Скачать презентацию Rapid HIV Testing 2003 Update Bernard M Branson Скачать презентацию Rapid HIV Testing 2003 Update Bernard M Branson

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Rapid HIV Testing: 2003 Update Bernard M. Branson, M. D. Chief, Lab Determinants and Rapid HIV Testing: 2003 Update Bernard M. Branson, M. D. Chief, Lab Determinants and Diagnostics Section Centers for Disease Control and Prevention

Why do we need rapid HIV tests? Why do we need rapid HIV tests?

HIV Prevalence, 1989 -2000 Publicly-funded Counseling & Testing Sites HIV Prevalence, 1989 -2000 Publicly-funded Counseling & Testing Sites

What if rapid HIV tests were used in all public testing sites? Site HIV What if rapid HIV tests were used in all public testing sites? Site HIV C/T sites STD Clinics Drug Treatment Family Planning Other testing sites Prevalence 1. 9% 1. 6% 2. 9% 0. 4% 2. 1% Rapid test Source: CDC Client Record Database, 1995 Return for Results HIV+ HIV 82. 1% 84. 3% 67. 8% 48. 1% 73. 6% 70. 8% 76. 9% 63. 0% 73. 2% 64. 6% 97. 0% 93. 0%

What if rapid HIV tests were used in all public testing sites? 1996 1997 What if rapid HIV tests were used in all public testing sites? 1996 1997 1998 1999 2000 40, 000 0 2, 000 Receive HIV Positive Results Receive HIV Negative Results Standard testing Additional, Rapid Test

1998: PHS Recommendation Changed MMWR 47: 211 -15, 1998 1998: PHS Recommendation Changed MMWR 47: 211 -15, 1998

Ora. Quick Rapid HIV-1 Antibody Test Ora. Quick Rapid HIV-1 Antibody Test

FDA-approved for use with whole blood; granted CLIA waiver. FDA-approved for use with whole blood; granted CLIA waiver.

Positive Negative Positive Negative

Requirements for Ora. Quick Testing Requirements for Ora. Quick Testing

Requirements for Ora. Quick Testing Requirements for Ora. Quick Testing

Reveal HIV-1 Antibody Test Reveal HIV-1 Antibody Test

Reveal HIV-1 Rapid Antibody Test for serum, plasma CLIA Category - Moderate Complexity Reveal HIV-1 Rapid Antibody Test for serum, plasma CLIA Category - Moderate Complexity

Centrifuge to obtain serum or plasma Centrifuge to obtain serum or plasma

Add 20 drops of buffer to reconstitute conjugate. (Refrigerate to store) Add 20 drops of buffer to reconstitute conjugate. (Refrigerate to store)

Add 3 drops buffer to moisten membrane Add 3 drops buffer to moisten membrane

Add one drop of serum or plasma, followed by 3 drops of buffer. Add one drop of serum or plasma, followed by 3 drops of buffer.

Add 4 drops of conjugate solution Add 4 drops of conjugate solution

Add 3 drops of buffer to wash Add 3 drops of buffer to wash

Positive Negative Read results immediately Positive Negative Read results immediately

Rapid Test Performance: Serum 206 HIV+, 194 HIV- stored sera Rapid Test Performance: Serum 206 HIV+, 194 HIV- stored sera

Point-of-Care Testing Point-of-Care Testing

Example: Three possible Ora. Quick test results Example: Three possible Ora. Quick test results

Non-reactive Non-reactive

Reactive Reactive

Invalid Invalid

Invalid Invalid

Invalid Invalid

Invalid Invalid

The challenge: Weakly Reactive The challenge: Weakly Reactive

The Need for Training The Need for Training

Remember the tradeoffs… Remember the tradeoffs…

Interpreting Rapid Test Results For a laboratory test: Sensitivity: Probability test=positive if patient=positive Specificity: Interpreting Rapid Test Results For a laboratory test: Sensitivity: Probability test=positive if patient=positive Specificity: Probability test=negative if patient=negative Predictive value: Probability patient=positive if test=positive Probability patient=negative if test=negative

Example: Test 1, 000 persons Test Specificity = 99. 6% (4/1000) HIV prevalence = Example: Test 1, 000 persons Test Specificity = 99. 6% (4/1000) HIV prevalence = 10% True positive: 100 Positive predictive value: False positive: 4 100/104 = 96%

Example: Test 1, 000 persons Test Specificity = 99. 6% (4/1000) HIV prevalence = Example: Test 1, 000 persons Test Specificity = 99. 6% (4/1000) HIV prevalence = 10% True positive: 100 False positive: 4 Positive predictive value: 100/104 = 96% HIV prevalence = 0. 4% True positive: 4 Positive predictive value: False positive: 4/8 = 50% 4

Positive Predictive Value of a Single Test Depends on Specificity & Varies with Prevalence Positive Predictive Value of a Single Test Depends on Specificity & Varies with Prevalence Predictive Value, Positive Test HIV Prevalence 10% 5% 2% 1% 0. 5% 0. 3% 0. 1% Test Specificity Ora. Quick EIA Reveal 99% 98% 95% 91% 83% 75% 50% 98% 96% 91% 83% 71% 60% 33% 92% 85% 69% 53% 36% 25% 10% 99. 9% 99. 8% 99. 1%

Reports from the 2003 HIV Prevention Conference Reports from the 2003 HIV Prevention Conference

Rapid Test Outcomes Rapid Test Outcomes

Characteristics Rapid Test Positive Patients Characteristics Rapid Test Positive Patients

HIV Screening in Acute Care Settings New HIV+ HIV Screening in Acute Care Settings New HIV+

HIV Screening with Ora. Quick in Labor and Delivery: the MIRIAD Study HIV Screening with Ora. Quick in Labor and Delivery: the MIRIAD Study

Point-of-Care Testing Station Point-of-Care Testing Station

Turnaround Times for Rapid Test Results, Point-of-Care vs Lab Testing MMWR 52: 36, Sept Turnaround Times for Rapid Test Results, Point-of-Care vs Lab Testing MMWR 52: 36, Sept 16, 2003

Ora. Quick Outreach to High Risk Persons of Color Patrick Keenan MD University of Ora. Quick Outreach to High Risk Persons of Color Patrick Keenan MD University of Minnesota Medical School Department of Family Practice and Community Health

Ora. Quick Outreach Study (7/02 – 6/03) N =1021 Ora. Quick Outreach Study (7/02 – 6/03) N =1021

Outreach Testing Sites Outreach Testing Sites

Results Results

Ora. Quick Fingerstick Results: N = 1021 Ora. Quick Fingerstick Results: N = 1021

Client Survey Results I Client Survey Results I

Client Survey Results II Client Survey Results II

Client Survey Results: III Client Survey Results: III

Confirmatory Testing Confirmatory Testing

Requirements for Ora. Quick Testing Requirements for Ora. Quick Testing

Additional Resources Additional Resources