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Module 2 Rapid HIV testing Algorithm.pptx
- 1. Module 2:Rapid HIVTesting Algorithm ________________________________
- 2. Learning Objectives At theend of this module, you will be able to: • Identify approved tests in the new algorithm • Understand the sequence of events the 3-test algorithm • Determine the HIV status based on the 3-test algorithm
- 3. National Rapid HIVTesting Algorithm • The algorithm involves use of combination of appropriate tests. • The rapid tests are performed serially • The sequence of tests in the algorithm should always be followed – Do not interchange them
- 4. Attributes of the3-test algorithm Test Characteristics Test 1 • Has a sensitivity value ≥99% • Has ability to correctly detect the presence of HIV antibodies (true positives) Test 2 • Has a specificity value ≥ 98% • Has ability to correctly identify the absence of HIV antibodies (true negatives). Test 3 • Has a specificity value ≥ 98% • provides definitive HIV positive status by increasing the positive predictive value of the Algorithm to 99%
- 5. The National ApprovedRapid HIV tests Test Kit Name Purpose Test 1 Trinscreen HIV • Screening for all populations 18 months and above except where Standard Q is used (as below) • NB: serological tests can also be used to test an infant in order to determine HIV exposure status when mother is unavailable for testing. Standard Q • Screening for all pregnant women presenting for the initial test at ANC in any trimester including labour and delivery • All pregnant women presenting themselves for third trimester and had a negative HIV/Syphilis test result during the 1st trimester. • All breastfeeding women presenting for the first time in the post-natal period and were never tested during ANC, labour and delivery. • Partners accompanying pregnant women for the first-time during ANC, labour and delivery or post-natal period. • Retesting for HIV. Test 2 One Step • Confirmatory 1 – when Test 1 is reactive
- 6. Testing in Non-PMTCTSettings
- 7.
- 8. HIV Testing Algorithm- 1st Tester Trinscreen OneStep Reactive Non-Reactive Report Negative Link to prevention services Report positive & refer to 2nd HTS provider at the CCC First Response Report Negative & Link to prevention services Report Inconclusive & retest after 14 days Repeat Trinscreen NOTE: If inconclusive after 14 days , report negative and advice to test again after 3 months Reactive Non-Reactive Reactive Non-Reactive Non-Reactive Reactive
- 9. What can causeinconclusive results 1. Early infection: If a person has recently been infected with HIV, their immune system may not have produced enough antibodies to be detected by the test. In such cases, it is recommended to repeat the test after 14 days. 2. Window period: The window period refers to the time between HIV infection and when the test can accurately detect antibodies or antigens related to HIV. Different tests have different window periods, and during this time, results may be inconclusive even if a person is infected. 3. Testing errors: In some cases, errors during sample collection, handling, or testing procedures can lead to inconclusive results. It is important to ensure that proper protocols are followed during testing. Note: Repeated inconclusive results are most likely to be NEGATIVE.
- 10. 2nd Tester PURPOSE: verification ofHIV status prior to ART initiation.
- 11. HIV Testing Algorithm- 2ndTester Trinscreen One Step Reactive Non-Reactive Report INCONCLUSIVE and & retest after 14 days Report POSITIVE & refer to initiate ART First Response Report INCONCLUSIVE & retest after 14 days Repeat Trinscreen NOTE: If inconclusive after 14 days , report negative and advice to test again after 3 months Reactive Non-Reactive Reactive Non-Reactive Non-Reactive Reactive Report Negative & Link to prevention services
- 12.
- 13. • What isthe sequence of tests in non-PMTCT settings. Probing Questions
- 14. Probing Questions • Whatis the sequence of tests in Non-PMTCT Settings.
- 15. Probing Questions • Whatare the three final outcomes that can be obtained after testing using the algorithm? Positive Negative Inconclusive
- 16. Probing Questions Identify the3 scenarios that lead to a negative result
- 17. HIV Testing Algorithm- 1st Tester Trinscreen OneStep Reactive Non-Reactive Report Negative Link to prevention services Report Negative & Link to prevention services Repeat Trinscreen Non-Reactive Non-Reactive Tester 1: 1. TriTrinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) 2. nscreen – non-reactive;
- 18. HIV Testing Algorithm- 2ndTester Trinscreen One Step Reactive Repeat Trinscreen Non-Reactive Non-Reactive Report Negative & Link to prevention services Tester 2: 3) Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive)
- 19. Probing Questions Discrepant ordiscordant is when two tests (e.g. Triniscreen and One step yield different results. Inconclusive is an outcome following various testing sequences in the algorithm e.g. T1 reactive, T2 non- reactive, T1 repeat reactive yields an INCONCLUSIVE result) What is the difference between discrepant /discordant results and inconclusive results
- 20. Probing Questions Identify thescenarios that lead to an inconclusive result
- 21. HIV Testing Algorithm- 1st Tester Trinscreen OneStep Reactive First Response Report Inconclusive & retest after 14 days Repeat Trinscreen NOTE: If inconclusive after 14 days , report negative and advice to test again after 3 months Reactive Non-Reactive Non-Reactive Reactive TESTER 1 1. Trinscreen: reactive, one-step: non-reactive, Repeat Trinscreen: reactive 2. Trinscreen: reactive, one-step: reactive, First response: non-reactive
- 22. HIV Testing Algorithm- 2ndTester Trinscreen One Step Reactive Non-Reactive Report INCONCLUSIVE and & retest after 14 days First Response Report INCONCLUSIVE & retest after 14 days NOTE: If inconclusive after 14 days , report negative and advice to test again after 3 months Reactive Non-Reactive TESTER 2 3. Tester 1 final result – POS, Tester 2 First Trinscreen non- reactive NEG 4. Trinscreen: reactive, one-step: reactive, First response: non- reactive
- 23. Probing Questions Tester 1gets a conclusive positive result. On retesting for initiation to treatment, Tester 2 gets first Trinscreen as non-reactive result • What is the final status given to this client? • inconclusive • Can this client be initiated to treatment? • cannot be initiated into treatment • What happens next? • request/advice to return after 14 days for retesting) NB: All QA procedures have to be in place
- 24. Probing Questions What aresome of the reasons for requesting the client to come back for retesting? Antibody concentration may be very low. Antibody levels may increase to detectable levels with time
- 25. Probing Questions A clientreturns for retesting after 14 days and gets the same results (inconclusive). What happens next? The client is considered negative and requested to return after 3 months for testing.
- 26. Dual HIV/Syphilis Testingin PMTCT settings
- 27. Standard Q One Step Reactive Non-Reactive ReportNegative Link to prevention services Report positive & refer to 2nd HTS provider First Response Report Negative Link to prevention services Report Inconclusive & retest after 14 days If inconclusive after 14 days , report negative and advice to test again after 3 months Reactive Non-Reactive Reactive Non-Reactive Non-Reactive Reactive Repeat Standard Q HIV Syphilis Reactive Non-Reactive Report Negative Report positive & treat for Syphilis HIV Testing Algorithm- 1st Tester - PMTCT
- 28. • No requirementfor syphilis retesting by a second tester. • Any syphilis results is actionable for syphilis treatment. NOTE
- 29. HIV Testing Algorithm- 2nd Tester- PMTCT Trinscreen One Step Reactive Non-Reactive Report INCONCLUSIVE and & retest after 14 days Report POSITIVE & refer to initiate ART First Response Report INCONCLUSIVE & retest after 14 days Repeat Trinscreen NOTE: If inconclusive after 14 days , report negative and advice to test again after 3 months Reactive Non-Reactive Reactive Non-Reactive Non-Reactive Reactive Report Negative & Link to prevention services
- 30. Probing Questions • Whatis the sequence of tests in PMTCT settings?
- 31. Probing Questions • Whatis the sequence of tests in PMTCT settings?
- 32. Probing Questions What canbe used in the absence of Standard Q? Triniscreen (eg when there is a stock out) Note that syphilis will not be tested in such a scenario
- 33. Probing Questions What aresome of the scenarios that you get an inconclusive result? Tester 1 • Std Q reactive, One Step non-reactive, Trinscreen reactive • Std Q reactive, One Step reactive, Std Q non-reactive Tester 2 • Trinscreen NEG • Tester 2 – any discrepant results
- 34. Probing Questions When isa client requested to come back for retesting after 3 months? • Returning after 14 days and getting an inconclusive result (definitive diagnosis not conclusive therefore follow up testing after 3 months).
- 35. FAQs • Is thethird assay a tie-breaker test? • NO. The 3rd assay is a confirmatory test . It helps to rule out false-positive. • If someone has been tested with the 2-test algorithm and is confirmed positive, do they need to be tested again with the 3-test algorithm? • No. They are tested again based on the current eligibility criteria
- 36. Key Messages 1. Alltests (Test 1, Test 2, Test 3) must be available before testing 2. An individual’s HIV status is concluded as positive when T1, T2 and T3 are all reactive 3. Only those conclusively positive by Tester 1 and Tester 2 are initiated into treatment 4. Inconclusive results should be retested after 14days 5. If on retesting after 14 days and the results are still inconclusive, the status is reported as negative, and the client is requested to retest after 3 months
Editor's Notes
- #3 _____ All people newly diagnosed with HIV Must be retested by a different testing provider to verify their HIV status prior to starting ART using the same testing strategy and algorithm. Anyone receiving HIV test should be encouraged to receive their HIV test results in the same session.
- #8 For one to be confirmed to have a HIV positive status, all the 3 tests must be reactive When two kits do not agree, they are discrepant Conclusive/inconclusive results are a final following the algorithm If repeatedly inconclusive, report negative. Such clients are reported HIV negative and should therefore be tested with the testing guidelines of the general population
- #11 T1 repeated to ensure there were no possible errors with test 1. For one to be confirmed to have a HIV positive status, all the 3 tests must be reactive For one to be confirmed to have a HIV negative status, they have to be negative by Triniscreen Emphasis on the fact that PCR is no longer used
- #13 What is the sequence of tests in general settings. (refer to testing algorithm for general settings) What are the three results that can be obtained after testing (negative, positive, inconclusive) What is the difference between discrepant /disagreement results and inconclusive results. Dispersant or disagreement is when two tests (eg Triniscreen and One step yield different results. Inconclusive is a final outcome following various testing sequences in the algorithm eg T1 reactive, T2 non-reactive, T1 repeat reactive yields and INCONCLUSIVE result) Identify the 2 scenarios that lead to an negative result Tester 1: Trinscreen – non-reactive; Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Tester 2: Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Identify the 2 scenarios that lead to an inconclusive result T1 reactive, T2 non-reactive, T1 repeat reactive Tester 1 final result – POS, Tester 2 Trinscreen NEG Tester 1 gets a conclusive positive result. On retesting for initiation to treatment, Tester 2 gets Trinscreen as non-reactive result What is the final status given to this client? (inconclusive – hence cannot be initiated into treatment) What is happens next? (request/advice to return after 14 days for retesting) NB: All QA procedures have to be in place What are some of the reasons for requesting the client to come for retesting at a later date? (antibody concentration may be very low. Antibody levels may increase to detectable levels with time) The client returns for retesting after 14 days and gets the same results (inconclusive). What happens next? (request client to return after 30 days for testing).
- #14 What is the sequence of tests in general settings. (refer to testing algorithm for Non-PMTCT settings) What are the three results that can be obtained after testing (negative, positive, inconclusive) What is the difference between discrepant /disagreement results and inconclusive results. Dispersant or disagreement is when two tests (eg Triniscreen and One step yield different results. Inconclusive is a final outcome following various testing sequences in the algorithm eg T1 reactive, T2 non-reactive, T1 repeat reactive yields and INCONCLUSIVE result) Identify the 2 scenarios that lead to an negative result Tester 1: Trinscreen – non-reactive; Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Tester 2: Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Identify the 2 scenarios that lead to an inconclusive result T1 reactive, T2 non-reactive, T1 repeat reactive Tester 1 final result – POS, Tester 2 Trinscreen NEG Tester 1 gets a conclusive positive result. On retesting for initiation to treatment, Tester 2 gets Trinscreen as non-reactive result What is the final status given to this client? (inconclusive – hence cannot be initiated into treatment) What is happens next? (request/advice to return after 14 days for retesting) NB: All QA procedures have to be in place What are some of the reasons for requesting the client to come for retesting at a later date? (antibody concentration may be very low. Antibody levels may increase to detectable levels with time) The client returns for retesting after 14 days and gets the same results (inconclusive). What happens next? (request client to return after 30 days for testing).
- #16 What is the sequence of tests in general settings. (refer to testing algorithm for general settings) What are the three results that can be obtained after testing (negative, positive, inconclusive) What is the difference between discrepant /disagreement results and inconclusive results. Dispersant or disagreement is when two tests (eg Triniscreen and One step yield different results. Inconclusive is a final outcome following various testing sequences in the algorithm eg T1 reactive, T2 non-reactive, T1 repeat reactive yields and INCONCLUSIVE result) Identify the 2 scenarios that lead to an negative result Tester 1: Trinscreen – non-reactive; Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Tester 2: Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Identify the 2 scenarios that lead to an inconclusive result T1 reactive, T2 non-reactive, T1 repeat reactive Tester 1 final result – POS, Tester 2 Trinscreen NEG Tester 1 gets a conclusive positive result. On retesting for initiation to treatment, Tester 2 gets Trinscreen as non-reactive result What is the final status given to this client? (inconclusive – hence cannot be initiated into treatment) What is happens next? (request/advice to return after 14 days for retesting) NB: All QA procedures have to be in place What are some of the reasons for requesting the client to come for retesting at a later date? (antibody concentration may be very low. Antibody levels may increase to detectable levels with time) The client returns for retesting after 14 days and gets the same results (inconclusive). What happens next? (request client to return after 30 days for testing).
- #19 What is the sequence of tests in general settings. (refer to testing algorithm for general settings) What are the three results that can be obtained after testing (negative, positive, inconclusive) What is the difference between discrepant /disagreement results and inconclusive results. Dispersant or disagreement is when two tests (eg Triniscreen and One step yield different results. Inconclusive is a final outcome following various testing sequences in the algorithm eg T1 reactive, T2 non-reactive, T1 repeat reactive yields and INCONCLUSIVE result) Identify the 2 scenarios that lead to an negative result Tester 1: Trinscreen – non-reactive; Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Tester 2: Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Identify the 2 scenarios that lead to an inconclusive result T1 reactive, T2 non-reactive, T1 repeat reactive Tester 1 final result – POS, Tester 2 Trinscreen NEG Tester 1 gets a conclusive positive result. On retesting for initiation to treatment, Tester 2 gets Trinscreen as non-reactive result What is the final status given to this client? (inconclusive – hence cannot be initiated into treatment) What is happens next? (request/advice to return after 14 days for retesting) NB: All QA procedures have to be in place What are some of the reasons for requesting the client to come for retesting at a later date? (antibody concentration may be very low. Antibody levels may increase to detectable levels with time) The client returns for retesting after 14 days and gets the same results (inconclusive). What happens next? (request client to return after 30 days for testing).
- #20 What is the sequence of tests in general settings. (refer to testing algorithm for general settings) What are the three results that can be obtained after testing (negative, positive, inconclusive) What is the difference between discrepant /disagreement results and inconclusive results. Dispersant or disagreement is when two tests (eg Triniscreen and One step yield different results. Inconclusive is a final outcome following various testing sequences in the algorithm eg T1 reactive, T2 non-reactive, T1 repeat reactive yields and INCONCLUSIVE result) Identify the 2 scenarios that lead to an negative result Tester 1: Trinscreen – non-reactive; Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Tester 2: Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Identify the 2 scenarios that lead to an inconclusive result T1 reactive, T2 non-reactive, T1 repeat reactive Tester 1 final result – POS, Tester 2 Trinscreen NEG Tester 1 gets a conclusive positive result. On retesting for initiation to treatment, Tester 2 gets Trinscreen as non-reactive result What is the final status given to this client? (inconclusive – hence cannot be initiated into treatment) What is happens next? (request/advice to return after 14 days for retesting) NB: All QA procedures have to be in place What are some of the reasons for requesting the client to come for retesting at a later date? (antibody concentration may be very low. Antibody levels may increase to detectable levels with time) The client returns for retesting after 14 days and gets the same results (inconclusive). What happens next? (request client to return after 30 days for testing).
- #23 What is the sequence of tests in general settings. (refer to testing algorithm for general settings) What are the three results that can be obtained after testing (negative, positive, inconclusive) What is the difference between discrepant /disagreement results and inconclusive results. Dispersant or disagreement is when two tests (eg Triniscreen and One step yield different results. Inconclusive is a final outcome following various testing sequences in the algorithm eg T1 reactive, T2 non-reactive, T1 repeat reactive yields and INCONCLUSIVE result) Identify the 2 scenarios that lead to an negative result Tester 1: Trinscreen – non-reactive; Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Tester 2: Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Identify the 2 scenarios that lead to an inconclusive result T1 reactive, T2 non-reactive, T1 repeat reactive Tester 1 final result – POS, Tester 2 Trinscreen NEG Tester 1 gets a conclusive positive result. On retesting for initiation to treatment, Tester 2 gets Trinscreen as non-reactive result What is the final status given to this client? (inconclusive – hence cannot be initiated into treatment) What is happens next? (request/advice to return after 14 days for retesting) NB: All QA procedures have to be in place What are some of the reasons for requesting the client to come for retesting at a later date? (antibody concentration may be very low. Antibody levels may increase to detectable levels with time) The client returns for retesting after 14 days and gets the same results (inconclusive). What happens next? (request client to return after 30 days for testing).
- #24 What is the sequence of tests in general settings. (refer to testing algorithm for general settings) What are the three results that can be obtained after testing (negative, positive, inconclusive) What is the difference between discrepant /disagreement results and inconclusive results. Dispersant or disagreement is when two tests (eg Triniscreen and One step yield different results. Inconclusive is a final outcome following various testing sequences in the algorithm eg T1 reactive, T2 non-reactive, T1 repeat reactive yields and INCONCLUSIVE result) Identify the 2 scenarios that lead to an negative result Tester 1: Trinscreen – non-reactive; Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Tester 2: Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Identify the 2 scenarios that lead to an inconclusive result T1 reactive, T2 non-reactive, T1 repeat reactive Tester 1 final result – POS, Tester 2 Trinscreen NEG Tester 1 gets a conclusive positive result. On retesting for initiation to treatment, Tester 2 gets Trinscreen as non-reactive result What is the final status given to this client? (inconclusive – hence cannot be initiated into treatment) What is happens next? (request/advice to return after 14 days for retesting) NB: All QA procedures have to be in place What are some of the reasons for requesting the client to come for retesting at a later date? (antibody concentration may be very low. Antibody levels may increase to detectable levels with time) The client returns for retesting after 14 days and gets the same results (inconclusive). What happens next? (request client to return after 30 days for testing).
- #25 What is the sequence of tests in general settings. (refer to testing algorithm for general settings) What are the three results that can be obtained after testing (negative, positive, inconclusive) What is the difference between discrepant /disagreement results and inconclusive results. Dispersant or disagreement is when two tests (eg Triniscreen and One step yield different results. Inconclusive is a final outcome following various testing sequences in the algorithm eg T1 reactive, T2 non-reactive, T1 repeat reactive yields and INCONCLUSIVE result) Identify the 2 scenarios that lead to an negative result Tester 1: Trinscreen – non-reactive; Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Tester 2: Trinscreen (reactive) , One step (non-reactive), Trinscreen (non-reactive) Identify the 2 scenarios that lead to an inconclusive result T1 reactive, T2 non-reactive, T1 repeat reactive Tester 1 final result – POS, Tester 2 Trinscreen NEG Tester 1 gets a conclusive positive result. On retesting for initiation to treatment, Tester 2 gets Trinscreen as non-reactive result What is the final status given to this client? (inconclusive – hence cannot be initiated into treatment) What is happens next? (request/advice to return after 14 days for retesting) NB: All QA procedures have to be in place What are some of the reasons for requesting the client to come for retesting at a later date? (antibody concentration may be very low. Antibody levels may increase to detectable levels with time) The client returns for retesting after 14 days and gets the same results (inconclusive). What happens next? (request client to return after 30 days for testing).
- #29 T1 repeated to ensure there were no possible errors with test 1. For one to be confirmed to have a HIV positive status, all the 3 tests must be reactive For one to be confirmed to have a HIV negative status, they have to be negative by Triniscreen Emphasis on the fact that PCR is no longer used
- #30 What is the sequence of tests in PMTCT settings. Note that Standard Q is the first test by Tester 1 If a client is POS by tester 1, Tester 2 will use Trinscreen as the first test Refer to PMTCT algorithm What can be used in the absence of Standard Q? Triniscreen (eg when there is a S/O.), Note that syphilis will not be tested in such a scenario What are some of the scenarios that you get an inconclusive result Std Q reactive, One Step non-reactive, repeat Std Q reactive Tester 1 final result – POS, Tester 2 first Trinscreen NEG When is a client requested to come back for testing after 3 months inconclusive after 1st testing Returning after 14 days and getting an inconclusive result (definitive diagnosis not conclusive therefore follow up testing after 3 months)
- #31 What is the sequence of tests in PMTCT settings. Note that Standard Q is the first test by Tester 1 If Standard Q and Onestep are discrepant by Tester 1, Trinscreen is used to co confirm If a client is POS by tester 1, Tester 2 will use Trinscreen as the first test Refer to PMTCT algorithm What can be used in the absence of Standard Q? Triniscreen (eg when there is a S/O.), Note that syphilis will not be tested in such a scenario What are some of the scenarios that you get an inconclusive result Std Q reactive, One Step non-reactive, Trinscreen reactive Tester 1 final result – POS, Tester 2 Trinscreen NEG When is a client requested to come back for testing after 3 months inconclusive after 1st testing Returning after 14 days and getting an inconclusive result (definitive diagnosis not conclusive therefore follow up testing after 3 months)
- #32 What is the sequence of tests in PMTCT settings. Note that Standard Q is the first test by Tester 1 If Standard Q and Onsterp are discrepant by Tester 1, Triniscreen is used to co confirm If a client is POS by tester 1, Tester 2 will use Trinscreen as the first test Refer to PMTCT algorithm What can be used in the absence of Standard Q? Triniscreen (eg when there is a S/O.), Note that syphilis will not be tested in such a scenario What are some of the scenarios that you get an inconclusive result Std Q reactive, One Step non-reactive, Trinscreen reactive Tester 1 final result – POS, Tester 2 Trinscreen NEG When is a client requested to come back for testing after 3 months inconclusive after 1st testing Returning after 14 days and getting an inconclusive result (definitive diagnosis not conclusive therefore follow up testing after 3 months)
- #33 What is the sequence of tests in PMTCT settings. Note that Standard Q is the first test by Tester 1 If a client is POS by tester 1, Tester 2 will use Trinscreen as the first test Refer to PMTCT algorithm What can be used in the absence of Standard Q? Triniscreen (eg when there is a S/O.), Note that syphilis will not be tested in such a scenario What are some of the scenarios that you get an inconclusive result Std Q reactive, One Step non-reactive, repeat std Q reactive Tester 1 final result – POS, Tester 2 Trinscreen NEG When is a client requested to come back for testing after 3 months inconclusive after 1st testing Returning after 14 days and getting an inconclusive result (definitive diagnosis not conclusive therefore follow up testing after 3 months)
- #35 Third test not a tie-breaker…. Give more details Tested again based on the current eligibility criteria