PSA assay used with ADVIA Centaur systems

Safety advisory - updating Instructions for Use

2 August 2016

Consumers and health professionals are advised that Siemens Healthcare Diagnostics, in consultation with the TGA, is in the process of updating the Instructions for Use (IFU) for prostate-specific antigen (PSA) assays used with ADVIA Centaur systems. The update will clarify the utility of the PSA assay.

ADVIA Centaur/XP/XPT PSA assay is intended to be used as an aid in the detection of prostate cancer and as an aid in the monitoring and management of prostate cancer patients.

It has been identified that PSA measurements at values <0.2 ng/mL are being used to monitor some patients for biochemical recurrence of prostate cancer post-radical prostatectomy.

The PSA assays should be used in accordance with current clinical guidelines, namely the 2013 American Urological Association (AUA) guidelines and/or the 2015 European Association of Urology (EAU) guidelines. These guidelines define biochemical recurrence of prostate cancer as a detectable or rising PSA value post-radical prostatectomy (removal of the prostate gland) that is ≥0.2 ng/mL with a second confirmatory level of ≥0.2 ng/mL thus use of PSA values <0.2 ng/mL is not recommended to identify patients at risk of biochemical recurrence of prostate cancer. Additionally, as indicated in the IFU, the PSA assay should not be used to predict disease recurrence solely based on serial PSA values.

If PSA measurements at values <0.2 ng/mL are used as a threshold for identifying patients who may be experiencing biochemical recurrence of prostate cancer, there is a potential risk of unnecessary follow-up and/or treatment for progression of residual disease.

Siemens Healthcare Diagnostics is updating the IFU for these products to reflect the above information.

Information for consumers

If you or someone you provide care for has had their prostate removed and is being monitored for possible recurrence of prostate cancer, be aware of this issue.

If you have any questions or concerns, contact your managing physician.

Information for health professionals

If you use the ADVIA Centaur PSA assay to monitor and manage prostate cancer patients post-radical prostatectomy, be aware of this issue.

In particular, be aware of the current clinical guidance (the 2013 AUA and 2015 EAU guidelines) and the limitations of the ADVIA Centaur PSA assay – use of PSA values <0.2 ng/mL is not recommended to identify patients at risk of biochemical recurrence of prostate cancer and disease recurrence should not be predicted solely based on serial PSA values.

In a recent study, the Limit of Quantitation (LoQ) level for the ADVIA Centaur/XP/XPT PSA assay was evaluated and determined to be 0.04 ng/mL at the level of 20% within laboratory precision. The LoQ calculations were conducted using within laboratory precision profile approach per Clinical and Laboratory Standards Institute (CLSI) EP17-A2.

Please note that Siemens is also generating LoQ for PSA on the ADVIA Centaur CP and will provide the information when it is available.

Siemens is not recommending a laboratory review of previously generated results. However, a review of previously generated results is at the discretion of the laboratory.

Please review this information with the Medical Director of your relevant laboratory.

If you have received any complaints of illness or adverse events associated with PSA assays used with ADVIA Centaur systems, or if you have any questions or concerns about this issue, contact Siemens Healthcare Diagnostics on 1800 310 300 (technical support).

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).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.