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Module 12 - HIV Testing Strategies and Algorithm

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Seifudin Usman
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29 views

Module 12 - HIV Testing Strategies and Algorithm

hibnnv

Uploaded by

Seifudin Usman
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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Module 11

Ethiopian Public
Health Institute

HIV Testing Strategies and


Algorithms
Learning Objectives
At the end of this module, you will be able to:
• Discuss the process for developing a national testing
algorithm
• Explain how sensitivity, specificity, positive/negative
predictive value relate to development of an HIV rapid
testing algorithm
• Explain the HIV rapid testing algorithm approved in
our country
• Determine HIV status following a particular algorithm
The Ethiopian Public
2
Lab workers Health workers Health Institute
Counselors
Content Overview
• Testing strategies and algorithms
• Developing national testing algorithm
• Measuring performance of HIV rapid tests
• Interpreting HIV status

The Ethiopian Public


3
Lab workers Health workers Health Institute
Counselors
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

The Ethiopian Public


4
Lab workers Health workers Health Institute
Counselors
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

The Ethiopian Public


5
Lab workers Health workers Health Institute
Counselors
HIV Testing Strategies
• Parallel testing
– Samples are tested simultaneously by two
different tests

• Serial testing
– Samples tested by a first test
– Result of first test determines whether additional
testing is required

The Ethiopian Public


6
Lab workers Health workers Health Institute
Counselors
Testing Algorithms Should be Developed at
National Level
Key Steps :
• Identify appropriate test kits
• Develop algorithm
• Build consensus
• Develop guidelines and conduct training
• Bring into national scale
• Review testing algorithms every 3-5 years

The Ethiopian Public


7
Lab workers Health workers Health Institute
Counselors
Timeline for Developing National Testing
Algorithm
Project Development Test Evaluation / Algorithm Development Monitoring

Phase I Phase II Phase III


(~ 3 months) (3-6 months) (6 months) (> 3 months)

Determine Capacity
Literature Review
Situation Analysis
Needs Analysis Proposal
Ethical Review Establish Panels
Procurement Evaluation
Analysis of Data Site Selection
Algorithm Decision Training of Staff
Publish Findings On Site Evaluation
Algorithm Approval
Pilot Manuals
Monitor Performance
Publish Algorithm

8
Lab workers Health workers Counselors
Advantages of National Testing Strategies
and Algorithms

Facilitates:
• Country-level standardization
• Procurement and supply management
• Training
• Quality assurance

The Ethiopian Public


9
Lab workers Health workers Health Institute
Counselors
Key Factors in Determining a Country’s
Algorithm

• Test performance in country


• Test availability in country
• Program needs
• Ease of use
• Type of specimen
• Cost
• Storage conditions

The Ethiopian Public


10
Lab workers Health workers Health Institute
Counselors
Evaluating Test Performance:
Basic Terms

• 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.
The Ethiopian Public
11
Lab workers Health workers Health Institute
Calculating Sensitivity, Specificity, PPV, & NPV

Actual HIV status (Gold Standard)


Test
resultt 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)
12
Lab workers Health workers
Calculating Sensitivity, Specificity, PPV, & NPV (Cont’d)

Actual HIV status (Gold Standard)


Test
result HIV infected HIV -uninfected Total
Positive A (370) B (2) A+B(372)
Negative C (4) D (624) C+D(628)
Total A+C (374) B+D (626) 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%
13
Lab workers Health workers
HIV Rapid Test Performance
• Not all test is 100 % sensitive
• Not all test is 100 % specific

Note: Performance of tests and subsequent


algorithm must be determined in context of
population

The Ethiopian Public


14
Lab workers Health workers Health Institute
Counselors
How Prevalence Affects PPV & NPV
(Prevalence) (Se)
PPV=
(Prevalence) (Se) + (1- Prevalence) (1- Sp)

(1-Prevalence) (Sp)
NPV=
(1-Prevalence) (Sp + (Prevalence) (1- Se)

The Ethiopian Public


Lab workers Health workers 15
Health Institute
How Prevalence Affects PPV & NPV
(Cont’d)
(Cont’d)

PPV for 10 % prevalence population:

(10/100) (98.9/100)
= ----------------------------------------------------------------------- = 97.3%
(10/100) (98.9/100) + (1- 10/100) (1- 99.7/100)

PPV for 1% prevalence population:

(1/100) (98.9/100)
= --------------------------------------------------------------------------- = 76.9%
(1/100) (98.9/100) + (1- 1/100) (1- 99.7/100)

The Ethiopian Public


Lab workers Health workers 16
Health Institute
Testing Algorithm Describes the Sequence
of Tests to be Performed
• An HIV Positive Status should be based upon the
outcome of 3 different tests
• When the two test results disagree (one is reactive,
the other non-reactive), repeat both tests to clear-
out the “discordant .”

Always follow the


sequence of the tests
in the algorithm

The Ethiopian Public


17
Lab workers Health workers Health Institute
Counselors
Ideal Algorithm
• Test kits need to be :
– Highly sensitive
– Highly specific

• Tests should not share the same false


negatives and false positives

The Ethiopian Public


18
Lab workers Health workers Health Institute
Counselors
Testing Algorithm

The Ethiopian Public


Health Institute
Summary
• Explain the importance of a tests’ Sensitivity,
Specificity, PPV, NPV
• Explain the testing algorithm adopted by MoH.
What rapid tests are used and in what order?

The Ethiopian Public


20
Lab workers Health workers Health Institute
Counselors
The Ethiopian Public
Health Institute

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