Screening Retest Fact Sheet
On 11 May 2009, invitations to participate in the National Bowel Cancer Screening Program (the Program) were temporarily suspended after problems were found in the buffer of the faecal occult blood test (FOBT) kits that were distributed in the Program from 1 December 2008 to 8 May 2009. The role of the buffer is to maintain haemoglobin, a component of blood in the sample. The buffer in the FOBT kit issued in this time broke down along with any haemoglobin when exposed to high temperatures. As a result the FOBT kit returned a lower than expected rate of positive results so that some participants may have received false negative results.
On 2 November 2009 the Program recommenced. Around 600,000 new FOBT kits will be issued to people affected by the suspension of the Program. The majority of participants affected by the temporary suspension of the Program have now received their new kit. The full rollout will be completed by June 2010.
To continue to meet the Government’s commitment to offering bowel cancer screening to eligible Australians, those people who were scheduled to receive a FOBT kit between 1 July 2009 and 31 December 2010 will be sent a test kit between April 2010 and April 2011.
The new FOBT kit, manufactured by Fujirebio, has been assessed and found fit for use in the Program by both the Therapeutic Goods Administration and a specially appointed, independent Expert Advisory Group.
Bowel cancer can develop with few, if any, early warning sings and early detection through screening can save lives. All people who receive a new FOBT kit are encouraged to retake the test to obtain a reliable result. Australia has one of the highest rates of bowel cancer in the world and bowel cancer is the second most common cause of cancer related death after lung cancer.
The National Bowel Cancer Screening Program commenced in August 2006 with screening people aged 55 and 65 years. The Australian Government allocated additional funding of $87.4 million to expand the Program and from 1 July 2008 people turning 50 years of age between January 2008 and December 2010 became eligible for screening.
When will I be sent my new FOBT kit?
All people affected by the temporary suspension of the Program between May and November 2009 have now been sent a new FOBT kit by the Program (with the exception of a small number of people living in warmer areas, who will receive a new kit by no later than June 2010).If you believe you should have received a new kit and have not yet, please contact the Program Information Line 1800 118 868.
New FOBT kits were sent by the Program between 2 November 2009 and 31 March 2010 in the following order:
1. participants who received a negative result;
2. participants who completed the test but whose samples were not able to be analysed (inconclusive result);
3. participants who were sent a FOBT kit but who had not yet completed the test;
4. participants who received a pre-invitation letter but not an invitation package;
5. participants who were scheduled to receive a pre-invitation letter and an invitation package between 11May to 30 June 2009.
Pre-invitation letters, followed by invitation packages, are now being sent to those people who were scheduled to receive a FOBT kit between 1 July 2009 and 31 December 2010. This is expected to be completed by April 2011.
Do I need to do anything to receive my new FOBT kit?
No. You will automatically be sent a new FOBT kit, if you fall into one of the five groups mentioned above or were scheduled to receive an invitation package between 1 July 2009 and 30 December 2010.How do I know that the new FOBT kit is reliable?
The new FOBT kit has been assessed and been found fit for use in the Program by both the Therapeutic Goods Administration and a specially appointed independent Expert Advisory Group. The Program remains an important element in the fight to prevent bowel cancer.Will the new FOBT kit look any different from the old FOBT kit?
Yes, you will be able to tell you have a new FOBT kit because the collection sticks will be different colours – one red and one blue.Is it necessary to re-take the test?
If you received a negative result using the old FOBT kit your result may not be accurate. It is recommended that you repeat the test to obtain a reliable result.Bowel cancer can develop with few, if any, early warning signs and early detection is the best protection we currently have to fight it. This is why re-taking the test and obtaining a reliable result is so important.
If I received a positive result before, am I OK?
Yes. Evidence suggests that positive results are reliable. People who have been advised of positive results should continue to consult their doctor to arrange for further investigation, including colonoscopy.I received a FOBT kit before 1 December 2008. Is result accurate or should I be re-take the test?
If you received a FOBT kit as part of the Program before 1 December 2008 you are not affected and do not need to re-take the test. Evidence suggests that results from these FOBT kits are reliable.What do I do with the old FOBT kit?
It is recommended that you dispose of the old FOBT kit by placing it in your waste disposal.Top of page
What was the problem?
A FOBT tests for the presence of blood in faeces, a possible indicator of bowel cancer.In December 2008 a ‘modified’ FOBT kit was introduced for use in the Program. The ongoing analysis of samples from the ‘modified’ FOBT kit saw a lower than expected number of positive results being returned.
Investigations revealed that the buffer solution contained in the collection tubes of the ‘modified’ FOBT kit was different to that in the previous FOBT kit. The buffer solution acts as a preservative for blood to help maintain the sample prior to analysis. At 25oC or higher, a decrease of haemoglobin, a component of blood, was observed in the buffer solution of the modified FOBT, increasing the likelihood of a false negative result. Once blood breaks down, it is cannot be detected through the screening process.
Who did the problem affect?
The problem only affects people who were issued with a FOBT kit issued between 1 December 2008 and 8 May 2009.The Department of Health and Ageing has written to all affected people. All people who received a FOBT kit issued between 1 December 2008 and 8 May 2009 will be offered a replacement FOBT kit. The exception is those people who completed the test and received a positive result.
What is bowel cancer?
Bowel cancer is a malignant growth that develops most commonly inside the large bowel. Most bowel cancers develop from tiny growths inside the colon or rectum called polyps, which look like small spots on the bowel lining or like cherries on stalks.Not all polyps become cancerous. If polyps are removed, the risk of bowel cancer is reduced.
How common is bowel cancer?
Bowel cancer is the most common internal cancer, with about 13,000 new cases detected each year in Australia. It is also a major cause of cancer deaths, with around 80 Australians dying from bowel cancer each week.Where can I find more information about bowel cancer or the Program?
Information about the National Bowel Cancer Screening Program can be found on the Internet at: www.cancerscreening.gov.auIs there a telephone number I can call for further information about the FOBT kit?
A FOBT Helpline for the National Bowel Cancer Screening Program is available. Please call 1300 738 365 for further information.Page currency, Latest update: 31 May, 2010