2 Draft Product Form 2005 HLA r6

CIBMTR Center Number: ___ ___ ___ ___ ___ CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

R

OMB No: 0915-0310

Expiration Date: 1/31/2017

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0915-0310. Public reporting burden for this collection of information, in combination with the IDM Form 2004 and HCT Infusion Form 2006, is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10-33, Rockville, Maryland, 20857.

egistry Use Only

Sequence Number:

Date Received:

CIBMTR Center Number: ___ ___ ___ ___ ___

CIBMTR Research ID: ___ ___ ___ ___ ___ ___ ___ ___ ___ ___

Event date: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

HCT type: (check all that apply)

 Autologous

 Allogeneic, unrelated

 Allogeneic, related

Product type: (check all that apply)

 Bone marrow

 PBSC

 Single cord blood unit

 Multiple cord blood units

 Other product

Specify:

Donor / Cord Blood Unit Identification

This form must be completed for all non-NMDP allogeneic or syngeneic donors or recipients, or non-NMDP cord blood units. If the donor, recipient, or cord blood unit was secured through the NMDP, then report HLA typing on the appropriate NMDP forms.

A separate copy of this form should be completed for each non-NMDP donor, recipient, or cord blood unit. Parental typing (maternal and paternal) should be submitted for all mismatched related donor transplants (CRF track only), if available. Cord blood maternal typing should be submitted for all unrelated cord blood transplants (CRF track only), if available.

1. Specify the person for whom this typing is being done:

 Recipient — final typing – Go to question 13

 Recipient’s biological relative– Go to question 5

 Unrelated donor — confirmatory typing – Go to question 2

 Cord blood unit — confirmatory typing – Go to question 3

 Cord blood unit maternal HLA typing – Go to question 3

2. Non-NMDP unrelated donor ID: (not applicable for related donor)

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ - Go to question 7

3. Non-NMDP cord blood unit ID: (include related and autologous CBUs)

___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ - If reporting Maternal HLA typing, go to question 12. If reporting Cord blood unit – confirmatory typing, go to question 4.

4. Is cord blood unit maternal HLA typing available?

 Yes – Go to question 7 Also complete form 2005 to report cord blood unit maternal HLA typing

 No – Go to question 7

5. Specify recipient’s biological relative and typing:

 Recipient’s mother — confirmatory typing – Go to question 7

 Recipient’s father — confirmatory typing – Go to question 7

 Recipient’s sibling – confirmatory typing – Go to question 7

 Recipient’s syngeneic (identical) twin– confirmatory typing – Go to question 7

 Recipient’s fraternal twin– confirmatory typing – Go to question 7

 Recipient’s child – confirmatory typing – Go to question 7

 Recipient’s aunt – confirmatory typing – Go to question 7

 Recipient’s uncle – confirmatory typing – Go to question 7

 Recipient’s cousin – confirmatory typing – Go to question 7

 Other biological relative – Go to question 6

6. Specify other biological relative and typing: ________________________________________

7. Date of birth: (donor / infant)

 Known – Go to question 8

 Unknown – Go to question 9

8. Date of birth: (donor / infant) ___ ___ ___ ___ — ___ ___ — ___ ___ - Go to question 11

YYYY MM DD

9. Age: (donor / infant)

 Known – Go to question 10

 Unknown – Go to question 11

10. Age: (donor / infant) ___ ___  Months (use only if less than 1 year old)

 Years

11. Sex: (donor / infant)

 Male

 Female

12. Was the person for whom this typing is being done used as the donor?

 Yes

 No

HLA Typing by DNA Technology

13. Was documentation submitted to the CIBMTR? (e.g. lab report)

 Yes

 No

HLA Alleles Defined by DNA Technology (e.g., Sequence Specific Oligonucleotide Probe (SSOP) typing, Sequence Specific Primer (SSP) typing or Sequence Based (SBT) typing.)

DNA technology can be used to type for a single allele, combinations of alleles (allele strings) or a “generic” allele designation which is similar to a serologic typing result. For this reason, the number of digits, as well as the number of alleles, for reporting will vary.

Laboratories may use “ / ” , “ – ” or a combination of numbers and letters on the typing report as a shorthand notation for the results. Transcribe the information onto the form as directly as possible. The letters are called allele codes, and will be 1 or more characters in length which represent a combination of possible alleles at a locus. The same allele combination may be reported several different ways (e.g., DRB1*01:01 or 01:02, DRB1*01:01/01:02, DRB1*01:01/02, or DRB1*01:AB).

There will be two alleles reported for each locus, unless the individual is presumed homozygous (i.e., carries two copies of the same allele) at a locus. Transcribe the first allele designation in the first box, and the second allele designation in the second box. If the person is homozygous, leave the second box blank.

Class I

14. Locus A

 Known – Go to question 15

 Unknown – Go to question 16

15. First A* allele designations

Second A* allele designations

16. Locus B

 Known – Go to question 17

 Unknown – Go to question 18

17. First B* allele designations

Second B* allele designations

18. Locus C

 Known – Go to question 19

 Unknown – Go to question 20

19. First C* allele designations

Second C* allele designations

Class II

20. Locus DRB1

 Known – Go to question 21

 Unknown – Go to question 22

21. First DRB1* allele designations

Second DRB1* allele designations

Class II (Optional)

Please provide the optional allele information if it is available from your laboratory.

22. Locus DRB3

 Known – Go to question 23

 Unknown – Go to question 24

23. First DRB3* allele designations

Second DRB3* allele designations

24. Locus DRB4

 Known – Go to question 25

 Unknown – Go to question 26

25. First DRB4* allele designations

Second DRB4* allele designations

26. Locus DRB5

 Known – Go to question 27

 Unknown – Go to question 28

27. First DRB5* allele designations

Second DRB5* allele designations

28. Locus DQB1

 Known – Go to question 29

 Unknown – Go to question 30

29. First DQB1* allele designations

Second DQB1* allele designations

30. Locus DPB1

 Known – Go to question 31

 Unknown – Go to question 32

31. First DPB1* allele designations

Second DPB1* allele designations

32. Locus DQA1

 Known – Go to question 33

 Unknown – Go to question 34

33. First DQA1* allele designations

Second DQA1* allele designations

34. Locus DPA1

 Known – Go to question 35

 Unknown – Go to question 36

35. First DPA1* allele designations

Second DPA1* allele designations

Antigens Defined by Serologic Typing

Use the following lists when reporting HLA-A and B antigens. Report broad antigens only when your laboratory was not able to confirm typing for a known split antigen.

Instructions for the use of the “X” Antigen Specificity for Typing By Serology

Each HLA locus has a serologically defined “X” antigen specificity: AX, BX, CX, DRX, DPX, and DQX. At this time an “X” specificity is defined as “unknown but known to be different from the other antigen at that locus.” This is different from a blank specificity, which is defined as “unknown but assumed to be the same as the other antigen at that locus.” When comparisons between recipient and donor antigens involve an “X” or “blank” specificity, the “X” or “blank” is assumed to be homozygous for the antigen reported at the locus. In other words, the search algorithm treats typings containing “blank” or “X” antigens in the same manner as known homozygous typings.

A Antigens

36. Number of antigens provided:

 One – Go to question 37, then continue with question 39

 Two – Go to questions 37-38

37. Specificity – 1st antigen

 A1

 A2

 A203

 A210

 A3

 A9

 A10

 A11

 A19

 A23(9)

 A24(9)

 A2403

 A25(10)

 A26(10)

 A28

 A29(19)

 A30(19)

 A31(19)

 A32(19)

 A33(19)

 A34(10)

 A36

 A43

 A66(10)

 A68(28)

 A69(28)

 A74(19)

 A80

 AX

38. Specificity – 2nd antigen

 A1

 A2

 A203

 A210

 A3

 A9

 A10

 A11

 A19

 A23(9)

 A24(9)

 A2403

 A25(10)

 A26(10)

 A28

 A29(19)

 A30(19)

 A31(19)

 A32(19)

 A33(19)

 A34(10)

 A36

 A43

 A66(10)

 A68(28)

 A69(28)

 A74(19)

 A80

 AX

B Antigens

39. Number of antigens provided:

 One – Go to question 40, then continue with question 42

 Two – Go to questions 40-41

40. Specificity – 1st antigen

 B5

 B7

 B703

 B8

 B12

 B13

 B14

 B15

 B16

 B17

 B18

 B21

 B22

 B27

 B2708

 B35

 B37

 B38(16)

 B39(16)

 B3901

 B3902

 B40

 B4005

 B41

 B42

 B44(12)

 B45(12)

 B46

 B47

 B48

 B49(21)

 B50(21)

 B51(5)

 B5102

 B5103

 B52(5)

 B53

 B54(22)

 B55(22)

 B56(22)

 B57(17)

 B58(17)

 B59

 B60(40)

 B61(40)

 B62(15)

 B63(15)

 B64(14)

 B65(14)

 B67

 B70

 B71(70)

 B72(70)

 B73

 B75(15)

 B76(15)

 B77(15)

 B78

 B81

 B82

 BX

41. Specificity – 2nd antigen

 B5

 B7

 B703

 B8

 B12

 B13

 B14

 B15

 B16

 B17

 B18

 B21

 B22

 B27

 B2708

 B35

 B37

 B38(16)

 B39(16)

 B3901

 B3902

 B40

 B4005

 B41

 B42

 B44(12)

 B45(12)

 B46

 B47

 B48

 B49(21)

 B50(21)

 B51(5)

 B5102

 B5103

 B52(5)

 B53

 B54(22)

 B55(22)

 B56(22)

 B57(17)

 B58(17)

 B59

 B60(40)

 B61(40)

 B62(15)

 B63(15)

 B64(14)

 B65(14)

 B67

 B70

 B71(70)

 B72(70)

 B73

 B75(15)

 B76(15)

 B77(15)

 B78

 B81

 B82

 BX

Optional Antigen Reporting

Please provide the following optional antigen information if it is available from your laboratory.

Antigens Defined by Serologic Typing

C Antigens

42. Number of antigens provided:

 One – Go to question 43, then continue with question 45

 Two – Go to questions 43-44

43. Specificity – 1st antigen

 Cw1

 Cw2

 Cw3

 Cw4

 Cw5

 Cw6

 Cw7

 Cw8

 Cw9(w3)

 Cw10(w3)

 CX

44. Specificity – 2nd antigen

 Cw1

 Cw2

 Cw3

 Cw4

 Cw5

 Cw6

 Cw7

 Cw8

 Cw9(w3)

 Cw10(w3)

 CX

Bw Specificity

45. Specificity Bw4 present?

 Yes

 No

46. Specificity Bw6 present?

 Yes

 No

DR Antigens

47. Number of antigens provided:

 One – Go to question 48, then continue with question 50

 Two – Go to questions 48-49

48. Specificity – 1st antigen

 DR1

 DR103

 DR2

 DR3

 DR4

 DR5

 DR6

 DR7

 DR8

 DR9

 DR10

 DR11(5)

 DR12(5)

 DR13(6)

 DR14(6)

 DR1403

 DR1404

 DR15(2)

 DR16(2)

 DR17(3)

 DR18(3)

 DRX

49. Specificity – 2nd antigen

 DR1

 DR103

 DR2

 DR3

 DR4

 DR5

 DR6

 DR7

 DR8

 DR9

 DR10

 DR11(5)

 DR12(5)

 DR13(6)

 DR14(6)

 DR1403

 DR1404

 DR15(2)

 DR16(2)

 DR17(3)

 DR18(3)

 DRX

DR51 Antigen

50. Specificity DR51 present?

 Yes

 No

DR52 Antigen

51. Specificity DR52 present?

 Yes

 No

DR53 Antigen

52. Specificity DR53 present?

 Yes

 No

DQ Antigens

53. Number of antigens provided:

 One – Go to question 54, then continue with question 56

 Two – Go to questions 54-55

54. Specificity – 1st antigen

 DQ1

 DQ2

 DQ3

 DQ4

 DQ5(1)

 DQ6(1)

 DQ7(3)

 DQ8(3)

 DQ9(3)

 DQX

55. Specificity – 2nd antigen

 DQ1

 DQ2

 DQ3

 DQ4

 DQ5(1)

 DQ6(1)

 DQ7(3)

 DQ8(3)

 DQ9(3)

 DQX

DP Antigens

56. Number of antigens provided:

 One – Go to question 57, then continue with signature line

 Two – Go to questions 57-58

57. Specificity – 1st antigen

 DPw1

 DPw2

 DPw3

 DPw4

 DPw5

 DPw6

 DPX

58. Specificity – 2nd antigen

 DPw1

 DPw2

 DPw3

 DPw4

 DPw5

 DPw6

 DPX

First Name:

Person completing form

Last Name:

E-mail address:

Date: ___ ___ ___ ___ — ___ ___ — ___ ___

YYYY MM DD

CIBMTR Form 2005 HLA revision 6 (page 20 of 20 DRAFT<

Copyright © 2010 National Marrow Donor Program and

The Medical College of Wisconsin, Inc. All rights reserved.

Internal use: Document number F00480 revision 3 Replaces: F00480 revision 2