News in Brief: RCPA alarmed over TGA allowing self-tests for HCV and Hep B; 9 chemoprevention tips for CRC; BMI for detecting NAFLD misleading

Wednesday, 17 Feb 2021

RCPA alarmed over TGA allowing self-tests for HCV and Hep B

The Royal College of Pathologists of Australasia (RCPA) has raised serious concerns over changes made by the TGA that would see the public being able to self test for Hepatitis B and C among a host of other infectious diseases.

The outcry was sparked in response to changes made to the Therapeutic Goods Specification that came into effect October last year after public consultation which amends the tests the association will allow manufacturers to provide directly to patients for self-testing.

RCPA president, Dr Michael Dray has voiced his alarm at the move to include self-tests for Hepatitis B & C despite repeated concerns being raised by the College that self-tests are not going to perform as well as a pathology test carried out in a NATA/RCPA accredited laboratory.

“Unfortunately, these self-tests will not be subject to the same regulations as laboratory testing and it is not clear what quality assurance standards the tests will have.  If the quality of the test being used in the community is not sufficiently high, then there is the possibility of false positive and/or false negative results which can have a severely detrimental effect,” he said in a press release.

The RCPA has also flagged other concerns including ‘significant consequences’ for outbreak management.

“By losing the ability to monitor diseases of public health significance, the ability to detect outbreaks early is greatly reduced and the potential to prevent transmission within the community is also lost”.

The specification includes approval for other self-test kits including for chlamydia,  gonorrhoea;  syphilis (Treponema pallidum); herpes simplex virus (HSV) 1 & 2; influenza (but not pandemic strains); and non-infectious conditions such as diabetes, kidney and cardiovascular disease. 

9 chemo-prevention tips for CRC

A list of nine best practice statements on the role of medicines for the chemo-prevention of colorectal neoplasia has been issued by an expert group of the the American Gastroenterology Association (AGA).

Among the ‘best practice advice’ is a recommendation for low-dose aspirin to be used for chemoprevention by individuals under 70 who have have a 10-year cardiovascular disease risk of at least 10% and are not at high risk for bleeding They also advise aspirin for individuals with a history of CRC to prevent recurrent colorectal neoplasia. Another statement cautions clinicians against the use of non-aspirin NSAIDs for prevention in patients at average risk for CRC because of a substantial risk of cardiovascular and gastrointestinal adverse events. Meanwhile folic acid, calcium and vitamin D have been ruled out as CRC neoplasia preventatives as have the use of statins in patients at average risk CRC.

The AGA said the best practice advice statements did not cover dietary factors and high-risk individuals with hereditary syndromes or IBD.

BMI misleads for detecting NAFLD

A BMI-driven approach to detecting NAFLD should be reconsidered – the approach could be misleading, according to new research.

An international study of more than 1300 Caucasian people with biopsy-proven NAFLD, including patients from Australia, revealed close to 15% had a BMI under 25 kg/m and defined as lean.

Researchers said that despite a more favourable profile at baseline compared to overweight and obese patients, lean patients were not spared from the risk of progressive liver disease. More than half of them had NASH and 1 in 10 had severe fibrosis at the time of diagnosis. Lean patients also experienced both hepatic and extrahepatic complications, including hepatocellular carcinoma and CVD events over at least three years follow up.

Researchers cautioned that lean subjects with NAFLD should not be overlooked in clinical practice as they developed all the disease outcomes in the long term, even without progression to obesity and independent of their PNPLA3 genotype.

Meanwhile, investigators noted that the link between BMI and clinical event became ‘almost negligible’ when corrected for age. They warned that the younger age of lean people and biopsy was another important confounding factor leading to an underestimation of risk of progression because older age was a main predictor of morbidity and mortality.

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