Unvalidated "Pathology" Tests

Friends of Science in Medicine has recently released a valuable report entitled “Friends of Science in Medicine (FSM) recommendations for Pathology Tests in Australia”. 

Friends of Science in Medicine is an Australian organisation dedicated to emphasising the importance of having scientific evidence of clinical effectiveness to underpin the delivery of health care in Australia. The many members of FSM include medical doctors, scientists, allied health practitioners, lawyers and many are professors or other academics.

The FSM recommendations for pathology tests are based on the following four principles:

  • Does the test result reflect the reality in the patient's body? In other words, does the measurement in the test tube accurately reflect the measurement in the patient's blood (or whatever tissue is being analysed)? This characteristic of the test is called its "analytical validity".
  • Does the test result have a significant relationship with the disease in question? In other words, is the measurement typically abnormal in patients with a particular disease? Can the test result be used to predict that a person is likely to develop a particular disease? This characteristic of the test is called its "clinical validity".
  • Does the test result provide additional information that is not already available? In other words, does the test result enable the patient to make a health care decision that would not have been otherwise possible? If the test result simply confirms something that the patient already knows, then the test has not provided useful information. This characteristic of the test is called its "clinical utility".
  • Is the test cost-effective? Is the cost of the test justified by its usefulness? This is important for both governments and individuals when they decide for what tests they will pay.


In Australia most pathology services are provided by NATA-accredited laboratories in either public hospitals or by private pathology organisations. However there is nothing to prevent non-accredited laboratories offering non-validated tests that do not meet the above four criteria and even accredited laboratories offering non-validated tests. However non-validated tests will not be covered by a Medicare benefit. This criterion alone is not sufficient to discriminate between validated and non-validated test however, as there are a number of tests that do meet the above criteria for particular patients but are not covered by Medicare. These tests include some new tests not yet assessed for the Medicare Benefits Schedule, some tests used for very rare diseases and many new genetic tests. Users may have to pay the full price from their own pocket or in some cases State Health Departments will cover the cost.

In order to assist Australians to make informed decisions about their own healthcare Lab Tests Online has established a list of Unvalidated Tests and included a link to the list from this title in our TEST drop-down list. Unvalidated tests will also be searchable using the SEARCH box.

Initially the list will consist mainly of those laboratory tests identified by the Friends of Science in Medicine report and also those identified by the Australasian Society for Clinical Immunology and Allergy. However we will continuously update the list as we become aware of further items that should be included.

We at Lab Tests Online understand that Australians have the right to have whatever tests they want as long as they are prepared to pay for them themselves. Our aim is to assist in decision making and point out some of the pitfalls:

  1. Results from unvalidated tests from non-accredited laboratories may be wrong or meaningless.
  2. If they are wrong or meaningless and the result is said to be “abnormal” this is almost certain to lead to further interventions, further costs and needless worry.
  3. Results of unvalidated tests may be overinterpreted by alternative health practitioners and this will lead to the same effects as 2 above.


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