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9-4 Regulatory Information
Methods Introduction
Overview
The Methods Introduction describes the types of information contained in the
ADVIA 2120/2120i Hematology System testing methods.
NOTE:
Unless otherwise stated, the performance data for the methods were
obtained using ADVIA 2120/2120i instruments, software, reagents, standards,
and controls designed for or intended for use on the ADVIA 2120/2120i
Hematology System.
Statement of Content
The Introduction contains information on ancillary reagents, controls, and
calibrators for the ADVIA 2120/2120i Hematology System.
The procedures necessary for the preparation, use, and storage of the ADVIA
2120/2120i Hematology System method reagents are provided in the applicable
method topics.
Sample Collection and Preparation
BIOHAZARD WARNING
All products or objects that come in contact with human or animal
body fluids should be handled, before and after cleaning, as if
capable of transmitting infectious diseases. Wear facial protection,
gloves, and protective clothing.
The operator should follow the recommendations to prevent the
transmission of infectious agents in health-care settings as
recommended for potentially infectious specimens in Protection
of Laboratory Workers from Infectious Disease Transmitted by
Blood, Body Fluids, and Tissue, 2d edition; Approved Guideline
(1997) Document M29-A, National Committee for Clinical
Laboratory Standards (NCCLS). This document contains
complete information on user protection and it can be used as
reference material for instructions on laboratory safety.
Refer to the Information Bulletin titled "Sample Handling Guidelines"
(Publication No. TN9-5729-31)
.
Collect samples in a blood collection tube or microsample blood collection
device that contains EDTA as the anticoagulant.
Refrigerate blood samples at 2°C to 8°C if they will not be analyzed within 8
hours of phlebotomy.