Download DoubleCheck II HIV 1&2

การประชุมวิชาการด ้านการตรวจทางห ้องปฏิบต ั ก ิ ารเอชไอวี/เอดส ์ ระดับชาติ ครัง้ ที่ 3 วันที่ 11-13 กรกฎาคม 2554 ณ โรงแรมฮอลิเดย์อน ิ น์ รีเจนท์ บีช ชะอา จ.เพชรบุรี

New Technologies and Innovations in Laboratory Support of HIV/AIDS Care and Treatment Sakchai Dettrairat HIV Laboratory

Division of Clinical Immunology Department of Medical Technology Faculty of Associated Medical Sciences, CMU

HIV/AIDS Diagnostic Landscape • Diagnostics for HIV/AIDS can be divided into 3 test categories: – Tests to facilitate initial diagnosis – Tests to stage the patient – Tests to monitor the patient, both before and after initiation of ART

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HIV Diagnostic Testing • • • •

Anti-HIV Antibody Test HIV p24 Antigen Test Nucleic Acid Amplification Tests (NAT) Viral Culture

HIV Markers During Early Infection

Theoritical Identify HIV RNA HIV p24 Ag HIV Antibody

Day 0 Day 11 Day 16 Day 22

5 Days 6 Days

11 Days

http://depts.washingto n.edu/labweb/Divisions /Viro/HIVTest.htm

Anti-HIV Antibody Tests  Screening Tests  EIA or CIA  Simple/Rapid Tests

 Confirmatory or Supplemental Tests  Western Blot (WB)  Immunofluorescence Assay (IFA)

Time during acute infection at which positive results of diagnostic tests can be obtained.

Third generation Double Antigen Sandwich ELISA for detection of HIV Ab Substrate Enzyme conjugated HIV Ag

E

Color Product E

E

IgG Ab

E

E

E IgM Ab

rHIV Ag and

synthetic peptides

Env/Core Ags

Fourth generation Sandwich ELISA for detection of HIV Abs and Ag Substrate Enzyme conjugated HIV Ag E E E E

Anti-HIV Ab rHIV Ag/ peptide

Color Product Enzyme-conjugated Anti-p24 Ab

E E

p24 Ag

Anti-p24 Ab

Fourth-generation combination EIAs

HIV Rapid Tests • Qualitative test to detect HIV-1/2 Abs • Simple/Moderate Complexity • Small sample volumes • Serum/Plasma/Whole blood • Visual Reading • Results in 10-15 minutes Lateral flow strip

Rapid testing is the method of choice when immediate information is necessary to determine the need for prophylaxis, such as in the labor/delivery, newborn, or post-exposure settings, or when the person who is being tested is unlikely to return for a follow-up visit.

HIV Lateral Flow Strips

HIV Rapid Test or Lateral Flow Strip for detection of antibodies to HIV-1/2

Control line (Anti-HIV) Test line (HIV Ag)

Colloidal Goldconjugated HIV Ag Patient sample

Thailand HIV testing algorithm for individual diagnosis • National Guidelines on HIV/AIDS Diagnosis and Treatment: Thailand 2010

• National Guide for HIV Testing. MOPH 2007

HIV testing Algorithms in Adults and Children >18 M

A1

A1- (NR)

A1+ (R)

A2 A1+, A2-

A1+, A2+

Repeat A1 and A2

A1-, A2-

A1+, A2-

A1+, A2+ A3

A1+, A2+, A3Anti-HIV negative

Indeterminate Retest at 2 W/3 and 6 m

A1+, A2+, A3+ Anti-HIV Positive Retest sample 2

HIV testing Algorithms in Children 29%, 200-500 ~ 14-28%,