Point Of Care Testing

Question 1

What is point of care testing?

Answer 1

This is analytical testing of patient specimens close to where healthcare is provided to the patient. At bedside or nurses station

Question 2

What does it mean when it is said point of care tests are waived or fault tolerant?

Answer 2

It means mistakes will not kill the patient

Question 3

What is the purpose of poc testing?

Answer 3

Reduce risk of patient discrepancy error
Reduce turn around time (immediate results esp in emergency situations)
Improve health outcome

Question 4

What is waived testing?

Answer 4

These are simple laboratory procedures that have insignificant risk of erroneous results.

Question 5

What are the 3 testing categories established by the CLIA?

Answer 5

Waived testing
Moderate complexity
High complexity

Question 6

What testing category has no established qualifications and no proficiency testing required?

Answer 6

Waived testing

Question 7

What are some examples of waived testing?

Answer 7

Urine dipstick

Glucometer

Question 8

What testing category require additional training and must meet QC, QA, and PT standards?

Answer 8

Moderate complexity

Question 9

What testing category requires the highest training and qualification, and must equally meet QC, QA and PT standards?

Answer 9

High complexity

Question 10

Give an example of moderate complexity

Answer 10

Urine microscopy

Question 11

ABG fall in what category of CLIA testing?

Answer 11

High complexity

Question 12

What are the benefits of poc testing to the providers?

Answer 12

Shorter therapeutic turnaround time
Makes immediate care available
More convenient

Question 13

What are the benefits of poc testing to the lab?

Answer 13

Fewer pre-analytical errors
More patient contact
Less manpower required

Question 14

What are the benefits of poc testing to the patients?

Answer 14

More patient focused
Usually less invasive
Less specimen requires

Question 15

What does the operator inferface do?

Answer 15

User friendly part that identifies errors, guid user throughout operation, identifies operator, patient and test being done

Question 16

What does the bar code do?

Answer 16

Identifies reagent, incorporates calibration data, programs set for a specific test

Question 17

What is the reaction cell?

Answer 17

Anywhere from a simple porous pad to complex (fluidic pathway)

Question 18

Name the two types of sensors.

Answer 18

Chemosensors

Biosensors

Question 19

What are chemosensors and how do they work?

Answer 19

They’re synthetic/chemical analogues of biosensors. The transducers bind the analyte and produce a signal read by the amplifier.

Question 20

What does the chemosensors use to detect a change when present in the analyte?

Answer 20

The intrinsic properties of the analyte

Question 21

How do biosensors work?

Answer 21

They have biological recognition elements in the sensor with optical or electrical signals.

Question 22

What are examples of the biological elements present in biosensors?

Answer 22

Enzymes
Ab
Aptamers (ssDNA, ssRNA)

Question 23

How are poc tests deigned?

Answer 23

With operator interface, bar code ID, reaction cell, sensors, data management

Question 24

How are POC testing devices characterized?

Answer 24

single-use, quantitative cartridge or strip devices

Question 25

What methods do poc testing devices use?

Answer 25

Colorimeter
Immunoassays
Potentiometry
Spectrophotometry

Question 26

How many analytes do complex strips with multi layer pads see?

Answer 26

More than one analyte

Question 27

What examples of tests is urine and blood chemistry used for with poc testing devices?

Answer 27

Urine chemistry
Serum cardiac markers 
Serum/urine b HCG (pregnancy test)
Serum infections (HIV, mono, flu, strep)
Urine drug screens

Question 28

What type of assay is used with cardiac marker poc testing cartridge?

Answer 28

Lateral flow immunoassay (LFIA)

Question 29

What allows these poc testing devices to be quantitative?

Answer 29

Presence of CCD camera; a multi-channel light detector

Question 30

Who is responsible for QC of POCT?

Answer 30

The clinical lab

Question 31

Why is QC of POCT ambiguous?

Answer 31

The clinical lab has to conduct QC even though they don’t do most of the POCT. Most users are non-laboratorians that do not understand QC and may never do it

Question 32

What is the difference in QC for non-instrument based systems and instrument-based systems?

Answer 32

Non-instrument based systems have built in internal QC based on a visible color reaction while instrument-based systems don’t have build in QC so can give erroneous results if instrument fails

Question 33

What type of proficiency testing is required for POCT QC?

Answer 33

Internal and extra all quality assurance

Question 34

What is another name for PT?

Answer 34

External quality assessment (EQA)

Question 35

What is proficiency testing?

Answer 35

The testing of unknown samples sent to a lab on a scheduked basis of usually ~3 times a year

Question 36

Give examples of centers that monitor lab performance

Answer 36

CMS
CLIA
CAP
COLA

Question 37

What do labs do after proficiency testing?

Answer 37

They report their sample results to their unbiased third party PT program who grade the results using CLIA guidelines and send the results back to the lab