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Assessment of diagnostic and prognostic accuracyTABLE 10 Index and reference standard tests used in studies of H-FABPStudy Index test analyser Threshold (µg/l) Reference test assay and timingReference Tn diagnosticthreshold (µg/l)MI prevalence insample (%)Body 2011 57 Alere Fluorescence immunoassay 58 Roche Elecsys TnT at least 12 hours aftersymptom onset0.01 18Cete 2010 58 CardioDetect ® 6.2 TnT; assay not reported; 6 hours 0.1 33Charpentier CardioDetect ® 7 ADVIA Centaur TnI system (Bayer Diagnostics) at2010 59 6 hours0.1 15Di Serio 2005 63 Randox Evidence Investigator 6.4 ESC/ACC, not further specified Not specified 53Ecollan 2007 64 CardioDetect ® 7 Dade Behring TnI over 24 hours 0.07 (99th percentile) 51Garcia-Valdecasas Dainippon Pharmaceutical ELISA 6.2 Dade Dimension TnI; timing not stated 0.6 392011 49Haltern 2010 67 HyCult Biotechnology ELISA 7 Roche Elecsys TnT at 12 hours 0.03 33Hjortshoj 2010 68 HyCult Biotechnology ELISA 6.0 Roche Elecsys TnT at 6–9 hours, and12–24 hours0.03 33Ilva 2009 50 Innotrac Aio! Immunoanalyzer 10.4 Abbott Architect TnI up to 24 hours 0.032 46Lefebvre 2007 72 CardioDetect ® 6.2 Dade Behring RxL TnI or Siemens Centaur TnI 0.14 and 0.33 48Li 2010 73 Wuhan EasyDiagnosis Biomedicine Co 7 TnT; assay not specified; 12 hours 0.1 50Liao 2009 74 CardioDetect ® 7 NR; NR; assumed to be 10–12 hours 0.5 73Mad 2007 75 CardioDetect ® 7 TnT; no details of assay; ACC and ESC guidelines(10–12 hours)0.04 39McCann 2008 76 HyCult Biotechnology ELISA 1.2 Roche Elecsys TnT at 12 hours 0.03 48Mion 2007 77 Evidence ® Cardiac Panel 6.02 Dimension RxL TnI; timing NR (as ESC/ACCguidelines)0.15 32Naroo 2009 78 CardioDetect ® 7 Assay not specified; 6–12 hours after initialsampling1 13Valle 2008 82 CardioDetect ® 7 TnT at 6–12 hours, assay not reported Not stated 35ACC, American College of Cardiology; ESC, European Society of Cardiology; NR, not reported.38NIHR Journals Library
DOI: 10.3310/hta17010 Health Technology Assessment 2013 Vol. 17 No. 1Representative spectrum?Acceptable reference standard?Acceptable delay between tests?Partial verification avoided?Differential verification avoided?Incorporation avoided?Reference standard results blinded?Index test results blinded?Body 2011 57 ++++++–+Cete 2010 58 ++++++??Charpentier 2010 59 ++++++++Di Serio 2005 63 ??+?++??Ecollan 2007 64 ++++++??Garcia-Valdecasas 2011 49 ++?+++++Haltern 2010 67 ++++++??Hjortshoj 2010 68 ++++++??Ilva 2009 50 ++++++??LeFevre 2007 72 ??++++++Li 2010 73 ++++++++Liao 2009 74 +??++?––Mad 2007 75 +??++?++McCann 2008 76 +++++?++Mion 2007 77 –+++?+??Naroo 2009 78 ++++++++Valle 2007 82 +?+++++?FIGURE 14 Quality assessment of diagnostic studies of H-FABP.test characteristics. Reporting of exclusion criteria was variable and some studies excluded patients withdiagnostic ECG changes. The prevalence of MI was generally high and varied from 18% to 73%. Themedian time from symptom onset to sampling varied from 2.2 to 7.8 hours. There was no consistencyin the diagnostic threshold used. It ranged from 51 to 150 µg/l and 5 out of 13 studies used differentthresholds for men and women, whereas 8 out of 13 studies used the same threshold. Several studies usedrelatively high thresholds for positivity for the reference standard troponin or did not report the timing ofsampling or the assay used.Quality assessment of diagnostic studies of myoglobinFigure 21 shows the quality assessments for studies of myoglobin, whereas Figure 22 shows themethodological quality summary. The quality assessment of acceptability of the reference standard waslimited to whether or not the reference standard criteria were reported clearly and met the universal© Queen’s Printer and Controller of HMSO 2013. This work was produced by Goodacre et al. under the terms of a commissioning contract issued by the Secretary of Statefor Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journalsprovided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should beaddressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton SciencePark, Southampton SO16 7NS, UK.39
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Discussionspecificity were 62% (95%
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Discussionneed for revascularisatio
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Discussionchanges in sensitivity an
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Discussionuncertainty about these p
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Discussiontroponin assays have bett
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ConclusionsSuggested research prior
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Appendix 9ES (Information Resources
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Appendix 923. Westwood ME, Whiting
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