2. 1985: First HIV-1 ELISA Approved by FDA
10,264 reported cases of AIDS in the United States

3. Traditional Diagnostic HIV Testing
Since inception, testing technology driven by
blood screening needs:
High volume
Maximal sensitivity
but…
Complex equipment
Technically demanding
Centralized, time-consuming
Expensive

4. 1987: What is the Role of Diagnostic Testing in the Prevention and Control of HIV?
35,068 reported cases of AIDS in the United States

5. 1989: Western Blot
161,073 reported cases of AIDS in the United States

6. The Roll-out of Rapid HIV Testing
The United States
Bernard M. Branson, M.D.
Associate Director for Laboratory Diagnostics Division of HIV/AIDS Prevention – CDC
12th CROI - February 23, 2005

8. The Roll-out of Rapid HIV Testing
CLIA-waived
The Roll-out of Rapid HIV Testing in
The United States
Bernard M. Branson, M.D.
Associate Director for Laboratory Diagnostics Division of HIV/AIDS Prevention – CDC
12th CROI - February 23, 2005

10. HIV Screening with OraQuick in the MIRIAD Study
4/30/2019
HIV Screening with OraQuick in the MIRIAD Study
To date
7680 women screened
54 (0.7%) new HIV infections identified
6 false positive OraQuick tests, no false negatives
15 false-positive EIAs: 7 p24 only, 8 WB negative
4 infants infected; 3 of these in utero
Specificity: OraQuick 99.92%; EIA 99.80%
Positive Predictive value: OraQuick 90%; EIA 76%
These are the results of PMTCT with rapid testing in labor and delivery in the U.S.
In this study, conventional EIA testing was performed on all persons, in addition to the rapid test.
The OraQuick rapid test showed no false-negative test results, and fewer false-positive tests than the EIA.
Bulterys et al, JAMA July 2004
Poster 788
Rapid Tests for HIV

11. 4/30/2019
Perinatally Acquired AIDS Cases by Year of Diagnosis, 1981–2002, United States
Number of cases
Year of diagnosis 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 81 82 83 84
Rapid Tests for HIV

12. Multispot HIV-1/HIV-2
Uni-Gold Recombigen
Reveal G2
OraQuick Advance

14. 2003-05 AHP Rapid Testing Demonstration Projects
4/30/2019
AHP Rapid Testing Demonstration Projects
Routine Testing in Medical Settings
Rapid Testing in Short-Stay Corrections Settings
Rapid Testing in Non-Medical Settings
PCRS with Rapid Testing
Social
Networks
Total Orgs Funded
4 HDs
7 CBOs
6 HDs
9 CBOs
Total Number Tested
6,506
12,300
8,060
179
1,048
Total HIV-positive (percent) 58
(0.9%)
196
(1.7%)
134
(1.6%) 15
(8%) 74
(7%)
Through December 2004
Rapid Tests for HIV

16. Laboratory Diagnostics
4/30/2019
Symptoms
p24 Antigen
HIV RNA
HIV ELISA*
HIV infection can be detected weeks before antibody tests turn positive
The presence of HIV can be detected using tests that detect HIV directly in the blood, as early as 1-2 weeks after infection. Antibody tests take one to nine weeks longer.
The big question is: do people show up for HIV tests during the first few weeks after infection? If not, the question of when different tests detect HIV would be moot. BUT IF THEY DO, we could be missing a lot of HIV infections with our HIV testing practices, which rely on HIV antibody detection alone.
Weeks Since Infection
*3rd generation, IgM-sensitive EIA
*2nd generation EIA
After Fiebig et al, AIDS 2003; 17(13):1871-9
*viral lysate EIA
Rapid Tests for HIV

17. EIAs Used by Public Health Labs
FDA approval date
% used by PHL labs, 2004
Vironostika HIV-1 Microelisa
1987
63%
Abbott HIVAB HIV-1/2
1992
20%
Genetic Systems rLAV
1998
Gen Sys HIV-1/HIV-2
2000
18%
Gen Sys HIV-1/2 Plus O
2003
10%
Vironostika HIV-1 Plus O 2%
viral lysate EIA

18. EIAs Used by Public Health Labs
FDA approval date
% used by PHL labs, 2004
Vironostika HIV-1 Microelisa
1987
63%
Abbott HIVAB HIV-1/2
1992
20%
Genetic Systems rLAV
1998
Gen Sys HIV-1/HIV-2
2000
18%
Gen Sys HIV-1/2 Plus O
2003
10%
Vironostika HIV-1 Plus O 2%
viral lysate EIA
2nd generation EIA

19. EIAs Used by Public Health Labs
FDA approval date
% used by PHL labs, 2004
Vironostika HIV-1 Microelisa
1987
63%
Abbott HIVAB HIV-1/2
1992
20%
Genetic Systems rLAV
1998
Gen Sys HIV-1/HIV-2
2000
18%
Gen Sys HIV-1/2 Plus O
2003
10%
Vironostika HIV-1 Plus O 2%
viral lysate EIA
2nd generation EIA
3rd generation, IgM-sensitive EIA

20. Monitor Performance of EIAs
FDA approval date
% used by PHL labs, 2004
Vironostika HIV-1 Microelisa
1987
63%
Abbott HIVAB HIV-1/2
1992
20%
Genetic Systems rLAV
1998
Gen Sys HIV-1/HIV-2
2000
18%
Gen Sys HIV-1/2 Plus O
2003
10%
Vironostika HIV-1 Plus O 2%
viral lysate EIA
2nd generation EIA
3rd generation, IgM-sensitive EIA

21. As New EIAs Are Used by Public Health Labs
FDA approval date
% used by PHL labs, 2004
Vironostika HIV-1 Microelisa
1987
63%
Abbott HIVAB HIV-1/2
1992
20%
Genetic Systems rLAV
1998
Gen Sys HIV-1/HIV-2
2000
18%
Gen Sys HIV-1/2 Plus O
2003
10%
Vironostika HIV-1 Plus O 2%
viral lysate EIA
2nd generation EIA
3rd generation, IgM-sensitive EIA

22. Pooled RNA Screening for Early HIV Infection

23. Awareness of Serostatus among Persons with HIV, United States
4/30/2019
Awareness of Serostatus among
Persons with HIV, United States
Number HIV infected , ,000
Number unaware of
their HIV infection , ,000
Rapid Tests for HIV

24. ~25% Unaware of Infection
4/30/2019
Awareness of Serostatus Among People with HIV and Estimates of Transmission
~25% Unaware of Infection
Accounting for:
~55% of New Infections
Currently, in the United States, there are an estimated 850, ,000 people who are infected with HIV. Of those, the majority of people, an estimated 670, ,000 – or 75% – are aware of their status.
But that leaves 25% – or 180,000 to 280,000 people – unaware they are infected with HIV.
It has been estimated that infections transmitted from this group account for 27,000, or 2/3, of the 40,000 new infections per year.
The importance of getting these individuals tested and into treatment that includes prevention interventions is critical.
~75% Aware of Infection
~45% of New Infections
People Living with HIV/AIDS: 850, ,000
New Sexual Infections Each Year: ~36,000
Rapid Tests for HIV

25. What is the Role of Diagnostic Testing in the
Prevention and Control of HIV?
21-24 million diagnostic HIV tests each year
16-18 million persons tested

27. Challenges Cost Regulatory constraints
The role for antibody diagnostics
More new developments