implementing rapid hiv testing: technologies, legal and cost issues vanessa lee, mph hiv rapid...

Implementing Rapid HIV Testing:Technologies, Legal and Cost Issues

Vanessa Lee, MPHHIV Rapid Testing Coordinator

CA Office of AIDS

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Overview

Background FDA-approved Rapid Tests Legal Issues Cost Issues Rapid Testing Resources

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Why do rapid HIV testing?

Accurate & simple Deliver results to everyone Convenient for patients

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Office of AIDS & Rapid Testing

Settings: Clinics, CBOs, Mobile units, outreach venues, jails

Populations: targeted high-risk Conclusions:

Clients like itPersonnel adapt quicklyEfficient use of resourcesQA elements important

FDA-approved Rapid HIV Tests

Factors to consider

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FDA-approved Rapid Tests

Reveal (MedMira) OraQuick (OraSure Technologies) Uni-Gold (Trinity Biotech) Multispot (Bio-Rad)

All test for HIV antibodies

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Reveal G-2 HIV-1 Test

Serum & Plasma

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Reveal G2

Pros:Fastest processing time

Cons:Somewhat complicatedLower specificitySerum or plasma only - requires

centrifuge equipmentRequires operator attention during

entire process

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OraQuick Advance

Oral Fluid Whole blood Plasma

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OraQuick

Pros:Simplest procedureFlexible read timeTests for HIV-2, oral fluidInternal control verifies addition of

sample Cons:

Longest [passive] processing time

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Uni-Gold

Whole blood Plasma & Serum

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UniGold

Pros:Relatively simple procedure10 minute processing time

Cons:No flexibility in read timeInternal control does not verify

addition of sample (03.04 PI)

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Multispot HIV-1/2

Serum Plasma

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Multispot

Pros-can distinguish between HIV-1 and 2

-approx. 10 minutes to complete process

-can read results immediately or up to 24 hours after completion

Cons

-more difficult processing steps-once test process started, must complete

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A net with very high sensitivity would not “miss” (m)any tuna

SensitivitySensitivity

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A net with very high specificity would not “catch” many dolphins

SpecificitySpecificity

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Test Sensitivity

Sensitivity & Specificity

Specificity

Uni-Gold 100% 99.7% - 99.8%

OraQuick 99.6% 99.9% - 100%

Reveal 99.8% 98.6% – 99.1%Multispot 100% 99.9%

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Confirmatory Protocols

Negative results considered conclusive (outside of window period)

Preliminary positive results must be confirmed!Oral Fluid or Blood

Lab must be informed of preliminary positive.All preliminary positives must be

confirmed by WB or IFA – even if EIA is negative.

Legal issues

Implementation requirements

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Implementation requirements

CLIA certification (Federal law) HIV approval (California law) Personnel requirements (California law)

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CLIA certification

Clinical Laboratory Improvement Amendment (CLIA)

To perform CLIA-waived tests, entities must:

1)Enroll in CLIA program2)Obtain a Certificate of Waiver3)Pay a biennial fee4)Follow manufacturers’ instructions5)Meet state requirements

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HIV approval

17 California Code of Regulations 1230 (17 CCR 1230)

Requires any entity conducting HIV testing to have a California laboratory license and be enrolled in a DHS-approved proficiency testing program.

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Personnel Requirements

California Business and Professions Code 1206.5 (BPC 1206.5)

Delineates personnel requirements for operating CLIA-categorized laboratory tests, including CLIA-waived tests.

Cost Issues

Billing and reimbursement

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Cost Issues for Non-OA Programs

Action Plan: explore how HIV testing is currently reimbursed in your site(s)

Sources mentioned by hospitals and family planning clinics include:

-private insurance

-Medi-Cal

-Family PACT

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Rapid HIV Testing Resources

CDC website Laboratory personnel (local and state) Office of AIDS guidance and protocols Test kit manufacturers

Handout includes links and contact information for resources above.

Thank you!!