_____ Health Center Laboratory Document#: _____/FCY/SOPs-01
TITLE:SOP for PIMA CD4 Testing Version No: 01
Effective Date: _____
Page 1 of 5
Procedure change history
Version # Replaced prepared by Reviewed by Approved by
version
Name
01 None Sign
Date
Annual Review Table for unchanged documents
Date Reviewed Reviewed By Initials
Amendment
Rev. Page Description of Amendment Amendment Effective Name &
Date Date Signature of
No. No
approval
Purpose The purpose of this SOP is to describe the procedures to be followed for
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Any document appearing in a paper form with a stamp of `CONTROLLED COPY ’in blue colour is a controlled document.
_____ Health Center Laboratory Document#: _____/FCY/SOPs-01
TITLE:SOP for PIMA CD4 Testing Version No: 01
Effective Date: _____
Page 2 of 5
the measurement of point of care CD4 testing
Abbreviations: ART – antiretroviral Treatment
EDTA - ethylenediaminetetraacetic acid (anticoagulant)
Materials: Glove ,syringe with needle
Alcohol 70%
Test tube lavender top EDTA tube
Waste bin, sharp box
PIMA analyzer
Lab coat
Pasteur pipet, micropipette
Printer, thermal paper
Reagents :
Test cartirige ,control (low & normal)
Specimen Whole blood using EDTA anticoagulants/capillary blood
The Pima test consists of a disposable Pima test cartridge, containing dried
reagents, and the Pima Analyser. A low sample volume of approx. 25 microliter
(μL) capillary or venous whole blood is collected into the test cartridge, which is
Principle then capped.
The Pima test cartridge is inserted into the Analyser and the sample sealed
within the cartridge is processed. During the course of processing the test, data is
recorded, analysed and interpreted using software embedded within the
Analyser.
Upon completion of the test the cartridge is removed from the Analyser and a test
result is displayed.
Scope The PIMA point of care CD4 analyzer will be used for the measurement of venous
CD4 count. Measurement of capillary CD4 count has also been included in this
SOP in the unlikely event that a patient refuses venous sampling but agrees to a
finger prick test.
Vinous blood collection
1. Put on a pair of clean, disposable gloves
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_____ Health Center Laboratory Document#: _____/FCY/SOPs-01
TITLE:SOP for PIMA CD4 Testing Version No: 01
Effective Date: _____
Page 3 of 5
2. Collect 5ml blood aseptically by venipuncture into a sterile EDTA tube
(purple top)
3. If other blood tubes are to be filled, the EDTA tube should be the last tube
to be filled
Specimen 4. Dispose venepuncture equipment in sharps container
collection 5. Invert EDTA tube 10 times
6. Remove a PIMA™ CD4 test cartridge from its packaging
7. Use syringe with small gauge needle, plastic pasture pipette, micropipette
100 ml to withdraw 0.1ml blood from EDTA tube
8. Transfer sample into the sample collector of the PIMA™ CD4 test cartridge
9. Dispose needle and syringe in sharps container
10. Hold the cartridge upright and observe the control window to ensure
sufficient sample has been inserted
11. Remove the sample collector from the cartridge
12. Dispose of sample collector as hazardous waste
13. Completely close orange plastic cap (should hear click)
Capillary 1. Wipe the tip of the third or fourth finger of the patient’s non-dominant
blood hand with an alcohol swab
collection 2. Use the sterile lancet to make a skin puncture
3. Do not squeeze or apply strong repetitive pressure to the finger
4. Wipe off the first drops of blood with dry gauze
5. Allow blood to flow freely into sample collector by holding the cartridge
at a 45° angle.
6. Wait until the sample collector is completely filled with blood
7. Hold the cartridge upright and observe the control window to ensure
sufficient sample has been inserted
8. Remove the sample collector from the cartridge
9. Dispose of sample collector, alcohol swab, and gauze as hazardous waste
Authority for Issue: _______ Authorized Date: ______
Any document appearing in a paper form with a stamp of `CONTROLLED COPY ’in blue colour is a controlled document.
_____ Health Center Laboratory Document#: _____/FCY/SOPs-01
TITLE:SOP for PIMA CD4 Testing Version No: 01
Effective Date: _____
Page 4 of 5
& Dispose the lancet in sharps container
10. Completely close orange plastic cap (should hear click)
Quality control 1. Daily performance check using the PIMA™ Bead control should be performed
every morning before testing any patient samples
2. Select <Run Test> on the PIMA™ CD4 analyzer
3. Insert the <PIMA Beads Normal> cartridge into the analyzer when prompted
4. Follow instructions on screen to select <Operator>
5. <Sample ID> should be entered as date (format YYYYMMDD with suffix N)
6. When prompted on completion of the analysis, remove the cartridge but DO
NOT dispose of cartridge
7. Check that the result falls within the range quoted on the cartridge container
8. Repeat steps 3.5.2 – 3.5.7 using the <PIMA Beads Low> cartridge (and using
suffix L for <Sample ID>)
9. Document that the performance check has been done on the register
(Should have a quality control log for all procedures)
1. Select <Run Test> on the PIMA™ CD4 analyzer
2. Insert the PIMA™ CD4 test cartridge into the analyzer in the direction indicated
Test procedure by the arrow on the cartridge
3. Follow instructions on screen to select <Operator>
4. <Sample ID> should be entered as SA ID number.
5. Once the message <Analysis done. Remove cartridge> appears then remove
cartridge.
6. Dispose of cartridge as hazardous waste
7. Record CD4 result in result form.
8. Print the result and attach with the request form.
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Any document appearing in a paper form with a stamp of `CONTROLLED COPY ’in blue colour is a controlled document.
_____ Health Center Laboratory Document#: _____/FCY/SOPs-01
TITLE:SOP for PIMA CD4 Testing Version No: 01
Effective Date: _____
Page 5 of 5
9. If thermal paper is not available copy the result from the PIMA LCD display.
Reference PIMA™ Analyzer User Guide
PIMA™CD4 Cartridge Guide
PIMA™ Bead Standard User Guide
Declaration
I, the undersigned laboratory personnel, certify that I am conducting every steps of
the procedures incorporated in this SOP after a prior reading.
Name Signature and Date
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Authority for Issue: _______ Authorized Date: ______
Any document appearing in a paper form with a stamp of `CONTROLLED COPY ’in blue colour is a controlled document.
