Pathologists have encouraged women to see a GP to confirm pregnancy instead of relying on home pregnancy tests
The Royal College of Pathologists of Australasia (RCPA) welcomed the TGA’s recent home pregnancy test review, which saw 14 brands withdrawn from the market
The review revealed that many of the home pregnancy tests available in Australia gave significant numbers of false negative results. Fourteen brands were withdrawn and three additional kits were recalled.
“The RCPA strongly encourages the use of Quality Assurance programs for all diagnostic tests, including those which are sold directly to patients,” said Dr Michael Harrison, President of RCPA.
“The recent review by the TGA has identified that a significant number of home pregnancy tests were not sensitive enough to detect early pregnancy, resulting in 40% of home pregnancy tests being withdrawn from the Australian market.
“This highlights the importance of the regulation of point-of-care and direct to consumer diagnostic tests.”
Many of the tests are manufactured overseas and do not meet the standards required to comply with the Australian Register of Therapeutic Goods.
Of the 36 home pregnancy tests tested as part of the review, nine chose to withdraw from the market rather than supply the information requested by the TGA.
And of the remaining 27, only 22 passed the TGA laboratory testing.
“It’s also worth noting that a number of the kits that were withdrawn from the market were sold directly to consumers on eBay,” Dr Harrison pointed out.
He encouraged patients to visit a GP or healthcare professional in order to accurately detect a pregnancy.
The step to remove the tests from the market is also supported by data from the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP), which has revealed that the majority of self-diagnostic tests do not detect a positive pregnancy at levels of hCG below 25 IU/L.