CHAPTER 3: HIV TESTING
STRATEGIES AND ALGORITHMS
Date 27 July 2022
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Outline
Outline
3.1. Testing Strategies and Algorithms
3.2. Process for the development of the National testing algorithm
3.3. Measuring Performance of HIV Rapid Tests
3.4. Chapter Summary
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Enabling objectives
Enabling objectives: By the end of this session the participants will be able to:
Explain the national testing strategy and algorithm
State the development of national testing algorithms
Describe sensitivity, specificity, and positive/negative predictive
value
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Strategies and Algorithms
Activity 3.1. Self-Reflection
Instruction:
Explain about the national HIV testing algorithms
Question
Reflect on HIV testing algorithms
Total time allotted: 5 minutes
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Strategies and Algorithms
• Strategies – Testing approach used to meet a specific need, such as:
– Blood Safety
– Surveillance
– Diagnosis including VCT
• Algorithms – The combination and sequence of specific tests used in a
given strategy
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Strategies and Algorithms (Cont.)
• For a given strategy, multiple algorithms may be used depending on the
needs of testing settings
• The number of algorithms should be limited
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HIV Testing Strategies
• Parallel testing
– Samples are tested simultaneously by two different tests
• Serial testing
– Samples tested by a first test
– Result of the first test determines whether additional testing is required
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HIV Testing Strategies (Cont.)
Before any test is adopted in-country for use, a series of key steps must be
taken. These steps include:
Identifying appropriate tests
Developing an algorithm
Building consensus
Developing policy
Bringing into the national scale
Reviewing testing algorithms annually
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Process for the development of the National testing algorithm
Activity 3.2. Think/Pair/Share
Instruction:
• Be in pair and discuss the below question to reflect the
larger group
Discussion Question:
• What is sensitivity?
• What is specificity?
• What are positive and negative predictive values?
Time: 5 min discussions 15 min for reflection
Total allotted time: 20 min
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Process for the development of the National testing algorithm (Cont.)
•The testing algorithm should be developed at the national level.
•A standardized approach to developing an algorithm must be taken.
•This involved building consensus and developing a policy before a test is
brought to a national scale.
•National algorithms must be reviewed every three to five years
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Process for the development of the National testing algorithm (Cont.)
Selection of Test kits Develop
Evaluation
Establishment of -Preparation of Algorithm
National TWG -Tester's training
criteria for RTK - Select tests
-Literature review selection - Conduct based on the
evaluation evaluation
-Protocol preparation -Auction
- Data collection -Develop
-Ethical approval -Receive RTK for
and analysis algorithm
evaluation
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Measuring Performance of HIV Rapid Tests
•The WHO recommends that countries conduct evaluations of HIV rapid
tests
•The evaluation considers operational characteristics.
•Product should consider its ease of use and potential for widespread
implementation.
•The choice of products must consider the technical skills of the testing
providers at the various testing sites.
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Measuring Performance of HIV Rapid Tests (con.)
Performance characteristic Suggested minimum requirement
Clinical sensitivity
Assay 1 ≥99%
Assay 2 and Assay 3 ≥99%
Clinical specificity
Assay 1 ≥98%
Assay 2 and Assay 3 ≥99%
Inter-reader variability for visually read assays
≤5% (faint test lines can increase the rate of inter-reader
Rate of variability between two or more readers of variability)
the same test result
Invalid rate
Rate of invalid test ≤5%
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Advantages of National Testing Strategies and Algorithms
• Nationally adopted testing strategies and algorithms facilitate:
• Country-level standardization of tests used in-country
• Procurement and supply management
• Implementation of a national training program
• Quality Assurance
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Key Terminology in Evaluating Test Performance
• Sensitivity (Se) of a test is its capacity to correctly identify people that are
infected with HIV.
• Specificity (Sp) of a test is its capacity to correctly identify people that are
not infected with HIV.
• Positive Predictive Value (PPV) is the probability that a person who tests
reactive is indeed infected with HIV.
• Negative Predictive Value (NPV) is the probability that a person who tests
negative is not infected with HIV.
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Calculating Sensitivity, Specificity, PPV, & NPV
Activity 3.3: Group discussion
Instruction:
Be in group of 7-8 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:
-Calculate the sensitivity, specificity, PPV and NPV of the below table
Actual HIV status (Gold Standard)
Test results HIV infected HIV -uninfected Total
Positive A (370) B (2) A+B (372)
Negative C (4) D (624) C+D (628)
Total A+C B+D 1000
Time: 5 min for discussion and 5 min for two groups presentation
Total 15 min for presentation
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Calculating Sensitivity, Specificity, PPV, & NPV
Actual HIV status (Gold Standard)
Test results HIV infected HIV -uninfected Total
Positive A B A+B
Negative C D C+D
Total A+C B+D
Sensitivity = A ÷ (A+C)
Specificity = D ÷ (B+D)
Positive Predictive Value = A ÷ (A+B)
Negative Predictive Value = D ÷ (C+D)
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Calculating Sensitivity, Specificity, PPV, & NPV
Actual HIV status (Gold Standard)
Test results HIV infected HIV -uninfected Total
Positive A (370) B (2) A+B (372)
Negative C (4) D (624) C+D (628)
Total A+C B+D 1000
Sensitivity = A ÷ (A+C) = 370 ÷ 374 = 98.9%
Specificity = D ÷ (B+D) = 624 ÷ 626 = 99.7%
PPV = A ÷ (A+B) = 370 ÷ 372 = 99.5%
NPV = D ÷ (C+D) = 624 ÷ 628 = 99.4%
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How Prevalence Affects PPV & NPV
(Prevalence) (Se)
PPV=
(Prevalence) (Se) + (1- Prevalence) (1- Sp)
(1-Prevalence) (Sp)
NPV=
(1-Prevalence) (Sp + (Prevalence) (1- Se)
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How Prevalence Affects PPV & NPV (Cont’d)
PPV for 10 % prevalence population:
(10/100) (98.9/100)
PPV = ----------------------------------------------------------------------- = 97.3%
(10/100) (98.9/100) + (1- 10/100) (1- 99.7/100)
PPV for 1% prevalence population:
(1/100) (98.9/100)
PPV = --------------------------------------------------------------------------- = 76.9%
(1/100) (98.9/100) + (1- 1/100) (1- 99.7/100)
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HIV testing Algorithms
National HIV Testing Strategy (three test algorithm instead of the tie-breaker test)
Perform A1
A1+ A1-
Report as HIV Negative
Perform A2
A1+, A2-
A1+, A2+ A1+, A2- Report HIV Inconclusive.
Plan testing after 14 days
Repeat A1 only
A1-, A2-
Report HIV Negative
Perform A3
A1+ A2+ A3+ A1+ A2+ A3-
Report HIV Positive Report HIV Inconclusive
Plan testing after 14 days
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Chapter summary
Testing strategies are defined as the testing approach used to meet a specific
need, such as blood safety, surveillance, and diagnosis.
Parallel and serial testing can be part of any testing strategy. Parallel testing
means that samples are tested simultaneously by different tests.
The testing algorithm should be developed at the national level. Because
multiple tests are marketed and available in-country, each country must
identify the appropriate tests for use within a given environment.
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