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3 User knows that “WNV” is abbreviation for West Nile virus and so clicks on
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Biologics HCT/P Donor Screening Test Kits Recalls


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Blood, Vaccines & When reviewing any of the test kits, be aware of these recommendations:
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Products These abbreviations are used:
o ChLIA - Chemiluminescent immunoassay
HCT/P Donor o EIA - Enzyme immunoassay
Screening Test Kits o PCR - Polymerase chain reaction
o TMA - Transcription-mediated amplification

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Licensed Donor Screening Tests (HBV, HCV, HIV, HTLV, T.cruzi, WNV) 3
Cleared Nucleic Acid Tests (NAT) for Chlamydia trachomatis and
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Cleared Donor Screening Tests for Cytomegalovirus (CMV)


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These documents discuss tests currently recommended to adequately and
appropriately reduce the risk of transmission of relevant communicable
disease agents and diseases under 21 CFR 1271.80.

Testing HCT/P Donors: Specific Requirements


Guidance for Industry: Eligibility Determination for Donors of Human
Cells, Tissues, and Cellular and Tissue-Based Products, dated 8/8/2007

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Hepatitis B Virus (HBV)
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Cleared Nucleic Acid Tests Human Immunodeficiency Virus (HIV)-1 AND 2


(NAT) for Chlamydia
Human Immunodeficiency Virus Type 1 (Anti-HIV-1 Assay)
trachomatis and Neisseria
gonorrheas Human Immunodeficiency Virus Type 2 (Anti-HIV-2 Assay)

Cleared Donor Screening HIV-1 Nucleic Acid Tests


Tests for Cytomegalovirus
Human T-Lymphotrophic Virus Types I & II (Anti-HTLV-I/II Assays)
(CMV)
Trypanosoma cruzi (Chagas Disease) (Anti- T. cruzi Assays)
Cleared Tests for Syphilis
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Biologics Biologics > Blood, Vaccines & Other Biologics > Tissue & Tissue Products > HCT/P Donor Screening Test Kits > Licensed Donor Screening Tests

Blood, Vaccines & Other


Biologics West Nile Virus
Tissue & Tissue Products
West Nile Virus Nucleic Acid Testing
HCT/P Donor Screening Test (Direct detection of WNV RNA)
Kits

Licensed Donor Screening Tradename Format Specimen Donors Manufacturer Approval


Collection Date
Tests
Procleix WNV Assay TMA Living: Living, Gen-Probe, Inc
Cleared Nucleic Acid Tests Plasma Cadaveric 12/1/2005
(NAT) for Chlamydia Cadaveric:
Serum,
trachomatis and Neisseria EDTA
Plasma 5
gonorrheas
Cobas TaqScreen West Nile PCR Living: Living, Roche Molecular
Cleared Donor Screening Virus Test Plasma Cadaveric Systems, Inc.
4/2/2008
Cadaveric:
Tests for Cytomegalovirus Plasma
(CMV)

Cleared Tests for Syphilis

Licensed or Cleared Tests


for Blood Donors

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DRAFT GUIDANCE: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of
West Nile Virus from Donors of Whole Blood and Blood Components Intended for
Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)

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