Q9-50: Laboratory Studies at Diagnosis

Report findings at the time of diagnosis. If multiple studies were performed prior to beginning therapy, report the values closest to the diagnosis date of the immune deficiency for which the HCT is being performed.

Question 9: Date CBC tested

Report the date of CBC testing done within 6 weeks of diagnosis. Continue with question 10.

Question 10: WBC

Report the white blood cell (WBC) count and unit of measure as documented on the laboratory report. If the WBC was not tested, leave the count and unit fields blank and select “WBC not tested.” Continue with question 11.

Question 11: Lymphocytes

Report the percentage of lymphocytes as documented on the laboratory report. If lymphocytes were not tested, leave the count field blank and select “Lymphocytes not tested.” Continue with question 12.

Question 12: Eosinophils

Report the percentage of eosinophils as documented on the laboratory report. If eosinophils were not tested, leave the count field blank and select “Eosinophils not tested.” Continue with question 13.

Question 13: Polymorphonuclear leukocytes (PMN)

Polymorphonuclear leukocytes are white blood cells containing cytoplasmic granules. PMNs are also referred to as granulocytes and include neutrophils, basophils, and eosinophils; however, this question refers to neutrophils. Report the percentage of neutrophils. If neutrophils were not tested, leave the count field blank and select “Polymorphonuclear leukocytes (PMN) not tested.” Continue with question 14.

!Transfusions
Currently there is an error on the Form 2031 regarding transfusion history. The form should read: “transfused RBC less than or equal to 30 days from date of most current test” and “transfused platelets less than or equal to 7 days from date of most current test.”

Question 14: Hemoglobin

Report the hemoglobin count and the unit of measure as documented on the laboratory report. If the hemoglobin was not tested leave the count and unit fields blank and indicate “Hemoglobin not tested.” Indicate if red blood cells (RBC) were transfused ≤ 30 days from date of test. Continue with question 15.

Question 15: Platelets

Report the platelet count and unit of measure as documented on the laboratory report. If the platelet count was not tested leave the count and unit fields blank and indicate “Platelets not tested.” Indicate if platelets were transfused ≤ 7 days from date of test. Continue with question 16.

Immunoglobulin Analysis

Specify the following quantitative immunoglobulins measured at the time of diagnosis; if multiple studies were performed prior to the initiation of therapy, report the values closest to the diagnosis date.

Question 16: IgG

Report the IgG level and the unit of measure documented on the laboratory report. Continue with question 17. If IgG was not tested, leave the value and unit fields blank and indicate “IgG not tested,” and continue with question 18.

Question 17: Date Tested: IgG

Report the date of IgG testing and continue with question 18.

Question 18: IgM

Report the IgM level and the unit of measure documented on the laboratory report. Continue with question 19. If IgM was not tested, leave the value and unit fields blank and indicate “IgM not tested,” and continue with question 20.

Question 19: Date Tested: IgM

Report the date of IgM testing and continue with question 20.

Question 20: IgA

Report the IgA level and the unit of measure documented on the laboratory report. Continue with question 21. If IgA was not tested, leave the value and unit fields blank and indicate “IgA not tested,” and continue with question 22.

Question 21: Date Tested: IgA

Report the date of IgA testing and continue with question 22.

Question 22: IgE

Report the IgE level in international units per milliliter (IU/ml). Continue with question 23. If IgE was not tested, leave the value field blank and indicate “IgE not tested,” and continue with question 24.

Question 23: Date Tested: IgE

Report the date of IgE testing and continue with question 24.

Question 24: Did the recipient receive supplemental intravenous immunoglobulins (IVIG) prior to any first treatment of ID?

IVIG is a product made from pooled human plasma that primarily contains IgG. It is used to provide immune deficient recipients with antibodies to prevent infection.

Indicate whether the recipient received IVIG prior to any first treatment for ID. If “yes,” continue with question 25. If “no,” continue with question 26.

Question 25: Was therapy ongoing within one month of immunoglobulin testing?

Indicate whether the recipient received IVIG ≤30 days prior to the immunoglobulin testing reported in questions 16-23. If IVIG is given within 30 days of immunoglobulin testing, the IgG level would not represent the recipient’s native IgG. Continue with question 26.

Lymphocyte Analysis

Specify the lymphocyte analyses performed at the time of diagnosis; if multiple studies were performed prior to the initiation of therapy, report the values closest to the diagnosis date.

Question 26: Were lymphocyte analyses performed?

Lymphocyte analyses include quantifying specific types of T cells, B Cells, and natural killer (NK) cells. Cells can be identified by cell-specific surface molecules using the clusters of differentiation (CD) nomenclature. For example, T cells can be classified as helper (CD4+) or cytotoxic (CD8+) cells depending on their cell surface markers designated with CD notation.

Indicate whether lymphocyte analyses were performed. If “yes,” continue with question 27. If “no,” continue with question 36.

Question 27: Date of most recent testing performed

Report the date of most recent lymphocyte testing performed prior to any treatment for Immune Deficiency. Continue with question 28.

Question 28: Absolute lymphocyte count

Report the absolute lymphocyte count in cells per microliter (cells/µL or cells/mm3). Continue with question 29.

Question 29: CD3 (T cells)

T cells are a type of lymphocyte that can be characterized by CD3. If the laboratory quantifies CD3 cells as a percent of total lymphocytes, then report the value in the percentage field. If the laboratory quantifies CD3 cells as an absolute value, then report the value in the count field and specify the count units. If CD3 cells were not tested, select the “CD3 (T cells) not tested” option. Continue with question 30.

Question 30: CD4 (T helper cells)

T helper cells are a subset of T cells characterized by CD4, sometimes reported as CD3+CD4+. If the laboratory quantifies CD4 cells as a percent of total lymphocytes, then report the value in the percentage field. If the laboratory quantifies CD4 cells as an absolute value, then report the value in the count field and specify the count units. If CD4 cells were not tested, select the “CD4 (T cells) not tested” option. Continue with question 31.

Question 31: CD8 (cytotoxic T cells)

Cytotoxic T cells are a subset of T cells characterized by CD8, sometimes reported as CD3+CD8+. If the laboratory quantifies CD8 cells as a percent of total lymphocytes, then report the value in the percentage field. If the laboratory quantifies CD8 cells as an absolute value, then report the value in the count field and specify the count units. If CD8 cells were not tested, select the “CD8 (T cells) not tested” option. Continue with question 32.

Question 32: CD20 (B lymphocyte cells)

B cells are a type of lymphocyte that can be characterized by CD20. If the laboratory quantifies CD20 cells as a percent of total lymphocytes, then report the value in the percentage field. If the laboratory quantifies CD20 cells as an absolute value, then report the value in the count field and specify the count units. If CD20 cells were not tested, select the “CD20 (B lymphocyte cells) not tested” option. Continue with question 33.

*If CD20+ cells were not tested, centers may report CD19+ results in these data fields.

Question 33: CD56 (natural killer (NK) cells)

NK cells are a type of lymphocyte that can be characterized by CD56. If the laboratory quantifies CD56 cells as a percent of total lymphocytes, then report the value in the percentage field. If the laboratory quantifies CD56 cells as an absolute value, then report the value in the count field and specify the count units. If CD56 cells were not tested, select the “CD56 (natural killer (NK) cells) not tested” option. Continue with question 34.

*If CD56+ cells were not tested, centers may report CD16+ results in these data fields.

Question 34: CD4+ / CD45RA+ (naïve T cells)

Naïve T cells are a type of T cell that can be characterized by CD4+/CD45RA+. T cells are considered naïve prior to encountering an antigen. If the laboratory quantifies CD4+/CD45RA+ cells as a percent of total lymphocytes, then report the value in the percentage field. If the laboratory quantifies CD4+/CD45RA+ cells as an absolute value, then report the value in the count field and specify the count units. If CD4+/CD45RA+ cells were not tested, select the “CD4+/CD45RA+ (naïve T cells) not tested” option. Continue with question 35.

Question 35: CD4+ / CD45RO+ (memory T cells)

Memory T cells are a type of T cell that can be characterized by CD4+/CD45RO+. If the laboratory quantifies CD4+/CD45RO+ cells as a percent of total lymphocytes, then report the value in the percentage field. If the laboratory quantifies CD4+/CD45RO+ cells as an absolute value, then report the value in the count field and specify the count units. If CD4+/CD45RO+ cells were not tested, select the “CD4+/CD45RO+ (memory T cells) not tested” option. Continue with question 36.

Antibody Response

The immune system produces antibodies in response to antigens. Tests that measure the antibody response to different antigens help determine if the immune system is properly functioning.

Specify the antibody response assessment performed at the time of diagnosis; if multiple studies were performed prior to the initiation of therapy (including IVIG), report the values closest to the diagnosis date.

Question 36: Date antibody responses were assessed

Report the date of most recent antibody response assessment performed prior to any treatment for ID. Continue with question 37.

Questions 37-43: Antibody response assessment

Specify the most recent antibody responses measured prior to any treatment for ID. For each of the antigens in questions 37-43, indicate if the antibody response was “Absent”, “Low”, “Normal”, or “Not Tested” based on normal values from the laboratory.

Unconjugated pneumococcal polysaccharide
The term unconjugated indicates that the pneumococcal capsule contains polysaccharides without the modification of proteins added to the surface to enhance the immune response.

Specify the number of serotypes producing a protective level out of the total serotypes tested from the vaccine. For example, if the Pneumococcal 23-valent vaccine was used for the test, then report the number of reactive serotypes out of the 23 serotype total.

Lymphocyte Function

Lymphocyte function tests assess immune function by measuring immune cell responses to antigens and mitogens relative to control responses.

Specify the lymphocyte function assessment performed at the time of diagnosis; if multiple studies were performed prior to the institution of therapy, report the values closest to the diagnosis date.

Question 44: Date lymphocyte function was assessed

Report the date of most recent lymphocyte function assessment performed prior to any treatment for ID. Continue with question 45.

Questions 45-50: Lymphocyte analysis assessment

For each of the lymphocyte function tests listed in questions 45-50, indicate whether the lymphocyte response was “Absent (<10% of control)” “Low (10-30% of control)” “Normal (>30% of control)” or “Not tested.”

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
Q9	4/21/2023	Modify	Clarified the instructions for the labs at diagnosis should reflect the labs closest to the date of diagnosis.	To ensure more consistent reporting, all labs for the “at diagnosis” timepoint were clarified to reflect the values obtained closest to the date of diagnosis, prior to the start of any therapy.
Q16	5/1/2023	Modify	Instructions above Q16 updated: Specify the following quantitative immunoglobulins measured at the time of diagnosis; if multiple studies were performed prior to the initiation of therapy, report the latest values prior to any first treatment of the immune deficiency values closest to the diagnosis date.	To ensure more consistent reporting, all labs for the “at diagnosis” timepoint were clarified to reflect the values obtained closest to the date of diagnosis, prior to the start of any therapy.
Q26	5/1/2023	Modify	Instructions above Q26 updated: Specify the lymphocyte analyses performed at the time of diagnosis; if multiple studies were performed prior to the initiation of therapy, report the latest values prior to any first treatment for ID values closest to the diagnosis date.	To ensure more consistent reporting, all labs for the “at diagnosis” timepoint were clarified to reflect the values obtained closest to the date of diagnosis, prior to the start of any therapy.
Q36	5/1/2023	Modify	Instructions above Q36 updated: Specify the antibody response assessment performed at the time of diagnosis; if multiple studies were performed prior to the initiation of therapy (including IVIG), report the latest values prior to any first treatment for ID values closest to the diagnosis date.	To ensure more consistent reporting, all labs for the “at diagnosis” timepoint were clarified to reflect the values obtained closest to the date of diagnosis, prior to the start of any therapy.
Q44	5/1/2023	Modify	Instructions above Q44 updated: Specify the lymphocyte function assessment performed at the time of diagnosis; if multiple studies were performed prior to the institution of therapy, report the latest values prior to any first treatment for ID. values closest to the diagnosis date.	To ensure more consistent reporting, all labs for the “at diagnosis” timepoint were clarified to reflect the values obtained closest to the date of diagnosis, prior to the start of any therapy.

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