Biomarkers And The Clinical Labratory

Question 1

What is a bio marker?

Answer 1

A characteristic that is measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacology responses to a therapeutic intervention

Question 2

What are some key needs of a diagnostic bio marker?

Answer 2

Detect disease early
Classify disease type

Question 3

What do predictive markers tell you?

Answer 3

Identify responders
Identify those likely to have an adverse event

Question 4

What are metabolism biomarker?

Answer 4

They help aid in defining drug doses

Question 5

What are outcome bio markers?

Answer 5

Response to therapy
Indication of progression
Evidence of recurrence

Question 6

How do biomarkers go from research to routine?

Answer 6

Research lab needs to contact clinical biochem labs or into the diagnostic industry. The diagnostic industry chats to the biochem lab to make sure it’s feasible

Question 7

Do the numbers of biomarkers decrease on the pathway from research lab to specialist lab to routine lab?

Answer 7

Yes.

Question 8

Do the quality of assay decrease on the pathway from research lab to specialist lab to routine lab?

Answer 8

No

Question 9

What are the research labs responsibility?

Answer 9

Investigate preanalytic requirements as soon as possible this includes the specimen, timing (e.g. Does it needs to be done in the morning) or the storage requirements

Undertake validation of assay performance - is it reproducible? Is there an okay detection limit, how accurately can you recover the added analyte, how robust is it?

You also need to look at clinical data on sufficient numbers of patients and controls

Question 10

Where is most bio markers research undertaken?

Answer 10

Diagnostic industry

Question 11

What are some key features of a research lab?

Answer 11

Reasonable resources - re staffing and times which means Experimental procedures consequently can be relatively complex.

Quality control is variable depending on lab - company/research institute. Standardisation unlikely

Patient cohorts may differ from those encountered in routine clinical practice

You want to make robust processes on relevant samples

Question 12

What defines a specialist assay?

Answer 12

Small workload and/or rare clinical condition

They are in transition from research into routine practice

Techinically difficult or requiring specialist equipment

Clinical interpretation difficult/complex

Question 13

What are specialist assays?

Answer 13

These are assays which are expensive to set up or aren’t needed often.

Question 14

What are some early requirements for introducing a new routine test?

Answer 14

Well documented evidence that the test improves patient management

• would this lead to fewer investigations, clinic visits and/or hospital bed days.
• beneficial affect on patient pathway and patient outcome
• Guideline recommendations desirable.

Question 15

after getting evidence what do yo do to introduce a new routine test?

Answer 15

A business case/ plan for funding

Careful consideration of workload implications of making the test available
— actively educate users on how and when you should use the test

Question 16

What are some consequences of introducing routine tests?

Answer 16

The CrP service was done by ELISA which took 2 weeks so they improved the service to in hospital 20 minutes.

This led to increase of workload as people started over asking for the test as it was easier to get.

Question 17

What are the pre-analytical requirements when introducing a new routine test

Answer 17

Ideally no special handling/storage required to transit - good stability

Absence of specific timing requirements

Awareness of possible effect on result of medication/ illness/ or intervention

Question 18

What happens in the sample reception?

Answer 18

Specimens are all bar coed during booking in - these contain details or patient and samples.

Samples come in the afternoon.

Samples kept for a week

Question 19

What are the analytic considerations when introducing a new routine test - what should new biomarkers show?

Answer 19

• Good linearity on dilution, good within and between run reproducibility and excellent precision
• be calibrated against an appropriate standard
• be robust to clinically relevant interferences

Question 20

What are some analytical considerations of a new routine test?

Answer 20

Internal quality control and external quality assessment must be in place

Automation of tests with high workload essential in clinical biochem labs

Question 21

In a modern hospital lab what is the process?

Answer 21

Sample track sorts and sends bar coded specimens to the correct analysis

When complete results are uploaded to the lab computer for checking an authorisation by a biomedical scientist

Question 22

What does a reaction vessel do?

Answer 22

Reagents and spinned at a control temperature and mixes appropriate volumes

Question 23

What is a sample delivery?

Answer 23

Bar coding identifies tests and excellently pipettes precision, speed and convenience

Question 24

When can new biomarkers be taken from research into routine use?

Answer 24

Evidence supports clinical utility, funding is assured, only done to those likely to benefit, quality assured, automation for high workload tests