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OraSure Technologies, Inc. 2011 National HIV Prevention Conference

Performance of a Prototype Rapid, Point-of-Care Test* for Identifying

HIV Infected Individuals

* In development. Not FDA approved

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OraQuick® Rapid Test Platform

• OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test is widely used for rapid HIV testing

• Same test platform supports blood and oral fluid specimens

• Enhanced version of the OraQuick HIV test was released in early 2009 – Extended shelf life (30 months) – Improved specificity1

• First FDA approved rapid HCV test uses the same OraQuick test platform

1HIV Diagnostic Conference (2010)

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Key Design Goals of a Next Generation OraQuick® HIV Test

• Earlier detection of antibody in acute infection • Detection of antibody contemporaneous with 3rd

generation antibody EIAs • Reduced assay time

• 10-minute test • Retain simplicity and flexibility

• Low sample size (5uL) for whole blood • Retain oral fluid capability

• Maintain high specificity

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Defining the Target: Reducing the Time to Detection of HIV Antibodies in Early Infection

WB

Pos

itiv

e

Pro

clei

x (N

AT

)

3rd

Gen

EIA

Late

ral F

low

R

apid

HIV

Tes

ts

WB

Ind

eter

min

ate

0 5 10 15 20 25 (Days) Delay in time to detection between

rapid lateral flow tests and 3rd Gen EIA

Time to Detection of HIV antibody (Days)

Adapted from: Owen SM et al. (2008) J. Clin Microbiol. 46; 1588-1595

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Prototype Next Generation OraQuick® HIV Test*

Test Device

Developer Vial

Solution

Reusable Test Stand

Absorbent Packet

Specimen Collection

Loop

*In development. Not FDA approved

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Prototype Next Generation OraQuick® HIV Test: Device Design

• Intended Use – Single-use, qualitative immunoassay – HIV-1 and HIV-2 antibody detection – Compatible with whole blood, oral fluid, serum and plasma

• Test Design – Use of combination of HIV recombinant antigens and

synthetic peptides – Novel biochemistry allows for improved reaction kinetics and

high affinity antibody capture – Improved seroconversion sensitivity and improved analytical

sensitivity

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Seroconversion Sensitivity of Prototype Next Gen OraQuick® HIV Test vs. 3rd Generation EIA

Number of Panels Tested

Number of Concordant

Series

Number Detected Earlier by

EIA*

Number Detected Earlier by OQ HIV

Next Gen

Average Time to

Detection by EIA (Days)

Average Time to

Detection OQ HIV

Next Gen (Days)

Delay Days (OQ HIV Next Gen

-EIA) (95% CIs)

24 14 7 3 32.21 32.75 0.54 (-0.93 – 2.01)

*FDA approved 3rd Generation EIA

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Comparison of Seroconversion Sensitivity vs FDA Approved Rapid Test

• 24 seroconversion panels tested by prototype OraQuick Next Gen Test and currently approved rapid test (Test A)

• 12/24 (50%) panels detected earlier by the prototype OraQuick test

• 4 series did not seroconvert in available bleeds in the FDA approved rapid test

• In the other 8 panels detected earlier by the prototype Next Gen Test, the average difference in time to detection was 5 days

PanelOQ HIV

Next Gen(10 min)

Rapid Test A(15 min)

HIV-1/2/O EIA

916 30 30 30925 44 44 44926 27 27 27930 7 10 7933 21 27 21934 7 7 0943 19 21 19947 9 11 9952 17 17 14957 23 28 28959 14 14 96243 32 32 329012 21 DNS 219015 35 DNS 359019 38 38 389021 57 DNS 579032 29 38 369076 69 74 609077 52 52 529079 47 55 499081 26 26 249089 20 DNS 249096 18 18 1812007 124 124 119

DNS = Did Not Seroconvert

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Performance with Commercial Low Titer Panel PRB107

OraQuick HIV Next

Gen

HIV-1/2 EIA

US FDA-Licensed Anti-HIV Confirmatory Test HIV Ag

EIA Western Blot

Specimen # 10-min read s/co Banding

Pattern Result s/co

107-1 R 6.6 No Bands Neg 5.1

107-2 R 3.7 24, 55 Ind 14.0

107-3 R 4.5 No Bands Neg 0.8

107-4 R 9.7 No Bands Neg 1.2

107-5 NR 0.1 No Bands Neg 0.4

107-6 R 7.3 No Bands Neg 4.4

107-7 R 1.0 No Bands Neg 0.4

107-8 R 7.1 No Bands Neg 19.3

107-9 NR 2.4 No Bands Neg >29.9

107-10 R 3.5 No Bands Neg 24.5

107-11 R 3.3 24, 55, 160 Pos 3.9

107-12 NR 5.0 No Bands Neg 11.3

107-13 R 3.3 24 Ind 0.8

107-14 R 14.3 24, 160 Pos 1.7

107-15 R 2.7 24 Ind 0.8

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Performance with Commercial Low Titer Panel PRB108

OQ HIV Next Gen

Rapid Test “A”

HIV-1/2 EIA

US FDA-Licensed Anti-HIV Confirmatory Test

Western Blot

Specimen # 10-min read

15-min read s/co Banding Pattern Result

108-1 R R 10.4 24, 55, 160 Pos

108-2 NR NR 0.2 No Bands Neg

108-3 R R 9.3 160 Ind

108-4 R R 15.7 41, 120, 160 Pos

108-5 R R 4.8 24, 41, 55, 120, 160 Pos

108-6 R R 6.4 160 Ind

108-7 R R 7.3 24, 160 Pos

108-8 R R 11.0 24, 160 Pos

108-9 R R 11.8 24, 160 Pos

108-10 R R 9.6 24 Ind

108-11 R R 10.1 24, 160 Pos

108-12 R NR 2.8 No Bands Neg

108-13 R NR 13.1 24 Ind

108-14 R NR 9.6 No Bands Neg

108-15 R R 16.2 160 Ind

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Genotype Performance with Worldwide Panel

OraQuick HIV Next

Gen

HIV-1/2 EIA

US FDA-Licensed Anti-HIV Confirmatory Test

HIV-1 Western Blot

Specimen # Origin Genotype 10-min read s/co Banding Pattern Result

303-1 Ghana A R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos

303-2 Ghana A R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos

303-3 South Africa C R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos

303-4 South Africa C R >15.9 18, 24, 41, 51, 55, 66, 120, 160 Pos

303-5 Uganda D R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos

303-6 Uganda D R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos

303-7 Ghana G R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos

303-8 Ivory Coast G R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos

303-9 Spain O R 2.4 31, 51, 66, 160 Ind

303-10 Argentina F R >15.9 18, 24, 31, 41, 51, 66, 120, 160 Pos

303-11 Ivory Coast HIV-2 R 0.3 24 Ind

303-12 Argentina Neg NR 0.4 No Bands Neg

303-13 Uganda A R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos

303-14 Zimbabwe C R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos

303-15 USA B R >15.9 18, 24, 31, 41, 51, 55, 66, 120, 160 Pos

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HIV-2 Sensitivity

HIV-2 EIA + -

+

171

0

-

0

0 O

raQ

uick

Nex

t Gen

P

roto

type

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Specificity of Prototype OraQuick Next Gen Test (Plasma)

HIV-1/2/O

EIA + -

+

0

1

-

0

749 O

raQ

uick

N

ext G

en

Prot

otyp

e

99.87% specificity (99.26% - 100%)

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Performance in Preclinical Human Subject Testing

Specimen Type Fingerstick Oral Fluid

Specificity 100% (98.15% - 100%)

99.50% (97.22% - 99.99%)

Prospective Testing of 198 Low Risk Subjects

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Conclusions

• Design goals of the Next Generation OraQuick HIV test have been achieved

• Earlier detection of antibody in seroconversion – Sensitivity similar to 3rd generation EIA – Improved detection in early HIV infection compared to current

lateral flow rapid tests – Measured difference in time to detection of antibody between EIA

and current rapid tests appears smaller than previously reported • Shortened testing time – 10 minute prototype • Retains oral fluid and blood capability • Public health value of rapid HIV tests continues to reside in

identification of established, undiagnosed infection and the immediacy of test results