Upload
avk11211
View
507
Download
15
Tags:
Embed Size (px)
Citation preview
Additional Master Table of Contents for CELL-DYN 3200 Software Version 3.1AT
CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum Master Table of Contents-1 9140189A—August 2003
Atypical Depolarization Flag
Overview .......................................................................................................... 15-1 Use or Function ................................................................................................ 15-3 Flagging............................................................................................................ 15-5
Additional Master Table of Contents for CELL-DYN 3200 Software Version 3.1AT
Master Table of Contents-2 CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum 9140189A—August 2003
NOTES
Additional List of Tables for CELL-DYN 3200 Software Version 3.1AT
CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum List of Tables-1 9140189A—August 2003
Atypical Depolarization Flag
Table 15.1 Flag Cause and Suggested Action .......................................... 15-5
Additional List of Tables for CELL-DYN 3200 Software Version 3.1AT
List of Tables-2 CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum 9140189A—August 2003
NOTES
CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum Revision Status & Log-1 9140189A—August 2003
Document Control
Number(s) Revision Date Section(s)
Revised Pages Revised and
Added
9140189A
August 2003 Atypical Depolarization Flag
All
Revision Status & Log-2 CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum 9140189A—August 2003
Revision Log Instructions: Use this log to provide a permanent record to verify that revised chapter(s) and/or page(s) have been added to this manual.
1. Record the document control number of the revised section in the first column. You will find the number in the footer. Make an entry for each chapter you receive and place in the manual.
2. Record the revision date, also found in the footer, in the second column.
3. Record the current CELL-DYN 3200 System software version in the third column.
4. Write your initials or signature in the fourth column to verify that you have placed the revised page(s) in the manual.
5. Record the date that you added the revised section to the manual in the fifth column.
Document Control Number
Revision Date Software Version
Revision Incorporated by
Date Incorporated
Section 15 CELL-DYN 3200 Atypical Depolarization Flag
CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum 15-1 9140189A—August 2003
Overview
The CELL-DYN 3200 Atypical Depolarization (AT) flag is available in Software Version 3.1AT. This flag, when activated, indicates that one or more cell events have located in the atypical depolarization area during CELL-DYN MAPSS algorithm analysis. This section contains all information needed for understanding and using the Atypical Depolarization flag. The organization of this section follows the organization of the rest of the CELL-DYN 3200 System Operator’s Manual.
CELL-DYN 3200 Atypical Depolarization Flag Section 15 Overview
15-2 CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum 9140189A—August 2003
NOTES
Section 15 CELL-DYN 3200 Atypical Depolarization Flag
CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum 15-3 9140189A—August 2003
Use or Function
For Software Version 3.1AT, every time a patient specimen is run, white cell differential data are automatically analyzed for atypical depolarization events. The Atypical Depolarization (ATYPDEP) flag is displayed when one or more atypical depolarization events are detected in the lobularity (90o), granularity (90o D) scatter data with a cross check done using size (0°) and complexity (10°) scatter data. Although there are anecdotal reports of an association with malaria, clinical significance has not been established for the Atypical Depolarization (ATYPDEP) flag. Abbott medical trials do not support its use for clinical diagnosis or patient management. The presence or absence of the ATYPDEP flag should not be used to replace any current diagnostic procedures applied in the laboratory. Software containing this flag is not available in the U.S.A.
CELL-DYN 3200 Atypical Depolarization Flag Section 15 Use or Function
15-4 CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum 9140189A—August 2003
NOTES
Section 15 CELL-DYN 3200 Atypical Depolarization Flag
CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum 15-5 9140189A—August 2003
Flagging Introduction
Data flags appear on the RUN screen, on printed reports and can be transmitted to a Laboratory computer system. Instructions for interpreting all flags and numeric, scatter, and histogram data should be incorporated into the laboratory’s procedure and used to determine the need for further action and / or review of results. Please see Section 3: Principles of Operation; Subsection: Operational Messages and Data Flagging for a more detailed description of CELL-DYN 3200 Data Flagging.
Suspect Population Flags
These flags are generated after the instrument evaluates the measured data for a particular parameter or group of parameters. The result may be suspect due to interfering substances or a specimen abnormality. The Atypical Depolarization flag is an additional Suspect Population Flag for WBC. The Atypical Depolarization flag (ATYPDEP) is displayed when one or more atypical depolarization events are detected in the lobularity (90o), granularity (90o D) scatter data and cross-checked with size (0°) and complexity (10°) scatter data. Table 15.1 contains the cause and suggested action for the ATYPDEP flag.
Table 15.1 Flag Cause and Suggested Action
Descriptor/Flag Cause Suggested Action
ATYPDEP One or more atypical depolarization events detected in the lobularity (90°), granularity (90° depolarizing) scatter data with cross check done using size (0°) and complexity (10°) scatter data.
Review a stained blood film to detect a possible morphologic correlate (situation), and follow your laboratory’s review criteria.
NOTE: The ATYPDEP flag is contained on a specific software upgrade that is only available outside the U.S.A., and has no clinical claims.
CELL-DYN 3200 Atypical Depolarization Flag Section 15 Flagging
15-6 CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum 9140189A—August 2003
NOTES
Additional Index CELL-DYN 3200 Atypical Depolarization Flag
CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum Additional Index-1 9140189A—August 2003
Atypical Depolarization ATYPDEP, 15-5
availability, 15-1 flag cause and suggested action, 15-5 flagging, 15-5 interfering substances, 15-5 introduction, 15-5 lobularity vs. scatter data 15-5 MAPSS™ algorithm analysis, 15-1 morphologic correlate, 15-5 overview, 15-1 review a stained blood film, 15-5 suspect population flag, 15-5
use or function, 15-3
Additional Index CELL-DYN 3200 Atypical Depolarization Flag
Additional Index-2 CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum 9140189A—August 2003
NOTES