One window for transplant laboratories

A stem-cell transplant replaces a patient's blood-forming system with a donor's. Every cell carries an HLA 'ID card'; the closer the donor's ID cards match the patient's, the less the new immune system attacks the patient (graft-versus-host disease) and the less the patient rejects the graft. Laboratories test before the transplant (diagnosis, matching, infections), during it (the graft) and for months afterwards (engraftment, viruses, relapse).

Typical customers: Bone-marrow transplant (BMT) units, haematology and oncology hospitals, HLA laboratories, blood banks

1. 1

   Record the disease's genetic fingerprint

   Before transplant, the leukaemia's markers (for example BCR-ABL, NPM1, FLT3) are measured so the smallest trace of relapse can be found later.

   • Healthincode Haematology OncoKitDx (NGS, CE-IVD) IMG-363
2. 2

   Collect samples and extract DNA

   EDTA blood from the patient and every potential donor (often siblings) gives the DNA for typing; serum is kept for antibody tests.

   • Takara Bio NucleoSpin / NucleoMag blood DNA purification
3. 3

   HLA-type the patient and donors

   HLA typing reads the ID-card genes (HLA-A, B, C, DRB1, DQB1 and others). Siblings are tested first; if none match, unrelated or half-matched (haploidentical) donors are typed.

   • BAG Diagnostics HISTO TYPE Rainbow: real-time PCR typing of 11 HLA loci on one plate 728220
4. 4

   Check for antibodies against the donor

   Some patients (after pregnancies or transfusions) already carry antibodies against HLA types. Antibodies against the chosen donor (donor-specific antibodies, DSA) can stop the graft taking.

   • BAG Diagnostics HISTO SPOT HLA AB Screen / ID Class I 728102
   • BAG Diagnostics HISTO SPOT AB Reagent Kit 728198
5. 5

   Match blood groups

   Unlike organ transplants, bone-marrow donors can have a different ABO group; the lab plans red-cell and plasma handling and watches the patient's blood group switch to the donor's.

   • BAG Diagnostics Blood-group serology sera and reagents
6. 6

   Screen donor and patient for infections

   CMV, EBV, hepatitis B and C, HIV and others are checked before transplant in both donor and recipient.

   • AM Diagnostics CE-marked PCR kits: HBV, HCV, HIV, CMV, EBV, TB
7. 7

   Collect, count and store the graft

   Stem cells are collected from bone marrow, blood (after mobilisation) or cord blood. CD34+ cells are counted by flow cytometry and the graft may be frozen.

   • Elabscience Anti-human CD34 and CD45 antibodies E-AB-F1324A
   • Elabscience 7-AAD viability reagent E-CK-A162
   • PAN-Biotech Cryopan II, chemically defined, protein-free freezing medium P07-93010
   • Takara Bio TaKaRa Mycoplasma qPCR Detection Kit RR277A
8. 8

   Confirm the graft has taken (chimerism)

   After transplant the blood should gradually become the donor's. Chimerism tests measure what percentage of DNA in blood or marrow comes from donor and from patient.

   • Healthincode Imegen-Quimera Screening Multiplex kits (qPCR, CE-IVD) IMG-116-24
   • Healthincode Imegen-Quimera qPCR (CE-IVD) IMG-116 qPCR
   • Takara Bio NucleoSpin / NucleoMag blood DNA purification
9. 9

   Watch for viruses and immunity

   While the new immune system rebuilds, CMV, EBV, adenovirus, BK virus and HHV-6 can reactivate. Viral load is measured weekly at first; T-cell tests show whether the patient can control the virus.

   • AM Diagnostics CMV and EBV quantitative real-time PCR kits
   • Mabtech ELISpot Path: CMV Human IFN-γ 3420-2AST-P2-1
10. 10

    Look for relapse (MRD)

    The disease markers recorded at the start are measured again at set times after transplant.

    • Healthincode BCR-ABL1 Screening dPCR OncoKit IMG-424
11. 11

    Personalise drug doses (pharmacogenomics) optional

    Genes such as CYP3A5 change how fast patients clear immunosuppressants like tacrolimus.

    • Atila Biosystems PGx Oncology & Immunosuppression SNP Panel
12. 12

    Research GvHD and complications optional

    Research groups measure blood markers of inflammation, infection and organ injury to predict GvHD or kidney damage.

    • Elabscience Human IP-10/CXCL10 ELISA Kit E-EL-H0050
13. 13

    Instruments optional

    Most of these tests run on a real-time PCR instrument; SSO typing and antibody tests can be automated.

    • Allsheng Real-time PCR system

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For a kidney, liver or heart, the donor's organ must not be destroyed by the recipient's immune system. The lab checks HLA match, looks for antibodies against the donor, performs a crossmatch (mixing recipient serum with donor cells), checks ABO compatibility and infections, and then monitors the patient for years.

Typical customers: Transplant centres, nephrology units, HLA and virology laboratories

1. 1

   HLA-type recipient and donor

   Recipient and living donors are typed in advance; deceased donors are typed urgently, often at night.

   • BAG Diagnostics HISTO TYPE Rainbow: real-time PCR typing of 11 HLA loci on one plate 728220
2. 2

   Screen and identify HLA antibodies

   Patients on the waiting list are screened regularly; antibodies are identified so incompatible donors are avoided (virtual crossmatch).

   • BAG Diagnostics HISTO SPOT HLA AB Screen / ID Class I 728102
   • BAG Diagnostics HISTO SPOT AB Reagent Kit 728198
3. 3

   Crossmatch

   Donor lymphocytes are separated from blood and mixed with recipient serum and complement. If the cells die, the transplant is not safe.

   • PAN-Biotech Pancoll human, density 1.077 g/ml P04-60100
   • BAG Diagnostics Rabbit Complement (lyophilised) 7018
4. 4

   Check ABO compatibility

   Organ donor and recipient must be ABO compatible, unless a planned ABO-incompatible protocol is used.

   • BAG Diagnostics Blood-group serology sera and reagents
5. 5

   Screen for infections

   Donor and recipient are tested for CMV, EBV, BK virus, hepatitis, HIV and TB.

   • AM Diagnostics CE-marked PCR kits: HBV, HCV, HIV, CMV, EBV, TB
6. 6

   Monitor after transplant

   Viral load (CMV, EBV, BK virus), new donor-specific antibodies, kidney function and drug levels are followed for years.

   • AM Diagnostics CMV and EBV quantitative real-time PCR kits
   • BAG Diagnostics HISTO SPOT HLA AB Screen / ID Class I 728102
7. 7

   Personalise immunosuppression optional

   CYP3A5 genotype predicts tacrolimus dose.

   • Atila Biosystems PGx Oncology & Immunosuppression SNP Panel
8. 8

   Instruments optional

   One real-time PCR platform runs typing, viral load and genotyping kits.

   • Allsheng Real-time PCR system

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Red cells carry their own ID markers: ABO, RhD and dozens of minor groups. Patients who receive many transfusions, such as children with thalassaemia, form antibodies to minor groups, so matching more than ABO and RhD prevents reactions. Platelets and white cells have their own systems (HPA, HNA), and in pregnancy the baby's RhD can be read from the mother's blood.

Typical customers: Hospital blood banks, regional transfusion centres, thalassaemia centres, obstetric units

1. 1

   Routine ABO and RhD grouping

   Antisera clump (agglutinate) red cells that carry the matching antigen.

   • BAG Diagnostics Blood-group serology sera and reagents
2. 2

   Resolve weak and partial D

   Some people have weakened or partial RhD that serology misreads. Genotyping tells whether they should receive RhD-negative blood or anti-D.

   • BAG Diagnostics ERY Q Weak D real-time PCR 728401
3. 3

   Extended matching for regularly transfused patients

   For thalassaemia and sickle-cell patients, Rh (C, c, E, e), Kell, Kidd, Duffy and MNS types are matched. Genotyping works even when the patient's blood is full of donor cells.

   • BAG Diagnostics ERY Q RH and ERY Q KKD/MNS real-time PCR 728405
4. 4

   Platelet and neutrophil antigens optional

   HPA and HNA typing supports platelet-refractory patients, neonatal alloimmune thrombocytopenia and transfusion reactions.

   • BAG Diagnostics ERY Q HPA real-time PCR 728402
5. 5

   Pregnancy: baby's RhD from the mother's blood optional

   Free fetal DNA in an RhD-negative mother's plasma shows whether the baby is RhD positive, so anti-D is given only when needed.

   • BAG Diagnostics FastQ RHD fetal real-time PCR
6. 6

   Screen donated blood for infections

   Molecular tests for HBV, HCV and HIV shorten the window in which an infection is missed.

   • AM Diagnostics HBV, HCV and HIV real-time PCR kits
7. 7

   Instruments optional

   Genotyping kits run on a standard real-time PCR instrument.

   • Allsheng Real-time PCR system

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Behind every transplant programme sits a lab that handles cells: separating, counting, freezing and testing grafts, and increasingly growing cells as medicines, such as MSCs to treat graft-versus-host disease or CAR-T cells for relapsed leukaemia.

Typical customers: Cell-processing laboratories of BMT units, regenerative-medicine and cell-therapy centres

1. 1

   Separate the cells you need

   Density gradients isolate mononuclear cells; red cells are lysed or removed.

   • PAN-Biotech Pancoll human, density 1.077 g/ml P04-60100
2. 2

   Count stem cells and check viability

   Flow cytometry counts CD34+ cells and checks they are alive.

   • Elabscience Anti-human CD34 and CD45 antibodies E-AB-F1324A
   • Elabscience 7-AAD viability reagent E-CK-A162
3. 3

   Freeze and store grafts

   Grafts are frozen with a cryoprotectant and stored in liquid nitrogen.

   • PAN-Biotech Cryopan II, chemically defined, protein-free freezing medium P07-93010
4. 4

   Test sterility

   Every graft and cell product is tested for mycoplasma and contamination.

   • Takara Bio TaKaRa Mycoplasma qPCR Detection Kit RR277A
5. 5

   Grow MSCs for GvHD treatment optional

   MSCs from bone marrow or umbilical cord calm the immune system and are studied for steroid-resistant GvHD.

   • Takara Bio Cellartis MSC Xeno-Free Culture Medium Y50200
6. 6

   Make CAR-T or other engineered cells optional

   Activate T cells, transduce them with lentivirus on RetroNectin, expand and test them.

   • Takara Bio RetroNectin T100A
   • Takara Bio LymphoONE T-Cell Expansion Xeno-Free Medium WK552S
7. 7

   Release QC and standards optional

   Products are tested for residual DNA and potency against reference standards.

   • Shentek Bio Residual DNA quantitation and mycoplasma kits

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