Introduction; Intended Use; Test Principle; Data Handling - Abbott Pima ANALYSER User Manual

1 INTRODUCTION

Intended Use

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The Pima Analyser is a portable bench-top fixed volume cytometer used for
the processing and analysis of a Pima CD4 test cartridge.
For in vitro diagnostic use. Designed to perform in a laboratory as well as in
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non-laboratory environments, the Pima Analyser can be operated on external
power or by using an on-board rechargeable battery.
The Pima Analyser requires no maintenance.
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Test Principle

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The Pima test consists of a disposable Pima test cartridge, containing dried
reagents, and the Pima Analyser. A low sample volume of approx.
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25 microliters (µL) of capillary or venous whole blood is collected into the test
cartridge, which is then capped.
The Pima test cartridge is inserted into the Pima Analyser and the sample
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sealed within the cartridge is processed. During the course of test processing,
data is recorded, analyzed and interpreted using software embedded in the
Pima Analyser.
Upon completion of the test the cartridge is removed from the Pima Analyser
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and a test result is displayed.
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Data Handling

The Pima Analyser provides for data entry (Operator ID, Sample ID),
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archiving and connectivity to printers and data storage media.
All results are saved in an on-board archive and may be retrieved and
downloaded by the operator at any time after the test.
A Pima Test Report may also be printed using an attached external USB Printer.
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1 INTRODUCTION