And How We Seek Out the Best
Have you ever wondered what sets some laboratories apart from others, or what testing standards ensure accurate and quality testing? We have provided some FAQs on testing standards below, so you can make fully informed choices on the labs you choose for your patient tests.
#1 – What’s the TGA got to do with Functional Testing?
The TGA provides one of the most stringent quality and safety standards in the world to ensure the safe and quality manufacture of goods. This includes the manufacture of test collection kits for clinical use. RN Labs has for many years pioneered the correct registration of sample collection kits with the TGA.
#2 – What’s an ISO and does it relate to test quality?
Broad international (ISO) standards exist for maintaining general quality manufacturing standards across all industries around the world (to assist those industries and countries that do not already have a framework like the TGA overseeing them).
An ISO standard pertains only to the production of test collection kits, and simply ensures a process is being followed, not necessarily that the product resulting from that process is optimum or appropriate.
Crucially, nor does it necessarily pertain to the accuracy or validity of the actual laboratory testing to be conducted on the samples collected by those kits.
#3 – So is there any framework in Australia that assesses test quality and accuracy?
For any Australian laboratories within Australia seeking to ensure the accuracy and standards of their actual lab analysis, the primary recognised body for supporting this in Australia is the National Association of Testing Authorities (NATA). NATA is an independent organisation that offers guidelines to all types of testing laboratories (including industrial) to assist them with maintaining consistent and accurate measurements.
#4 – What about laboratories in the U.S.A.?
The USA has a more established, compulsory and thorough regulatory framework for overseeing the actual analyses carried out by clinical laboratories, to ensure that they are suitable and valid for clinical use. American labs with both CLIA and CAP certifications are trained and audited to ensure that not only the technology and processes are being executed correctly, but the qualifications and expertise of their staff, and therefore interpretation of results stemming from these tests, is sound.
Australian practitioners sourcing quality clinical testing services carried out in America can be assured of some of the highest standards of validation currently available. Furthermore, RN Labs believes in maintaining full transparency of who and where your test is being carried out, so that you can make fully informed decisions with your patients.
RN Labs seeks out the most advanced clinical testing services from around the world, and delivers them to Australian practitioners with complete transparency and support, in order to demonstrate their validity and utility by maintaining the ability to trace the laboratory conducting an analysis, and review the scientific premise and processes that underlie their testing.
With the increased scrutiny on practitioners to demonstrate that their clinical practice is based on the most evidence-based and rigorously executed technologies, it is important for practitioners to be informed in this regard.
Please don’t hesitate to contact us should you have any further questions.
The RN Labs team