18/02/2004

Pregnancy test kit reports 'false negatives'

It is thought that hundreds of women tested for pregnancy in the UK inside the last 12 weeks may have been incorrectly told they are not pregnant.

The Medicines and Healthcare products Regulatory Agency (MHRA) said a problem had recently been identified with the SAS One Step pregnancy test kits. This kit manufactured by SA Scientific has subsequently been submitted for further independent testing.

According to MHRA the test kit has produced a higher than expected number of incorrect “false negative” results and urgent advice has been issued today withdrawing this pregnancy testing kit.

Doctors and other health professionals have been advised not to use this particular pregnancy test kit and have been asked to review those patients who may be adversely affected by a “false-negative” result.

A MHRA spokesperson said: "Concerned women who have had a pregnancy test in a GP surgery, health clinic or in a hospital over the previous twelve weeks should make an appointment with their GPs or consultants."

Test kits bought by women for home use are unaffected.

(SP)

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