Single Combination Test Detects Three Major Cardiac Markers within Five Minutes

AMI is primarily diagnosed via electrocardiograms (ECGs) and cardiac marker tests. As per American and global AMI guidelines, clinicians should ideally confirm an AMI diagnosis via ECG within the first 10 minutes of patient admission. However, this method fails to provide specific results for around 40-50% of AMI patients, thus creating the need for prompt cardiac marker tests. The challenge, however, is that current cardiac marker tests, requiring blood sample collection and testing, often exceed the crucial 10-minute diagnosis window. A new test now offers AMI detection within five minutes, thereby permitting additional time for sample collection while staying within the recommended diagnostic timeframe.

Changzhou Biowin Pharmaceutical’s (Changzhou, China) Cardiac 5-Minute Test provides a comprehensive assessment of the three key cardiac markers, namely, cardiac troponin I, myoglobin, and heart fatty acid binding protein in one combination test. This assists in the clinical diagnosis of AMI, where blood flow blockage to the heart can result in heart muscle damage - the longer the blockage, the greater the damage. By complying with the AMI detection guidelines of under 10 minutes, the Cardiac 5-Minute Test provides an effective AMI management tool, thereby improving patient outcomes. Its room temperature storage capability eliminates the need for a cold chain during transportation. This test holds immense potential for use across hospitals, emergency rooms, cardiology departments, and doctors' offices.

The Jiangsu Bureau of the National Medical Products Administration (NMPA), China's regulatory equivalent of the U.S. Food and Drug Administration (FDA), has given the Cardiac 5-Minute Test marketing approval. This followed the product recently passing the NMPA's quality inspection test, which evaluated its sensitivity for early-stage myocardial infarction detection, specificity to cardiac markers only, and accuracy, precision, and stability. The most critical part of the NMPA's quality inspection was verifying that the Cardiac 5-Minute Test's detection time was five minutes or less, a significant improvement over the 15-minute window required by other cardiac marker tests currently available.

"We are very glad to have received marketing approval for our Cardiac 5-Minute Test from the NMPA. This is a significant milestone for our business, and we believe that the diagnostic test will achieve high acceptance in the Chinese market," said Dr. Marvin Liu, CEO of Biowin. “As the inventor of the technology for the Cardiac 5-Minute Test, we are pleased that its fast detection marks a significant technical breakthrough that sets our diagnostic medical product apart from other products on the market. It provides a new and highly valuable approach to conducting cardiac marker tests within 5 minutes, which we believe will save lives in China and throughout the world.”

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