There are calls for tighter regulation of pathology testing, amid concerns unvalidated tests sold by unaccredited pathology labs pose a public health risk.

All pathology tests which attract a Medicare rebate must be accredited by a joint program run by the National Association of Testing Authorities (NATA) and the Royal College of Pathologists of Australasia (RCPA), a process that involves a review of evidence that they work.

But a plethora of unvalidated tests are sold by labs which sit outside the accreditation system.

Typically ordered by natural health practitioners and doctors practicing integrative medicine, they include saliva tests for reproductive hormones, “live blood analysis”, “digestive stool analysis” and unvalidated cancer markers.

These tests are a cause of concern for the anti-quackery group Friends of Science in Medicine (FSM), which is worried about the undermining of evidence-based pathology and the potential to generate false diagnoses leading to unnecessary clinical interventions.

One clinician recently wrote to FSM about the impact of such tests on a tertiary hospital in Victoria.

“We have seen several cases of patients having unvalidated tests (e.g. salivary hormones) at unaccredited laboratories… and as a result of ‘abnormal’ test results are being referred to our specialists for further investigations (which often turn out to be normal).

“Is there a way the authorities or associations could put a stop to such disgraceful laboratories out there to profit at patients’ expense?”

FSM vice president Emeritus Professor Alastair MacLennan said in his gynaecology practice he’d seen patients prescribed high doses of oestrogen or testosterone which were prepared by compounding pharmacies, all on the basis of the results of unvalidated saliva tests.

“The common thing that happens is these laboratories give false diagnoses and they cause a lot of angst to these patients (who believe) they have a lot of weird and wonderful diseases,” Professor MacLennan said.

“And often they don’t and the tests are unreliable, but it takes a lot of money and time to unravel the ball of wool that these laboratories have created.

“They are ripping off the system and ripping off the patients because there is no effective regulation.

“I believe the Minister for Health needs to take responsibility to tell his departments to close these loopholes.”

All tests which attract a Medicare rebate must be accredited by NATA/RCPA – a process that involves a review evidence that they work – and from July any diagnostic test produced in an Australian lab needs this accreditation.

But the requirement does not extend to commercial test kits that don’t attract a Medicare rebate, explains NATA sector manager of legal and clinical services Andrew Griffin.

In these cases, a lab can buy the kit and register it on the Australian Register for Therapeutic Goods, he said.

“My personal opinion is all testing for diagnostic use should be accredited, so there is the same level of oversight,” Mr Griffin said.

“But that’s not the regulation at the moment, if a test is Medicare rebatable and/or in-house you need accreditation but if you’re selling commercial kits which are not MBS rebatable the oversight is the TGA.”

the limbic contacted two unaccredited labs that offer saliva hormone testing, but both declined to comment.