CHAPTER 8

Quality Assurance of HIV Rapid Testing

National Laboratory and Capacity Building

Directorate
Basics Training for HIV Rapid Test in
Ethiopia
August 2022

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 Outline

• Basic principles of quality assurance in HIV rapid testing

• Errors that may compromise the quality of HIV rapid testing
• Internal and external source of quality controls at HIV rapid testing
sites.
• common problems associated with invalid test results
• External quality Assessment
• Chapter summery

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 Enabling objectives

• Explain principle of Quality assurance.

• Recognize errors that may compromise the quality of HIV rapid testing
• Apply internal and external source of quality controls at HIV rapid
testing sites
• Analyze common problems associated with invalid test results
• Practice external quality assessment (EQA) at HIV rapid testing sites

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 8.1 Basic Principle of Quality assurance (QA)

Activity 8.1. Self Reflection

Instruction: Read the following question and
answer it.

Question: What is quality assurance

Time: 3 min

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 8.1 Basic Principle of QA…

• Quality is the ability of a product or service to satisfy the needs of a

specific customer

• QA is a system designed to improve the reliability and efficiency of

laboratory services

• To ensure reliability and to reduce errors, a quality system must address

all parts of laboratory testing

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 8.1 Basic Principle of QA…

• Quality assurance is about

• Knowing what you want to do and how you want to do it
• Leaning from what you do
• Using what you learn to develop your organization and its services
• Seeking to achieve continues improvement
• Satisfying your customer

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 8.1 Basic Principle of QA…

Why Quality
assurance?
Test Site quality

Accurate,
reliable testing

Quality in all aspects of

health care

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 8.1 Basic Principle of QA…

• Components of a quality assurance include:

• Internal quality control (IQC)
• External Quality Assessment (EQA)
• Quality Improvement (QI)

• IQC:
• It is systematic internal monitoring of work practices, technical
procedures, including the HIV rapid testing kit

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 8.1 Basic Principle of QA…

• EQA:
• It is a schematic assessment by an external entity of a laboratory’s
performance
• It comparing the results with those of other participating laboratories
to assess laboratory practices and identify problems and
weaknesses

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 8.1 Basic Principle of QA…

• QI:
• It is a process by which the components HIV rapid testing services
are analyzed with the aim of identifying and permanently correcting
any deficiencies
• Data collection, data analysis, and creative problem solving are
skills used in this process

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 8.1 Basic Principle of QA…
• Quality Assurance cycle at all testing level

Patient/Client

Prep
Personnel

Reporting Data and Lab

Competency
Management

Safety

Sample Receipt &

Customer Accessioning

Record

Quality Testing & Control

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 8.2 Errors compromise the quality of HIV rapid
testing
Activity 8.2a. Think/Pair/share

Instruction: First think about the following

question and then discuss in a pair with the
participant sitting next to you and share our idea.
Question: Why do errors occur during HIV rapid
testing?
Time: 5 min

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 8.2 Errors compromise the quality of HIV rapid
testing …
• Errors can occur throughout the testing process include:
• Individual responsibilities unclear
• No written procedures
• Written procedures not followed
• Training is not done or not completed
• Checks not done for transcription errors
• Test kits not stored properly
• QC, EQA not performed
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 8.2 Errors compromise the quality of HIV rapid
testing …
Activity 8.2b: Group discussion
Instruction:
 Be in group of 5-6 people
 Discuss the below question in your group and report the
work in the plenary (share group response to the larger
groups using flipchart)
Discussion Question:
Pre testing errors and prevention action
Testing errors and prevention action
Post testing errors and prevention action
Time: 15 min for reading and discussion 5 min for each group
presentation
Total allocate time: Ꝫ25 min

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 8.2 Errors compromise the quality of HIV rapid
testing …
• Examples of errors that may occur during the three phases of the
Quality Assurance Cycle, and what you can do to prevent them
BEFORE TESTING DURING TESTING AFTER TESTING

Common • Testing device • Country algorithm not • Transcription error in

Errors mislabeled or followed reporting
unlabeled • Incorrect timing of test
• Report illegible
• Report sent to the
wrong location
• Information system
not maintained

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 8.2 Errors compromise the quality of HIV rapid
testing
• Some examples of prevention …
and detection of errors
• Check storage and • Perform and review • Re-check client/client
room temperature Quality Control (QC) identifier
• Follow safety
How to
Prevent/ precautions
Detect • Select an • Conduct test • Write legibly
Errors appropriate testing according to written
• Clean up and
workspace procedures
dispose of
• Check inventory • Correctly interpret contaminated waste
and expiration dates test results

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 8.3. Sources of quality control at HIV rapid testing sites

Activity 8.3. Think/Pair/share

Instruction: First think about the following

question and then discuss in a pair with the
participant sitting next to you and share your idea.
Question: what are sources of quality control for
HIV rapid testing
Time: 5 min

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 8.3. Sources of quality control at HIV rapid testing sites…

• QUALITY CONTROL (QC)

• QC ensures that the test is working correctly and the tester
can report accurate test results with confidence.

• There are two sources of quality control for HIV rapid testing:
• Internal and
• External

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 8.3. Sources of quality control at HIV rapid testing sites…

• Internal quality control (Procedural or in-built control):

• Internal control is an area or region within the individual testing
device.
• This area or region is also termed the procedural or in-built control
• It verifies the flow of either specimen and/or buffer through the test
device resulting in an appearance of a line or dot in the control
region.

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 8.3. Sources of quality control at HIV rapid testing sites…

• External quality controls

• Control samples that do not come with the test kit.
• They are provided by an external source such as your regional
reference laboratory or a facility laboratory.
• This type of control should also be tested in the same manner as
you would test a client or client specimen

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 8.3. Sources of quality control at HIV rapid testing sites…

• For all controls, you must:

• Label vial with date when first used
• Test before expiration date
• Take care as to not contaminate the control materials
• When do we do external source quality control samples?
At a minimum,
• Once a week
• When a new shipment of test kits are received at the testing site
• In the beginning of a new lot number
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 8.3. Sources of quality control at HIV rapid testing sites…

Quality control record

• The tester should record the QC result on the provided HIV rapid
testing quality control log sheet. (Annex 8a)
• You should review QC results periodically to detect any problems

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 8.3. Sources of quality control at HIV rapid testing sites…

• This review involves:

• Daily review of internal control results before accepting test results
• Review of external control results by test performer
• weekly or monthly review of external quality control results by testing
site supervisor

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 8.4 Common problems associated with invalid test results
Activity 8.4: Group discussion

Instruction:
 Be in group of 5-6 people
 Discuss the below question in your group and report the
work in the plenary (share group response to the larger
groups using flipchart)
Discussion Question: What do you do when you encounter
invalid test result
Time: 10 min for reading and discussion 5 min for
presentation
Total time allowed : 20 min

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 8.4 Common problems associated with invalid test results…

• INVALID result:
• If no presence of colored control line ’C’ in the results window
(irrespective of presence of test lines) indicates an invalid result
• If you get an invalid result, you must repeat the test
• In addition, you should identify the cause of the problem, inform your
supervisor and take corrective actions

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 8.4 Common problems associated with invalid test results…

• It is important to always follow the SOP for each

• type of test used, as the following may differ from kit to kit:
• Sample volume: This may differ from kit to kit, and might differ
depending on the sample type (e.g., whole blood vs. serum).
• Buffer volume: Some kits require different volumes of buffer.
• Incubation time: This time may also differ from kit to kit. Always
follow the time required by the manufacturer

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 8.4 Common problems associated with invalid test results…

• Troubleshooting Invalid Results

• Every time when you test quality record materials, you should also
record all invalid results and inform supervisor. Eg
PROBLEM POTENTIAL CAUSE ACTION

No control line or Damaged test device or controls • Repeat the test using new device and
band present blood sample
Proper procedure not followed • Follow each step of testing according
to SOP
• Re-checkbuffer and/or specimen
volumes
• Wait for the specified time before
reading the test
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 8.5 External quality Assessment (EQA)

Activity 8.5. Think/Pair/share

Instruction: First think about the following questions and

then discuss in a pair with the participant sitting next to
you and share your idea.
Question: 1. What do you mean by external quality
Assessment(EQA)

Time: 5 min

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 8.5 External quality Assessment (EQA)

• EQA is effective means of assessing a laboratory’s performance.

• The objective of EQA is to help laboratories identify errors and

improve practices for better performance

• Why participating in EQA program

• EQA allows comparison of performance and results among
different test sites
• EQA also provides objective evidence of testing quality
indicates areas that need improvement and identifies training
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 8.5 EQA…

• EQA Methods

• There are three main EQA methods:

• Proficiency testing (PT) – Proficiency panel may be used during
on-site visits.
• On-site evaluation, which is sometimes referred to as onsite
monitoring visits or audits.
• Re-testing of specimens. Now a day, this method is not
relevant for HIV rapid testing.
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 8.5 EQA…
• EQA should lead to corrective action
Identify
EQA Take Corrective
Problems

• A corrective action is an action taken to correct a problem or non-

conformance/ deficiency within the quality management system

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 8.5 EQA…

• Examples of a non- conformance include:

• Production of an incorrect result
• Test performed by untrained personnel
• Not following SOPs
• When the quality system does not meet the requirements of
quality standards or requirements

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 8.5 EQA…

• Whenever problems are detected, corrective actions must be

taken:
• Investigate root causes and develop appropriate corrective
actions
• Implement corrective actions
• Examine effectiveness
• Record all actions and findings
• Check the sample corrective action log book/form
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 8.5 EQA…
• Structure of HIV rapid panel testing

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 Roles and responsibilities at different levels

• Ethiopian Public Health Institute

• Prepare validated PT and distribute to RRLs, Sub Regional
Laboratories, Federal Hospitals, Uniformed Referral Hospitals
etc
• Prepare and send feedback results to the listed above facilities
• Follow the implementation of corrective actions
• Provide consolidated bi-annually summary report to FMOH
• Organize annual review meetings.
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 Roles and responsibilities at different levels…

• Regional Reference Laboratories

• Prepare or borrow well characterized and validated PT and
distribute to SRL, EQA Centers HFs
• Prepare and send feedback to participant laboratories
• Participate in panel testing organized by EPHI
• Take corrective actions for identified gaps
• Follow the implementation of corrective actions
• Organize review meetings annually
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 Roles and responsibilities at different levels…

• Sub-Regional Laboratories
• Participate in PT organized by EPHI and/or RRLs
• Take corrective actions on identified gaps and report to EPHI
and/or RRLs within two weeks
• Federal hospital Laboratories
• Participate in PT program organized by EPHI.
• Take corrective actions on the identified gaps and report to
EPHI within two weeks.

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 Roles and responsibilities at different levels…

• Peripheral Laboratories
• Participate in PT conducted by RRLs /uniformed referral
hospitals
• Take corrective actions on the identified gaps and report to
EPHI/RRLs/uniformed service laboratories within two weeks

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 8.6 Chapter summary

• What is principle of quality assurance at HIV rapid testing?

• What is an internal and external source of quality control at HIV

rapid testing?

• What is external quality assessment?

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 References

• CDC, U. . D. of H. and H. S. (2007). Quality Assurance Guidelines

for Testing Using Rapid HIV Antibody Tests Waived Under the
Clinical Laboratory Improvement Amendments of 1988. 27.

• Participant, E. S. T. (n.d.). COMMUNITY AND EVENT- BASED

SURVEILLANCE TRAINING PARTICIPANT.

• Quality Management System Handbook. (n.d.)

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