Scribd
Upload
54 views

Calibrators and Control Material

The document outlines the importance of calibrators and control materials in ensuring the reliability and accuracy of test systems. It details the implementation steps for quality control, differences between calibrators and control materials, and guidelines for their preparation, storage, and calibration. Additionally, it provides troubleshooting scenarios and Westguard rules for calibration verification.

Uploaded by

Numan Majeed
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
54 views

Calibrators and Control Material

The document outlines the importance of calibrators and control materials in ensuring the reliability and accuracy of test systems. It details the implementation steps for quality control, differences between calibrators and control materials, and guidelines for their preparation, storage, and calibration. Additionally, it provides troubleshooting scenarios and Westguard rules for calibration verification.

Uploaded by

Numan Majeed
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
You are on page 1/ 20

Calibrators and Control

Material
How and when to use
Dr. Numan Majeed
Implementation steps
• Establish policies and procedures
• Assign responsibility, train staff
• Select high quality controls
• Establish control ranges
• Develop graphs to plot control values - levey-jennings charts
• Monitor control values
• Develop procedures for corrective action
• Record all actions taken
Why Should QC Materials be Analyzed?

• To validate reliability of the test system

• Provides confidence that your patient test results are accurate


and method is precise

• To monitor both the precision and the accuracy of the assay in


order to provide reliable results.
Difference in Control material and
Calibrator
Calibrator Control
Matrix Similar to samples tested (usually animal Can be different, usually pooled sera or synthetic
origin eg. Roche used equine)
Use To assign set points To see the accuracy and precision of the system
Value Fixed assigned value Target and range (no fixed value) (due to matrix
difference)
Purity Very high Low
Traceability Have traceability to standard/certified No traceability
reference material
Levels Not applicable, can be at any level, but Minimum two, recommended 3, atleast one should
at least two levels be at or near to clinical decision limit
Cost High Low
Characteristics of Control Materials
• appropriate for the diagnostic sample
• values cover medical decision points
• similar to test sample (matrix)
• available in large quantity; ideally enough for one year
• store in small aliquots
Types of Control Materials
• may be frozen, freeze-dried, or chemically preserved
• Origin
• Human
• Animal
• Synthetic
• Type
• Liquid
• Lyophilized
• requires very accurate reconstitution if required
Choosing Control Materials
• values cover medical decision points
• similar to the test sample
• controls are usually available in high, normal, and low ranges
Preparation and Storage of Control
Material
• Adhere to manufacturer’s instructions
• Keep adequate amount of same lot number
• Store at prescribed temperature
• Always store reconstituted/ opened vial as
aliquots
• Never thaw the control material by rubbing or
keeping it in hand/fist
• Mix using shaker, try not to mix by hand
Calibration
Calibration
Why use multipoint calibrators? Use of more than 2 points of calibrators
Verification of Calibration
• In routine practice:
• Daily QC
• EQA/PT programs

• When to calibrate
• Expiry of calibration
• New lot of reagents
• Bias/trend/shift (systematic error)
• When not to calibrate?
• Random error
Scenario 1
You got a call from ICU that potassium results are higher while there is
no indication of high potassium in the patients clinically. Your QC is all
in range, but lower side of the mean in all the levels and one control for
today was crossing -3SD, what corrective action is required?

+3SD
+2SD
+1SD
Mean
+1SD
-2SD
-3SD
Level 1
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD

Level 2
+3SD
+2SD
+1SD
Mean
-1SD
-2SD
-3SD
What is the likely cause of error and what corrective action required
Case 1 Case 2

Level 1 Level 1

Level 2 Level 2
Level 1

Level 2
ALT ALP

What is the
likely cause
and what
corrective
action
required?
Total bilirubin

Level 1

Level 2
When to calibrate (Westguard Rules)
Rules Calibration required
1 2S No, no action required
2 2S Yes
1 3S No
R 4S No
4 1S Mostly yes
10 x May be, mostly no
7T May be

For all errors except 7 T, apply across all the levels


General Sequence of trouble
shooting
• Repeat control (in case of random error)
• If systematic error
• Check expiry of all the reagents (kit, control and calibration (NOT CALIBRATOR)
• Use fresh vial of control material
• Use fresh reagent
• Use fresh calibrator (also see for expiry of calibrator)
• Look for errors in the analyzer also like life of lamp, cuvettes, light leaks in
measuring cell

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy