Novel biofluid diagnostics in context of the health care system

Question 1

What is a clinical chemist?

Answer 1

• A specialilst in laboratory medicine, responsible for reliable diagnostic test results in blood, urine, feces, CSF.
• Supervises the team of laboratory technicians and phlebotomists
• Advises medical specialists (which test to order and interpretation of results)
• Ensures quality, regulatory and safety standards are met

Question 2

From biomarker identification to implementation:
- What steps are involved in the implementation of the biomarker?

Answer 2

• Research impact on clinical decision making
• Monitor diagnostic and prognostic performance across different setting
• Assess cost-outcome effectiveness
• Establish reimbursement
• Integrate biomarker into clinical guidelines
• In vitro diagnostic assay certification (quality assurance)

Question 3

What is meant with: justify the use of the biomarker in clinical practice?

Answer 3

The biomarkers needs to:
- be able to conform to predefined technical specifications
- be able to detect patients with a particular condition or in physiological state (clinical validity)
- be able to improve the health outcomes that are relevant to the individuals being tested (clinical utility)
- have an impact beyond clinical- and cost-effectiveness
- evaluate the change in costs with respect to changes in health outcomes when introducing the biomarker

Question 4

What is the In Vitro Diagnostic Regulation?

Answer 4

A new European regulation for in vitro diagnostic tests, with the aim to protect the patient and prevent dramatic consequences. Because of this regulation, laboratories need to use CE-certified medical tests. The certification of these medical tests is done by notifying bodies.

Question 5

What are the requirements for in vitro diagnostic test regulation approval for a new test?

Answer 5

• Application of test on a non-industrial scale, for patient care
• Prove the need for this test and make sure it gets a CE-mark by provide information to the competent authority.
• Provide a public statement (on the justification) on the website.

Question 6

How can you get a test integrated into clinical guidelines?

Answer 6

• Publish data in peer-reviewed international journals
• Present findings at conferences
• Share success on social media
• Lobby

Question 7

How do you get reimbursement for a newly developed test/biomarker?

Answer 7

• Get support from your national scientific society (e.g. NVKC)
• Gather all the evidence of (cost-)effectiveness
• Official procedures + lobby (request for declaration code at Nederlandse Zorgautoriteit and ask for reimbursement from healthcare insurers)

Question 8

How is quality in laboratory medicine defined?

Answer 8

As the guarantee that each and every step in the total testing process is correctly performed, thus ensuring valuable decision making and effective patient care.

Question 9

What is an ISO 15189 accreditation for medical labs?

Answer 9

It is used for the certification/accreditation of supplier by a third party, and accepted by all customers.
- In NL, the accreditation is given by the Raad van Accreditatie.

Question 10