ALMOST half the home pregnancy tests available in Australia have been pulled from the market after pregnant women received negative results using the kits.
The Therapeutic Good Administration has conducted a sweeping review of the DIY testing kits to ensue they meet sensitivity claims, with worrying results.
Of more than 30 self-test urine pregnancy test kits on the market, 14 have ceased sale or been recalled across Australia.
The crackdown was prompted after a report of three false negative results using the One Step HCG urine pregnancy test from a family planning clinic.
The TGA tested the product, finding it to be "insensitive", recalled and cancelled it from the Australian Register Therapeutic Goods, and proceeded to test the remaining pregnancy test kits on the register.
After being contacted by the regulator to provide information on the devices, nine suppliers withdrew their products from sale rather than undergo testing. Another two were removed from the ARTG by the TGA for being improperly included.
Of the remaining products, five were found to be ineffective and have been recalled and removed from the ARTG. The TGA is considering "further regulatory action" against one supplier: Thermo Fisher Scientific Australia, which produces the QuickVue One-Step hCG urine test kit.
Pregnancy tests are designed to tell if urine contains the hCG hormone, which is produced by cells that will develop into the placenta after a fertilised egg attaches to the wall of a woman's uterus, the TGA explains.
The kits that were found faulty were found to be ineffective in detecting the hCG hormone - including some that have claimed to be able to detect extremely low levels as would be found in the first week after contraception, the TGA said.
"All devices remaining on the market in Australia have been shown to work reliably and accurately," a statement from the regulator assured.
Consumer advocacy organisation Choice has expressed concern that the regulator has only released details of five of the kits that have been recalled.
Only names of the kits that failed testing have been made public. The products that were voluntary recalled remain unknown.
Consumers are being urged to return all recalled kits to a pharmacy for an exchange or a refund, Choice said.
- PregSure digital: Batch 16D119-1100
- PregSure test strips: Batch 16D119-0000
First Response Digital Pregnancy Test and First Response Test & Reassure: Batches SU5341, SU6207, SU6237, SU6308, SU6335, SU6196, SU6305A, SU6315A
One Step Pregnancy test has been removed from the ARTG and ceased supply, though failed batches were not supplied to Australia.
QuickVue One-Step hCG urine test is having further regulatory action considered against its sponsor, though failed batches were not supplied to Australia.
Details of the nine products voluntarily withdrawn from sale have not been released.
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