American journal of clinical pathology
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Am. J. Clin. Pathol. · May 2008
Multicenter Study Comparative Study Clinical TrialA rapid point-of-care cardiac marker testing strategy facilitates the rapid diagnosis and management of chest pain patients in the emergency department.
We compared a rapid, point-of-care multimarker protocol with a single and serial troponin I (TnI)-only protocol in 5,244 patients admitted to the emergency department with chest pain. The diagnosis of acute myocardial infarction (AMI) was based on a doubling myoglobin level accompanied by at least a 50% increase in the creatine kinase (CK)-MB level with no detectable TnI; a doubling of myoglobin level together with any detectable TnI; or a TnI level of 0.4 ng/mL (0.4 microg/L) or more, irrespective of myoglobin or CK-MB results. By using these new criteria, 145 of 148 cases were positive for AMI (positive predictive value [PPV], 92.4%) and 3 were negative, which were also negative by the core laboratory TnI assay. ⋯ The TnI-only protocol had a sensitivity of 68.2% with an NPV of 99.1%. With lower TnI-only cutoffs, 4 patients had false-negative results, and a PPV of 36.4% was observed. Our rapid multimarker protocol seems superior to a TnI-only approach for rapidly triaging patients with chest pain or AMI.
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Am. J. Clin. Pathol. · Feb 2001
Multicenter Study Comparative Study Clinical TrialPoint-of-care prothrombin time measurement for professional and patient self-testing use. A multicenter clinical experience. Oral Anticoagulation Monitoring Study Group.
We enrolled 386 subjects in a multicenter study of a point-of-care (POC) prothrombin time (PT) testing device. POC tests were performed by health care professionals using venous and finger-stick specimens and by patients using finger-stick specimens. Venous blood also was analyzed in the local hospital laboratory and a national reference laboratory. ⋯ Patients overwhelmingly reported satisfaction with the self-test, including the finger stick and device operation. The INR from the POC device is clinically equivalent to the laboratory INR for assessment of anticoagulation status and management decisions in professional and self-testing environments. Patients can learn to perform accurate PT testing, and POC PT testing is feasible in patients' homes.