Blood products are collected from individuals (subjects) who are screened in accordance with the Food and Drug Administration’s current requirements and recommendations for donors of blood products intended for transfusion in the U.S. Health history of prospective subjects is assessed before each collection by soliciting the individual’s responses to more than 50 questions on Key Biologics (A Cellero Company)’s Health History Record which includes all questions on the current FDA-approved health history questionnaire that is used to screen donors of transfusable components. Key Biologics’ health history record also includes several questions approved by the FDA to screen donors of tissue for transplantation.

Most blood products are collected under protocols approved by an Institutional Review Board with specific inclusion/exclusion criteria that must also be assessed to determine the potential subject’s eligibility to provide a specific blood product. Subjects must be found eligible in accordance with all the guidelines for screening donors of transfusable products unless the final use of the product and protocol’s inclusion/exclusion criteria allows an exception. Screening materials and protocol inclusion/exclusion criteria will be provided to the customer for review upon request and may be modified to meet customer specifications if subject safety would not be adversely impacted by the changes.

Infectious disease screening is performed with each product collection using blood samples collected concurrently with the product. Infectious disease screening is outsourced to a laboratory inspected and licensed by the FDA. Test results are generally received and provided to the customer on the day following collection, usually before noon. If requested by the customer, infectious disease screening can be performed in advance of collection, and products will be released for shipment based on those results. Additionally, a customer may request additional testing of prospective subjects to qualify them for the intended use of the product.

The test panel listed and frequency of testing are the same as required and recommended by the FDA for screening blood products intended for transfusion.

If upon a subsequent donation, a subject is found to have a reactive infectious disease test, customers who received a blood product collected from this subject are notified in accordance with FDA guidelines for transfusable blood components.

TestFrequency
Hepatitis B virus (HBV) surface antigenEach donation
Antibody to hepatitis B virus core antigen (Anti-HBC)Each donation
Hepatitis C virus (HCV) antibodyEach donation
Human T-cell lymphotropic virus types I and II antibody (HTLV I/II)Each donation
Human immunodeficiency virus (HIV) type 1- Groups M and O and/or type 2 antibodyEach donation
HIV–1 RNA by NAT pooled testing*Each donation
HCV RNA by NAT pooled testing*Each donation
HBV DNA by NAT pooled testing*Each donation
West Nile Virus (WNV) RNA by NAT pooled testing*Each donation
Serological test for syphilisEach donation
Zika Virus RNA by NAT single donor testingEach donation
Red cell antibody screen (ABS)Each donation
Blood ABO group and Rh type (ABO/Rh)Each donation
T. cruzi antibodyPerformed once and blood products released based on historic results unless repeat requested by customer
Cytomegalovirus antibodies (CMV)Upon customer request
*Tissue donor level screening using single donor unit testing can be performed at customer’s request.