Patients who had tests carried out at Mayo General Hospital to determine whether they had prostate cancer or not may have received inaccurate results, it has been revealed.
Almost 13,000 investigations for prostate disease which were carried out at the hospital between July 6, 2012 and June 25, 2013 will be reviewed to determine how many returned an elevated reading.
It has been discovered that the Siemens Immunoassay analysers and reagents which are used as part of diagnostic tests for prostate disease were giving a positive bias which means the readings were 20 to 23 per cent higher than other similar tests and relative to the World Health Organisation standard.
In a statement issued by Setanta Communications this week on behalf of the HSE West it said the incident was “outside the control of the Mayo General Hospital” and was considered to be of low clinical risk in relation to long term negative outcomes for patients.
According to the statement the PSA is a blood test which may be raised in patients with prostate cancer. However, it can also be raised in certain benign prostate conditions such as prostatitis. On average two out of every three men with a raised PSA level will not have prostate cancer, and PSA may be normal even when prostate cancer is present.