Only approved point of care test kits for COVID-19 will be able to be imported and sold in New Zealand from today (Wednesday April 22), the Ministry of Health has announced. 

Medsafe is today banning the importation and sale of all point of care COVID-19 test kits, unless they gain approval. No point of care test for COVID-19 has so far been approved.

Medsafe acknowledged that internationally there has been a lot of work done in developing point of care testing, but believes that more development is required to produce a reliable point of care test.

Point of care tests kits are described as rapid and easy-to-use devices to facilitate testing outside of laboratory settings. The simple test kits are based either on detection of proteins from the COVID-19 virus in respiratory samples from the nose or throat, or detection in a blood sample of antibodies generated in response to infection.

In particular, Medsafe has concerns about both the quality of testing from many of these kits and the likely impact of misinterpreted results. Its concerns about the accuracy of the kits and the potential for them to be misinterpreted or provide a misleading result are shared internationally.

Notification was published in the New Zealand Gazette today that prohibits the importation, manufacture, packing, sale, supply, or use of COVID-19 point of care test kits that have not been otherwise authorised by Medsafe.

It does not affect the PCR test kits used by the Ministry of Health that take a tissue sample which is then sent away to a laboratory for positive identification of the SARS-CoV-2 virus. 

The decision has been taken in the interests of public safety and to ensure that only test kits that are of an appropriate quality and used in circumstances where the results can be interpreted effectively are available for use, the Ministry of Health said.

As the quality of the kits improves, the Ministry of Health expects a point of care test kit might be approved for use in New Zealand.

Medsafe’s approach is supported by the ministry’s chief science advisor and chair of the COVID-19 technical advisory group, Dr Ian Town, and the NZ Point of Care Testing Advisory group.

PHOTO: Supplied