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Supplemental Testing of Donors for HIV and HCV . September 18, 2003 BPAC Meeting Robin Biswas, M.D. Indira Hewlett, Ph.D. FDA/CBER/OBRR/DETTD. Supplemental Testing of Donors for HIV and HCV. Discussion of the utility of various supplemental testing strategies to

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Supplemental Testing of Donors for HIV and HCV

September 18, 2003 BPAC Meeting

Robin Biswas, M.D.

Indira Hewlett, Ph.D.

FDA/CBER/OBRR/DETTD

supplemental testing of donors for hiv and hcv
Supplemental Testing of Donors for HIV and HCV
  • Discussion of the utility of various

supplemental testing strategies to

CONFIRM A REPEATEDLY REACTIVE ENZYME IMMUNOASSAY (EIA) SCREENING TESTRESULT

for

- HIV using Western Blot, Nucleic

Acid Tests, second EIA, and for

- HCV using RIBA, Nucleic Acid

Tests, high signal-to-cutoff ratio in

screening EIA

reason for discussing hiv and hcv supplemental testing of donors
Reason for Discussing HIV and HCV Supplemental Testing of Donors
  • 1998 MMWR recommended that, in the clinical

laboratory, diagnostic setting, an anti-HCV reactive

screening test result be verified by a more specific

supplemental test, e.g., RIBA.

  • 2003 MMWR repeats and emphasizes

the desirability of performing supplemental

testing on screen reactives. It offers an option for

reporting positive test results using high signal-to-

cutoff ratios in the screening test, in the clinical

laboratory, diagnostic setting.

current testing of blood donations for antibodies to hiv and hcv contd
Current Testing of Blood Donations for Antibodies to HIV and HCV, contd.

EIA Screening Test

Non-reactive (NR)

Initially reactive (IR)

Use unit, retain donor

Test sample in duplicate

Both duplicates NR

Next slide

Use unit, retain donor

current testing of blood donations for antibodies to hiv and hcv contd5
Current Testing of Blood Donations for Antibodies to HIV and HCV, contd.

Test sample in duplicate

Both duplicates NR

Use unit, retain donor

Either or both duplicates test reactive

Unit is repeatedly reactive (RR),

Unit not used, defer donor

Donor evaluated by more testing using

supplemental assays

current testing of blood donations for antibodies to hiv and hcv contd6
Current Testing of Blood Donations for Antibodies to HIV and HCV, contd.
  • Supplemental testing on EIA

screening test RRs

- for anti-HCV use RIBA

- for anti-HIV use Western Blot

or IFA followed by anti-HIV 2, if indeterminate results are obtained

supplemental testing of donors donations
Supplemental Testing of Donors/Donations
  • Each screening test reactive donation must be tested by a supplemental test if approved for such use, 21 CRF 610.40
  • Donors must be notified of deferral; an attempt must be made to obtain supplemental test results prior to donor notification, 21 CFR 630.6
supplemental testing of donors donations contd
Supplemental Testing of Donors/Donations, contd.
  • Alternative donor testing algorithms, not using supplemental tests, would conflict with regulations
  • Confirmation by “orthogonal testing” (testing using a different technique) advantageous over statistical validation methods, e.g., 2nd EIA, high EIA s/co ratio
why perform supplemental testing on donors
Why Perform Supplemental Testing on Donors?
  • 1) Providing deferred donors with accurate information about their disease status and deferral helps ensure a healthy donor population.

- This impacts directly on blood safety

in preventing communicable disease

transmission.

why perform supplemental testing on donors contd
Why Perform Supplemental Testing on Donors? contd.
  • 2) Information from supplemental testing can be used to evaluate donor for possible reentry into donor pool.

- Requalification of donors contributes

to donor availability

testing in different settings
Testing in Different Settings
  • Donor Setting: selected, low risk population tested outside the health care environment
  • Medical Diagnostic Setting: higher risk populations, medical “index of suspicion,” doctor-patient relationship permits additional considerations

-rapid HIV testing at point of care; inability to perform delayed confirmatory testing

discussion objectives
Discussion Objectives

Discuss:

  • The scientific merit and public health benefit of supplemental testing in a blood donor setting.
  • Relative performance of supplemental

testing strategies for HIV and HCV:

- HIV: Western Blot, NAT, 2nd EIA

- HCV: RIBA, NAT, high s/co in the

screening EIA

questions for the committee
Questions for the Committee
  • 1. Please comment on the relative performance of:

(i) RIBA versus HCV NAT

(ii) RIBA versus signal-to-cutoff

ratio in the screening test for

anti-HCV

to confirm/validate a reactive screening test

result in the blood donor testing setting.

questions for the committee14
Questions for the Committee
  • 2. Please comment on the relative performance of:

(i) Western Blot versus HIV NAT

(ii) Western Blot versus a second EIA for

anti-HIV

to confirm/validate a reactive screening test

result in the blood donor testing setting.

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