EPIC Lab Number

LAB58358

Collect

Lavender (EDTA), pink (K2EDTA), or green (sodium or lithium heparin). Hemogard tubes are preferred for laboratory automation and safety.

Additional Requirements

Collect:   Lavender ( K2 EDTA Tube)
Auto Lab Accepts:
BD Vacutainer EDTA Tube with BD Hemogard Closure (Lavender) | Dufort et Lavigne

Unacceptable Conditions

Clotted or hemolyzed specimens.

Specimen Preparation

Transport 4 mL whole blood. (Min: 0.5 mL)

Ordering Recommendations

Preferred lymphocyte subset panel for the investigation of primary immunodeficiency disorders.

Storage/Transport Temperature

CRITICAL ROOM TEMPERATURE.

Stability (from collection to initiation)

EDTA: Ambient: 72 hours; Refrigerated: Unacceptable; Frozen: Unacceptable
Heparin: Ambient: 48 hours; Refrigerated: Unacceptable; Frozen: Unacceptable
New York State Clients: Same as the above.

Performed

Sun-Sat

Reported

1-3 days

Remarks

Specimens must be analyzed within stability times provided. Some medication may affect immunophenotyping results and should be provided on the patient test request form.

Notes

This assay is designed for enumerating the percents and absolute cell counts of lymphocyte subsets in lysed whole blood. Whole blood is added to fluorochrome-labeled antibodies that bind specifically to cell surface antigens on lymphocytes. After incubation, lysing, and fixation, percents and absolute counts are enumerated utilizing an internal quantitation standard. Additional CBC data is not required.

Methodology

Quantitative Flow Cytometry

Synonyms

  • Primary Immunodeficiency Profile

Additional Technical Information

  • Time Sensitive

Reference Interval

Components
Reference Interval
Absolute HLA-DR
AgeReference Interval (cells/µL)
0-6 days140-2000
1 week-1 month180-3500
2-4 months520-2300
5-8 months130-6300
9-14 months110-7700
15-23 months160-3700
2-4 years180-1300
5-9 years100-800
10-15 years120-740
16-64 years100-640
65 years or older98-430

Absolute CD19
AgeReference Interval (cells/µL)
0-6 days140-2000
1 week-1 month180-3500
2-4 months520-2300
5-8 months130-6300
9-14 months110-7700
15-23 months160-3700
2-4 years180-1300
5-9 years100-800
10-15 years120-740
16-64 years91-610
65 years or older74-510

% Natural Killer Cells
AgeReference Interval (Percent)
0-6 days8-62
1 week-1 month3-23
2-4 months2-20
5-8 months2-36
9-14 months1-64
15-23 months1-96
2-4 years2-25
5-9 years2-31
10-15 years4-51
16-64 years4-26
65 years or older5-28

Absolute Natural Killer Cells
AgeReference Interval (cells/µL)
0-6 days500-3100
1 week-1 month140-1900
2-4 months97-2000
5-8 months68-3900
9-14 months71-3500
15-23 months55-4000
2-4 years61-510
5-9 years70-590
10-15 years92-1200
16-64 years78-470
65 years or older74-620

Absolute CD45RO
AgeReference Interval (cells/µL)
0-6 days98-1300
1 week-1 month110-1200
2-4 months90-1400
5-8 months100-950
9-14 months160-710
15-23 months68-630
2-4 years150-640
5-9 years100-510
10-15 years160-700
16-64 years190-1050
65 years or older490-1200

% CD45RO
Age
Reference Interval (Percent)
0-6 days2-44
1 week-1 month2-36
2-4 months1-42
5-8 months1-46
9-14 months4-29
15-23 months5-39
2-4 years11-50
5-9 years8-76
10-15 years18-68
16-64 years28-72
65 years or older38-81

Absolute CD45RA
AgeReference Interval (cells/µL)
0-6 days900-4500
1 week-1 month1100-5200
2-4 months1200-5300
5-8 months800-5900
9-14 months900-5200
15-23 months400-5600
2-4 years380-2500
5-9 years250-2000
10-15 years230-1400
16-64 years150-870
65 years or older260-1000

% CD45RA
Age
Reference Interval (Percent)
0-6 days60-100
1 week-1 month63-100
2-4 months66-100
5-8 months68-99
9-14 months68-98
15-23 months57-100
2-4 years53-96
5-9 years47-97
10-15 years39-93
16-64 years28-71
65 years or older19-62

% HLA-DR
AgeReference Interval (Percent)
0-6 days3-30
1 week-1 month3-60
2-4 months8-33
5-8 months4-54
9-14 months3-77
15-23 months8-45
2-4 years8-39
5-9 years4-33
10-15 years7-24
16-64 years8-24
65 years or older7-20

Absolute CD3
AgeReference Interval (cells/µL)
0-6 days1400-6800
1 week-1 month1900-8400
2-4 months2200-9200
5-8 months1400-11500
9-14 months2400-8300
15-23 months700-8800
2-4 years850-4300
5-9 years770-4000
10-15 years850-3200
16-64 years570-2400
65 years or older660-2200

% CD3
AgeReference Interval (Percent)
0-6 days38-88
1 week-1 month55-90
2-4 months49-97
5-8 months49-95
9-14 months56-87
15-23 months36-92
2-4 years52-92
5-9 years55-97
10-15 years52-90
16-64 years62-87
65 years or older62-89

Absolute CD4
Age
Reference Interval (cells/µL)
0-6 days1000-4800
1 week-1 month1500-6000
2-4 months1600-6500
5-8 months1000-7200
9-14 months1300-7100
15-23 months400-7200
2-4 years500-2700
5-9 years400-2500
10-15 years400-2100
16-64 years430-1800
65 years or older490-1600

Absolute CD8
Age
Reference Interval (cells/µL)
0-6 days200-2700
1 week-1 month300-2700
2-4 months300-3400
5-8 months200-5400
9-14 months400-4100
15-23 months200-2800
2-4 years200-1800
5-9 years200-1700
10-15 years300-1300
16-64 years210-1200
65 years or older150-1050

% CD4
AgeReference Interval (Percent)
0-6 days26-62
1 week-1 month39-69
2-4 months37-69
5-8 months27-81
9-14 months25-86
15-23 months16-91
2-4 years25-66
5-9 years26-61
10-15 years20-65
16-64 years32-64
65 years or older35-68

% CD8
AgeReference Interval (Percent)
0-6 days5-37
1 week-1 month7-35
2-4 months6-41
5-8 months10-35
9-14 months7-58
15-23 months7-40
2-4 years9-49
5-9 years13-47
10-15 years14-40
16-64 years15-46
65 years or older10-46

% CD19
AgeReference Interval (Percent)
0-6 days3-30
1 week-1 month3-60
2-4 months8-33
5-8 months4-54
9-14 months3-77
15-23 months8-45
2-4 years8-39
5-9 years4-33
10-15 years7-24
16-64 years6-23
65 years or older5-21

CD4:CD8 Ratio
AgeReference Interval
0-6 days1.00-2.60
1 week-1 month1.30-6.30
2-4 months1.70-3.90
5-8 months1.60-3.80
9-14 months1.30-3.90
15-23 months0.90-3.70
2-4 years0.90-2.90
5-9 years0.90-2.60
10-15 years0.90-3.40
16-64 years0.80-3.90
65 years or older0.80-6.17

% CD2
AgeReference Interval (Percent)
0-6 days46-97
1 week-1 month58-97
2-4 months51-98
5-8 months51-98
9-14 months57-97
15-23 months37-92
2-4 years54-92
5-9 years57-97
10-15 years56-93
16-64 years73-91
65 years or older78-92

Absolute CD2
AgeReference Interval (cells/µL)
0-6 days1900-8300
1 week-1 month2000-9200
2-4 months2300-10200
5-8 months1500-13500
9-14 months2500-10000
15-23 months750-1080
2-4 years900-4500
5-9 years840-4300
10-15 years950-3800
16-64 years700-2600
65 years or older680-2400


Interpretive Data

This profile screens for inherited immunodeficiencies. The CD4 cells are Helper T-cells expressing both CD3 and CD4. The CD8 cells are Cytotoxic T-cells expressing both CD3 and CD8. The B-cells express CD19 but not CD3. The NK-cells express either CD16 or CD56 (or both) but not CD3. CD3, CD4, CD8, CD19 and NK-cell percentages are reported as a percent of total lymphocytes. The CD45RA cells express both CD4 and "naive" CD45RA antigens while CD45RO cells express both CD4 and CD45RO "memory" antigens. CD45RA and CD45RO percentages are reported as a percent of total CD4 cells. Primary immune deficiencies that show phenotypic abnormalities include X-linked hypogammaglobulinemia, DiGeorge syndrome, bare lymphocyte syndrome, and severe combined immunodeficiency disease (SCID).

X-linked hypogammaglobulinemia (X-linked agammaglobulinemia, Bruton agammaglobulinemia) is caused by defective B-cell maturation secondary to mutations in the BTK (Bruton/B-cell tyrosine kinase) gene. T-cells (CD2, CD3) are normal or increased in number, and the CD4:CD8 ratio is normal or decreased. Most of the CD4 cells express the CD45RA antigen characteristic of naive rather than memory cells. B-cells (CD19, HLA-DR) are severely decreased or absent in the peripheral blood.

X-linked hypogammaglobulinemia can be distinguished from transient hypogammaglobulinemia of infancy by the absence of B-cells. Transient hypogammaglobulinemia of infancy results from delayed capacity for immunoglobulin synthesis and spontaneously resolves with age.

Thymic aplasia (congenital thymic aplasia, DiGeorge syndrome) results in impaired T-cell maturation and function. B-cells (CD19, HLA-DR) and NK-cells (CD16/CD56) are normal but T-cells (CD2, CD3) are usually decreased with an elevated CD4:CD8 ratio. The clinical course is variable, ranging from "partial DiGeorge syndrome" to cases that resemble SCID.

SCID has multiple genetic causes, including mutations in the gamma chain of the interleukin 2 receptor and the purine degradation enzymes, adenosine deaminase, and nucleoside phosphorylase. In adenosine deaminase deficiency, both B-cells (CD19, HLA-DR) and T-cells (CD2, CD3) are decreased in the peripheral blood. In other forms of SCID, the lymphopenia is not as severe, but the lymphocyte count is usually less than 1,000/µL even though B-cells (CD19, HLA-DR) may be normal or increased. In contrast to thymic aplasia, any T-cells present may have an immature phenotype.

Major histocompatibility complex class II deficiency, bare lymphocyte syndrome, is caused by defective transcription of HLA class II genes; B-cells (CD19) and T-cells (CD2, CD3) are present in normal numbers, but HLA-DR is absent. The CD4+ cells are usually CD45RA+.

Common variable immunodeficiency (CVID) describes a heterogeneous group of disorders with defective antibody formation. B-cells (CD19, HLA-DR) and T-cells (CD2, CD3) are usually normal in number, although B-cells may be decreased when CVID occurs concurrently with systemic lupus erythematosus. The CD4:CD8 ratio may be normal or decreased.

Wiskott-Aldrich syndrome includes immunodeficiency with thrombocytopenia and eczema. Lymphopenia is usually present with a progressive decline in T-cells numbers. The CD4:CD8 ratio is normal. The gene is X-linked and encodes the Wiskott-Aldrich syndrome protein.

Immunophenotyping is generally not useful in characterizing selective IgA deficiency, IgG subclass deficiencies, the hyper IgM syndrome, or hyperimmunoglobulin E syndrome (Job syndrome).

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

ARUP Test Code

0095899

LOINC

  • 33617-2
  • 48767-8
  • 15195-1
  • 32519-1
  • 20604-5
  • 34475-4
  • 41994-5
  • 26759-1
  • 17157-9
  • 31113-4
  • 8122-4
  • 20599-7
  • 24467-3
  • 14135-8
  • 8123-2
  • 32518-3
  • 20593-0
  • 54218-3
  • 8118-2
  • 9557-0

CPT Codes

86355; 86357; 86359; 86360; 86356 x4
Test Information

EPIC Lab Number

LAB58358

Collect

Lavender (EDTA), pink (K2EDTA), or green (sodium or lithium heparin). Hemogard tubes are preferred for laboratory automation and safety.

Additional Requirements

Collect:   Lavender ( K2 EDTA Tube)
Auto Lab Accepts:
BD Vacutainer EDTA Tube with BD Hemogard Closure (Lavender) | Dufort et Lavigne

Unacceptable Conditions

Clotted or hemolyzed specimens.

Specimen Preparation

Transport 4 mL whole blood. (Min: 0.5 mL)

Ordering Recommendations

Preferred lymphocyte subset panel for the investigation of primary immunodeficiency disorders.

Storage/Transport Temperature

CRITICAL ROOM TEMPERATURE.

Stability (from collection to initiation)

EDTA: Ambient: 72 hours; Refrigerated: Unacceptable; Frozen: Unacceptable
Heparin: Ambient: 48 hours; Refrigerated: Unacceptable; Frozen: Unacceptable
New York State Clients: Same as the above.

Performed

Sun-Sat

Reported

1-3 days

Remarks

Specimens must be analyzed within stability times provided. Some medication may affect immunophenotyping results and should be provided on the patient test request form.

Notes

This assay is designed for enumerating the percents and absolute cell counts of lymphocyte subsets in lysed whole blood. Whole blood is added to fluorochrome-labeled antibodies that bind specifically to cell surface antigens on lymphocytes. After incubation, lysing, and fixation, percents and absolute counts are enumerated utilizing an internal quantitation standard. Additional CBC data is not required.

Methodology

Quantitative Flow Cytometry

Synonyms

  • Primary Immunodeficiency Profile

Additional Technical Information

  • Time Sensitive

Reference Interval

Components
Reference Interval
Absolute HLA-DR
AgeReference Interval (cells/µL)
0-6 days140-2000
1 week-1 month180-3500
2-4 months520-2300
5-8 months130-6300
9-14 months110-7700
15-23 months160-3700
2-4 years180-1300
5-9 years100-800
10-15 years120-740
16-64 years100-640
65 years or older98-430

Absolute CD19
AgeReference Interval (cells/µL)
0-6 days140-2000
1 week-1 month180-3500
2-4 months520-2300
5-8 months130-6300
9-14 months110-7700
15-23 months160-3700
2-4 years180-1300
5-9 years100-800
10-15 years120-740
16-64 years91-610
65 years or older74-510

% Natural Killer Cells
AgeReference Interval (Percent)
0-6 days8-62
1 week-1 month3-23
2-4 months2-20
5-8 months2-36
9-14 months1-64
15-23 months1-96
2-4 years2-25
5-9 years2-31
10-15 years4-51
16-64 years4-26
65 years or older5-28

Absolute Natural Killer Cells
AgeReference Interval (cells/µL)
0-6 days500-3100
1 week-1 month140-1900
2-4 months97-2000
5-8 months68-3900
9-14 months71-3500
15-23 months55-4000
2-4 years61-510
5-9 years70-590
10-15 years92-1200
16-64 years78-470
65 years or older74-620

Absolute CD45RO
AgeReference Interval (cells/µL)
0-6 days98-1300
1 week-1 month110-1200
2-4 months90-1400
5-8 months100-950
9-14 months160-710
15-23 months68-630
2-4 years150-640
5-9 years100-510
10-15 years160-700
16-64 years190-1050
65 years or older490-1200

% CD45RO
Age
Reference Interval (Percent)
0-6 days2-44
1 week-1 month2-36
2-4 months1-42
5-8 months1-46
9-14 months4-29
15-23 months5-39
2-4 years11-50
5-9 years8-76
10-15 years18-68
16-64 years28-72
65 years or older38-81

Absolute CD45RA
AgeReference Interval (cells/µL)
0-6 days900-4500
1 week-1 month1100-5200
2-4 months1200-5300
5-8 months800-5900
9-14 months900-5200
15-23 months400-5600
2-4 years380-2500
5-9 years250-2000
10-15 years230-1400
16-64 years150-870
65 years or older260-1000

% CD45RA
Age
Reference Interval (Percent)
0-6 days60-100
1 week-1 month63-100
2-4 months66-100
5-8 months68-99
9-14 months68-98
15-23 months57-100
2-4 years53-96
5-9 years47-97
10-15 years39-93
16-64 years28-71
65 years or older19-62

% HLA-DR
AgeReference Interval (Percent)
0-6 days3-30
1 week-1 month3-60
2-4 months8-33
5-8 months4-54
9-14 months3-77
15-23 months8-45
2-4 years8-39
5-9 years4-33
10-15 years7-24
16-64 years8-24
65 years or older7-20

Absolute CD3
AgeReference Interval (cells/µL)
0-6 days1400-6800
1 week-1 month1900-8400
2-4 months2200-9200
5-8 months1400-11500
9-14 months2400-8300
15-23 months700-8800
2-4 years850-4300
5-9 years770-4000
10-15 years850-3200
16-64 years570-2400
65 years or older660-2200

% CD3
AgeReference Interval (Percent)
0-6 days38-88
1 week-1 month55-90
2-4 months49-97
5-8 months49-95
9-14 months56-87
15-23 months36-92
2-4 years52-92
5-9 years55-97
10-15 years52-90
16-64 years62-87
65 years or older62-89

Absolute CD4
Age
Reference Interval (cells/µL)
0-6 days1000-4800
1 week-1 month1500-6000
2-4 months1600-6500
5-8 months1000-7200
9-14 months1300-7100
15-23 months400-7200
2-4 years500-2700
5-9 years400-2500
10-15 years400-2100
16-64 years430-1800
65 years or older490-1600

Absolute CD8
Age
Reference Interval (cells/µL)
0-6 days200-2700
1 week-1 month300-2700
2-4 months300-3400
5-8 months200-5400
9-14 months400-4100
15-23 months200-2800
2-4 years200-1800
5-9 years200-1700
10-15 years300-1300
16-64 years210-1200
65 years or older150-1050

% CD4
AgeReference Interval (Percent)
0-6 days26-62
1 week-1 month39-69
2-4 months37-69
5-8 months27-81
9-14 months25-86
15-23 months16-91
2-4 years25-66
5-9 years26-61
10-15 years20-65
16-64 years32-64
65 years or older35-68

% CD8
AgeReference Interval (Percent)
0-6 days5-37
1 week-1 month7-35
2-4 months6-41
5-8 months10-35
9-14 months7-58
15-23 months7-40
2-4 years9-49
5-9 years13-47
10-15 years14-40
16-64 years15-46
65 years or older10-46

% CD19
AgeReference Interval (Percent)
0-6 days3-30
1 week-1 month3-60
2-4 months8-33
5-8 months4-54
9-14 months3-77
15-23 months8-45
2-4 years8-39
5-9 years4-33
10-15 years7-24
16-64 years6-23
65 years or older5-21

CD4:CD8 Ratio
AgeReference Interval
0-6 days1.00-2.60
1 week-1 month1.30-6.30
2-4 months1.70-3.90
5-8 months1.60-3.80
9-14 months1.30-3.90
15-23 months0.90-3.70
2-4 years0.90-2.90
5-9 years0.90-2.60
10-15 years0.90-3.40
16-64 years0.80-3.90
65 years or older0.80-6.17

% CD2
AgeReference Interval (Percent)
0-6 days46-97
1 week-1 month58-97
2-4 months51-98
5-8 months51-98
9-14 months57-97
15-23 months37-92
2-4 years54-92
5-9 years57-97
10-15 years56-93
16-64 years73-91
65 years or older78-92

Absolute CD2
AgeReference Interval (cells/µL)
0-6 days1900-8300
1 week-1 month2000-9200
2-4 months2300-10200
5-8 months1500-13500
9-14 months2500-10000
15-23 months750-1080
2-4 years900-4500
5-9 years840-4300
10-15 years950-3800
16-64 years700-2600
65 years or older680-2400


Interpretive Data

This profile screens for inherited immunodeficiencies. The CD4 cells are Helper T-cells expressing both CD3 and CD4. The CD8 cells are Cytotoxic T-cells expressing both CD3 and CD8. The B-cells express CD19 but not CD3. The NK-cells express either CD16 or CD56 (or both) but not CD3. CD3, CD4, CD8, CD19 and NK-cell percentages are reported as a percent of total lymphocytes. The CD45RA cells express both CD4 and "naive" CD45RA antigens while CD45RO cells express both CD4 and CD45RO "memory" antigens. CD45RA and CD45RO percentages are reported as a percent of total CD4 cells. Primary immune deficiencies that show phenotypic abnormalities include X-linked hypogammaglobulinemia, DiGeorge syndrome, bare lymphocyte syndrome, and severe combined immunodeficiency disease (SCID).

X-linked hypogammaglobulinemia (X-linked agammaglobulinemia, Bruton agammaglobulinemia) is caused by defective B-cell maturation secondary to mutations in the BTK (Bruton/B-cell tyrosine kinase) gene. T-cells (CD2, CD3) are normal or increased in number, and the CD4:CD8 ratio is normal or decreased. Most of the CD4 cells express the CD45RA antigen characteristic of naive rather than memory cells. B-cells (CD19, HLA-DR) are severely decreased or absent in the peripheral blood.

X-linked hypogammaglobulinemia can be distinguished from transient hypogammaglobulinemia of infancy by the absence of B-cells. Transient hypogammaglobulinemia of infancy results from delayed capacity for immunoglobulin synthesis and spontaneously resolves with age.

Thymic aplasia (congenital thymic aplasia, DiGeorge syndrome) results in impaired T-cell maturation and function. B-cells (CD19, HLA-DR) and NK-cells (CD16/CD56) are normal but T-cells (CD2, CD3) are usually decreased with an elevated CD4:CD8 ratio. The clinical course is variable, ranging from "partial DiGeorge syndrome" to cases that resemble SCID.

SCID has multiple genetic causes, including mutations in the gamma chain of the interleukin 2 receptor and the purine degradation enzymes, adenosine deaminase, and nucleoside phosphorylase. In adenosine deaminase deficiency, both B-cells (CD19, HLA-DR) and T-cells (CD2, CD3) are decreased in the peripheral blood. In other forms of SCID, the lymphopenia is not as severe, but the lymphocyte count is usually less than 1,000/µL even though B-cells (CD19, HLA-DR) may be normal or increased. In contrast to thymic aplasia, any T-cells present may have an immature phenotype.

Major histocompatibility complex class II deficiency, bare lymphocyte syndrome, is caused by defective transcription of HLA class II genes; B-cells (CD19) and T-cells (CD2, CD3) are present in normal numbers, but HLA-DR is absent. The CD4+ cells are usually CD45RA+.

Common variable immunodeficiency (CVID) describes a heterogeneous group of disorders with defective antibody formation. B-cells (CD19, HLA-DR) and T-cells (CD2, CD3) are usually normal in number, although B-cells may be decreased when CVID occurs concurrently with systemic lupus erythematosus. The CD4:CD8 ratio may be normal or decreased.

Wiskott-Aldrich syndrome includes immunodeficiency with thrombocytopenia and eczema. Lymphopenia is usually present with a progressive decline in T-cells numbers. The CD4:CD8 ratio is normal. The gene is X-linked and encodes the Wiskott-Aldrich syndrome protein.

Immunophenotyping is generally not useful in characterizing selective IgA deficiency, IgG subclass deficiencies, the hyper IgM syndrome, or hyperimmunoglobulin E syndrome (Job syndrome).

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

ARUP Test Code

0095899

LOINC

  • 33617-2
  • 48767-8
  • 15195-1
  • 32519-1
  • 20604-5
  • 34475-4
  • 41994-5
  • 26759-1
  • 17157-9
  • 31113-4
  • 8122-4
  • 20599-7
  • 24467-3
  • 14135-8
  • 8123-2
  • 32518-3
  • 20593-0
  • 54218-3
  • 8118-2
  • 9557-0

CPT Codes

86355; 86357; 86359; 86360; 86356 x4

ARUP Consult®

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