Performing Maxim Swift RIA: Testing algorithm HIV-1 Rapid Test for Recent Infection: Maxim Swift Recent Infection Assay (RIA) Performing Maxim Swift RIA: Testing algorithm International Laboratory Branch Division of Global HIV/AIDS & Tuberculosis Centers for Disease Control and Prevention

Learning Objectives At the end of this module, you will be able to: 2005 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

Content Overview To determine HIV status To determine recent infection 2005 Content Overview To determine HIV status Testing strategies Testing algorithms To determine recent infection Interpreting test results of Maxim Swift Recent Infection Assay (RIA) HIV Rapid Testing Algorithms - Serial Algorithm

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

HIV Diagnosis – HIV Status 2005 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 or repeat testing determines the algorithm result The order of the tests in the algorithm is important. HIV Rapid Testing Algorithms - Serial Algorithm

HIV Diagnosis – Serial Testing Algorithm 9/4/2019 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

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.

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

Importance of National Testing Algorithms 2005 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

Example of Testing Algorithm 9/4/2019 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 Maxim Swift RIA 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

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

Diagnostic Algorithm: Example 2 9/4/2019 12 Diagnostic Algorithm: Example 2 Test 1 Test 2 HIV status HIV positive HIV Rapid Testing Algorithms - Serial Algorithm

Diagnostic Algorithm: Example 3 13 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

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

Recent Infection Algorithm: Inclusion Criteria Counselling/ CBS record 15 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.

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

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

Recent Infection Algorithm: Result Interpretation-3 18 Recent Infection Algorithm: Result Interpretation-3 RTRI RTRI Result HIV Status Negative HIV positive (based on national Algo)

Review When can HIV be diagnosed with a single test? 2005 19 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

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