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Gerald Schochetman, Ph.D. Abbott Laboratories Diagnostics Division BPAC Meeting September 14, 2000 PowerPoint PPT Presentation


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DISCONTINUATION OR NO DISCONTIUNATION: COMPARISON OF SINGLE UNIT HIV ANTIGEN TESTING VS. POOLED NAT TESTING. Gerald Schochetman, Ph.D. Abbott Laboratories Diagnostics Division BPAC Meeting September 14, 2000. OBJECTIVE. To develop more sensitive HIV antigen assays

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Gerald Schochetman, Ph.D. Abbott Laboratories Diagnostics Division BPAC Meeting September 14, 2000

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Gerald schochetman ph d abbott laboratories diagnostics division bpac meeting september 14 2000

DISCONTINUATION OR NO DISCONTIUNATION:COMPARISON OF SINGLE UNIT HIV ANTIGEN TESTING VS. POOLED NAT TESTING

Gerald Schochetman, Ph.D.

Abbott Laboratories

Diagnostics Division

BPAC Meeting

September 14, 2000


Gerald schochetman ph d abbott laboratories diagnostics division bpac meeting september 14 2000

OBJECTIVE

To develop more sensitive HIV antigen assays

Short term: Comparable sensitivity to pooled

NAT testing

Long term: Sensitivity equivalent to single

unit NAT testing


Sensitivity of research prism hiv ag vs current hiv antigen assay

SENSITIVITY OF RESEARCH PRISM HIV Ag VS. CURRENT HIV ANTIGEN ASSAY

ASSAY

p24 ANTIGEN

Estimated RNA

Copies/ml @ Dilution of

pg/ml (est.)

copies/ml

1:96

1:1200

4

4

Research

PrismHIV Ag

1-2

1x10

-2x10

104-208

8-16

HIVAG-1MC

7-10

7x10

4

-1x10

5

729-1041

58-83

1 pg = 1x104 copies/ml


Gerald schochetman ph d abbott laboratories diagnostics division bpac meeting september 14 2000

Comparison Between Sensitive HIV Antigen Testing and NAT

  • Sensitivity of antigen assay is ~1.0 pg or ~10,000

  • copies of viral RNA

  • Even at a claimed 50 copies/ml sensitivity for NAT:

  • - a sample must have at least 4800 copies of

  • viral RNA/ml to be detected in a pool of 96, or

  • - 60,000 copies of viral RNA/ml in a pool of 1200


Gerald schochetman ph d abbott laboratories diagnostics division bpac meeting september 14 2000

EARLY SEROCONVERSION SAMPLES:

COMPARISON OF POOLED NAT VS.

HIV ANTIGEN TESTING

PANEL/BLEED #

ABBOTT

Research

NAT (copies/ml)a

Copies/ml @ Dilution of

HIVAG-1MCa

PRISM AGc

Roche

NGI

bDNA

1:96

1:1200

S/COb

S/CO

SV-0251/D

0.34

3.05

16000

167

13

SV-0321/A

0.46

3.08

20000

208

17

PRB-941/3

0.55

2.32

50000

521

42

PRB-943/3

0.72

2.35

100000

1042

83

PRB-945/3

0.72

1.96

90000

20000

938/208

75/17

BCP-9013/6

0.47

1.98

56350

587

47

BCP-6240/7

0.53

1.98

11690

122

10

BCP-9016/9

0.72

2.06

69010

719

58

a Data obtained from panel information sheets

b S/CO > 1.00 is reactive

c Research data


Gerald schochetman ph d abbott laboratories diagnostics division bpac meeting september 14 2000

Advantages of Individual HIV Antigen Testing vs Pooled NAT Testing

  • Fully automated system for antigen testing

  • Rapid test results

  • Process controls for enhanced GMP compliance

  • No sample preparation/contamination issues

  • Ability to confirm using neutralization test

  • Simplicity for implementation

    • No pools to dilute sensitivity

    • No dissection of pools

    • No shipping of specimens


Gerald schochetman ph d abbott laboratories diagnostics division bpac meeting september 14 2000

CONCLUSIONS

  • Gap between individual antigen testing

  • using a sensitive assay for HIV antigen

  • and NAT of pooled samples may not be significant

  • As opposed to discontinuation:

  • Manufacturers should be encouraged to develop ultra-sensitive HIV antigen assays with sensitivities equal to or greater than single unit NAT


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