Almost half the home DIY pregnancy tests available in Australia have been pulled from the market today after pregnant women received negative results using the kits.
The Australian Therapeutic Good Administration (TGA) has conducted a sweeping review of the DIY testing kits to ensure they meet sensitivity claims. The result is drastic with many lines being pulled from retailer’s shelves.
Of more than 30 self-test urine pregnancy test kits on the market, 14 have ceased sale, been voluntarily withdrawn or been recalled by TGA due to lack of accuracy.
A family planning clinic was the first to raise concerns when it notified the Therapeutic Goods Administration of three ‘‘false negative results’’ of the One Step HCG urine pregnancy test.
The product was subsequently examined by the TGA and found to have insufficient sensitivity to pick up the human chorionic gonadotropin (hCG) hormone that is an early indicator of pregnancy.
This finding them prompted a total sweep of the market category and identified 36 other self-test urine pregnancy test kits that were then contacted to substantiate their claims of accuracy and results.
- After being contacted nine suppliers voluntarily withdrew their products from sale rather than undergo testing.
- Two suppliers were removed by the TGA.
- Of the remaining products, five underwent testing and were found to be ineffective and have been recalled.
- 22 remaining products have passed testing and are reliable.
So, where does this leave Australian women right now?
The TGA has not yet published a comprehensive list of brands that are accurate / approved and brands that are not. This is expected to be released soon however if you suspect you could be pregnant and need a test RIGHT NOW your family GP is your best bet.
If you’ve recently taken a pregnancy test and wish to ‘double check’ your result please make a visit to your GP as well.
All home pregnancy tests that will be on the market as of tomorrow (24-03-17) will meet all regulatory standards.
Here’s the latest information on the situation from Today:
