Solid Organ and Hematopoietic Stem Cell Transplantation Laboratory Testing for Donors and Recipients
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.
Test Guide
Solid Organ and Hematopoietic Stem Cell Transplantation
Laboratory Testing for Donors and Recipients
This Test Guide provides a description of tests available for transplant donors and recipients. Laboratory testing includes US Food and Drug Administration (FDA)-required testing of donors for certain infectious diseases,1 testing for genetic kidney diseases to evaluate donor candidates,2 guideline-indicated compatibility testing (human leukocyte antigen [HLA] typing and HLA antibody screening) for transplant donors and recipients,3 and post-transplant testing to monitor immunosuppressive and antifungal drug therapies and follow-up for infectious disease.
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.
Donor testing
Laboratory testing can help avoid transmission of infectious disease through transplanted human cells, tissues, and cellular-based products (HCT/Ps) by identifying diseases or disease agents in potential donors with active or latent infections; immunosuppressive drugs used to prevent transplant rejection can reactivate latent infections.4
The 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.1 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 1).5,6
For potential living kidney donors who self-report African ancestry, detection of any 2 APOL1 risk alleles (G1/G1, G2/G2, or G1/G2) indicates an increased risk for developing APOL1-associated chronic kidney disease. The risk of premature allograft loss associated with a high-risk genotype in a living donor is currently unknown, but a high-risk genotype in a deceased donor is associated with shorter allograft survival in transplant recipients.7,8
Quest Diagnostics offers a menu of pretransplant tests that includes APOL1 renal risk variant genotyping and donor screening panels for infectious diseases (Table 1); components of panels can be ordered separately. These panels, based on FDA guidelines for approved testing,5,9 include tests for HIV-1/2, HBV, HCV, CMV, T pallidum, and others.
Table 1. APOL1 Risk Variant and Infectious Disease Testing for Donors
Test code |
Test name |
Primary clinical use |
|
Genotyping |
|||
1291 |
Apolipoprotein L1 (APOL1) Renal Risk Variant Genotyping |
Assist evaluation of a potential donor for kidney transplantation |
|
Infectious disease testing |
|||
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; HCT/Ps, human cells, tissues, and cellular and tissue-based products; HIV, human immunodeficiency virus;; HTLV, human T-cell lymphotropic virus; NAT, nucleic acid amplification; 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). |
Compatibility testing for transplant donors and recipients
A person's HLA type and antibody profile are important for assessing immunological compatibility between donor and recipient, as incompatibility can result in transplant rejection. HLA typing and antibody testing can help assess donor-recipient immunological risk. Testing options vary by HLA class and resolution (Table 2).
HLA proteins are grouped into 2 classes: class I includes A, B, and C antigens, and class II includes DR, DQ, and DP antigens. HLA A, B, and DR antigens are considered the most important in transplant survival; however, current Organ Procurement and Transplantation Network/United Network for Organ Sharing (OPTN/UNOS) guidelines mandate molecular typing of all HLA loci, which may be performed at different levels of resolution depending on transplant center requirements.3 DNA-based typing at low resolution identifies the group of alleles that encode a particular HLA antigen. Intermediate-resolution typing is limited to particular allele groups expected in a population. High-resolution typing allows for a more precise determination of an allelic variant by identifying variants based on differences in antigen recognition site domains. HLA antibody tests identify preformed antibodies to donor HLA antigens in transplant recipients, which may develop from prior sensitization.10
Table 2. Donor–Recipient Compatibility Tests for Solid Organ and Bone Marrow Transplantation
Test code |
Test name |
HLA typing |
|
92157 |
HLA A, B, C, Class I Typing, Intermediate Resolutiona |
92076 |
HLA-A, B, C, DRB1 and DQ High Resolution |
92078 |
HLA-A, B, C High Resolution |
15484 |
HLA A, B, C Low Resolutiona |
92158 |
HLA-A, B, Intermediate Resolutiona |
15757 |
HLA A, B Low Resolutiona |
92044 |
HLA A 02:01 Determinationa |
10951 |
HLA A Low Resolutiona |
17397 |
HLA A Typing, High Resolutiona |
92746 |
HLA-B*15:02 Determination with Reflex to HLA-B High Resolutiona |
10950 |
HLA B Low Resolutiona |
17395 |
HLA C High Resolutiona |
15463 |
HLA C Low Resolutiona |
95730 |
HLA DPB1 Typing, High Resolutiona |
19525 |
HLA DQA1 Low Resolutiona |
10953 |
HLA DQB1 Low Resolutiona |
17394 |
HLA DQB1 Typing, High Resolutiona |
92159 |
HLA DRB1, DQB1, Intermediate Resolutiona |
15485 |
HLA DRB1, DQB1 Low Resolutiona |
97112 |
HLA DRB1,3,4,5,DQB1, Low Resolutiona |
10952 |
HLA DRB1 Low Resolutiona |
19526 |
HLA DRB3,4,5 Low Resolutiona |
17393 |
HLA DRB1 Typing, High Resolutiona |
95732 |
HLA DRB3,4,5 Typing, High Resolutiona |
92160 |
HLA DRB1 Typing, Intermediate Resolutiona |
92161 |
HLA DRB3,4,5 Typing, Intermediate Resolutiona |
HLA antibody screening and identification |
|
95731 |
HLA Antibody Identification, Class Ia |
97111 |
HLA Antibody Identification, Class IIa |
95735 |
HLA Antibody Screen, Class Ia |
95736 |
HLA Antibody Screen, Class IIa |
| a | This test was developed and its performance characteristics determined by this laboratory. It has not been cleared or approved by the US Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high-complexity clinical laboratory testing. |
Post-transplant infectious disease testing
The risk of post-transplant infection varies with a patient’s state of immunosuppression and source of infectious exposures.11,12 Reactivation of donor-derived latent infections commonly occur within the first 4 weeks after transplantation, followed by a 1- to 12-month period during which patients who are immunosuppressed are at risk for opportunistic bacterial, fungal, or viral infections.11 After 1 year, patients are at highest risk for community-acquired infections.11 Certain types of infectious diseases are more common depending on epidemiological exposure, which may help guide diagnostic testing (Table 3).
Table 3. Post-transplant Tests for Infectious Diseases
Test code |
Test name |
39950 |
Specialized Transplant Services, Post-Transplanta |
Donor-derived latent infections (<4 weeks) |
|
18143 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Bloodb |
18142 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Plasmab |
18144 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Respiratoryb |
18141 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Serumb |
18060 |
Post-Transplant, Hepatitis B Virus DNA, Real-Time PCR, Plasmab |
18059 |
Post-Transplant, Hepatitis B Virus DNA, Real-Time PCR, Serumb |
18104 |
Post-Transplant, Hepatitis C Viral RNA, Real-Time PCR, Plasmab |
18103 |
Post-Transplant, Hepatitis C Viral (HCV) RNA, Real-Time PCR, Serumb |
18003 |
Post-Transplant, HIV-1 RNA, Real-Time PCR, Plasmab |
Opportunistic (1 month to 12 months) and community acquired infections (>12 months) |
|
18122 |
Post-Transplant, Adenovirus DNA, Real-Time PCR, Bloodb |
18120 |
Post-Transplant, Adenovirus DNA, Real-Time PCR, Plasmab |
18124 |
Post-Transplant, Adenovirus DNA, Real-Time PCR, Respiratoryb |
18118 |
Post-Transplant, Adenovirus DNA, Real-Time PCR, Serumb |
18126 |
Post-Transplant, Adenovirus DNA, Real-Time PCR, Urineb |
18000 |
Post-Transplant, Aspergillus DNA, Qualitative Real-Time PCR, Bloodb |
18001 |
Post-Transplant, Aspergillus DNA, Qualitative Real-Time PCR, Respiratoryb |
18051 |
Post-Transplant, BK Virus DNA, Real-Time PCR, Bloodb |
18050 |
Post-Transplant, BK Virus DNA, Real-Time PCR, Plasmab |
18049 |
Post-Transplant, BK Virus DNA, Real-Time PCR, Serumb |
18052 |
Post-Transplant, BK Virus DNA, Real-Time PCR, Urineb |
18143 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Bloodb |
18142 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Plasmab |
18144 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Respiratoryb |
18141 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Serumb |
18090 |
Post-Transplant, Epstein-Barr Virus DNA, Real-Time PCR, Bloodb |
18089 |
Post-Transplant, Epstein-Barr Virus DNA, Real-Time PCR, Plasmab |
18088 |
Post-Transplant, Epstein-Barr Virus DNA, Real-Time PCR, Serumb |
18060 |
Post-Transplant, Hepatitis B Virus DNA, Real-Time PCR, Plasmab |
18059 |
Post-Transplant, Hepatitis B Virus DNA, Real-Time PCR, Serumb |
18104 |
Post-Transplant, Hepatitis C Viral RNA, Real-Time PCR, Plasmab |
18103 |
Post-Transplant, Hepatitis C Viral RNA, Real-Time PCR, Serumb |
18022 |
Post-Transplant, Herpesvirus 6 DNA, Real-Time PCR, Bloodb |
18020 |
Post-Transplant, Herpesvirus 6 DNA, Real-Time PCR, P0lasmab |
18078 |
Post-Transplant, Herpesvirus 7 DNA, Real-Time PCR, Bloodb |
18076 |
Post-Transplant, Herpesvirus 7 DNA, Real-Time PCR, Plasmab |
18074 |
Post-Transplant, Herpesvirus 7 DNA, Real-Time PCR, Serumb |
18132 |
Post-Transplant, Herpesvirus 8 DNA, Real-Time PCR, Bloodb |
18130 |
Post-Transplant, Herpesvirus 8 DNA, Real-Time PCR, Plasmab |
18128 |
Post-Transplant, Herpesvirus 8 DNA, Real-Time PCR, Serumb |
18003 |
Post-Transplant, HIV-1 RNA, Real-Time PCR, Plasmab |
18011 |
Post-Transplant, JC Virus DNA, Real-Time PCR, CSFb |
18010 |
Post-Transplant, JC Virus DNA, Real-Time PCR, Plasmab |
18009 |
Post-Transplant, JC Virus DNA, Real-Time PCR, Serumb |
18070 |
Post-Transplant, Parvovirus B19 DNA, Real-Time PCR, Bloodb |
18068 |
Post-Transplant, Parvovirus B19 DNA, Real-Time PCR, Plasmab |
18066 |
Post-Transplant, Parvovirus B19 DNA, Real-Time PCR, Serumb |
18146 |
Post-Transplant, Varicella-zoster Virus DNA, Real-Time PCR, Bloodb |
18148 |
Post-Transplant, Varicella-zoster Virus DNA, Real-Time PCR, CSFb |
18005 |
Post-Transplant, Pneumocystis jiroveci, Real-Time PCR, Respiratoryb |
| a | Specialized transplant services include collection and shipping kits provided to the customer, direct shipping via FedEx, post-transplant-specific requisitions, and rapid turnaround (8-12 hours from laboratory receipt of sample). Test code 39950 designates special handling for these services; it is a single-use test code that may be applied to 1 or more tests in this section. |
| b | This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. |
Other tests
Laboratory tests can also be used to monitor immunosuppressive and antifungal drug therapies (Table 4) and help optimize dose, avoid toxicity, and assure patient adherence.
Table 4. Post-transplant Testing for Therapeutic Drug Monitoring
Test code |
Test name |
Primary clinical use |
|
Immunosuppressive therapy |
|||
10720 |
Cyclosporine A Panel (Trough, 1 Hour, 2 Hour Post) |
Monitor immunosuppressive therapy to optimize dose, avoid toxicity, and help assure adherence to a treatment regimen |
|
10719 |
Cyclosporine A Peak (2 Hour), Blood |
||
8812 |
Cyclosporine A, Trough, Blood |
||
15220 |
Cyclosporine A Trough, LC/MS/MS, Blooda |
||
18883 |
Everolimus, LC/MS/MS, Blooda |
||
10662 |
Mycophenolic Acida |
||
36712 |
Sirolimus, LC/MS/MSa |
||
70007 |
Tacrolimus, Highly Sensitive, LC/MS/MSa |
||
91745 |
Thiopurine Metabolitesa |
||
Antifungal therapy |
|||
94092 |
Itraconazolea |
Monitor drug levels when unexpected toxicity is encountered; optimize dosage when drug interactions are suspected |
|
94010 |
Posaconazolea |
||
94096 |
Voriconazolea |
||
94692 |
Voriconazole, CSFa |
||
| a | This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. |
Laboratory tests can also be used during early follow-up to evaluate transplant viability, bone marrow cell engraftment, cell-mediated immune response complications, and the possibility of rejection or complications (Table 5).
Table 5. Post-transplant Testing for Early Follow-up
Test code |
Test name |
Primary clinical use |
|
4944 |
Beta-2-Microglobulin, Random Urine |
Evaluate transplant viability and anticipate rejection |
|
38994 |
Beta-2-Microglobulin, Random Urine with Creatinine |
||
852 |
Beta-2-Microglobulin, Serum |
||
14619 |
FISH, X/Y, Post Opposite Sex Bone Marrow Transplant (BMT) |
Monitor progression of bone marrow cell engraftment when bone marrow is from a donor of the opposite sex |
|
15435 |
Immune Cell Function |
Monitor cell-mediated immune response to optimize immunosuppressant therapy |
|
34298 |
Interleukin-2 Receptor Alpha Chain (IL-2Ra/CD25), Solublea |
Assess possibility of acute transplant rejection |
|
34473 |
Interleukin-6 (IL-6), Seruma |
Assess possibility of transplant-related complications after hematopoietic stem cell transplantation (SCT) |
|
93917 |
Neopterin, Serumb |
Monitor cell-mediated immunity |
| a | This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Quest Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means. |
| b | This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Laboratory Corporation of America (LabCorp). This test should not be used for diagnosis without confirmation by other medically established means. |
- 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
- Lentine KL, Kasiske BL, Levey AS, et al. Summary of kidney disease. Transplantation. 2017;101(8):1783-1792. doi:10.1097/tp.0000000000001770
- Policies. The Organ Procurement and Transplantation Network. Updated May 29, 2024. Accessed June 1, 2024. https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf#nameddest=Policy_07
- 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
- 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
- Freedman BI, Pastan SO, Israni AK, et al. APOL1 genotype and kidney transplantation outcomes from deceased African American donors. Transplantation. 2016;100(1):194-202. doi:10.1097/tp.0000000000000969
- Reeves-Daniel AM, DePalma JA, Bleyer AJ, et al. The APOL1 gene and allograft survival after kidney transplantation. Am J Transplant. 2011;11(5):1025-1030. doi:10.1111/j.1600-6143.2011.03513.x
- 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
- HLA testing for solid organ transplantation. American Association of Clinical Chemistry. Updated August 27, 2019. Accessed June 20, 2024. https://www.myadlm.org/Science-and-Research/Clinical-Chemistry/Clinical-Chemistry-Trainee-Council/Pearls-of-Laboratory-Medicine-in-English/2019/HLA-Testing-for-Solid-Organ-Transplantation
- Fishman JA. Infection in organ transplantation. Am J Transplant. 2017;17(4):856-879. doi:10.1111/ajt.14208
- Singh N, Limaye AP. Infections in solid-organ transplant recipients. In: Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases. 2015:3440-3452. doi:10.1016/b978-1-4557-4801-3.00313-1
Content reviewed 08/2024
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.
Test Guide
Solid Organ and Hematopoietic Stem Cell Transplantation
Laboratory Testing for Donors and Recipients
This Test Guide provides a description of tests available for transplant donors and recipients. Laboratory testing includes US Food and Drug Administration (FDA)-required testing of donors for certain infectious diseases,1 testing for genetic kidney diseases to evaluate donor candidates,2 guideline-indicated compatibility testing (human leukocyte antigen [HLA] typing and HLA antibody screening) for transplant donors and recipients,3 and post-transplant testing to monitor immunosuppressive and antifungal drug therapies and follow-up for infectious disease.
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.
Donor testing
Laboratory testing can help avoid transmission of infectious disease through transplanted human cells, tissues, and cellular-based products (HCT/Ps) by identifying diseases or disease agents in potential donors with active or latent infections; immunosuppressive drugs used to prevent transplant rejection can reactivate latent infections.4
The 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.1 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 1).5,6
For potential living kidney donors who self-report African ancestry, detection of any 2 APOL1 risk alleles (G1/G1, G2/G2, or G1/G2) indicates an increased risk for developing APOL1-associated chronic kidney disease. The risk of premature allograft loss associated with a high-risk genotype in a living donor is currently unknown, but a high-risk genotype in a deceased donor is associated with shorter allograft survival in transplant recipients.7,8
Quest Diagnostics offers a menu of pretransplant tests that includes APOL1 renal risk variant genotyping and donor screening panels for infectious diseases (Table 1); components of panels can be ordered separately. These panels, based on FDA guidelines for approved testing,5,9 include tests for HIV-1/2, HBV, HCV, CMV, T pallidum, and others.
Table 1. APOL1 Risk Variant and Infectious Disease Testing for Donors
Test code |
Test name |
Primary clinical use |
|
Genotyping |
|||
1291 |
Apolipoprotein L1 (APOL1) Renal Risk Variant Genotyping |
Assist evaluation of a potential donor for kidney transplantation |
|
Infectious disease testing |
|||
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; HCT/Ps, human cells, tissues, and cellular and tissue-based products; HIV, human immunodeficiency virus;; HTLV, human T-cell lymphotropic virus; NAT, nucleic acid amplification; 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). |
Compatibility testing for transplant donors and recipients
A person's HLA type and antibody profile are important for assessing immunological compatibility between donor and recipient, as incompatibility can result in transplant rejection. HLA typing and antibody testing can help assess donor-recipient immunological risk. Testing options vary by HLA class and resolution (Table 2).
HLA proteins are grouped into 2 classes: class I includes A, B, and C antigens, and class II includes DR, DQ, and DP antigens. HLA A, B, and DR antigens are considered the most important in transplant survival; however, current Organ Procurement and Transplantation Network/United Network for Organ Sharing (OPTN/UNOS) guidelines mandate molecular typing of all HLA loci, which may be performed at different levels of resolution depending on transplant center requirements.3 DNA-based typing at low resolution identifies the group of alleles that encode a particular HLA antigen. Intermediate-resolution typing is limited to particular allele groups expected in a population. High-resolution typing allows for a more precise determination of an allelic variant by identifying variants based on differences in antigen recognition site domains. HLA antibody tests identify preformed antibodies to donor HLA antigens in transplant recipients, which may develop from prior sensitization.10
Table 2. Donor–Recipient Compatibility Tests for Solid Organ and Bone Marrow Transplantation
Test code |
Test name |
HLA typing |
|
92157 |
HLA A, B, C, Class I Typing, Intermediate Resolutiona |
92076 |
HLA-A, B, C, DRB1 and DQ High Resolution |
92078 |
HLA-A, B, C High Resolution |
15484 |
HLA A, B, C Low Resolutiona |
92158 |
HLA-A, B, Intermediate Resolutiona |
15757 |
HLA A, B Low Resolutiona |
92044 |
HLA A 02:01 Determinationa |
10951 |
HLA A Low Resolutiona |
17397 |
HLA A Typing, High Resolutiona |
92746 |
HLA-B*15:02 Determination with Reflex to HLA-B High Resolutiona |
10950 |
HLA B Low Resolutiona |
17395 |
HLA C High Resolutiona |
15463 |
HLA C Low Resolutiona |
95730 |
HLA DPB1 Typing, High Resolutiona |
19525 |
HLA DQA1 Low Resolutiona |
10953 |
HLA DQB1 Low Resolutiona |
17394 |
HLA DQB1 Typing, High Resolutiona |
92159 |
HLA DRB1, DQB1, Intermediate Resolutiona |
15485 |
HLA DRB1, DQB1 Low Resolutiona |
97112 |
HLA DRB1,3,4,5,DQB1, Low Resolutiona |
10952 |
HLA DRB1 Low Resolutiona |
19526 |
HLA DRB3,4,5 Low Resolutiona |
17393 |
HLA DRB1 Typing, High Resolutiona |
95732 |
HLA DRB3,4,5 Typing, High Resolutiona |
92160 |
HLA DRB1 Typing, Intermediate Resolutiona |
92161 |
HLA DRB3,4,5 Typing, Intermediate Resolutiona |
HLA antibody screening and identification |
|
95731 |
HLA Antibody Identification, Class Ia |
97111 |
HLA Antibody Identification, Class IIa |
95735 |
HLA Antibody Screen, Class Ia |
95736 |
HLA Antibody Screen, Class IIa |
| a | This test was developed and its performance characteristics determined by this laboratory. It has not been cleared or approved by the US Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high-complexity clinical laboratory testing. |
Post-transplant infectious disease testing
The risk of post-transplant infection varies with a patient’s state of immunosuppression and source of infectious exposures.11,12 Reactivation of donor-derived latent infections commonly occur within the first 4 weeks after transplantation, followed by a 1- to 12-month period during which patients who are immunosuppressed are at risk for opportunistic bacterial, fungal, or viral infections.11 After 1 year, patients are at highest risk for community-acquired infections.11 Certain types of infectious diseases are more common depending on epidemiological exposure, which may help guide diagnostic testing (Table 3).
Table 3. Post-transplant Tests for Infectious Diseases
Test code |
Test name |
39950 |
Specialized Transplant Services, Post-Transplanta |
Donor-derived latent infections (<4 weeks) |
|
18143 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Bloodb |
18142 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Plasmab |
18144 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Respiratoryb |
18141 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Serumb |
18060 |
Post-Transplant, Hepatitis B Virus DNA, Real-Time PCR, Plasmab |
18059 |
Post-Transplant, Hepatitis B Virus DNA, Real-Time PCR, Serumb |
18104 |
Post-Transplant, Hepatitis C Viral RNA, Real-Time PCR, Plasmab |
18103 |
Post-Transplant, Hepatitis C Viral (HCV) RNA, Real-Time PCR, Serumb |
18003 |
Post-Transplant, HIV-1 RNA, Real-Time PCR, Plasmab |
Opportunistic (1 month to 12 months) and community acquired infections (>12 months) |
|
18122 |
Post-Transplant, Adenovirus DNA, Real-Time PCR, Bloodb |
18120 |
Post-Transplant, Adenovirus DNA, Real-Time PCR, Plasmab |
18124 |
Post-Transplant, Adenovirus DNA, Real-Time PCR, Respiratoryb |
18118 |
Post-Transplant, Adenovirus DNA, Real-Time PCR, Serumb |
18126 |
Post-Transplant, Adenovirus DNA, Real-Time PCR, Urineb |
18000 |
Post-Transplant, Aspergillus DNA, Qualitative Real-Time PCR, Bloodb |
18001 |
Post-Transplant, Aspergillus DNA, Qualitative Real-Time PCR, Respiratoryb |
18051 |
Post-Transplant, BK Virus DNA, Real-Time PCR, Bloodb |
18050 |
Post-Transplant, BK Virus DNA, Real-Time PCR, Plasmab |
18049 |
Post-Transplant, BK Virus DNA, Real-Time PCR, Serumb |
18052 |
Post-Transplant, BK Virus DNA, Real-Time PCR, Urineb |
18143 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Bloodb |
18142 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Plasmab |
18144 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Respiratoryb |
18141 |
Post-Transplant, Cytomegalovirus DNA, Real-Time PCR, Serumb |
18090 |
Post-Transplant, Epstein-Barr Virus DNA, Real-Time PCR, Bloodb |
18089 |
Post-Transplant, Epstein-Barr Virus DNA, Real-Time PCR, Plasmab |
18088 |
Post-Transplant, Epstein-Barr Virus DNA, Real-Time PCR, Serumb |
18060 |
Post-Transplant, Hepatitis B Virus DNA, Real-Time PCR, Plasmab |
18059 |
Post-Transplant, Hepatitis B Virus DNA, Real-Time PCR, Serumb |
18104 |
Post-Transplant, Hepatitis C Viral RNA, Real-Time PCR, Plasmab |
18103 |
Post-Transplant, Hepatitis C Viral RNA, Real-Time PCR, Serumb |
18022 |
Post-Transplant, Herpesvirus 6 DNA, Real-Time PCR, Bloodb |
18020 |
Post-Transplant, Herpesvirus 6 DNA, Real-Time PCR, P0lasmab |
18078 |
Post-Transplant, Herpesvirus 7 DNA, Real-Time PCR, Bloodb |
18076 |
Post-Transplant, Herpesvirus 7 DNA, Real-Time PCR, Plasmab |
18074 |
Post-Transplant, Herpesvirus 7 DNA, Real-Time PCR, Serumb |
18132 |
Post-Transplant, Herpesvirus 8 DNA, Real-Time PCR, Bloodb |
18130 |
Post-Transplant, Herpesvirus 8 DNA, Real-Time PCR, Plasmab |
18128 |
Post-Transplant, Herpesvirus 8 DNA, Real-Time PCR, Serumb |
18003 |
Post-Transplant, HIV-1 RNA, Real-Time PCR, Plasmab |
18011 |
Post-Transplant, JC Virus DNA, Real-Time PCR, CSFb |
18010 |
Post-Transplant, JC Virus DNA, Real-Time PCR, Plasmab |
18009 |
Post-Transplant, JC Virus DNA, Real-Time PCR, Serumb |
18070 |
Post-Transplant, Parvovirus B19 DNA, Real-Time PCR, Bloodb |
18068 |
Post-Transplant, Parvovirus B19 DNA, Real-Time PCR, Plasmab |
18066 |
Post-Transplant, Parvovirus B19 DNA, Real-Time PCR, Serumb |
18146 |
Post-Transplant, Varicella-zoster Virus DNA, Real-Time PCR, Bloodb |
18148 |
Post-Transplant, Varicella-zoster Virus DNA, Real-Time PCR, CSFb |
18005 |
Post-Transplant, Pneumocystis jiroveci, Real-Time PCR, Respiratoryb |
| a | Specialized transplant services include collection and shipping kits provided to the customer, direct shipping via FedEx, post-transplant-specific requisitions, and rapid turnaround (8-12 hours from laboratory receipt of sample). Test code 39950 designates special handling for these services; it is a single-use test code that may be applied to 1 or more tests in this section. |
| b | This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. |
Other tests
Laboratory tests can also be used to monitor immunosuppressive and antifungal drug therapies (Table 4) and help optimize dose, avoid toxicity, and assure patient adherence.
Table 4. Post-transplant Testing for Therapeutic Drug Monitoring
Test code |
Test name |
Primary clinical use |
|
Immunosuppressive therapy |
|||
10720 |
Cyclosporine A Panel (Trough, 1 Hour, 2 Hour Post) |
Monitor immunosuppressive therapy to optimize dose, avoid toxicity, and help assure adherence to a treatment regimen |
|
10719 |
Cyclosporine A Peak (2 Hour), Blood |
||
8812 |
Cyclosporine A, Trough, Blood |
||
15220 |
Cyclosporine A Trough, LC/MS/MS, Blooda |
||
18883 |
Everolimus, LC/MS/MS, Blooda |
||
10662 |
Mycophenolic Acida |
||
36712 |
Sirolimus, LC/MS/MSa |
||
70007 |
Tacrolimus, Highly Sensitive, LC/MS/MSa |
||
91745 |
Thiopurine Metabolitesa |
||
Antifungal therapy |
|||
94092 |
Itraconazolea |
Monitor drug levels when unexpected toxicity is encountered; optimize dosage when drug interactions are suspected |
|
94010 |
Posaconazolea |
||
94096 |
Voriconazolea |
||
94692 |
Voriconazole, CSFa |
||
| a | This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. |
Laboratory tests can also be used during early follow-up to evaluate transplant viability, bone marrow cell engraftment, cell-mediated immune response complications, and the possibility of rejection or complications (Table 5).
Table 5. Post-transplant Testing for Early Follow-up
Test code |
Test name |
Primary clinical use |
|
4944 |
Beta-2-Microglobulin, Random Urine |
Evaluate transplant viability and anticipate rejection |
|
38994 |
Beta-2-Microglobulin, Random Urine with Creatinine |
||
852 |
Beta-2-Microglobulin, Serum |
||
14619 |
FISH, X/Y, Post Opposite Sex Bone Marrow Transplant (BMT) |
Monitor progression of bone marrow cell engraftment when bone marrow is from a donor of the opposite sex |
|
15435 |
Immune Cell Function |
Monitor cell-mediated immune response to optimize immunosuppressant therapy |
|
34298 |
Interleukin-2 Receptor Alpha Chain (IL-2Ra/CD25), Solublea |
Assess possibility of acute transplant rejection |
|
34473 |
Interleukin-6 (IL-6), Seruma |
Assess possibility of transplant-related complications after hematopoietic stem cell transplantation (SCT) |
|
93917 |
Neopterin, Serumb |
Monitor cell-mediated immunity |
| a | This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Quest Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means. |
| b | This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Laboratory Corporation of America (LabCorp). This test should not be used for diagnosis without confirmation by other medically established means. |
- 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
- Lentine KL, Kasiske BL, Levey AS, et al. Summary of kidney disease. Transplantation. 2017;101(8):1783-1792. doi:10.1097/tp.0000000000001770
- Policies. The Organ Procurement and Transplantation Network. Updated May 29, 2024. Accessed June 1, 2024. https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf#nameddest=Policy_07
- 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
- 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
- Freedman BI, Pastan SO, Israni AK, et al. APOL1 genotype and kidney transplantation outcomes from deceased African American donors. Transplantation. 2016;100(1):194-202. doi:10.1097/tp.0000000000000969
- Reeves-Daniel AM, DePalma JA, Bleyer AJ, et al. The APOL1 gene and allograft survival after kidney transplantation. Am J Transplant. 2011;11(5):1025-1030. doi:10.1111/j.1600-6143.2011.03513.x
- 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
- HLA testing for solid organ transplantation. American Association of Clinical Chemistry. Updated August 27, 2019. Accessed June 20, 2024. https://www.myadlm.org/Science-and-Research/Clinical-Chemistry/Clinical-Chemistry-Trainee-Council/Pearls-of-Laboratory-Medicine-in-English/2019/HLA-Testing-for-Solid-Organ-Transplantation
- Fishman JA. Infection in organ transplantation. Am J Transplant. 2017;17(4):856-879. doi:10.1111/ajt.14208
- Singh N, Limaye AP. Infections in solid-organ transplant recipients. In: Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases. 2015:3440-3452. doi:10.1016/b978-1-4557-4801-3.00313-1
Content reviewed 08/2024