Medical testing kits should be regulated in Aotearoa, experts say

Embargoed until: Publicly released: 2025-11-21 00:01

New Zealand

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We are behind international standards on regulating medical tests used at home or in hospitals, like pregnancy tests, RATs for COVID, and blood glucose meters, write experts in a NZMJ Viewpoint article. While devices used in medical labs are selected and used by experts following established processes, those used outside of accredited labs, including tests used by the public, don't get that sort of oversight and aren't assessed or regulated. The authors highlight local examples, like a pregnancy test with high rates of false positives, and an at-home test for sexually transmitted infections with "unacceptable" performance overseas. They say NZ's current situation is "unsafe" and outline how the proposed Medical Products Bill could include a regulatory process.

Media release

From: New Zealand Medical Journal

Point-of-care testing (POCT) devices are used to obtain rapid medical diagnostic test results near to, or at, the patient’s bedside. Examples of POCT devices include: rapid antigen test kits for COVID-19, urine pregnancy test kits and glucose meters for monitoring diabetes. These POCT devices are not regulated in New Zealand and faulty devices have been supplied to public hospitals (and may also be available on the internet). This paper calls for POCT devices to be regulated and checked for
accuracy, so that quality assured devices are supplied to hospitals and to the public, in the interests of patient safety.

Journal/
conference: New Zealand Medical Journal

Organisation/s: Pathology Services Te Tai Tokerau Northern Region, Whangarei Hospital, LabPlus, NZ Point of Care Testing Network, NZ Point of Care Testing Advisory Group

Funder: N/A

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