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Perspectives |
1 Mayo Clinic, Rochester, MN; 2 Hennepin County Medical Center and University of Minnesota, Minneapolis, MN.
aAddress correspondence to the authors at: A.S. Jaffe at CV Division, Gonda 5, Mayo Clinic, 200 1st St SW, Rochester, MN 55905. E-mail allan.jaffe@mayo.edu. F.S. Apple at Clinical Laboratories, Hennepin County Medical Center, 701 Park Avenue, Minneapolis, MN 55415. Fax 612-904-4229; e-mail apple004@umn.edu.
| The first 300 words of the full text of this article appear below. |
Articles in The New England Journal of Medicine get tremendous publicity, some justified and some not. Recently, 2 articles and an editorial (1)(2)(3) were published about the use of "high-sensitivity" cardiac troponin (cTn).1 These articles are welcome because they emphasize important concepts for clinicians. Some aspects, however, require clarification. Here we examine these articles and separate out new data from hype.
Are the Assays "High-Sensitivity" (hs) Assays?
No. Most of the assays used are contemporary assays (4), including the Siemens Ultra and Abbott Architect assays. Two new assays were included, both from Roche: a hs-cTnT assay (1) and a first description of a cTnI assay. There are no analytical data to evaluate the cTnI assay, but it appears similar to contemporary cTnI assays at best. The new hs-cTnT assay (2) is a novel high-sensitivity assay. Although there are no published analytical studies of the assay, there are several clinical publications. The hs-cTnT assay appears more analytically sensitive (4) than the others (see "What Does the Future Hold?" below). Despite that, the hs-cTnT assay was not statistically better clinically than the other assays for detection of acute myocardial infarction (AMI) (1).
How Novel Are the Findings?
They are not novel. The findings are more robust because larger patient groups were used. But the concept is not new that if one uses (a) sensitive contemporary assays as opposed to many presently available insensitive assays and (b) the 99th percentile cutoff recommended by guidelines groups, then early diagnosis occurs frequently. It is the use of the 99th percentile value as a decision cutpoint that is key for early diagnosis. Similar findings were reported in 2006 and confirmed. The New England Journal of Medicine results (1)(2) are impressive, which likely reflects
Since Some of These Assays Are Currently in Use in the US and Most Are in Use in Europe, Is This the Approach Clinicians Use?
How Did These Studies Deal with the Problem of Increased cTn Concentrations Produced by These Other Disease Processes?
Can Such a Large Number of Patients Be Diagnosed as Early as Claimed?
What Are the Important Take-Home Points?
What Does the Future Hold?
The following articles in journals at HighWire Press have cited this article:
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D. C. Gaze and P. O. Collinson High-Sensitivity Cardiac Troponin: Seeing the Wood from the Trees Clin. Chem., July 1, 2010; 56(7): 1197 - 1198. [Full Text] [PDF] |
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T. Reichlin, R. Twerenbold, and C. Mueller Comment on "High-Sensitivity Cardiac Troponin: Hype, Help, and Reality" Clin. Chem., July 1, 2010; 56(7): 1198 - 1199. [Full Text] [PDF] |
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