Point Of Care Testing Flashcards
What is point of care testing?
This is analytical testing of patient specimens close to where healthcare is provided to the patient. At bedside or nurses station
What does it mean when it is said point of care tests are waived or fault tolerant?
It means mistakes will not kill the patient
What is the purpose of poc testing?
Reduce risk of patient discrepancy error
Reduce turn around time (immediate results esp in emergency situations)
Improve health outcome
What is waived testing?
These are simple laboratory procedures that have insignificant risk of erroneous results.
What are the 3 testing categories established by the CLIA?
Waived testing
Moderate complexity
High complexity
What testing category has no established qualifications and no proficiency testing required?
Waived testing
What are some examples of waived testing?
Urine dipstick
Glucometer
What testing category require additional training and must meet QC, QA, and PT standards?
Moderate complexity
What testing category requires the highest training and qualification, and must equally meet QC, QA and PT standards?
High complexity
Give an example of moderate complexity
Urine microscopy
ABG fall in what category of CLIA testing?
High complexity
What are the benefits of poc testing to the providers?
Shorter therapeutic turnaround time
Makes immediate care available
More convenient
What are the benefits of poc testing to the lab?
Fewer pre-analytical errors
More patient contact
Less manpower required
What are the benefits of poc testing to the patients?
More patient focused
Usually less invasive
Less specimen requires
What does the operator inferface do?
User friendly part that identifies errors, guid user throughout operation, identifies operator, patient and test being done
What does the bar code do?
Identifies reagent, incorporates calibration data, programs set for a specific test
What is the reaction cell?
Anywhere from a simple porous pad to complex (fluidic pathway)
Name the two types of sensors.
Chemosensors
Biosensors
What are chemosensors and how do they work?
They’re synthetic/chemical analogues of biosensors. The transducers bind the analyte and produce a signal read by the amplifier.
What does the chemosensors use to detect a change when present in the analyte?
The intrinsic properties of the analyte
How do biosensors work?
They have biological recognition elements in the sensor with optical or electrical signals.
What are examples of the biological elements present in biosensors?
Enzymes
Ab
Aptamers (ssDNA, ssRNA)
How are poc tests deigned?
With operator interface, bar code ID, reaction cell, sensors, data management
How are POC testing devices characterized?
single-use, quantitative cartridge or strip devices
What methods do poc testing devices use?
Colorimeter
Immunoassays
Potentiometry
Spectrophotometry
How many analytes do complex strips with multi layer pads see?
More than one analyte
What examples of tests is urine and blood chemistry used for with poc testing devices?
Urine chemistry Serum cardiac markers Serum/urine b HCG (pregnancy test) Serum infections (HIV, mono, flu, strep) Urine drug screens
What type of assay is used with cardiac marker poc testing cartridge?
Lateral flow immunoassay (LFIA)
What allows these poc testing devices to be quantitative?
Presence of CCD camera; a multi-channel light detector
Who is responsible for QC of POCT?
The clinical lab
Why is QC of POCT ambiguous?
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
What is the difference in QC for non-instrument based systems and instrument-based systems?
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
What type of proficiency testing is required for POCT QC?
Internal and extra all quality assurance
What is another name for PT?
External quality assessment (EQA)
What is proficiency testing?
The testing of unknown samples sent to a lab on a scheduked basis of usually ~3 times a year
Give examples of centers that monitor lab performance
CMS
CLIA
CAP
COLA
What do labs do after proficiency testing?
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
