.1161/01.CIR.102.10.1193Search in Google Scholar

3 Panteghini M, Apple FS, Christenson RH, Dati F, Mair J, Wu AH. IFCC Scientific Division, Committee on Standardization of Markers of Cardiac Damage. Use of biochemical markers in acute coronary syndromes. Clin Chem Lab Med 1999; 37: 687–93. 10.1515/CCLM.1999.107Search in Google Scholar

4 Wu AH, Apple FS, Gibler WB, Jesse RL, Warshaw MM, Valdes RJ. National Academy of Clinical Biochemistry standards of laboratory practice: recommendations for the use of cardiac markers in coronary artery diseases. Clin Chem 1999; 45: 1104–21. 10.1093/clinchem/45.7.1104Search in Google Scholar

5 Di Serio F, Antonelli G, Trerotoli P, Tampoia M, Matarrese M, Pansini N. Appropriateness of point-of-care testing (POCT) in an emergency department. Clin Chim Acta 2003; 333: 185–9. 10.1016/S0009-8981(03)00184-0Search in Google Scholar

6 Public Health Service Act. S353, 42 USC S263a, 1988. Search in Google Scholar

7 US Department of Health and Human Services. Medicare, Medicaid and CLIA programs: regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Final rule. Fed Reg 1993; 58:5215–37. Search in Google Scholar

8 National Committee for Clinical Laboratory Standards. Point-of-care in vitro diagnostic (IVD) testing; approved guideline. NCCLS guideline AST2-A. Wayne, PA: NCCLS, June 1999. Search in Google Scholar

9 Hudson MP, Christenson RH, Newby LH, Kaplan AL, Ohman EG. Cardiac markers: point of care testing. Clin Chim Acta 1999; 284: 223–37. 10.1016/S0009-8981(99)00083-2Search in Google Scholar

10 Panteghini M, Gerhardt W, Apple FS, Dati F, Ravkilde J, Wu AH. International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). IFCC Scientific Division Committee on Standardization of Markers of Cardiac Damage. Quality specifications for cardiac troponin assays. Clin Chem Lab Med 2001; 39: 174–8. 10.1515/cclm.2001.39.2.175Search in Google Scholar PubMed

11 Panteghini M. The measurement of cardiac markers. Where should we focus? Am J Clin Pathol 2002; 118: 354–61. 10.1309/RNTM-05T3-TWBX-V0NUSearch in Google Scholar PubMed

12 Wu AHB. Point-of-care testing for cardiac markers. Point Care 2002; 1: 39–41. 10.1097/00134384-200203000-00010Search in Google Scholar

13 Singh P, Moll F, Lin SH, Ferzli C, Yu KS, Koski RK, et al. Starburst™ dendrimers: enhanced performance and flexibility for immunoassays. Clin Chem 1994; 40: 1845–9. 10.1093/clinchem/40.9.1845Search in Google Scholar

14 Heeschen C, Goldmann BU, Langenbrink L, Matschuck G, Hamm CW. Evaluation of a rapid whole blood ELISA for quantification of troponin I in patients with acute chest pain. Clin Chem 1999; 45: 1789–96. 10.1093/clinchem/45.10.1789Search in Google Scholar

15 Altinier S, Mion M, Cappelletti A, Zaninotto M, Plebani M. Rapid measurement of cardiac markers on Stratus CS. Clin Chem 2000; 46: 991–3. 10.1093/clinchem/46.7.991Search in Google Scholar

16 Kim WJ, Laterza OF, Hock KG, Pierson-Perry JF, Kaminski DM, Mesguich M, et al. Performance of a revised cardiac troponin method that minimizes interferences from heterophilic antibodies. Clin Chem 2002; 48: 1028–34. 10.1093/clinchem/48.7.1028Search in Google Scholar

17 Bodor GS, Porter S, Landt Y, Landenson JH. Development of monoclonal antibodies for an assay of cardiac troponin-I and preliminary results in suspected cases of myocardial infarction. Clin Chem 1992; 38: 2201–14. 10.1093/clinchem/38.11.2203Search in Google Scholar

18 National Committee for Clinical Laboratory Standards. Evaluation of precision performance of clinical chemistry devices; approved guideline. NCCLS guideline EP5-A. Wayne, PA: NCCLS, February 1999. Search in Google Scholar

19 Geiger DU, Wu AHB, Apple FS, Jevans AW, Venge P, Olson MD et al. Multicenter evaluation of an automated assay for troponin I. Clin Chem 2002; 48: 869–76. 10.1093/clinchem/48.6.869Search in Google Scholar

20 National Committee for Clinical Laboratory Standards. Evaluation of the linearity of quantitative measurement procedures: a statistical approach; proposed guideline. NCCLS guideline EP6-A. Wayne, PA: NCCLS, September 1986. Search in Google Scholar

21 National Committee for Clinical Laboratory Standards. Method comparison and bias estimation using patient samples; approved guideline. NCCLS guideline EP9–A. Wayne, PA: NCCLS, December 1995. Search in Google Scholar

22 Kost GJ. Connectivity, the millennium challenge for point-of-care testing. Arch Pathol Lab Med 2000; 124: 1108–10. 10.5858/2000-124-1108-CSearch in Google Scholar

23 Kaminski D, Sivakoff S, McCormack B, Pierson-Perry J. Development and analytical performance of an improved method for cardiac troponin-I on the Dade Behring Dimension clinical chemistry system. Clin Chem 2001; 47(Suppl): A211. Search in Google Scholar

24 Martin RF. General Deming regression procedures for methods comparison studies. Clin Chem 1993; 39: 424–32. 10.1093/clinchem/39.3.424Search in Google Scholar

25 Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; i: 307–10. 10.1016/S0140-6736(86)90837-8Search in Google Scholar

26 Di Serio F, Trerotoli P, Serio G, Varraso L, Pansini N. Analytical evaluation of an automated immunoassay for cardiac troponin I: the Vidas troponin I assay. Clin Chem Lab Med 2003; 41: 1363–8. 10.1515/CCLM.2003.209Search in Google Scholar PubMed

27 Panteghini M, Pagani F, Yeo KJ, Apple FS, Christenson RH, Dati F, et al. Evaluation of imprecision for cardiac troponin assay at low-range concentration. Clin Chem 2004; 50: 327–32. 10.1373/clinchem.2003.026815Search in Google Scholar PubMed

28 Christenson RH, Cervelli DR, Bauer RS, Gordon M. Stratus CS cardiac troponin I method: performance characteristics including imprecision at low concentration. Clin Biochem 2004; 37: 679–83. 10.1016/j.clinbiochem.2004.03.009Search in Google Scholar PubMed

29 Lamb LS. Responsibilities in point-of-care testing: an institutional perspective. Arch Pathol Lab Med 1995; 119: 886–9. Search in Google Scholar

30 Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem 2002; 48: 691–8. 10.1093/clinchem/48.5.691Search in Google Scholar

31 Galvani M, Panteghini M, Ottani F, Cappelletti P, Chiarello F, Crea F, et al. “La nuova definizione di infarto miocardico” analisi del documento di consenso ESC/ACC e riflessioni sulla applicabilità alla realtà sanitaria Italiana. Biochim Clin 2002; 26: 21–40. Search in Google Scholar

32 Lee-Lewandrowski E, Corboy D, Lewandrowski K, Siclair J, McDermot S, Benzer TI. Implementation of a point-of-care satellite laboratory in the emergency department of an academic medical center. impact on test turnaround time and patient emergency department length of stay. Arch Pathol Lab Med 2003; 127: 456–60. 10.5858/2003-127-0456-IOAPSLSearch in Google Scholar PubMed