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

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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

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CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum Revision Status & Log-1 9140189A—August 2003

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9140189A

August 2003 Atypical Depolarization Flag

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Revision Status & Log-2 CELL-DYN® 3200 System Operator’s Manual Atypical Flag Addendum 9140189A—August 2003

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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

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Section 15 CELL-DYN 3200 Atypical Depolarization Flag

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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

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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

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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

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