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Given the sensitivity of modern troponin tests, health professionals should be alert to the potential for false positive results and the associated risk of unnecessary patient treatment.
Troponin testing is a key investigative tool for diagnosing and monitoring acute coronary syndrome, including myocardial infarction.
Troponin levels are also used to investigate and monitor unstable angina, myocardium trauma post-surgery and other diseases with related cardiac muscle injury.
Modern troponin tests are highly specific for cardiac forms of troponin and extremely sensitive to enhance early detection. While fewer cases of disease will be missed, there is a greater chance of false positive results.
An article in the March 2014 issue of Medical Devices Safety Update provided useful background detail about assessing accuracy and predictive value in testing.
The TGA Incident Reporting and Investigation Scheme (IRIS) received 289 reports of false positive troponin tests in the past nine years. Given the large number of tests performed annually, the incident rate is extremely low.
Conditions that may cause raised troponin levels include certain medications, chronic renal failure, other forms of heart disease, sepsis, chemotherapy, any condition that results in insufficient oxygen supply to the heart muscle, and the presence of heterophile antibodies.
Assess all the information
A positive troponin reading must be considered in light of other pathology results by laboratory staff prior to release of a report, and in combination with clinical signs and symptoms and electrocardiogram (ECG) results by medical staff, to prevent misdiagnosis.
Failure to detect a false positive troponin may result in the patient receiving unnecessary treatments, including invasive procedures.
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According to current Australian guidelines (pdf,3.99Mb), it is recommended that serial troponin testing is undertaken during a patient's evaluation and to use the troponin results as part of an established assessment protocol which includes other parameters in the analysis.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS) or contact the TGA's Devices Post Market Monitoring Section on 1800 809 361.
What to report? Please report adverse events, as well as near misses
The TGA encourages the reporting of any suspected adverse event or potential adverse event relating to a medical device. Adverse events can involve actual harm to a patient or caregiver, or a near miss that may have resulted in harm.
Some issues relating to medical devices that may lead to adverse events and prompt you to report include:
- mechanical or material failure
- design issues
- labelling, packaging or manufacturing deficiencies
- software deficiencies
- device interactions
- user/systemic errors.
Suspected adverse events or near misses can be reported directly to the TGA:
- online at Report a problem
- by emailing iris@tga.gov.au
- by mail to IRIS, TGA, PO Box 100, Woden ACT 2606
- by fax to 02 6203 1713.
For more information about reporting, visit www.tga.gov.au or contact the TGA's Medical Devices Branch on 1800 809 361.
Disclaimer
The Medical Devices Safety Update (MDSU) is aimed at health professionals and is intended to provide practical information on medical device safety, including emerging safety issues. The information in the MDSU is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Therapeutic Goods Administration gives no warranty that the information in this document is accurate or complete, and does not accept liability for any injury, loss or damage whatsoever, due to negligence or otherwise, arising from the use of or reliance on the information provided in this document.
© Commonwealth of Australia 2020
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to tga.copyright@tga.gov.au.
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For correspondence or further information about Medical Devices Safety Update, contact the TGA's Medical Devices Branch at iris@tga.gov.au or 1800 809 361.