HIV:

Testing:

• The central component in the diagnosis of HIV infection is the detection of anti-HIV
antibodies in serum, plasma, or whole blood
• Some of these assays can differentiate between HIV-1 and HIV-2 infections
• Serological tests for the detection of HIV are classified as first to fourth generation
tests based on the type of antigens used and principle of the assays

• NACO recommends the use of rapid test kits, which detect >99.5% of all HIV-infected
individuals and have false-positive results in <2% of all those who are tested.
• Common screening tests:
o ELISA
o Rapid tests:
▪ Immunoconcentration/Dot Blot assay (vertical flow)
▪ Immunochromatographic assay (lateral flow)
▪ Agglutination assay
▪ Dipstick and comb assay based on Enzyme Immune Assay (EIA)
• False positive ELISA:
o Autoimmune disease
o Alcoholic hepatitis
o Primary billiary cirrhosis
o Leprosy
o Multiple pregnancy
• False negative ELISA:
o Technical error
o Window period
• Molecular & other assays:
o Qualitative PCR for HIV DNA
o Qualitative transcription mediated amplification assay for HIV RNA
o Quantitative HIV RNA assay
o Virus isolation
o Ag detection (p24)
• National strategy for HIV detection:
o Objectives:
▪ Blood & blood product safety
 ▪ Screening of sperm, organ & tissue donors
▪ Dx of HIV in clinically suspected cases
▪ Voluntary testing after counselling
▪ Epidemiological survillence
▪ Research
• There are 3 strategies. ELISA & Rapid tests are used in these strategies
• Confirmatory tests with high specificity, like WBs and line immunoassays, are used in
problem cases, e.g., in cases of indeterminate/discordant result of E/R.
• NACO recommends the use of ELISA kits with a sensitivity of ≥99.5 percent and the
specificity of ≥98 percent and rapid kits with a sensitivity of ≥99.5 percent and the
specificity of ≥98 percent.
• Strategy 1 (for blood transfusion/transplant safety):
o The test used in strategy 1 must have high sensitivity.
o If non reactive, the specimen is to be considered free of HIV (negative) and if
reactive, the specimen is considered as HIV positive.
o The unit of blood that tests reactive (positive) is discarded.
o If the donor is to be notified of his result, based on his prior consent, it
becomes a matter of diagnosis (in which case strategies II & III must be used
after proper counselling)

o
• Strategy 2 A (used in sentinel surveillance):
o

o A specimen is considered negative for HIV if the first ELISA or rapid test reports
it so.
 o In case it is reactive, it is subjected to a second ELISA or rapid test, which
utilizes a system different from the first one (i.e., the principle of the test
and/or the antigen used is different)
o It is reported positive only if the second ELISA/rapid test also gives a reactive
report like the first test.
o In case the second E/R is non reactive, the result is taken as negative for
sentinel surveillance purposes
o This type of HIV testing is anonymous and unlinked.
• Strategy 2 B (used for diagnosis in symptomatic patients):

• Strategy 3 (used for diagnosis in asymptomatic patients):

Laboratory Tests for Monitoring Progression of HIV Infection and the Response to Antiretroviral
Therapy:

1. Immunolgical test: CD4 count

2. Virological assays:
a. HIV RNA load assay
b. Others: p24, Reverse Transcriptase activity assay
HIV PEP:

• Factors influencing risk of infection:

• Various epidemiological and laboratory studies have shown that the risk of infection,
following exposure, varies with the type of exposure:
o Type of needle (hollow bore vs. solid)
o Device visibly contaminated with patient’s blood
o Depth of injury
o The amount of blood involved in the exposure
o The amount of virus (viral load) in the exposed blood/body fluid at the time of
exposure
o Timely (<2 hours and up to 72 hours) availability and efficacy of the PEP.
• Steps of Post Exposure Management:
o Steps to be followed after accidental exposure to blood/other potentially infectious
materials:
1. First aid
2. Risk assessment
3. Informed consent and counselling
4. Decision on prophylactic treatment for HIV and HBV
5. Monitoring and follow up of HIV, HBV, and HCV status
6. Documentation and recording of exposure
 • Because PEP has its greatest effect if started within 2 hours of exposure it is essential
to act immediately. Ideally, therapy should be started within 2 hours and definitely
within 72 hours of exposure.

Monitoring and Follow-up of HIV, HBV and HCV Status:

Follow up of exposed HCPs:

• Long term follow up, counselling, and education
• Testing for at least 6 months after exposure (6 weeks, 12 weeks and 6 months)
• If PEP is used: drug toxicity monitoring at base line and after 2 weeks.