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: Guidance for Industry

Description

We, FDA, are issuing this guidance to provide you1with recommendations for testing donations of Whole Blood and blood components for West Nile Virus (WNV) using an FDA-licensed donor screening assay2. We believe that the use of a licensed nucleic acid test (NAT) will reduce the risk of transmission of WNV, and therefore recommend that you use a licensed to screen donors of Whole Blood and blood components intended for transfusion for infection with WNV.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

3

Whole Blood

Blood component subject to the recommendations in this guidance

blood components

Components intended for transfusion or used to prepare medical devices.; Product category for which a donor may be reentered

Whole Blood and Blood Components

Products intended for transfusion subject to WNV testing

Stakeholders

4

blood establishment

Entity responsible for implementing testing and deferral procedures

licensed blood establishment

Entity responsible for reporting based on license status

contract laboratory

filed a supplement to your Biologics License Application to use a contract laboratory

Donor

Potential HCT/P donor screening

Regulatory Context

Regulatory Activities

6

Investigational New Drug Application

IND for treatment use; Regulatory submission required for clinical trials and expanded access.

biologics license applications

designed to aid clinical and statistical reviewers in the review of vaccine applications

IND

Investigational New Drug submissions

Biologics License Application

BLA for biological products

Prior Approval Supplement

Major changes requiring FDA approval before implementation

Changes Being Effected

Reporting category for moderate changes (CBE-30)

Document Types

3

standard operating procedure

Abbreviated as SOP.

SOP

Standard Operating Procedures for evaluating suppliers; Based on the manufacturer's established SOP for evaluating suppliers.; Standard Operating Procedures for regulatory compliance

instruction circular

also known as the Circular of Information

Attributes

3

reactive

Test result status indicating presence of a marker

Non-Reactive

A negative test result status for NAT screening

high WNV activity

recommend that you use ID-NAT screening during high WNV activity

Technical Details

Substances

5

WNV ribonucleic acid

detecting WNV ribonucleic acid (RNA) using plasma specimens

antibody to WNV

testing for antibody to WNV may be of value in donor counseling

WNV RNA

target for NAT assays in plasma specimens

West Nile Virus

arthropod-borne virus in the family Flaviviridae

Japanese Encephalitis serogroup

Group of viruses including SLEV, JEV, MVEV, and Kunjin virus that may cross-react

Testing Methods

7

Enzyme-Linked Immunosorbent Assay

Analytical test for binding properties

nucleic acid test

recommend that you use a licensed NAT to screen donors

NAT

Nucleic Acid Testing used for donor screening; Nucleic Acid Test for HIV-1

MP-NAT

pooled-donor sample nucleic acid testing; Minipool Nucleic Acid Testing

ID-NAT

individual donor sample nucleic acid testing; Individual Donation Nucleic Acid Testing; Individual Donor Sample Nucleic Acid Testing; Individual Donor Nucleic Acid Test used for HIV-1 follow-up

Nucleic Acid Tests

NAT used to reduce the risk of HBV transmission.

WNV antibody test

Cleared test for antibodies to West Nile Virus used in donor counseling

Identified Hazards

Hazards

3

West Nile Virus

relevant communicable disease agent or disease; Pathogen identified as a risk for transmission through blood transfusion and organ transplantation

WNV

infection with WNV

Japanese Encephalitis serogroup

NAT screening assay does not discriminate between WNV and other Flaviviruses

Related CFR Sections (4)

21CFR640.1§ 640.1 Whole Blood.
The proper name of this product shall be Whole Blood. Whole Blood is defined as blood collected from human donors for transfusion to human recipients.Read full regulation →
21CFR312.38§ 312.38 Withdrawal of an IND.
(a) At any time a sponsor may withdraw an effective IND without prejudice.Read full regulation →
21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
21CFR606.122§ 606.122 Circular of information.
A circular of information must be available for distribution if the product is intended for transfusion. The circular of information must provide adequate directions for use, including the following information:Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Failure to ensure that the investigation was conducted according to the investigational plan

21

Failure to submit an Investigational New Drug application (IND)

9

Failure to obtain informed consent

5

Unapproved new drug

5

Misbranded drug

4

Failed to ensure that the investigation was conducted according to the investigational plan

3

Enrollment of subjects who do not meet eligibility criteria

3

Failure to submit INDs for the conduct of clinical investigations

3

Unlicensed biological product

2

unapproved new drugs

2