Wrong pregnancy test results due to 'incorrect techniques'

EasyCheck Pregnancy test cassette Supplied 8 JUNE 2016

The maker of a pregnancy test being investigated by health authorities says initial tests have shown it to be accurate.

The Herald reported this morning that the Health Ministry's Medsafe division had received "several" reports from health sector workers saying the EasyCheck Pregnancy Test Cassette was producing false negative results in some cases - indicating no pregnancy, when the woman was pregnant.

The supplier, Phoenix MedCare, said it had only heard of two unconfirmed instances of this happening.

Phoenix managing director Brad Rodger said following reports of the test's accuracy, Labtec Scientific & Technical Services tested 150 randomly selected packaged cassettes and all had shown correct results.

"Our conclusion is that any false negative result is likely due to incorrect procedural or storage techniques. We have only been able to replicate this issue by purposely following an incorrect testing method such as shaking the product after the test has been taken."

False negatives could also be caused by testing too early in the pregnancy and testing after drinking too much and urine was diluted, among other factors.

"We provide full instructions to the health care professionals that administer these tests but understand sometimes these instructions are not adhered to.

"The notification to the MedSafe website is a positive step to encourage robust and thorough reporting to the regulators so if there is any product concern it can be fully investigated and the appropriate facts are available to MedSafe and Phoenix MedCare."
It was possible the product could be recalled if Medsafe deemed it necessary after further investigation.

The Auckland Women's Health Council had already demanded a recall, saying Medsafe's response of monitoring reports about the device and placing an early warning system note on its website was "pathetic".

"They should get it taken off the market," said council co-ordinator Lynda Williams.

Medsafe compliance manager Derek Fitzgerald said: "When investigating claims of problems with medical devices, [options] may include fault with the product, user error or the need for user education. Recall of the product could be considered after further investigation."