1 st and 2 nd Generation EIA
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1 HIV Diagnostic Tests Bernard M. Branson, M.D. Associate D irector for Laboratory D iagnostics Division of HIV/AIDS Prevention Centers for D isease Control & Prevention The views expressed in this presentation are those of the author and do not necessarily represent those of the Centers for Disease Control and Prevention
2 Generations
3 1 st and 2 nd Generation EIA Plasma/serum (1 h/37 o C) Plasma/serum IgG HIV antibody Antigen 1 st - Viral lysate 2 nd Recombinant proteins or synthetic peptides Enzymedetection enzyme anti-human IgG Detects HIV IgG Color reagent
4 EIA Western blot IFA
5 3 rd Generation Sandwich EIA HIV antibody Plasma/serum IgG IgM Antigen: Recombinant proteins or synthetic peptides Enzymedetection enzyme HIV antigen Detects HIV IgM or IgG Color reagent
6 4 th Generation Combo EIA Plasma/serum HIV antibodies p24 antigen HIV antigen p24 antibody Enzymedetection HIV antigen p24 antibody Detects IgM or IgG antibody or p24 antigen i Color reagent
7 HIV Infection and Laboratory Markers HIV RNA (plasma) HIV Antibody HIV p24 Ag Days Infection 4th gen 3 rd gen 2 nd gen 1 st gen Modified after Busch et al. Am J Med
8 1987 Vironostika EIA Abbott Genetic Systems HIV-1/HIV-2 HIV-1/HIV-2 EIA Peptide EIA 3 rd & 4 th gen lab screening tests 2003 GS HIV-1 HIV-2 Plus O EIA 2006 Advia Centaur 1/O/2 CIA 2008 Ortho Vitros HIV 1+2 CIA 2010 Abbott Architect Ag/Ab Combo CIA 2011 Bio-Rad Ag/Ab Combo EIA 1985 Abbott HIV-1 EIA 1991 Cambridge Western blot 1992 Fluorognost IFA 1998 Genetic Systems rlav (HIV-1) 1 st gen confirmatory 2002 OraQuick HIV-1/HIV-2 Rapid Test 2003 Unigold Reveal HIV-1 Rapid Tests 2004 Multispot HIV-1/HIV-2 Rapid Test 2006 Aptima Qualitative RNA 2009 Avioq HIV-1 EIA 2 nd gen rapid tests 2010 INSTI HIV-1 Rapid Test
9 Uni-Gold Recombigen 2003 Multispot HIV-1/HIV Clearview Complete HIV 1/ Reveal G OraQuick Advance 2002 Clearview HIV 1/2 Stat Pack 2006
10 Rapid HIV Test Results without Rapid Test Kits
11 Random Access Multiplatform analyzers for HIV testing On-board Refrigeration of Multiple Different Assays
12 Random Access Multiplatform analyzers for HIV testing STAT sample requests without pausing Results in < 60 minutes
13 ADVIA Centaur H IV 1/O /2 Enhanced (EH IV) Chemiluminescent immunoassay 3 rd generation format - HIV-1: gp41, p24 - HIV-2: gp36 - group O Time to result < 1 hour FDA-approved July 2006
14 Ortho VITROS ECi/ECiQ Chemiluminescent immunoassay 3 rd generation format - HIV-1: gp41, gp120, p24 - HIV-2: gp36 - group O Time to result < 1 hour Repeat only borderline results FDA-approved March 2008
15 Abbott Architect 4 th Generation Ag/Ab Combo Assay Chemiluminescent immunoassay D etects p24 antigen and H IV antibody Time to result: 29 minutes FDA-approved June 22, 2010
16 APTIMA Qualitative HIV-1 RNA Assay Aid to H IV-1 diagnosis D iagnosis of acute H IV-1 infection in antibody-negative persons Confirmation of H IV-1 infection in antibody-positive persons when it is reactive FDA-approved July 2006
17 Bio-Rad GS HIV Combo Ag/Ab EIA Microwell plate EIA 3 rd generation format: - HIV-1: gp160 - HIV-2: gp36 - Group O p24 antigen FDA-approved July 25, 2011
18 Relative Seroconversion Sensitivity 1.00 Cumulative frequency of positive tests days to WB positive Genprobe Architect 4th BioRad 4th Advia 3rd Vitros 3rd Abbott 3rd BioRad 3rd Insti Multispot Reveal Statpak Complete Unigold Oraq Adv 26 seroconverters were analyzed with 14 tests 17 seroconverters with WB positive used for cumulative frequency analysis
19 Sequence of Test Positivity Relative to WB APTIMA (-26) 166 specimens, 17 Seroconverters - 50 % Positive Cumulative Frequency Architect Ag/Ab Combo (-20) Bio-Rad Ag/Ab Combo (-19) Determine Ag/Ab Combo (-15) Advia (-14) Vitros (-13) GS 1/2+ O (-12) INSTI (-9) Multi-Spot (-7) Reveal G3, Avioq (-6) CO M PLETE H I V-1/2 (-5) HIV-1/2 STAT-PAK (-5) Unigold (-2) OraQuick (-1) WB positive Vironostka (+ 2) Days before WB positive Modified from Masciotra et al, J Clin Virol 2011 and Owen et al, J Clin Micro
20 Acute Infections in MSM detected by RNA only 0.3% of 14,005 frequently tested MSM in Seattle STD clinic; 20% of all HIV infections detected - Stekler et al, Clin Infect Dis (74%) of 35 AHI cases detected in LA at MSM clinic; 25% of all HIV infections detected - Patel et al, Archives Int Med % of 21,425 STD clinic patients in New York City; 9% of all HIV infections detected; 94% were MSM - Shepard et al, MMWR 2009
21 RNA vs. 4 th Generation Ag/Ab Assay RN A+ / 3 rd gen-negative specimens detected by 4 th generation EIA: 38 of 46 (83%) Australia* 10 of 14 (71%) CDC AHI study* * 51 of 61 (84%) CDC panel** * 4 days after RNA 9 seroconversion panels* * * * Cunningham P, HIV Diagnostics Conf 2007 ** Patel P, CROI 2009 *** Owen M, CROI 2009
22 On the Horizon
23 Ag/Ab Rapid Test Point-of-care finger-stick viral load and CD4 analyzer Point-of-careHIV-1/2 antibody differentiation assay with automated reader
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