0-9
A B C D E F G H I J K L M N O
P Q R S T U V W X Y Z
  • No FAQs found
  • No FAQs found
  • No FAQs found
  • No FAQs found
  • No FAQs found
  • No FAQs found

Donor Testing

Test code(s) 91986, 17385, 17388, 19618, 90557, 17378, 17375, 93305 17380, 94973, 19854, 17379, 17389, 19412, 93308, 93309, 93306, 93307

Question 1. What is Donor Testing?

The FDA requires that all blood donors and donors of human cells, tissues, and products (HCT/P) be screened for relevant communicable disease agents or diseases (RCDADs) using assay kits that are FDA approved or FDA cleared specifically for donor testing.1,2

For blood donors, donor testing for RCDADs includes tests for3

  • Cytomegalovirus antibody
  • Human immunodeficiency virus (HIV), types 1 and 2
  • Hepatitis B virus (HBV)
  • Hepatitis C virus (HCV)
  • Human T-lymphotropic virus (HTLV), types I and II
  • Treponema pallidum (syphilis)
  • West Nile virus
  • Zika virus
  • Babesia (for donations in Babesia-endemic regions)

For HCT/P donors, donor testing for RCDADs includes tests for1,2

  • Human immunodeficiency virus (HIV), types 1 and 2
  • Hepatitis B virus (HBV)
  • Hepatitis C virus (HCV)
  • Treponema pallidum (syphilis)
  • For living donors
    - West Nile virus
  • For viable, leukocyte-rich HCT/Ps
    - Human T-lymphotropic virus (HTLV), types I and II
  • - Cytomegalovirus antibody
  • For reproductive HCT/Ps
    - Chlamydia trachomatis
    - Neisseria gonorrhea

Question 2. How does donor testing differ from diagnostic testing?

Donor testing is performed to screen potential donors for infectious diseases prior to donation. For many RCDADs, donor testing requires testing the donor specimens by both an antibody test and a nucleic acid amplification test (NAAT or NAT).1

Donor testing must be performed with appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer’s instructions. Until such time as appropriate FDA-licensed, approved, or cleared donor screening tests for Chlamydia trachomatis and for Neisseria gonorrhea are available, donor testing must be performed with FDA-licensed, approved, or cleared diagnostic tests labeled for the detection of those organisms in an asymptomatic, low-prevalence population.2

Consistent with FDA guidelines, Quest Diagnostics does not make any alteration to tests used for donor testing.2 Laboratory-developed tests or modifications to an FDA-approved test are prohibited for use in donor testing.

Question 3.  What types of donors does Quest accept for donor testing?

Quest performs donor testing for both blood and HCT/P donors.

Question 4. Which Quest laboratories perform donor testing?

Quest has a dedicated facility for donor testing in Chantilly, Virginia. All donor testing specimens are sent to this location for donor testing.

Question 5. Is Quest registered with the FDA to perform blood and HCT/P donor testing?

Quest maintains FDA registration to perform both blood and HCT/P donor testing. Quest complies with all FDA regulations regarding donor testing.

Question 6. Are panels available for donor testing?

Yes. Four panels are available (Table). All panel components can be ordered separately.

References

  1. Guidance for industry: eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). US Food and Drug Administration. Updated May 16, 2019. Accessed December 21, 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/eligibility-determination-donors-human-cells-tissues-and-cellular-and-tissue-based-products
  2. When do I register, submit an HCT/P list, and submit updates? 21 CFR §1271.21 (2004). https://www.ecfr.gov/cgi-bin/text-idx?SID=01c345bc6df91cd9ccef85e9a72f1c3d&mc=true&node=se21.8.1271_121&rgn=div8
  3. Complete list of donor screening assays for infectious agents and HIV diagnostic assays. US Food and Drug Administration. Updated October 23, 2020. Accessed December 21, 2020 .https://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays/
This FAQ is provided for informational purposes only and is not intended as medical advice. A clinician’s test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, and assessment of the patient.
Document FAQS.220Version: 0
Version 0: Effective 12/22/2020 to present