Test Guide

Donor Transplant Eligibility: Laboratory Testing

This Test Guide discusses the use of laboratory tests that can help avoid transmission of infectious disease through transplanted human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Donor Transplant Eligibility

Laboratory Testing

Laboratory testing can help avoid transmission of infectious disease through transplanted human cells, tissues, and cellular and tissue-based products (HCT/Ps). Testing helps avoid disease transmission by identifying diseases or disease agents in potential donors. Testing may also help avoid disease transmission through transplanted tissues with latent infections; immunosuppressive drugs used to prevent transplant rejection can reactivate such infections.1

The US Food and Drug Administration (FDA) requires testing of all donors of HCT/Ps for infections including HIV-1, HIV-2, hepatitis B virus (HBV), hepatitis C virus (HCV), and Treponema pallidum (syphilis); testing for West Nile virus (WNV) is required for living donors.2 Depending on HCT/P type, requirements may also include testing for human T-lymphotropic virus (HTLV), cytomegalovirus, Chlamydia trachomatis, Neisseria gonorrhea, and Trypanosoma cruzi, the parasite that causes Chagas disease (Table).3,4

Quest Diagnostics offers a menu of pretransplant tests that includes donor screening panels for infectious diseases (Table). These panels, based on FDA guidelines for approved testing,3,5 include tests for HIV-1/2, HBV, HCV, CMV, T pallidum, and others. Components of panels can be ordered separately. Quest also offers HLA compatibility testing and other transplant-related testing that support the laboratory phases in the continuum of transplant care. See Solid organ and hematopoietic stem cell transplantation: laboratory testing for transplant recipients for details.

The information in this Test Guide is provided for informational purposes only and is not intended as medical advice. Test selection and interpretation, diagnosis, and patient management decisions should be based on the physician’s education, clinical expertise, and assessment of the patient.

Table. Specialized Transplant Services, Infectious Disease Testing for Donor Eligibility

Test code	Test name	Primary clinical use
91986	Donor, Chagas Screen	Screen for Trypanosoma cruzi infection in potential donors of HCT/Ps
17385	Donor, Chlamydia trachomatis/Neisseria gonorrhoeae, RNA, TMA	Screen for C trachomatis and N gonorrhoeae RNA in potential donors of reproductive HCT/Ps
17388	Donor, Cytomegalovirus Antibody, Total	Screen for CMV infection in potential donors of viable, leukocyte-rich cells or tissues
90557	Donor, Cytomegalovirus Antibody, Total With Reflex to (IgG, IgM)a	Screen with reflex to diagnostic testing for CMV infection in potential donors of viable, leukocyte-rich cells or tissues
19618	Donor, Cytomegalovirus Antibody Total With Reflex Non-donor CMV IgMa
17378	Donor, Hepatitis B Core Total Antibody	Screen for history of HBV infection in potential donors of HCT/Ps
17375	Donor, Hepatitis B Surface Antigen With Reflex to Confirma	Screen and confirmation for acute or chronic HBV infection in potential donors of HCT/Ps
93305	Donor, Hepatitis C Antibody (Anti-HCV)	Screen for acute or chronic HCV infection in potential donors of HCT/Ps
19854	Donor, HIV/HCV/HBV NAT Procleix® With Reflexesa	Screen for HIV-1 RNA, HIV-2 RNA, HCV RNA, and HBV DNA in potential donors of HCT/Ps
17380	Donor, HIV-1/2 plus O Antibody Screen	Screen for HIV-1 and HIV-2 infection in potential donors of HCT/Ps
94973	Donor, HIV-1/2 plus O Antibody Screen With Reflex to Differentiationa	Screen for HIV-1 and HIV-2 infection with reflex to confirmation/differentiation in potential donors of HCT/Ps
17379	Donor, HTLV-I/II Antibody Screen	Screen for human T-cell lymphotrophic virus I and II infection in potential donors of viable, leukocyte-rich cells and tissues
93309	Donor, Stem Cells Donor Panel	Screen for CMV, HBV, HCV, HIV, HTLV-I/II, syphilis, and WNV in potential stem cell donors
17389	Donor, Syphilis IgG Antibody	Screen for acute or chronic Treponema pallidum infection in potential donors of HCT/Ps
93308	Donor, Tissue Donor Panel Includes Donor, Hepatitis B Core Total Antibody; Donor, Hepatitis B Surface Antigen with Reflex to Confirm; Donor, Hepatitis C Antibody (Anti-HCV); Donor, HIV/HCV/HBV NAT Procleix® with Reflexes; Donor, HIV-1/2 plus O Antibody Screen; Donor, Syphilis IgG Antibody; Donor, West Nile Virus, NAT.	Screen for infectious diseases in potential tissue or blood donors
19412	Donor, West Nile Virus, NAT	Screen for WNV RNA in potential donors of HCT/Ps

CMV, cytomegalovirus; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; HCT/Ps, human cells, tissues, and cellular and tissue-based products; HTLV, human T-cell lymphotropic virus; TMA, transcription-mediated amplification; WNV, West Nile virus.
a	Reflex tests are performed at an additional charge and are associated with an additional CPT® code(s).

References

Malinis M, Boucher HW. Screening of donor and candidate prior to solid organ transplantation—Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13548. doi:10.1111/ctr.13548
Donor screening and testing. Centers for Disease Control and Prevention. Updated October 13, 2022. Accessed May 1, 2024. https://www.cdc.gov/transplant-safety/hcp/clinical-guidance/?CDC_AAref_Val=https://www.cdc.gov/transplantsafety/protecting-patient/screening-testing.html
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 2, 2024. Accessed May 13, 2024. https://www.fda.gov/media/73072/download
Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components. Guidance for industry. US Food and Drug Administration. Updated May 16, 2019. Accessed May 13, 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-serological-tests-reduce-risk-transmission-trypanosoma-cruzi-infection-blood-and-blood
Complete list of donor screening assays for infectious agents and HIV diagnostic assays. US Food and Drug Administration. Updated April 12, 2024. Accessed May 13, 2024. https://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays

Content reviewed 05/2024

top of page

Related tests (17)

19618 - Donor, Cytomegalovirus Total with Reflex Non-donor CMV, IgM

This test is intended to be used as a primary screening test for serological evidence of previous cytomegalovirus (CMV) infection. This test has been approved by the FDA for the screening of donors of blood, blood components and human cells, tissues and tissue-based products (HCT&Ps).

39949 - Specialized Transplant Services, Donor

Quest Advanced Specialized Transplant Services (QASTS) Donor Kit Code should be used whenever Donor infectious disease testing is ordered for enhanced and expedited services including rapid turnaround time and white glove customer service.

DO NOT order this kit code with Quest Advanced Specialized Transplant Services Post-Transplant Kit Code or any other Post-Transplant QASTS testing. To find related Donor codes type "Donor" in the Test Directory.

93305 - Donor, Hepatitis C Antibody (Anti-HCV)

This test is intended to be used as a primary screening test for the diagnosis of acute or chronic hepatitis due to Hepatitis C virus (HCV) infection. This test has been approved by the FDA for the screening of donors of blood, blood components and human cells, tissues and tissue-based products (HCT&Ps). It is also intended for use to screen organ donors when specimens are obtained while the donor's heart is still beating and in testing blood specimens to screen cadaveric (non-heart-beating) donors.

This test is not intended for use on samples of cord blood. A positive result is indicative of an infection with HCV, and may be used to disqualify a potential cell or tissue donor. This test is not intended to be used for routine clinical diagnostic testing.

19412 - Donor, West Nile Virus, NAT

The Procleix® WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WVN) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors. It is also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating. The assay is intended for use in testing individual donor samples. This assay is not intended for use as an aid in the diagnosis of West Nile Virus infection. It is not intended for use on cord blood specimens.

94973 - Donor, HIV-1/2 plus O Antibody Screen with Reflex to Differentiation

This test is for the eligibility determination of donors of blood and blood components and human cells, tissues, and cellular tissue based products (HCT/Ps). This test is not intended to be used for routine clinical or routine diagnostic evaluation.

17389 - Donor, Syphilis IgG Antibody

Detection of treponemal antibodies may indicate recent, past, or successfully treated syphilis infections, therefore, the test cannot be used to differentiate between active and cured cases. A reactive syphilis antibody test result may be used to disqualify a potential blood, cell or tissue donor.

93309 - Donor, Stem Cells Donor Panel

Blood donors and donors of human cells, tissues and cellular and tissue-based products (HCT/Ps) must be tested for infectious diseases using assay kits that are FDA-approved or FDA-cleared specifically for donor screening.

91986 - Donor, Chagas Screen

Trypanosoma cruzi is a flagellated, protozoan parasite, which is endemic to regions of South and Central America and Mexico. It is the causative agent of Chagas Disease. Infection is chronic, asymptomatic and untreatable. The Chagas screening assay detects antibodies to T. cruzi and is used to screen blood and tissue donors.

17380 - Donor, HIV-1/2 plus O Antibody Screen

This test is for the eligibilty determination of donors of blood and blood components and human cells, tissues, and cellular tissue based products (HCT/Ps). This test is not intended to be used for routine clinical or routine diagnostic evaluation.

17378 - Donor, Hepatitis B Core Total Antibody

This test in intended to be used as a primary screening test for the diagnosis of acute or chronic hepatitis due to hepatitis B virus (HBV) infection. This test has been approved by the FDA for the screening of donors of blood, blood components and human cells, tissues, and tissue-based products (HCT&Ps). It is also intended for use to screen organ donors when specimens are obtained while the donor's heart is still beating. This test is not intended for use on samples of cord blood.

A positive result is indicative of an infection with HBV, and may be used to disqualify a potential cell or tissue donor. This test is not intended to be used for routine clinical diagnostic testing.

19854 - Donor, HIV/HCV/HBV NAT Procleix® with Reflexes

The Procleix® Ultrio® Elite HIV/HBV/HCV Assay is a qualitative in vitro nucleic acid assay for the detection in Human Immunodeficiency Virus RNA, Hepatitis B Virus DNA, and Hepatitis C Virus RNA in human plasma. The test is intended to be used to screen blood, solid organ, and tissue donors for these agents. When used in conjunction with licensed tests for detecting antibodies to HIV, HBV, and HCV, test results may be used to determine eligibility for blood, solid organs, or tissue transplantation.

17388 - Donor, Cytomegalovirus Antibody, Total

93308 - Donor, Tissue Donor Panel

90557 - Donor, Cytomegalovirus Antibody, Total with Reflex to (IgG, IgM)

17385 - Donor, Chlamydia trachomatis/Neisseria gonorrhoeae, RNA, TMA

This test is intended to be used as the primary screening test for the diagnosis of infection with Chlamydia trachomatis or Neisseria gonorrhoeae and is required for screening all potential semen or egg donors for in vitro fertilization or other reproductive procedures; reactive results may be sufficient to consider a donor ineligible.

17375 - Donor, Hepatitis B Surface Antigen with Reflex to Confirm

A positive result is indicative of an infection with HBV, and may be used to disqualify a potential cell or tissue donor. This test is not intended to be used for routine clinical diagnostic testing.

17379 - Donor, HTLV-I/II Antibody Screen

This test is to be used for the screening of donors of human cells, tissues, and cellular and tissue-based products for infectious diseases.

Related guides (1)

Solid Organ and Hematopoietic Stem Cell Transplantation Laboratory Testing for Donors and Recipients

This Test Guide discusses the use of laboratory tests that help match donors and recipients for solid organ and bone marrow transplantation, and also discusses tests that identify and monitor infectious disease in post-transplant recipients.

Top of page

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The tests listed by specialty and category are a select group of tests offered. For a complete list of Quest Diagnostics tests, please adjust the filter options chosen, or refer to our Directory of Services.