Australian Biologics testing changes from 30 June 2017

With the changes to the TGA in-house testing regulations coming into effect on the 30th of June 2017, all testing not carried out using kits and techniques listed with the ARTG will be required to stop (including bespoke techniques we’ve developed at Australian Biologics for the detection of Borrelia). This has affected every laboratory across Australia that carries out in-house testing.

As such, while we continue our process of NATA accreditation, in compliance with these changes Australian Biologics will no longer be offering PCR testing through our bespoke and highly-sensitive “in-house” tests after the 30th of June 2017.

The substitutes :

We have sourced ARTG-listed kits for Borrelia Urine, Mycoplasma Pneumoniae and Chlamydia Pneumoniae. Additionally, we have sourced IFA (Immunofluorescence kits for Bartonella).

If and when our NATA accreditation is granted for Borrelia testing, we may explore “adding-on” additional tests for accreditation.

Additional Information

What is in-house testing?

In-house testing is a bespoke test developed and optimized by a laboratory for its own use, which is then validated through quality assurance programmes and in our case DNA testing through sequencing (sequencing provides proof that the bacteria detected is in the fact the bacteria tested for). In-house kits also allow independent laboratories to develop highly accurate and sensitive testing methods for niche diseases, which may not otherwise be commercially available.

in-house-testing

Our confidence in our process and the presence of Borrelia in Australia :

Testing and correlation :

Testing of Australians has shown positives not only through our laboratory but also with many overseas.

Australian Biologics has also participated in a formal exchange of samples (both positive and negative) with the National Reference Laboratory for Borreliosis in the Czech Republic. Our test results were a complete match with the results from this laboratory and we have received a validation report from them which is available here

Additionally, we’ve demonstrated correlation with laboratories and universities across the USA, Canada, and Germany.

Quality assurance :

Australian Biologics have participated in annual quality assurance programs over the past five years. You can find the results here.

DNA matching and positivity :

We’ve carried out DNA sequencing from both people and local animals which confirmed (with up to 98% matches) the presence of Borrelia. Examples can be viewed here.

The Australian Museum has also formally identified ornate kangaroo ticks, kangaroo tick larvae, and wallaby ticks which were tested positive for Borrelia.

Our standards :

Our current standards (cycles) are the same as the National Reference Laboratory for Borreliosis in Europe. However, given the NATA requirements, we are trialing various techniques in order to lower the cycles while increasing our ability to detect Borrelia.

Despite the regulatory changes, we will aim to assist practitioners and patients through ARTG listed IFA tests and kits. We thank you all for your support of our laboratory and intend to continue providing good quality science to aid both patients and the doctors who seek to make them well.

 

Yours sincerely,
The Australian Biologics Team

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