HMC/QA/GDE/001 Effective date: Review date: 01/02/2019 ... · Anti GAD antibodies Clotted blood 5ml...
20
HMC/QA/GDE/001 Appendix F Ver. 9 Effective date: 01/02/2017 Review date: 01/02/2019 Page 37 of 57 Written by: N Fynes Reviewed by: N Fynes Authorised by : P Thornton HERMITAGE MEDICAL CLINIC PRODUCTION OF UNAUTHORIZED COPIES OF THIS SOP IS FORBIDDEN AUTHORIZED COPY IF STAMPED IN RED – OFFICIAL COPY 37 Appendix F- Immunology Testing Frequency All Immunology tests are processed externally in St James Hospital or the Blackrock Clinic. Table 1.Tests Available, Specimen Type and Turnaround Times Name Specimen Type Sample Container & Volume Turnaround Time Acetyl Choline Receptor abs. Clotted blood 5ml Serum Up to eight weeks Adrenal Antibodies Clotted blood 5ml Serum Up to eight weeks Alpha-1-Antitrypsin Clotted blood 5ml Serum 4 days Anti GAD antibodies Clotted blood 5ml Serum Up to six weeks. Anti HU abs. Clotted blood 5ml Serum Up to eight weeks Anti RI antibodies Clotted blood 5ml Serum Up to eight weeks Anti-Amphiphysin Ab. Clotted blood 5ml Serum Up to eight weeks Anti-Neutrophil Cytoplasmic Antibodies (ANCA) Clotted blood 5ml Serum 4 days. Anti-Voltage Gated Calcium Channel Clotted blood 5ml Serum Up to eight weeks Anti-Yo abs. Clotted blood 5ml Serum Up to eight weeks Antinuclear Antibodies (ANA) Clotted blood 5ml Serum 6 days. Aquaporin 4 antibodies blood 5ml Red Up to eight weeks B-Cell and Natural Killer (NK) Cell Quantitiation by Flow Cytometry Blood 4ml Purple EDTA 2 days Basophil Histamine Release Test Serum 5ml Serum Up to eight weeks Beta-2 Glycoprotein 1 Antibodies (IgG) Clotted blood 5ml Red 7 days
Transcript of HMC/QA/GDE/001 Effective date: Review date: 01/02/2019 ... · Anti GAD antibodies Clotted blood 5ml...
HMC/QA/GDE/001
Appendix F Ver. 9 Effective date:
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Appendix F- Immunology Testing
Frequency
All Immunology tests are processed externally in St James Hospital or the Blackrock Clinic.
Table 1.Tests Available, Specimen Type and Turnaround Times
Name
Specimen
Type
Sample
Container &
Volume Turnaround Time
Acetyl Choline Receptor abs. Clotted blood 5ml Serum Up to eight weeks
Adrenal Antibodies Clotted blood 5ml Serum Up to eight weeks
Alpha-1-Antitrypsin Clotted blood 5ml Serum 4 days
Anti GAD antibodies Clotted blood 5ml Serum Up to six weeks.
Anti HU abs. Clotted blood 5ml Serum Up to eight weeks
Anti RI antibodies Clotted blood 5ml Serum Up to eight weeks
Anti-Amphiphysin Ab. Clotted blood 5ml Serum Up to eight weeks
Anti-Neutrophil Cytoplasmic Antibodies
(ANCA)
Clotted blood 5ml Serum 4 days.
Anti-Voltage Gated Calcium Channel Clotted blood 5ml Serum Up to eight weeks
Anti-Yo abs. Clotted blood 5ml Serum Up to eight weeks
Antinuclear Antibodies (ANA) Clotted blood 5ml Serum 6 days.
Aquaporin 4 antibodies blood 5ml Red Up to eight weeks
B-Cell and Natural Killer (NK) Cell
Quantitiation by Flow Cytometry
Blood 4ml Purple
EDTA
2 days
Basophil Histamine Release Test Serum 5ml Serum Up to eight weeks
Beta-2 Glycoprotein 1 Antibodies (IgG) Clotted blood 5ml Red 7 days
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Beta-2-Microglobulin Clotted blood 5ml Serum 4 days
C1 Esterase Inhibitor (Function) Clotted blood 5ml Serum 21 days
C1-Inhibitor function
by
arrangement
contact
laboratory.
21 days
C3 Nephritic Factor Blood 5ml Serum 21 days
Caeruloplasmin Clotted blood 5ml Serum 4 days
Cardiac Antibodies Clotted blood 5ml Serum Up to eight weeks
Cardiolipin Antibodies (IgG) Clotted blood 5ml Serum 7 days
Complement C1-Inhibitor clotted blood 5ml Serum 10 days
Complement C1q
by
arrangement
contact
laboratory.
Up to 8 weeks
Complement C1r by
arrangement
contact
laboratory.
Up to 8 weeks
Complement C1s
by
arrangement
Up to 8 weeks
Complement C2
By
arrangement
contact
laboratory.
21 days
Complement C3 Clotted blood 5ml Serum 4 days
Complement C4 Clotted blood 5ml Serum 4 days
Complement C5
by
arrangement
contact
laboratory.
Up to 8 weeks
Complement C6
by
arrangement
contact
laboratory.
Up to 8 weeks
Complement C7
by
arrangement
contact
laboratory.
Up to 8 weeks
Complement C8
by
arrangement
contact
laboratory.
Up to 8 weeks
Complement C9
By
arrangement
contact
laboratory.
Up to 8 weeks
Complement CH100 Clotted blood 5ml Serum 21 days
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Complement Factor B
clotted blood contact
laboratory.
Up to 8 weeks
Complement Lectin (mannose binding
lectin)
clotted blood 5ml Serum Up to eight weeks
Cryoglobulin
Clotted blood
(maintained at
37 degrees
Celcius)
5ml Serum 21 days
CSF Neurodegeneration Biomarker
Assay
CSF 10 ml Sterile
Polypropylene
Tube
31 days
Cyclic Citrullinated Peptide (CCP)
Antibodies
Clotted blood 5ml Serum 7 days
DNA Screen Clotted blood 5ml Serum 7 days
Double Negative T-Cells
Blood 4ml Purple
EDTA
4 days
Electrophoresis (Urine)
Urine (early
morning
sample)
25 ml 9 days
Electrophoresis Clotted blood 5ml Serum 4 days.
Endomysial Antibodies (IgA), EMA Clotted blood 5ml Serum 10 working days
Extractable Nuclear Antigens, ENA Clotted blood 5ml Serum 9 days
Factor B
by
arrangement
contact
laboratory.
Up to 8 weeks
Factor D
by
arrangement
contact
laboratory.
Up to 8 weeks
Factor H
By
arrangement
contact
laboratory.
Up to 8 weeks
Factor I
by
arrangement
contact
laboratory.
Up to 8 weeks
Ganglioside Abs. Clotted blood 5ml Serum Up to 8 weeks
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Glomerular Basement Membrane
Antibodies (IgG)
Clotted blood 5ml Serum 3 days
IgG EMA clotted blood 5ml Serum 9 days
Immunofixation (Urine)
Urine (early
morning
sample)
25 ml 10 days
Immunofixation clotted blood 5ml Serum 7 days
Immunoglobulin A (IgA) Clotted blood 5ml Serum 7 days
Immunoglobulin E (IgE) Clotted blood 5ml Serum 7 days
Immunoglobulin G (IgG) Subclasses Clotted blood 5ml Serum 10 days
Immunoglobulin G (IgG) Clotted blood 5ml Serum 6 days
Immunoglobulin M (IgM) Clotted blood 5ml Serum 6 days
Immunoglobulin Subclass 4 (IgG4) Clotted blood 5ml Serum 7 days
Insulin antibodies clotted blood 5ml Serum Up to 8 weeks
Interferon-Gamma Release Assay
(IGRA)
Blood Contact
Laboratory
21 days
Islet Cell antibodies clotted blood 5ml Serum Up to 8 weeks
k/l ratio clotted blood 5ml Serum 7 days
Liver/Kidney Microsome Antibodies
(LKM)
Clotted blood 5ml Serum 6 days
Mast cell tryptase clotted blood 5ml Serum 9 days
Mitochondrial Antibodies (MITA) Clotted blood 5ml Serum 6 days.
Muscle tyrosine kinase Abs. Clotted blood 5ml Serum Up to 8 weeks
Myelin associated Glycoprotein
Antibody
Clotted blood 5ml Serum Up to 8 weeks
Myeloperoxidase Antibodies (IgG) Clotted blood 5ml Serum 3 days
Naive and Effector T-Cells
Blood 4ml Purple
EDTA
4 days
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Naive and Memory B-Cells
Blood 4ml Purple
EDTA
4 days
Neutrophil adhesion CD11a,b,c, CD18
Blood 4ml Purple
EDTA
4 days
NMDA Receptor Antibodies Clotted Blood 5ml Serum Up to 8 weeks
Oligoclonal banding
CSF and
Blood
Universal
containing a
minimum of
300ul of CSF
and one 5ml
Red
14 days
Ovarian Antibodies clotted blood 5ml Serum Up to 8 weeks
Oxidative burst
Blood 4ml Purple
EDTA
2 days
P.D.H. Antibodies clotted blood 5ml Serum 9 days
Paraprotein clotted blood 5ml Serum 7 days
Parietal Cell Antibodies (PCA) Clotted blood 5ml Serum 6 days
Properidin
By
arrangement
contact
laboratory.
Up to 8 weeks
Proteinase 3 Antibodies (IgG) Clotted blood 5ml Serum 3 days
Rheumatoid Factor Clotted blood 5ml Serum 4 days
Skin Biopsy
Fresh punch
biopsy, sent
on saline
moistened
gauze
3 mm 15 days
Skin Bullous Pemph. abs. clotted blood 5ml Serum 9 days
Skin Pemph. Vulgaris abs. clotted blood 5ml Serum 9 days
Smooth Muscle Antibodies (SMA) Clotted blood 5ml Serum 6 days
Specific IgE Clotted blood 5ml Serum 9 days
HMC/QA/GDE/001
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Specific IgG to Budgie clotted blood 5ml Serum 16 days
specific IgG to Micropolysporum Faeni clotted blood 5ml Serum 16 days
Specific IgG to Pidgeon clotted blood 5ml Serum 16 days
Specific Response to Haemophilus
Influenza Type b capsular polysaccharide
(IgG)
Clotted blood 5ml Serum 21 days
Specific Response to Pneumococcal
Capsular Polysaccharide (Total IgG and
IgG2)
Clotted blood 5ml Serum 21 days
Specific Response to Tetanus Toxoid
(IgG)
Clotted blood 5ml Serum 21 days
T-Cell Activation Markers
Blood 4ml Purple
EDTA
4 days
T-Cell Quantitiation by Flow Cytometry
Blood 4ml Purple
EDTA
4 days
Thyroid Peroxidase (TPO) Antibodies Clotted blood 5ml Serum 7 days
Tissue Transglutaminase (tTG) IgA Clotted blood 5ml Serum 7 days
TPMT functional activity
EDTA 2.5ml Purple
EDTA
Up to 8 weeks
Transferrin clotted blood 5ml Serum 4 days
Urinary Casts
Random Urine
(<24 hours
old)
25mls of urine
in a Universal
Container
2 days
Urinary paraprotein
Urine (early
morning
sample)
25 ml 10 days
Voltage Gated Potassium Channnel Abs. serum Serum Up to 8 weeks
HMC/QA/GDE/001
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Table 2 .Tests Available & Reference Ranges
Test Reference Range
Acetyl Choline
Receptor abs. Negative =0-5 x10/-10M
Adrenal Antibodies Negative
Alpha-1-Antitrypsin Adults: 1.1g/L - 2.2g/L
Anti GAD antibodies Negative: 0 - 10U/ml
Anti HU abs. Negative, Not Tested, Positive
Anti RI antibodies Negative, Not Tested, Positive
Anti-Amphiphysin
Ab. Negative
Anti-Neutrophil
Cytoplasmic
Antibodies (ANCA) Negative, 1:20= Positive at 1:20, 1:80= Positive at 1:80
Anti-Voltage Gated
Calcium Channel Negative:<45pM, Equivocal: 45-100pM, Positive: >100pM
Anti-Yo abs. Negative, Not Tested, Positive
Antinuclear
Antibodies (ANA) Negative, 1:80 Positive at 1:80, 1:160 Positive at 1:160, >1:160: Positive at >1 in 160
Aquaporin 4
antibodies Negative
Basophil Histamine
Release Test a histamine release > 16.5% is a positive result.
Beta-2 Glycoprotein 1
Antibodies (IgG) <7.0 IU/ml = Negative, 7.0 - 10 IU/ml = Equivocal, >10 IU/ml = Positive
HMC/QA/GDE/001
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Beta-2-Microglobulin 1.2-2.5 mg/L
Test Reference Range
C1 Esterase Inhibitor
(Function) 0-39% - Reduced, 40-70% - Equivocal, 71-150% - Normal
C1-Inhibitor function None available
C3 Nephritic Factor
Normal: Uncleaved C3 pattern detected on immunofixation indicating the absence of C3 Nephritic Factor
Positive: Cleaved C3 pattern detected on immunofixation indicating the presence of C3 Nephritic Factor
Caeruloplasmin Adults : 0.22-0.66g/L
Cardiac Antibodies Negative
Cardiolipin
Antibodies (IgG) Negative, Low positive, Positive
Complement C1-
Inhibitor 0.15-0.35g/L
Complement C1q 0.05 - 0.25g/L
Complement C1r None available
Complement C1s None available
Complement C2 0.014 - 0.025g/L
Complement C3 0.83g/L - 1.8g/L
Complement C4 0.14g/L - 0.54 g/L
Complement C5 None available
Complement C6 0.04 - 0.08g/L
Complement C7 None available
Complement C8 None available
Complement C9 None available
HMC/QA/GDE/001
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Test Reference Range
Complement CH100
Normal:Normal complement cascade activation
Reduced:Reduced complement cascade activation. Repeat sample advised for verification, Absent:
Alternative-Absent, Total-Normal: Indicates a deficiency in the Alternative Pathway. Repeat sample advised for verification.
Alternative-Absent, Total-Absent: Indicates a deficiency in the Terminal Pathway. Repeat sample advised for verification.
Alternative-Normal, Total-Absent: Indicaties a deficiency in the Classical Pathway. Repeat sample advised for verification.
Complement Factor B 0.1-0.43g/L
Complement Lectin
(mannose binding
lectin) 1.0-4.0 mg/L, Values less than 1mg/L may indicate a diminished Lectin pathway function.>1.0 mg/L = Negative
Cryoglobulin
0% - No cryoglobulin present. <1% - <1% cryoglobulin present (Insufficent cryoglobulin present for typing).2 - 100% - Percentage of
cryoglobulin present (Sufficient cryoglobulin present for typing).Type I - Monoclonal Cryoglobulin. Type II - Mixed Cryoglobulin (Two or
more immunoglobulins present, one of which is monoclonal).Type III - Polyclonal Immunoglobulin.
CSF
Neurodegeneration
Biomarker Assay CSF Phospho-Tau: 35-64pg/ml, CSF Total Tau: 135-345pg/ml, CSF ß-Amyloid: 591-997pg/ml
Cyclic Citrullinated
Peptide (CCP)
Antibodies <7.0 IU/ml = Negative, 7.0 - 10 IU/ml = Equivocal, >10 IU/ml = Positive
DNA Screen Negative <10 IU/ML Equivocal 10-15 IU/ML Positive >15.0 IU/ ML
Electrophoresis
(Urine) Electrophoresis: NPD - No Protein Detected, PD - Protein Detected, BD - Band Detected
HMC/QA/GDE/001
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Test Reference Range
Electrophoresis
No Abnormal Bands - Normal pattern, Monoclonal Band - Monoclonal band detected, Minor Abnormality - Repeat after 1 year, For
Immunofixation - Performed on patients with IgG<5g/L
Endomysial
Antibodies (IgA),
EMA Negative, Weak Positive, Positive
Extractable Nuclear
Antigens, ENA
The ENA Screen is Reported as a Ratio
<0.7 = Negative, 0.7-1.0 = Equivocal, >1.0 = Positive
.
Individual Antigens
SSA/Ro, SSB/La, Sm, Jo-1 and Scl70:
<7.0 U/ml = Negative
7.0-10 U/ml = Equivocal
>10 U/ml = Positive
.
RNP:
<5.0 U/ml = Negative
5.0-10 U/ml = Equivocal
>10 U/ml = Positive
Factor B 0.1-0.45g/L
Factor D Not Available
Factor H Not Available
Factor I Not Available
Ganglioside Abs. GM1 ab, GQ1B ab Negative, Weak Positive, Positive
HMC/QA/GDE/001
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Test Reference Range
Glomerular Basement
Membrane Antibodies
(IgG) <7.0 U/ml = Negative, 7.0-10 U/ml = Equivocal, >10.0 U/ml = Positive
IgG EMA negative
Immunofixation
(Urine) Free light chains detected - Bence Jones Protein positive, Monoclonal immunoglobulin detected - Bence Jones Protein negative
Immunofixation No abnormal bands
Immunoglobulin A
(IgA) Adults : 0.62 - 2.9g/L
Immunoglobulin E
(IgE) Neonates: <1.5 IU/mL, 1-5yr: <15IU/mL, 6-9yr:<90IU/mL, 10-15yr:<200IU/mL, Adults <100IU/mL
Immunoglobulin G
(IgG) Subclasses Available at (http://www.immqas.org.uk/pru.asp?ID=316)
Immunoglobulin G
(IgG) Adults : 6.26 - 14.96g/L
Immunoglobulin M
(IgM) Adults : 0.47 - 1.82g/L
Immunoglobulin
Subclass 4 (IgG4) Reference Ranges are sourced from the kit Manufacturer - Binding Site, Bermingham and were last updated 30th April 2013.
Insulin antibodies Negative
Islet Cell antibodies Negative
k/l ratio Ratio reference range = 0.4-1.7, Free Kappa chains = 3.3-19.4 g/L, Free Lambda chains = 5.7- 26.3 g/L
Liver/Kidney
Microsome
Antibodies (LKM) NEG: Negative, 1:40: Positive at 1:40, 1:80: Positive at 1:80, 1:160: Positive at 1:160
Mast cell tryptase 2-14 ug/L
HMC/QA/GDE/001
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Test Reference Range
Mitochondrial
Antibodies (MITA) Negative/ Positive
Muscle tyrosine
kinase Abs. Negative
Myelin associated
Glycoprotein
Antibody (0-1000) BTU = Negative
Myeloperoxidase
Antibodies (IgG) <3.5 IU/ml = Negative, 3.5-5.0 IU/ml = Equivocal, >5.0 IU/ml = Positive
Neutrophil adhesion
CD11a,b,c, CD18 Not Available
NMDA Receptor
Antibodies Negative
Oligoclonal banding IgG Index: 0 - 0.7, CSF Pattern: NOR - Normal, MB - Monoclonal Band, MA - Minor Abnormality, OB - Oligoclonal Bands
Ovarian Antibodies Negative
Oxidative burst Not Available
P.D.H. Antibodies Negative
Paraprotein Negative
Parietal Cell
Antibodies (PCA) NEG: Negative, POS: Positive
Properidin Not Available
Proteinase 3
Antibodies (IgG) <2.0 IU/ml = Negative, 2.0-3.0 IU/ml = Equivocal, >3.0 IU/ml = Positive
Rheumatoid Factor 0-20 IU/ml
Skin Biopsy Negative
Skin Bullous Pemph.
abs. Negative
HMC/QA/GDE/001
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Test Reference Range
Skin Pemph. Vulgaris
abs. Negative
Smooth Muscle
Antibodies (SMA) NEG: Negative, 1:40: Positive at 1:40, 1:80: Positive at 1:80
Specific IgE Negative = 0 - 0.35 kU/L
Specific IgG to
Budgie Reference range = (0-89)mgA/l
specific IgG to
Micropolysporum
Faeni Reference Range =(0-9)mgA/L
Specific IgG to
Pidgeon Reference Range = (0-29)mgA/l
Specific Response to
Haemophilus
Influenza Type b
capsular
polysaccharide (IgG) Minimum protective level is 0.15 mg/L, Optimum protective level is >1.0 mg/L
Specific Response to
Tetanus Toxoid (IgG) minimum protective level - 0.01 IU/ml, optimum protective level - >0.1 IU/ml
Tissue
Transglutaminase
(tTG) IgA <7.0 IU/ml = Negative, 7.0 - 10 IU/ml = Equivocal, >10 IU/ml = Positive
TPMT functional
activity Normal : 26-50pmol/h/mgHb ; Carrier: 10-25pmol/h/mgHb; Deficiency: <10pmol/h/mgHb
Transferrin 2.0-3.2g/L
Urinary Casts The presence of red cells, white cells, red cell casts, white cell casts, granular casts and crystals is reported.
Urinary paraprotein Negative
HMC/QA/GDE/001
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Test Reference Range
Voltage Gated
Potassium Channnel
Abs. Not Available
Table 3. B Cell and Natural Killer Cells Reference Ranges
B-Cell and Natural Killer (NK) Cell Quantitiation by Flow Cytometry
B-Cells
(CD19)
Natural Killer (NK) Cells
(CD16 and CD56)
Age Percentage
(%)
Absolute Count
(x10^6)
Percentage (%) Absolute Count
(x10^6)
0-3 Months 6-32 300-2000 4-18 170-1100
3-6 Months 11-41 430-3000 3-14 170-830
6-12 Months 14-37 610-2600 3-15 160-950
1-2 Years 16-35 720-2600 3-15 180-920
2-6 Years 14-33 370-1400 4-17 130-720
6-12 Years 13-27 270-860 4-17 100-480
12-18 Years 6-23 110-570 3-22 70-480
Adult 5-19 99-618 4-24 72-577
HMC/QA/GDE/001
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Table 4. Double Negative T-Cells Reference Ranges
TCRαβ Double Negative T-
Cells
TCRαβ T-Cells TCRγδ T-Cells
Age % TCRαβCD4 Absolute
Count (x10^6)
% Lymphs Absolute Count
(x10^6)
% Lymphs Absolute Count
(x10^6)
1 Week - 2 Months 0.24-1 31533 48-91 1600-8600 0.27-15 13-1000
2-5 Months 0.18-3 8-140 43-93 2200-8300 1-7 56-510
5-9 Months 0.39-4 16-140 39-94 1200-12000 0.82-10 38-890
9-15 Months 0.42-2 12-140 46-88 2000-8000 1-10 70-630
15-24 Months 0.55-4 11-100 26-100 600-8500 1-13 41-640
2-5 Years 1-7 16-140 31-100 600-4300 0.92-38 27-960
5-10 Years 0.77-6 10-100 44-92 600-3700 2-24 27-960
10-16 Years 0.54-6 9-78 39-92 700-2800 2-17 39-540
>16 Years 0.57-5 7-74 36-98 600-3300 0.83-11 25-200
Adult 0.8-3.2 11-55 62-79 806-2234 0-12.1 0-230
HMC/QA/GDE/001
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Table 5. Interferon Gamma Release Assay Reference Ranges
Nil (IU/ml) TB Antigen minus Nil (IU/ml) Mitogen minus Nil (IU/ml) QFT result Report/ Interpretation
<0.35 Negative M. Tuberculosis infection NOT likely
≤0.8 ≥0.5
≥0.35 and <25% of Nil value Negative M. Tuberculosis infection NOT likely
≥0.5
≥0.35 and ≥25% of Nil value Any Positive M. Tuberculosis infection likely
<0.35 <0.5 Intermediate Results are indeterminate for TB-Antigen Responsiveness
≥0.35 and <25% of Nil value <0.5 Intermediate Results are indeterminate for TB-Antigen Responsiveness
>8.0 Any Any Intermediate Results are indeterminate for TB-Antigen Responsiveness
HMC/QA/GDE/001
Appendix F Ver. 9 Effective date:
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Review date: 01/02/2019 Page 53 of 57
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Table 6. Naive and Effector T-Cells Reference Ranges
Naïve CD4+ T-Cells Naïve CD4- T-Cells Effector CD4- T-Cells
Age Percentage
(%)
Absolute Count
(x10^6)
Percentage
(%)
Absolute Count
(x10^6)
Percentage
(%)
Absolute
Count (x10^6)
1 Week - 2 Months 66-100 1300-5700 44-100 140-2200 3-42 15-480
2-5 Months 73-100 1600-6000 47-100 290-1650 3-40 13-820
5-9 Months 77-97 800-7600 31-100 150-3200 5-78 17-2800
9-15 Months 77-96 1100-6400 16-100 140-2460 4-92 29-1700
15-24 Months 56-100 200-7500 10-100 30-3100 8-71 55-460
2-5 Years 52-92 300-2300 19-100 53-1100 6-83 25-530
5-10 Years 46-99 200-2500 16-100 42-1300 15-41 57-340
10-16 Years 37-97 200-1700 20-95 78-640 9-65 35-420
>16 Years 16-100 100-2300 6-100 16-1000 7-53 25-280
Adult 38-52 191-383 37-56 184-289 0-9 0-49
HMC/QA/GDE/001
Appendix F Ver. 9 Effective date:
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Table 7. Naïve and Memory B Cells Reference Range
Naive B-Cell (CD27-, IgD+) Memory B-Cell (CD27+, IgD+) CSMB (CD27+, IgD-) CD21lowB-Cells
Age (Years) % Count (10^6/L) % Count (10^6/L % Count (10^6/L) % Count (10^6/L)
0-1 91-96 537-1179 2-4 12-36 0.1-2 1-16 0.3-4 3-35
2-3 83-90 571-1323 4-7 38-90 1-4 13-42 1.8-3.6 15-36
4-5 76-85 334-611 4-9 25-60 3-7 16-44 1.8-5.2 8-23
6-10 70-80 133-389 7-12 22-43 5-12 16-31 0.9-3.5 3-4
11-18 75-87 171-293 5-10 12-32 3-10 10-29 0.9-3.3 2-12
19-25 66-80 92-199 7-14 12-34 7-13 10-31 0.9-3.1 6-17
26-50 58-72 112-169 13-21 22-54 9-19 18-40 1.8-4.7 4-11
Table 8. Specific Response to Pneumococcal Capsular Polysaccharide (Total IgG and IgG2) Regerence Ranges
Age Pneumococcal (Total IgG
(mg/L))
Pneumococcal
(IgG2 (mg/L))
6-12
Months
0.9-93.0 0.5-117.3
1-2 Years 0.9-29.2 0.5-87.0
2-3 Years 1.4-110.4 1.2-142.8
3-4 Years 0.8-262.1 1.2-113.4
4-8 Years 9.2-225.9 0.8-122.4
8-12 Years 11.0-320.8 1.2-107.1
12-18 Years 8.7-502.6 1.9-69.2
Adult 10.0-191.2 4.7-89.4
HMC/QA/GDE/001
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Table 9. T Cell Activation Markers Reference Ranges
Activated Helper T-Cells
(CD4)
Activated Cytotoxic T-Cells(CD8)
HLA-DR+, CD38+ CD27+, CD45RA+
Age Percent CD4 (%) Absolute Count (x10^6) Percent CD8 (%) Absolute Count (x10^6)
0-6 Months 0.5-0.8 0.5-4.1
6-12 Months 0.4-1 0.6-2
12-24 Months 0.3-1.3 0.4-4.4
2-3 Years 0.6-1.2 1.3-8.8
3-4 Years 0.4-1.5 1.1-16
4-6 Years 0.3-2.5 0.5-10.7
6-9 Years 0.3-1.8 1.1-3.2
9-12 Years 0.3-2 0.9-3.6
12-15 Years 0.5-1.6 0.4-3.7
15-18 Years 0.3-1 0.9-4.2
Adult 0.5-3.3 6-27 0.-12 0-108
HMC/QA/GDE/001
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Table 10. T Cell Quantitation by Flow Cytometry Reference Ranges
Total T-Cells (CD3) Helper T-Cells (CD4) Cytotoxic T-Cells (CD8)
Age Percentage
(%)
Absolute
Count (x10^6)
Percentage
(%)
Absolute Count
(x10^6)
Percentage
(%)
Absolute Count
(x10^6)
0-3 Months 53-84 2500-5500 35-64 1600-4000 12-28 560-1700
3-6 Months 51-77 2500-5600 35-56 1800-4000 12-23 590-1600
6-12 Months 49-76 1900-5900 31-56 1400-4300 12-24 500-1700
1-2 Years 53-75 2100-6200 32-51 1300-3400 14-30 620-2000
2-6 Years 56-75 1400-3700 28-47 700-2200 16-30 490-1300
6-12 Years 60-76 1200-2600 31-47 650-1500 18-35 370-1100
12-18 Years 56-84 1000-2200 31-52 530-1300 18-35 330-920
Adult 66-85 797-2996 35-60 502-1749 18-49 263-1137
Table 11. Thyroid Peroxidase Antibodies
Age TPO (IU/ml)
Newborn <117
6 Days-3 Months <47
4-12 Months <32
1-6 Years <13
7-11 Years <18
12-20 Years <26
Healthy Adults <34
