STANDARD OPERATING PROCEDURE
(SOP)
Title: HIV Testing Procedure
SOP Number: HIV-LAB-001
Version: 1.0
Effective Date: __________
Review Date: __________
Prepared By: __________
Approved By: __________
1. PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to provide standardized guidelines
for the collection, handling, testing, interpretation, documentation, and reporting of Human
Immunodeficiency Virus (HIV) test results. This procedure ensures accuracy, reliability,
confidentiality, and compliance with national and international HIV testing guidelines.
2. SCOPE
This SOP applies to all healthcare workers, laboratory personnel, counselors, and other
authorized staff involved in HIV testing services within the healthcare facility. It covers HIV
rapid testing using approved diagnostic kits and related documentation procedures.
3. RESPONSIBILITIES
Laboratory Personnel
• Perform HIV testing according to approved protocols.
• Ensure quality control procedures are followed.
• Record and report results accurately.
• Maintain equipment and testing supplies.
HIV Testing Counselors
• Provide pre-test and post-test counseling.
• Obtain informed consent where required.
• Maintain patient confidentiality.
Laboratory Supervisor
• Monitor compliance with this SOP.
• Ensure staff competency and training.
• Review quality assurance records.
Facility Management
• Provide adequate resources and approved testing kits.
• Ensure safe working conditions.
4. DEFINITIONS
HIV: Human Immunodeficiency Virus, the virus that attacks the immune system.
Rapid HIV Test: A diagnostic test that detects HIV antibodies and/or antigens and provides
results within a short period.
Quality Control (QC): Procedures used to verify the performance of testing kits and processes.
Personal Protective Equipment (PPE): Equipment worn to minimize exposure to hazards,
including gloves, laboratory coats, and masks.
5. SAFETY PRECAUTIONS
All specimens must be treated as potentially infectious.
Required PPE
• Laboratory coat
• Disposable gloves
• Face mask (where necessary)
Biosafety Measures
• Wash hands before and after specimen handling.
• Do not eat, drink, or apply cosmetics in testing areas.
• Dispose of sharps in approved sharps containers.
• Decontaminate work surfaces before and after testing.
• Report spills, accidents, and exposure incidents immediately.
Waste Disposal
• Dispose of used lancets, pipettes, and test devices as biohazardous waste.
• Follow facility waste management procedures.
6. MATERIALS AND EQUIPMENT
Materials
• Approved HIV rapid test kits
• Alcohol swabs
• Sterile lancets
• Capillary tubes or micropipettes
• Cotton wool or gauze
• Biohazard waste bags
• Sharps disposal containers
Equipment
• Timer or stopwatch
• Refrigerator (if required for kit storage)
• Temperature monitoring device
• Hand sanitizer
7. CLIENT PREPARATION
1. Welcome the client respectfully.
2. Verify client identification according to facility policy.
3. Explain the purpose, benefits, and limitations of HIV testing.
4. Provide pre-test counseling.
5. Obtain informed consent where applicable.
6. Answer any questions before specimen collection.
8. SPECIMEN COLLECTION
Finger-Prick Blood Collection
1. Verify the client's identity.
2. Label all documentation appropriately.
3. Perform hand hygiene.
4. Put on gloves.
5. Clean the selected fingertip with an alcohol swab.
6. Allow the finger to air dry.
7. Use a sterile lancet to puncture the fingertip.
8. Wipe away the first drop of blood.
9. Collect the required volume of blood using the kit-supplied collection device.
10. Apply gentle pressure to stop bleeding.
11. Dispose of the lancet immediately into a sharps container.
Venous Blood Collection (if applicable)
1. Collect blood according to the facility's phlebotomy procedure.
2. Label specimen tubes correctly.
3. Transport specimens according to established guidelines.
9. TESTING PROCEDURE
Preparation
1. Check kit expiry dates before use.
2. Ensure test kits have been stored according to manufacturer instructions.
3. Bring kits and specimens to room temperature if required.
4. Prepare a clean testing area.
Performing the Test
1. Open the test kit package immediately before use.
2. Place the test device on a flat surface.
3. Add the required amount of blood specimen to the sample well.
4. Add buffer/reagent according to the manufacturer's instructions.
5. Start the timer.
6. Allow the test to develop for the specified time.
7. Read results only within the manufacturer's recommended reading window.
Quality Control
• Run external controls according to facility policy.
• Document all quality control results.
• Do not use test kits that fail quality control requirements.
10. INTERPRETATION OF RESULTS
Non-Reactive (Negative)
• Control line appears.
• No test line appears.
• Report as HIV non-reactive according to the testing algorithm.
Reactive (Positive)
• Both control and test lines appear.
• Follow the approved national HIV testing algorithm for confirmation.
• Do not diagnose HIV infection based on a single screening test unless permitted by
national guidelines.
Invalid Result
• Control line does not appear.
• Repeat testing using a new test device.
• Document the invalid result and corrective action taken.
11. DOCUMENTATION AND REPORTING
Record the following information:
• Client identification number
• Date and time of testing
• Test kit name and lot number
• Expiry date of kit
• Test result
• Name and signature/initials of tester
Reporting Results
1. Provide results confidentially.
2. Ensure post-test counseling is conducted.
3. Explain the meaning of the results.
4. Refer reactive clients for appropriate confirmatory testing and care according to national
guidelines.
5. Maintain secure storage of records.
12. POST-TEST COUNSELING
For Non-Reactive Results
• Explain the result.
• Discuss HIV prevention measures.
• Explain the window period if relevant.
• Recommend retesting when appropriate.
For Reactive Results
• Communicate results sensitively and confidentially.
• Provide emotional support.
• Explain the need for confirmation according to national protocols.
• Refer the client to HIV care and treatment services.
13. QUALITY ASSURANCE
To ensure reliability of HIV testing services:
• Use only approved testing kits.
• Monitor storage temperatures daily.
• Participate in proficiency testing programs.
• Conduct regular staff competency assessments.
• Review documentation routinely.
• Investigate and document all testing errors.
14. REFERENCES
1. World Health Organization Guidelines on HIV Testing Services.
2. Joint United Nations Programme on HIV/AIDS HIV Testing and Counseling Guidance.
3. National HIV Testing Services Guidelines (country-specific).
4. Manufacturer Instructions for Use (IFU) for approved HIV rapid test kits.
15. DOCUMENT CONTROL
Version Date Description of Change Approved By
1.0 __________ Initial Release __________