1. Performing Sedia Asante: Testing algorithm
HIV-1 Rapid Test for Recent Infection: Sedia Asante HIV-1 Rapid Recency Assay
Performing Sedia Asante: Testing algorithm
International Laboratory Branch
Division of Global HIV/AIDS & Tuberculosis
Centers for Disease Control and Prevention

2. Learning Objectives At the end of this module, you will be able to:
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Learning Objectives
At the end of this module, you will be able to:
Define HIV diagnosis testing algorithms
Define HIV recent infection testing algorithm
Define HIV status and HIV recent/long-term status using an algorithm
HIV Rapid Testing Algorithms - Serial Algorithm

3. Content Overview To determine HIV status To determine recent infection
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Content Overview
To determine HIV status
Testing strategies
Testing algorithms
To determine recent infection
Interpreting test results of Asante® HIV-1 Rapid Recency Assay
HIV Rapid Testing Algorithms - Serial Algorithm

4. HIV Diagnosis – Rapid Testing Algorithm4
HIV Diagnosis – Rapid Testing Algorithm
Use HIV rapid tests at point of care
Follow defined testing steps to establish a person’s HIV status
Usually includes 2-3 different tests, performed serially or in parallel
Always follow the
sequence of the tests
in the algorithm

5. HIV Diagnosis – HIV Status
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HIV Diagnosis – HIV Status
Positive HIV diagnosis is based on reactive result of two or more different tests
When the first two tests are discordant, a third test or repeat testing must be performed as per country algorithm
The result of the third test or repeat testing determines the algorithm result
The order of the tests in the algorithm is important.
HIV Rapid Testing Algorithms - Serial Algorithm

6. HIV Diagnosis – Serial Testing Algorithm
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HIV Diagnosis – Serial Testing Algorithm
Blood Sample
1st test
Non-reactive
Reactive
Interpretation:
Negative
2nd test
Reactive
Non-reactive
**Example of testing algorithm that countries may adopt based on in-country evaluation
Interpretation:
Positive
Discordant results:
3rd test or repeat testing
Non-reactive
Reactive
Interpretation:
Negative
Interpretation:
Positive
HIV Rapid Testing Algorithms - Serial Algorithm

7. RTRI Testing Algorithm7
RTRI Testing Algorithm
Use a rapid test for recent infection (RTRI)
Add RTRI to national diagnostic algorithm as a supplementary test
Determine the HIV recent infection status of a newly diagnosed HIV patient
Viral load test can be used to confirm the recent infection status determined by RTRI.

8. RTRI Testing Algorithm (RITA)8
RTRI Testing Algorithm (RITA)
Use viral load (VL) testing to rule out false recent
Determined by rapid test for recent infection (RTRI)
According to CBS record or client self-report
Determined by diagnostic testing algorithm
HIV positive
Newly diagnosed
Recent infection
VL ≥ 1000 copies/mL: Confirmed recent infection
VL < 1000 copies/mL:
Long-term infection with viral load suppressed
Long-term infection
Negative
Previously diagnosed
Record and report the result per country guidance
Record and report the RTRI result on the recency result form. Client’s HIV status is positive, determined by diagnostic algorithm.
Optional: Rule out elite controller or patient on successful ART

9. Importance of National Testing Algorithms
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Importance of National Testing Algorithms
Country-wide standardization
Simplified procurement
Simplified supply management
Uniform training
Quality monitoring
The order of the tests in the algorithm is important.
HIV Rapid Testing Algorithms - Serial Algorithm

10. Example of Testing Algorithm
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Example of Testing Algorithm
Blood Sample
Determine HIV-1/2
Non-reactive
Reactive
Interpretation:
Negative
Stat-Pak
Non-reactive
Reactive
UniGold
Reactive
Interpretation:
Positive
Newly diagnosed
Non-reactive
Asante HIV-1 Recency Test
Interpretation:
Negative
Previously diagnosed
Long-term
Negative
Recent
**Example of testing algorithm that countries may adopt based on in-country evaluation
Interpretation:
Infection was likely acquired more than one year ago.
Interpretation:
Infection was likely acquired within last year.
Interpretation:
HIV status is not changed (positive).
Record and report per guidance
VL < 1000 copies/mL
Viral load testing
VL ≥ 1000 copies/mL
Interpretation:
Long-term infection with viral load suppressed
Interpretation:
Confirmed recent infection
HIV Rapid Testing Algorithms - Serial Algorithm

11. Diagnostic Algorithm: Example 111
Diagnostic Algorithm: Example 1
Test 1
Test 2
HIV status
No 2nd test
because
initial test was
non-reactive
HIV negative

12. Diagnostic Algorithm: Example 2
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Diagnostic Algorithm: Example 2
Test 1
Test 2
HIV status
HIV positive
HIV Rapid Testing Algorithms - Serial Algorithm

13. Diagnostic Algorithm: Example 313
Diagnostic Algorithm: Example 3
Test 1
Repeat Test 1
Test 2
HIV status
No 2nd test
is needed
because
repeat test
was valid and
non-reactive
HIV negative

14. Diagnostic Algorithm: Example 414
Diagnostic Algorithm: Example 4
Test 1
Test 2
Test 3
HIV status
HIV Positive

15. Recent Infection Algorithm: Inclusion Criteria Counselling/ CBS record15
Recent Infection Algorithm: Inclusion Criteria
Rapid Test for
Recent Infection
Diagnostic Algorithm
Counselling/ CBS record
The client was never tested for HIV before.
HIV Negative
No need to test
The client has previously been tested as HIV negative. ?
The client has been on ART.
HIV Positive
Need to be tested
The client was tested HIV positive more than one year ago but not on ART yet.
After testing with national diagnostic algorithm, we will need to use information from counselling/CBS record to find our if RTRI will be performed.
The client was not aware of his/her HIV status before.
The client was first tested HIV positive within last year but not on ART yet.

16. Recent Infection Algorithm: Result Interpretation-116
Recent Infection Algorithm: Result Interpretation-1
RTRI
RTRI Result
HIV Status
Long-term infection
HIV positive based on national algorithm

17. Recent Infection Algorithm: Result Interpretation-217
Recent Infection Algorithm: Result Interpretation-2
RTRI
RTRI Result
HIV Status
Recent infection
HIV positive based on national algorithm

18. Recent Infection Algorithm: Result Interpretation-318
Recent Infection Algorithm: Result Interpretation-3
RTRI
RTRI Result
HIV Status
Negative
HIV positive
(based on National Algorithm)

19. Review When can HIV be diagnosed with a single test?
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Review
When can HIV be diagnosed with a single test?
What is the diagnostic algorithm?
What is the recent infection testing algorithm?
What is the HIV status if RTRI result is negative?
HIV Rapid Testing Algorithms - Serial Algorithm

20. Thank You