Point of Care CD4

www.pimatest.com
Pima™ - Improving access to CD4 testing

The enumeration of absolute numbers of T-helper The Pima Way - Simple, Effective POC CD4 The Pima Analyser
cells (commonly referred to as a CD4 count) has Utilising a disposable Pima CD4 test cartridge The Pima Analyser is a portable bench-top fixed • Portable & Robust

become an essential part of monitoring the course containing sealed reagents, and the portable volume cytometer used for the processing and • ‘Walk Away’ testing

of immunosuppression caused by the Human Pima Analyser, the Pima CD4 test delivers an analysis of a Pima test cartridge. • Mains A/C & Battery Powered

Immunodeficiency Virus (HIV) and the initiation of absolute count of T-helper cells in whole blood • Embedded software

Anti Retroviral Therapy. in 20 minutes. Designed to perform in a laboratory as well as in • No external calibration
non-laboratory environments, the Pima Analyser • On-board data archive
Action Impact can be operated on external power or using an
Routinely, health practitioners wishing to test
patients for CD4 are faced with the challenge of on-board rechargeable battery and requires no
not only transporting a patient sample to a testing Patient visits Patient and test maintenance.
site, but also the provision of the CD4 test result the local clinic are at the same
back to the patient. Consequently, many patients or the health place at the Data Handling
are lost to follow up. care worker may same time The Pima Analyser provides for data entry
travel to the (operator ID, sample ID), archiving and
The Pima™ CD4 test from Inverness Medical patient connectivity to printers and data storage media.
provides a revolutionary point of care solution to
the challenge of providing an absolute CD4 count All results are saved in an on-board archive
to those previously with restricted access to such Waiting time to The patient and may be retrieved and down-loaded by the
testing. result just 20 obtains CD4 result operator at any time after the test is performed.
minutes in a single visit A test report may also be printed using an
attached external Pima Printer.

If necessary*, No further delay

start or change before a clinical
therapy or refer decision is
to ART clinic implemented

• Easy
• Rapid
• Cost effective
• Point of Care
• Absolute CD4 Count

www.pimatest.com * Treatment decisions based on CD4 count should be made In accordance with your national CD4 testing guidelines www.pimatest.com
Pima™ - Improving access to CD4 testing

The enumeration of absolute numbers of T-helper The Pima Way - Simple, Effective POC CD4 The Pima Analyser
cells (commonly referred to as a CD4 count) has Utilising a disposable Pima CD4 test cartridge The Pima Analyser is a portable bench-top fixed • Portable & Robust

become an essential part of monitoring the course containing sealed reagents, and the portable volume cytometer used for the processing and • ‘Walk Away’ testing

of immunosuppression caused by the Human Pima Analyser, the Pima CD4 test delivers an analysis of a Pima test cartridge. • Mains A/C & Battery Powered

Immunodeficiency Virus (HIV) and the initiation of absolute count of T-helper cells in whole blood • Embedded software

Anti Retroviral Therapy. in 20 minutes. Designed to perform in a laboratory as well as in • No external calibration
non-laboratory environments, the Pima Analyser • On-board data archive
Action Impact can be operated on external power or using an
Routinely, health practitioners wishing to test
patients for CD4 are faced with the challenge of on-board rechargeable battery and requires no
not only transporting a patient sample to a testing Patient visits Patient and test maintenance.
site, but also the provision of the CD4 test result the local clinic are at the same
back to the patient. Consequently, many patients or the health place at the Data Handling
are lost to follow up. care worker may same time The Pima Analyser provides for data entry
travel to the (operator ID, sample ID), archiving and
The Pima™ CD4 test from Inverness Medical patient connectivity to printers and data storage media.
provides a revolutionary point of care solution to
the challenge of providing an absolute CD4 count All results are saved in an on-board archive
to those previously with restricted access to such Waiting time to The patient and may be retrieved and down-loaded by the
testing. result just 20 obtains CD4 result operator at any time after the test is performed.
minutes in a single visit A test report may also be printed using an
attached external Pima Printer.

If necessary*, No further delay

start or change before a clinical
therapy or refer decision is
to ART clinic implemented

• Easy
• Rapid
• Cost effective
• Point of Care
• Absolute CD4 Count

www.pimatest.com * Treatment decisions based on CD4 count should be made In accordance with your national CD4 testing guidelines www.pimatest.com
The Pima™ CD4 test

The Pima CD4 Test Cartridge Sample Collection The Pima CD4 Test Principle
• Absolute CD4 detection
The Pima CD4 cartridge is a unique and break­ 25μL of whole blood sample is collected into The Pima CD4 test cartridge is inserted into
• Fingerstick or Venous whole blood
through technology in the enumeration of T-helper the Pima CD4 test cartridge using the sample the Analyser and the sample sealed within the
• Low sample volume – 25μL
cells in whole blood samples. collector. cartridge is processed.
• All reagents sealed in test cartridge
• No cold-chain requirements
Requiring only 25μL of fingerstick or venous whole The sample collector is then removed and the During the course of processing the test, the
blood and with all test reagents sealed within the cartridge cap closed, sealing the sample within sample interacts with CD3 and CD4 specific
disposable cartridge, obtaining a CD4 count is now the test cartridge. monoclonal antibodies each labelled with a
Locking
easier than ever. different fluorescent dye.
Sample Collector cartridge cap
The Pima CD4 test cartridge is now ready to be
to collect the
Built-in Quality Control Features blood sample analysed by the Pima Analyser. T helper cells are automatically detected by
Each Pima CD4 test cartridge contains built-in determining where fluorescent signals from both
control features to check Analyser and reagent CD4 and CD3 antibodies are found on the same cell.
functionality.
Fingerstick Sample Collection
The collocated signals within the detection
Expiry date: The linear barcode on the Pima CD4 channel are then counted and correlated against
test cartridge contains expiry date information the volume of the detection channel and the CD4
which is checked by the Pima Analyser prior to count displayed in Cells/μL.
analysis.
Sample volume: The Pima Analyser checks Control window
Collect 25μL Sample Running a test
to check sufficient
whether sufficient sample has been loaded onto
sample volume
the Pima CD4 test cartridge.
Reagent validation: The stability of the test
reagents is validated for every individual Pima CD4
test cartridge using a built-in reagent control.
Instrument function: Fluorescent control features Check Sample Volume Insert Capped Pima CD4 Cartridge
on the Pima CD4 test cartridge are analysed to 2009–09–23 11:14
determine functionality of the Pima Analyser. pima cd4
Analysing
67352
time—to—result: 11:00
Remove Sample Collector Analysis in 20 Minutes

2009–09–23 11:25
pima cd4
Detection channel with
Sample 67352
a transparent cover CD3 CD4

BACK PRINT
Cap Cartridge View and Print CD4 Result

www.pimatest.com www.pimatest.com
The Pima™ CD4 test

The Pima CD4 Test Cartridge Sample Collection The Pima CD4 Test Principle
• Absolute CD4 detection
The Pima CD4 cartridge is a unique and break­ 25μL of whole blood sample is collected into The Pima CD4 test cartridge is inserted into
• Fingerstick or Venous whole blood
through technology in the enumeration of T-helper the Pima CD4 test cartridge using the sample the Analyser and the sample sealed within the
• Low sample volume – 25μL
cells in whole blood samples. collector. cartridge is processed.
• All reagents sealed in test cartridge
• No cold-chain requirements
Requiring only 25μL of fingerstick or venous whole The sample collector is then removed and the During the course of processing the test, the
blood and with all test reagents sealed within the cartridge cap closed, sealing the sample within sample interacts with CD3 and CD4 specific
disposable cartridge, obtaining a CD4 count is now the test cartridge. monoclonal antibodies each labelled with a
Locking
easier than ever. different fluorescent dye.
Sample Collector cartridge cap
The Pima CD4 test cartridge is now ready to be
to collect the
Built-in Quality Control Features blood sample analysed by the Pima Analyser. T helper cells are automatically detected by
Each Pima CD4 test cartridge contains built-in determining where fluorescent signals from both
control features to check Analyser and reagent CD4 and CD3 antibodies are found on the same cell.
functionality.
Fingerstick Sample Collection
The collocated signals within the detection
Expiry date: The linear barcode on the Pima CD4 channel are then counted and correlated against
test cartridge contains expiry date information the volume of the detection channel and the CD4
which is checked by the Pima Analyser prior to count displayed in Cells/μL.
analysis.
Sample volume: The Pima Analyser checks Control window
Collect 25μL Sample Running a test
to check sufficient
whether sufficient sample has been loaded onto
sample volume
the Pima CD4 test cartridge.
Reagent validation: The stability of the test
reagents is validated for every individual Pima CD4
test cartridge using a built-in reagent control.
Instrument function: Fluorescent control features Check Sample Volume Insert Capped Pima CD4 Cartridge
on the Pima CD4 test cartridge are analysed to 2009–09–23 11:14
determine functionality of the Pima Analyser. pima cd4
Analysing
67352
time—to—result: 11:00
Remove Sample Collector Analysis in 20 Minutes

2009–09–23 11:25
pima cd4
Detection channel with
Sample 67352
a transparent cover CD3 CD4

BACK PRINT
Cap Cartridge View and Print CD4 Result

www.pimatest.com www.pimatest.com
Accessories

The Pima Bag Order Code Product

Designed to protect the Pima Analyser during
260100100 Pima CD4 Cartridge kit
transportation in the field, the Pima Bag also
­ 100x Pima CD4 foil sealed test
has compartments to store additional testing
cartridges
components as well as a Pima Printer.
260400199 Finger Stick Sample Collection Kit
­ 4x units of safety lancets (x28)
­ 4x units of gauze swabs (x25)
­ 1x unit of alcoholic swabs (x100)
­ 4x units of plasters (x25)

260300001 Pima Analyser

­ 1x Pima Analyser
­ 1x Power transformer
­ 1x Power cable
­ 1x Pima Bead Standard

The Pima Printer 260400001 Pima Analyser Bag

Connected and powered through the Pima
Analyser's USB interface, the rechargeable Pima
Printer enables rapid printing of a single or
multiple test results.
­ 1x Pima Analyser Bag
260400007 Pima Printer
­ 1x Pima Printer
­­ 1x Roll Thermal Paper I
260400009 Pima Printer Paper I
­ 10x Roll Thermal Paper,
non-adhesive
260400010 Pima Printer Paper II
­ 10x Roll Thermal Paper,
coated, adhesive
260400011 Pima Bead Standard
­ 1x Normal cartridge
­ 1x Low cartridge

Inverness Medical
c/o Biosite International Inverness Medical has
Rue des Vignerons 1A changed it’s name to Alere
1110 Morges, Switzerland 0161 483 5884
Tel: +41 21 804 7 1 40 ukcustomer@alere.com
E-mail: professionaldiagnostics@invmed.com www.alere.co.uk
www.invernessmedical.com

© 2009 Inverness Medical. All rights reserved.

02PIM0693EN