Abbott's Architect Stat High Sensitivity Troponin-I blood test can measure very low levels of troponin

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Image: The FDA has approved Abbott's High Sensitivity Troponin-I blood test to diagnose heart attacks. Photo: courtesy of Reaper DZ from Pixabay.

Abbott has secured approval from the US Food and Drug Administration (FDA) for its Architect Stat High Sensitivity Troponin-I blood test to quickly diagnose heart attacks.

Doctors use a troponin blood test when people enter the emergency room with a suspected heart attack. Troponin-I proteins, which are released from the heart, can be found at elevated levels in the blood when the heart muscle is damaged.

Abbott’s Architect Stat High Sensitivity Troponin-I blood test

Abbott’s High Sensitivity Troponin-I blood test holds capacity to measure very low levels of troponin, enabling doctors to assess heart attack in patients within two to four hours of admission.

The approval allows to run the blood test on the company’s fully-automated Architect analyser. The Architect Stat High Sensitivity Troponin-I results can be used in conjunction with other diagnostic information such as electrocardiogram (ECG), clinical observations and information and patient symptoms to help diagnose heart attacks.

The company’s test is believed to be more beneficial to women, as they often have lower levels of troponin than men.

Known as High Sensitive Troponin-I in Europe and Asia, the company’s blood test has been used across hospitals worldwide and researched in over 200 studies for its role in identifying heart disease and cardiac events.

Abbott’s High Sensitive Troponin-I test is claimed to be the first test outside of the US to offer gender-specific cut-offs, helping physicians to more precisely diagnose heart attacks in women.

Abbott is set to launch the Heart Partnership Programme to support hospital care teams implement the blood test into their care pathway, including using technologies that can automate the process and use the test results to help diagnose patients and make treatment plans.

Abbott diagnostics global medical and scientific affairs senior medical director Dr Agim Beshiri said: “This important milestone will allow U.S. physicians to utilize the advanced, proven capabilities of this blood test as they evaluate patients suspected of a heart attack.

“As one of the most widely researched high sensitivity troponin tests, this technology could help address several challenges in emergency departments today, including overcrowding and more accurately identifying heart attacks in women.”

Recently, Abbott has secured CE mark approval for two paediatric heart devices, including Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo occluder.