Additional Master Table of Contents for CELL-DYN 3200 Software Version 3.

1AT

Atypical Depolarization Flag

Overview .......................................................................................................... 15-1 Use or Function ................................................................................................ 15-3 Flagging............................................................................................................ 15-5

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

Master Table of Contents-1

Additional Master Table of Contents for CELL-DYN 3200 Software Version 3.1AT

NOTES

Master Table of Contents-2

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

Additional List of Tables for CELL-DYN 3200 Software Version 3.1AT

Atypical Depolarization Flag

Table 15.1 Flag Cause and Suggested Action .......................................... 15-5

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

List of Tables-1

Additional List of Tables for CELL-DYN 3200 Software Version 3.1AT

NOTES

List of Tables-2

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

Document Control Number(s) 9140189A

Revision Date

Section(s) Revised Atypical Depolarization Flag

Pages Revised and Added All

August 2003

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

Revision Status & Log-1

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

Revision Status & Log-2

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

Section 15

CELL-DYN 3200 Atypical Depolarization Flag

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 Operators Manual.

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

Overview

15-1

CELL-DYN 3200 Atypical Depolarization Flag Overview

15-2

Section 15

NOTES

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

Section 15

CELL-DYN 3200 Atypical Depolarization Flag

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 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

Use or Function

15-3

CELL-DYN 3200 Atypical Depolarization Flag Use or Function

15-4

Section 15

NOTES

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

Section 15

CELL-DYN 3200 Atypical Depolarization Flag

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 laboratorys 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 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.

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

Flagging

Suggested Action Review a stained blood film to detect a possible morphologic correlate (situation), and follow your laboratorys 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.

15-5

CELL-DYN 3200 Atypical Depolarization Flag Flagging

15-6

Section 15

NOTES

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

Additional Index 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

CELL-DYN 3200 Atypical Depolarization Flag

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003

Additional Index-1

Additional Index NOTES

CELL-DYN 3200 Atypical Depolarization Flag

Additional Index-2

CELL-DYN 3200 System Operators Manual Atypical Flag Addendum 9140189AAugust 2003