TSH: Our demonstration assay

The TSH (thyroid stimulating hormone) test is the largest volume immunoassay run in central laboratories today, with around 200 million assays run each year globally.

It is also one of the most sensitive, requiring picomolar sensitivity, which has previously been a barrier to bringing the test to PoC.

The first cartridge developed for Vivacta's PoC system will be a single test for TSH.

Thyroid abnormalities – a global issue
Millions of sufferers: thyroid disorders affect more people worldwide than diabetes. In the US alone, 27 million people have thyroid disease and more than 50% go undiagnosed.

Even subclinical cases can endanger health: recent clinical studies show that even subclinical hypothyroid conditions can significantly increase the risk of cardiovascular problems, including doubling the chance of heart failure.

Testing nearer the patient

• TSH testing at the PoC delivers numerous clinical benefits.
• Improved clinical efficiency - test and treat, no need for secondary meetings .
• Thyroxine drug titration is a slow and multistep process, PoC testing simplifies and speeds achievement of patients targeted dose.
• Patients referred to third party labs often “no show”.
• Laboratory tests, unlike PoC tests, can be off-putting for patients because they require a tube of venous blood.
• As with all lab tests, patients often don't follow-up their results.
  
• Subclinical thyroid abnormality results are hard to discuss fully with just a phone follow-up.