Inaccurate pregnancy test kits removed from store shelves

Five pregnancy kits have failed accuracy tests.

Five pregnancy kits have failed accuracy tests. Photo: Getty

Batches of do-it-yourself pregnancy test kits have been withdrawn from sale in Australia after they were found to be unreliable and inaccurate.

The move was sparked by the Therapeutic Goods Administration’s recent review of 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.

“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.

Increased levels of hCG are usually detected in a pregnant woman’s urine about six weeks after fertilisation, but some kits claim to be extra sensitive and can pick up on the rise much earlier.

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).

The makers of another 38 kits were then asked by the TGA to provide information about their pregnancy tests.

Nine companies responded by stopping supply of their kits, with the TGA removing another two other devices from the ARTG.

Tests on the remaining 27 kits found five were inaccurate.

One brand, the First Response Digital kit from Church and Dwight, could not be tested as too many devices malfunctioned.

“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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