Beckman Coulter’s Access AccuTnI+3 troponin-I blood test identifies the precise magnitude of change in cardiac troponin level required for the early diagnosis of a heart attack (myocardial infarction or MI). The results of the research based on a large, multi-center study by Beckman Coulter Diagnostics were published recently in the Clinical Biochemistry journal.
According to the 2015 Heart Disease and Stroke Statistics Update, cardiovascular disease is the leading global cause of death, and accounts for 17.3 million deaths per year, with the number expected to grow to more than 23.6 million by 2030.
Troponins are regulatory proteins found in skeletal and cardiac muscle. The existing guidelines for the diagnosis of a heart attack do need demonstration of a rise and/or fall in troponin values between samples collected on a sequential basis by the Emergency Department. However, these guidelines do not specify the magnitude of a clinically significant ‘delta’ or rise and/or fall. The absence of a defined delta leaves physicians with no consistent approach for diagnosing a heart attack.
The only FDA-cleared troponin assay, Beckman Coulter’s chemiluminescent immunoassay enables the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay System or UniCel DxI Access Immunoassay System. The FDA did not evaluate the precise magnitude of change in the post-market cardiac troponin study data as part of providing 510(k) clearance for the product.
The percentage-change in troponin levels that earlier studies identified as the proper change criteria for identifying if a patient has had a heart attack have not proven fully reliable. More recent research has suggested that absolute values may provide more reliable evidence. The Beckman Coulter’s study recommends using an absolute difference by ng/mL change in troponin levels instead of a percentage-change reading.
The study found that as troponin values rose, the possibility of myocardial infarction increased. Baseline troponin values greater than 0.20 ng/mL were linked to nearly 90 percent chances of a heart attack.
“Earlier rule-in and rule-out may potentially save patient lives,” says Paula Southwick, PhD, co-author and principal clinical research scientist at Beckman Coulter Diagnostics.