News

19th February 2004

Faulty pregnancy test warning

Thousands of women may have been wrongly told by NHS staff that they weren't pregnant. The error was noted after staff at County Durham and Darlington Acute Hospitals NHS Trust spotted a possible fault with a pregnancy testing kit.

Between October and January, more than 3000 women were tested at hospitals and GP surgeries in the Durham area and an 'unexpectedly high amount of negatives' was discovered, indicating that some women who were given a negative result could in fact be pregnant.

It has already been reported that two women in the area are pregnant despite being told that they were not.

The faulty tests, SAS 1 Step testing kit manufactured in the US, are only used by some hospitals and GP surgeries and the Department of Health have advised that home pregnancy kits are not affected by the fault.

Sue Ludgate, medical director of the Medicines and Healthcare Products Regulatory Agency (MHRA), said clinicians and health professionals should not use the kits and should "retest those patients who may be adversely affected by a falsely negative result. I appreciate that some women will be understandably concerned at this news."

It is not known how many of the tests were used but the DoH says the figure is likely to run into tens of thousands.

The MHRA has sent the kits for independent testing and are expected to release further advice on Thursday. In the meantime they are advising women who have had a test during the past 12 weeks and who think they may be pregnant to contact their GP or phone NHS Direct on 0845 46 47.

A special helpline has also been set up for women who are concerned (see Where to next?)

Tricia Creswell of the Durham and Chester-le-Street Primary care trust, said: "We are especially keen that women we cannot contact, because they have had a test anonymously, get in touch with their doctor or a clinic as soon as possible."

• If you are concerned you can call this special helpline, the number is 01482 670829.
• NHS Direct: 0845 46 47
• Discuss your worries on the Your Shout forum