2. HIV TESTING TECHNOLOGIES
Highly sensitive, specific, simple-to-use, rapid
antibody tests that do not require sophisticated
laboratory services, running water or electricity is
an important advance
Testing can occur outside laboratory settings,
does not require specialized equipment and can
be carried out in primary health facilities by
appropriately trained non- laboratory personnel,
including counselors
3. Overview of HIV Testing
HIV tests detect antibodies or antigens
associated with HIV in whole blood, saliva, or
urine
Blood sampling is the
most common method
of testing
HIV tests are very accurate
4. Types of HIV tests
1. Antibody test
ELISA
Western Blot
Rapid tests
1. Antigen test(HIV Viral Tests)
p24 antigen test
PCR (polymerase chain reaction) tests
DNA.RNA PCR
5. Antibody testsAntibody tests
After infection with HIV, the body makes
antibodies to fight the virus
It may take 4 to 6 weeks, but occasionally up
to 3 months for antibodies to become
detectable in the blood
Rapid HIV tests and the ELISA are the most
common antibody tests
6. ELISAELISA
99.5% sensitive, standard screening test
Identifies antibodies to HIV infected pt.
Highly sensitive but not always specific.
Accurate only in pt over 18 month of age
Does not detect “window period”
Designed for large number of patients
Is not cost effective b/se all positive result
should be confirmed by additional tests?
7. Limitations of the ELISA:Limitations of the ELISA:
Tests must be done in batches of 40−90
Positive results must be confirmed with
another ELISA or Western blot
Specimens sent to a laboratory for testing—
results may take days to weeks
Test requires refrigeration and specific
reagents
8. Western BlotWestern Blot
Detects bands of protein specific to HIV
antibody
Negative in the absence of protein band
Positive with the presence of protein band
Confirmatory test.
9. Several rapid test detects HIV Anti body
They share characteristics of ELISA
Most of them are 99-100% sensitive and
specific
Specimen saliva, urine or blood
Determine KHB (screening test)
Capillus stat –pack test (confirmatory)
Uni-Gold or serocard Tie breaker
Rapid tests
10. Accurate results within 20-40 minutes
Can be done in the clinic setting
No batching required
Limitation- under 18 month & window
period
HCWs can be trained to perform the tests
Usually do not require special equipment,
electricity or refrigeration
Rapid tests cont’d
11. Benefits of rapid HIV testing includeBenefits of rapid HIV testing include
On-site testing and same day results
Lower risk of administrative error
Accepted by clients
Fewer resources required:
Human resources
Resources at the facility
Financial resources
Lower risk of occupational exposure
12. Rapid HIV Testing AlgorithmsRapid HIV Testing Algorithms
1. Serial testing
2. Parallel testing
13. Serial testingSerial testing
Blood sample taken and tested once
If first test result is non-reactive, result is
given to client as HIV-negative
If first test result is reactive, blood sample is
tested again using different brand of rapid
test
¨ If second test is reactive, result is reported as
HIV-positive
¨ If second test is negative, a third test known as
a “tiebreaker” is performed
14. 14
Algorithm for Use of 3 Rapid Tests
in Testing and Counseling Services
Pre-Test Education and/or Counseling
First HIV Rapid Test
Positive Test Result Negative test result/ Counsel for Negative Results
Second HIV rapid Test
Positive Test Result/Counsel for Positive
Results
Negative Test Result
Third HIV Rapid Test
Negative Test Result/ Counsel
for Negative Test Result
Positive Test Result/Counsel
for Positive Test Result
First HIV Rapid Test
Positive Test Result Negative test result/ Counsel for Negative Results
Positive Test Result/Counsel for Positive
Results
Negative Test Result
Third HIV Rapid Test
Negative Test Result/ Counsel
for Negative Test Result
Positive Test Result/Counsel
for Positive Test Result
15. Rapid HIV Testing
(Serial testing)
Rapid HIV Testing
(Serial testing)
First TestFirst Test
PositivePositive Negative
Counsel for Negative Result
Negative
Counsel for Negative Result
Second TestSecond Test
NegativeNegativePositive
Counsel for Positive
Result
Positive
Counsel for Positive
Result
Tie-breaker TestTie-breaker Test
Positive
Counsel for Positive
Result
Positive
Counsel for Positive
Result
Negative
Counsel for Negative
Result
Negative
Counsel for Negative
Result
16. Two HIV tests are performed on same
sample at the same time, e.g., in parallel
If both are non-reactive, client reported
HIV-negative
If both are reactive, client reported HIV-
positive
If one is reactive and the other non-reactive,
a “tiebreaker test” is performed
Parallel testingParallel testing
17. Rapid HIV Testing
(Parallel Testing)
Rapid HIV Testing
(Parallel Testing)
Both Tests Positive
Counsel for Positive Result
Both Tests Positive
Counsel for Positive Result
Both Tests Negative
Counsel for Negative Result
Both Tests Negative
Counsel for Negative Result
Tie-breaker TestTie-breaker Test
Positive
Counsel for Positive
Result
Positive
Counsel for Positive
Result
Negative
Counsel for Negative
Result
Negative
Counsel for Negative
Result
First AND Second TestFirst AND Second Test
DiscordantDiscordant
18. Interpreting HIV Antibody TestsInterpreting HIV Antibody Tests
A positive HIV test
Means that antibodies to HIV are present.
It does not mean that the client has AIDS
A negative HIV test :
The person is not infected with HIV, or
The person is infected with the virus but is in
the window period
A negative test does not mean that person cannot
become infected.
There is no such thing as immunity to HIV infection
19. Antigen test( HIV Viral Tests)Antigen test( HIV Viral Tests)
Viral tests detect the presence of HIV in blood
Viral tests must be done by trained personnel
in the laboratory
20. p24 antigen testp24 antigen test
Measures one of the HIV proteins
used for
screening blood
Infant diagnosis
21. PCR (polymerase chain reaction) testsPCR (polymerase chain reaction) tests
DNA.RNA PCR
Highly sensitive and specific for HIV
Used when the result of diagnostic tests are
unclear
Antigen testing
Most commonly utilized to diagnose HIV
infection in children <18 month
RNA PCR detects and measures amount of virus
in blood (viral load)
22. Five Steps to HIV TestingFive Steps to HIV Testing
1. A specimen is obtained
2. The specimen is processed
3. Test is conducted by a HCW or laboratory
technician
4. The client is told their result
5. HCW provides post-test counselling, support
and appropriate referrals
23. Testing Procedure for HIV InfectionTesting Procedure for HIV Infection
Infection control and
Standard Precautions
Proper labelling
Proper specimen
collection procedures
Required volume per
test
Proper reagents per
test
Correct timing per test
Interpretation of results
Proper record-keeping
Proper disposal
procedures
Observe these points:
24. Testing Procedure for HIV Infection (Continued)Testing Procedure for HIV Infection (Continued)
Factors affecting test performance:
Storage and handling of test kits
Changes in the environment
Accuracy of equipment;
external and internal controls
Shelf-life of the chemicals for the
tests (reagents)
Technique for sample collection
Quality of sample
Use of equipment
25. Monitoring
Progress in implementation
Assess effectiveness and impact (+ and -)
Access to testing and counselling, knowledge of serostatus
Uptake of prevention, treatment, care and support services
Mortality and morbidity
HIV awareness and treatment literacy
Social impact (e.g. rates of disclosure, discrimination,
adverse outcomes)
Cost effectiveness, Quality of lab services
Reasons why PITC is performed