Why Should Complex Diagnostic Testing Only Be Performed Within Diagnostic Laboratories?

The recent announcement that a biotech company is going to place a diagnostic testing instrument in a select group of pharmacies has raised some real concerns from the New Zealand Institute of Medical Laboratory Science (NZIMLS). We have all seen the direct effects of the recent overestimation of the COVID PCR capability and to ignore the input and advice of expert medical laboratory scientists reinforces the lack of respect once again for this undervalued group of health professionals.

‘It is unacceptable to not have those who are specialized registered medical practitioners in the scope of providing diagnostic testing, advice and quality assurance performing diagnostic tests that are to be used for medical and social decisions’, says Terry Taylor, the president of the NZIMLS.

‘Clearly this situation highlights a major gap in the regulatory environment for diagnostic testing on human samples. One can imagine the consequences for a medical laboratory scientist prescribing and dispensing pharmaceuticals outside their scope of practise’, says Taylor.

‘The diagnostic laboratories in Aotearoa New Zealand are controlled environments that require stringent accreditation standards and are staffed by registered medical laboratory health professionals. Surely in a situation where testing is going to be in a pharmacy then the expectation at the very least would be oversight from a suitable qualified registered medical laboratory professional’, says Taylor

To become a medical laboratory scientist (MLS) involves 4 years of intensive university medical education coupled with a 6–12-month practical internship depending on the laboratory discipline that is chosen to specialise in. Many of our scientists continue onto further study gaining a Postgraduate diploma (PG Dip), or a Master of Medical Laboratory Science (MMLSc) and a few standouts go on to complete a PhD in Medical laboratory science. This ensures that the public of Aotearoa New Zealand can have total confidence that their precious testing samples are being analysed with the safeguard of a regulatory environment with accountability and expertise that gives confidence and certainty about the validity of any test result that these health professionals release.

COVID antibody testing is offered in all the larger private and DHB laboratories and the commercial assays used are all standardized to WHO standards. The clinical use of these tests has become more blurred because the high vaccination rates show most of our adult population has a level of detectable antibodies against the spike proteins on the COVID viral surface. However, as all scientists realise, the immunological processes involved with Omicron infection are very complex and difficult to predict or correlate at this time. Omicron is after all the master of evading our immune response and this is shown by the high R value and high infection numbers compared to previous variants. And then there is the issue of true neutralising antibodies versus innate or inert circulating antibodies. This is a complex situation that already causes a lot of confusion in the public arena, and without having expert microbiology and immunology advice readily available will only cause more misinformation and presumption in the public domain.

‘It is not helpful to compare the strong correlation with quantitative antibody levels and disease protection that are seen in vaccination for different viral infections like Hepatitis B. This correlation and standardization involved large scale clinical trials over many years’, says Taylor

‘The NZIMLS will always promote innovative and diagnostically useful research and development but are pleading to all those in the biotechnology industry to utilize collaborative pathways with the diagnostic laboratory providers. To completely bypass those who are experts in all aspects of regulation, quality assurance, and clinical pathways just reinforces the lack of respect our medical scientists face almost daily’, says Taylor

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