Position statement on Direct-to-Consumer self-testing kits: NZ POCTAG and NZIMLS

Position of the New Zealand Point of Care Testing Advisory Group (NZ POCTAG) and the New Zealand Institute of Medical Laboratory Science (NZIMLS) on Direct-to-Consumer self-testing kits. May 2025

Direct to consumer testing (DTCT) is of three types, namely: home self-testing, self-sampled testing, and direct access testing. [Shi et al 2024] This Position Statement focuses on home self-testing.

Self-testing kits are point of care testing (POCT) kits. They have several sociological advantages, including convenience and privacy.

Self-testing kits should cause more good than harm to the individual consumer, their whānau and to society, and should complement health services and a healthcare system that has finite resources.

Currently in New Zealand, there are minimal mechanisms to support the sale of safe self-testing kits, and to ensure the consumer is adequately informed of their limitations. Therefore, the NZ POCTAG and NZIMLS make the following recommendations in the interest of the consumer and of the public.

Recommendations and rationale:

Multidisciplinary stakeholders including POCT pathologists and scientists, Ministry of Health, Industry, consumers, the Commerce Commission, and the Pharmacy Guild work together to achieve the following:

1- Regulation: Commercially available self-testing kits to be included in the Ministry of Health’s regulatory framework, as well as codes for advertising and commercial practices.

Rationale: The Ministry of Health is updating the Medicines Act 1981 to align it to international standards of regulation. The new Act will include regulation of publicly funded POCT kits and devices. The Ministry of Health and healthcare professionals have an ethical obligation towards commercial kits also. Regulation should be based on the magnitude of risk posed to consumers while aiming to minimise barriers to innovation. [Tidy et al 2018]

2- Support independent evaluation of the self-testing kits.

Rationale: Manufacturer claims of performance e.g., sensitivity and specificity, are often not reproducible in real life because they were achieved under specific conditions and on different populations. [RCGP 2023, Heinrich et al 2021]

3- Support mechanisms to provide adequate health information fluency that ensures consumers make informed choices.

Rationale: Consumers may not be aware that information provided by some manufacturers of self-testing kits can be vague, and not relevant to some groups of consumers e.g., due to co-existing medical conditions or ethnic differences. [Khan et al 2024, Drain et al 2023]

4- Industry to expand its efforts and take more responsibility at ensuring self-testing kits are sufficiently robust for home use by minimising the potential for errors in sampling, testing, and interpreting results.

Rationale: It is to the benefit of Industry that their kits work properly but competing market interests can stand in the way. [Drain et al 2023, Oudendammer et al 2019]

5- Resource and enable commercial health providers e.g., pharmacists, and community workers and peer workers who provide facilitated testing in community led health services, to provide a wraparound service to consumers of self-testing kits.

Rationale: A test result is only one part of an examination or assessment; in isolation it can be useless at best, or even harmful. Contextual details and counselling when needed, would provide information such as the pre-test probability, enable the correct choice of kit, alleviate anxiety related unexpected results and capture the essence of the consumers’ health concern.

6- Reduce the potential for inequity

Rationale: Not all consumers can afford to purchase self-testing kits. Where the kit is fit-for-purpose and the consumer would benefit from it, access may be inequitable.