Numerous pregnancy test kits have been withdrawn from sale in Australia after they were found to be unreliable and inaccurate.
Therapeutic Goods Administration recently reviewed a wide range of pregnancy self-test kits that rely on detecting the hormone known as human chorionic gonadotropin, or hCG, in a woman’s urine shortly after conception, reports AAP.
“Some devices were found not to work reliably and accurately and have either been corrected or removed from the market,” the TGA said in a statement.
“All devices remaining on the market in Australia have been shown to work reliably and accurately.”
The TGA tests focused on claims by the test kits’ makers that they could detect extremely low levels of hCG as early as the first week after conception.
The hormone hCG is produced by cells that will develop into the placenta, with levels rising rapidly once a woman is pregnant.
The TGA began testing pregnancy kits after receiving reports of three false negative results of the One Step HCG urine pregnancy test from a family planning clinic.
The regulator found the kits to be “insensitive”, prompting a recall from shop shelves and them being cancelled from the Australian Register of Therapeutic Goods (ARTG).
“All affected batches were recalled from pharmacies,” the TGA said.
“An investigation by the sponsor revealed a manufacturing flaw, which was corrected and the corrected devices were found to pass in subsequent testing.”
PREGNANCY KITS THAT FAILED THE TEST
* PregSure digital – recalled and cancelled from sale
* Pregsure test strips – recalled and cancelled from sale
* QuickVue One-Step hCG urine test kit – removed from sale by manufacturer
* One Step Pregnancy test – removed from sale by manufacturer
* First Response Digital Pregnancy Test/First Response Test & Reassure – manufacturing fault corrected
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