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Equ59-01 SMILE Carryover Guide

This document outlines guidelines for testing laboratory instruments for potential carryover from high specimen samples to subsequent low specimen samples. The procedure involves running a very high specimen sample followed immediately by a very low specimen sample multiple times on the same instrument run. The results are analyzed statistically to determine if there is a significant difference between the low sample results that directly follow a high sample versus low samples that follow another low sample, which could indicate potential carryover contamination. If carryover is detected that is greater than three times the standard deviation of the low-low sample results, the carryover test fails. This testing helps validate that the instrument does not have carryover issues that could contaminate subsequent patient sample results.

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372 views4 pages

Equ59-01 SMILE Carryover Guide

This document outlines guidelines for testing laboratory instruments for potential carryover from high specimen samples to subsequent low specimen samples. The procedure involves running a very high specimen sample followed immediately by a very low specimen sample multiple times on the same instrument run. The results are analyzed statistically to determine if there is a significant difference between the low sample results that directly follow a high sample versus low samples that follow another low sample, which could indicate potential carryover contamination. If carryover is detected that is greater than three times the standard deviation of the low-low sample results, the carryover test fails. This testing helps validate that the instrument does not have carryover issues that could contaminate subsequent patient sample results.

Uploaded by

benchmark Innovation
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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SMILE

Johns Hopkins University


Baltimore, MD USA

Carryover Guidelines
Name of Procedure Guideline Number Equ59-01-
G
Serum Carryover Procedure
Effective Date 6 October
2009
Subject Page 1 of 4

Serum Carryover Guidelines Supersedes New

Review date 14-Feb-


Review by Heidi Hanes 2020
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your
lab’s specific processes and/or specific protocol requirements. Users are encouraged to ensure compliance with
local laws and study protocol policies when considering the application of this document. If you have any
questions contact SMILE.

Carryover Guidelines Document Number 050

Effective Date 21 Sep 09

Subject Page 1 of 1

Guidelines for performing carryover studies Supercedes New

Author(s) Name, Title Date

Jo Shim MBA, MT(ASCP) Sep 09

Approved by Name, Title Date

Penny S. Stevens, MBS, MT (ASCP), CLS (NCA) 21 Sep 09

Review History Date of last review: 11 Aug 2010

Reviewed by: Heidi Hanes

Version Revision Date [dd/mm/yy] Description (notes)


# [0.0]

Revision History

640375981.doc Page 1 of 4
SMILE
Johns Hopkins University
Baltimore, MD USA

SMILE Carryover Guidelines


Purpose:
“Carryover” in laboratory testing, is defined as “the contamination of a specimen by the previous
one”.3. Carryover testing is performed to help to prove or disprove carryover from the sample
probe in clinical laboratory testing.

This procedure outlines the steps for testing instruments for carryover from very high specimens
being analyzed as part of a run. Two specimens, one very high and one very low are selected
and analyzed in a specific order. Statistical analysis is performed using a spreadsheet (See
Appendix 1) to determine if there is a statistical difference when a very low specimen is
analyzed following a very high specimen.

Definitions:
Low-Low Results – A low result that immediately follows another low result
High-Low results – A low result that immediately follows a high result.

Precautions:
Use Standard precautions and appropriate Personal Protective Equipment as outlined in the lab
Safety manual.

Procedure:

Step Action

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 Then

Patient specimens are not Select appropriate controls or


available. EQA specimens.

2 Perform start-up testing as identified in the instrument


operations SOP and run QC following the established
procedure.

3 Do not run any other specimens while carry over testing is being
conducted

3 Run the samples on the same run in the following order:

3 Low specimens

640375981.doc Page 2 of 4
SMILE
Johns Hopkins University
Baltimore, MD USA
2 High specimens

1Low specimen

2 High specimens

4 Low specimens

2 High specimens

1 Low Specimen

2 High specimens

1 Low Specimen

2 High specimens

1 Low Specimen

If Then

The specimens are not The results are invalid.


analyzed on the same run
in the correct order

4 Record your results and enter them into the spreadsheet (see
Appendix 1) or into EP evaluator or a similar data analysis
program.

Results:

The spreadsheet (Appendix 1) will calculate the SD of the Low-Low results. The error limit is
equal to three 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

Appendices:

640375981.doc Page 3 of 4
SMILE
Johns Hopkins University
Baltimore, MD USA
1. Appendix 1 - Carryover Spreadsheet.

640375981.doc Page 4 of 4

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