Implementing Rapid HIV Testing: Technologies, Legal and Cost Issues

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Implementing Rapid HIV TestingTechnologies,
Legal and Cost Issues

• Vanessa Lee, MPH
• HIV 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 it
• Personnel adapt quickly
• Efficient use of resources
• QA elements important

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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 complicated
• Lower specificity
• Serum or plasma only - requires centrifuge
  equipment
• Requires operator attention during entire process

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OraQuick Advance

• Oral Fluid
• Whole blood
• Plasma

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OraQuick

• Pros
• Simplest procedure
• Flexible read time
• Tests for HIV-2, oral fluid
• Internal 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 procedure
• 10 minute processing time
• Cons
• No flexibility in read time
• Internal 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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Sensitivity
A net with very high sensitivity would not miss
(m)any tuna
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Specificity
A net with very high specificity would not
catch many dolphins
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Sensitivity Specificity
Test
Sensitivity
Specificity
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Positive Predictive Value

• PPV is the likelihood that a positive result is a
  true positive.
• Another way to say it
• What is the chance that this person who just
  tested positive, is actually positive?

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S/S PPV

• Sensitivity is the probability that
• Test positive if patient positive
• PPV is the probability that
• Patient positive if test positive

To confuse matters even more, it is actually a
combination of prevalence and specificity (not
sensitivity) that determines a tests positive
predictive value.
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Positive Predictive Value
Test 1000 peopleSpecificity of 99.9
99.9 x 1000 999 correct negative results
1 False Positive
Positivity rate 5
Positivity rate .1
5 x 1000 50
.1 x 1000 1
50 True positives
1 True positive
1 False positive
1 False positive
51 Total positives
2 Total positives
50/51 98 ppv
1/2 50 ppv
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Positive Predictive Value
Positivity rate of 1 results in PPV of greater
than 90
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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.

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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
• Enroll in CLIA program
• Obtain a Certificate of Waiver
• Pay a biennial fee
• Follow manufacturers instructions
• 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.

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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.
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Thank you!!