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Carry Over

method validation psmile files

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10 views

Carry Over

method validation psmile files

Uploaded by

omaromran
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Carryover

Testing Procedure
Dr. Tamer Soliman
Carryover
Testing Procedure
Dr. Tamer Soliman

“Carryover” in laboratory testing, is defined as


“the contamination of a specimen
by the previous one”
Carryover
Testing Procedure
Dr. Tamer Soliman

Carryover testing is performed to help to


prove or disprove carryover from
the sample probe
in clinical laboratory testing
Carryover
Testing Procedure
Dr. Tamer Soliman

Principle

2 specimens,
one very high
one very Low
are selected and analyzed
in a specific order
Carryover
Testing Procedure
Dr. Tamer Soliman

Principle

Statistical analysis is performed to


determine if there is
a statistical difference
when a very low specimen is analyzed
following a very high specimen
Carryover
Testing Procedure
Dr. Tamer Soliman

Definitions

Low-Low Results –
A low result that immediately follows another
low result

High-Low results –
low result that immediately follows a high result
Carryover
Testing Procedure
Dr. Tamer Soliman

Procedure
Step 1
• Select specimens for the analytes to be tested.
• Select one patient specimen with a very low level
of the analyte and one with a very high level.
• Select specimens with enough volume so that
they can each be run approximately 10 to 11 times.
• If patient specimens are not available, Select
appropriate controls or EQA specimens.
Carryover
Testing Procedure
Dr. Tamer Soliman

Procedure
Step 2
• Perform start-up testing as identified in the
instrument operations SOP

• Run QC following the established procedure

• Do not run any other specimens while carry


over testing is being conducted
Carryover
Testing Procedure
Dr. Tamer Soliman

3 Low specimens
Procedure 2 High specimens
1 Low specimen
Step 3 2 High specimens
Run the samples 4 Low specimens
on the same run 2 High specimens
in the following order : 1 Low Specimen
2 High specimens
1 Low Specimen
2 High specimens
1 Low Specimen

If the specimens are not analyzed on the same run


in the correct order, The results are invalid
Carryover
Testing Procedure
Dr. Tamer Soliman

Procedure
Step 4
• Record results and enter them into the spreadsheet
• or into EP evaluator (the link provided below)
• or a similar data analysis program

https://drive.google.com/open?id=1Js6gdCdXO6
HRIjMh4oKVoZstpPhB7Cra
Carryover
Testing Procedure
Dr. Tamer Soliman

Results
Step 4
• The SD of the Low-Low results will be calculated.
• The error limit is equal to 3 times the Low –Low SD.
• The Carryover test passes if the carryover is less than the error
limit.

References:
1. College of American Pathologists (CAP): Serum Carryover Survey
Product information, downloaded from www.cap.org 17 August 2009
2. EP Evaluator 8.0.0. Carryover – Report Interpretation Guidelines, David
G. Rhodes and Associates Inc.
3. Kaplan L. A., Pesce A. J., Clinical Chemistry –theory, analysis and
correlation: The C. V. Mosby Company St. Louis 1984
https://drive.google.com/open?id=1Js6gdCdXO6HR
IjMh4oKVoZstpPhB7Cra
Thanks
Dr. Tamer Soliman

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