IBD - 6MP METABOLITE LEVELS

LAB3067

Collect

5 mL purple top [EDTA] whole blood

Unacceptable Conditions

Frozen samples

Storage/Transport Temperature

Internal: Deliver to lab immediatley
Offsite: Ship whole blood refrigerated (DO NOT FREEZE)

Stability (from collection to initiation)

Ambient: 24 hours; Refrigerated: 8 days

Remarks


Drugs with these metabolites include:
Azathioprine[ Imuran], 6-Mercaptopurine [6-MP]
Metabolites measured: 6-Methylmercaptopurine [6-MMP] and 6-Thioquanine [6-TG]

Performed by

Prometheus Laboratories

Performed

Varies

Methodology

Quantitative High Pressure Liquid Chromotography (HPLC)

Reported

In 5 days

Synonyms

  • 6-THIOQUANINE
  • IMURAN METABOLITES
  • 6-METHYLMERCAPTOPURINE
  • 6-MERCAPTOPURINE METABS
  • LAB3067
  • IBD METABS

Reference Interval

Therapeutic Range: (6-TGN): 235-400 pmole/8x108 RBC
(6-MMPN): <5,700 pmole/8x108 RBC

Performed by

Prometheus Laboratories

CPT Codes

82491 Thioguanine; 82491 6-Methyl-metecaptopurine

Collection

LAB3067

Collect

5 mL purple top [EDTA] whole blood

Unacceptable Conditions

Frozen samples

Storage/Transport Temperature

Internal: Deliver to lab immediatley
Offsite: Ship whole blood refrigerated (DO NOT FREEZE)

Stability (from collection to initiation)

Ambient: 24 hours; Refrigerated: 8 days

Remarks


Drugs with these metabolites include:
Azathioprine[ Imuran], 6-Mercaptopurine [6-MP]
Metabolites measured: 6-Methylmercaptopurine [6-MMP] and 6-Thioquanine [6-TG]

Performed by

Prometheus Laboratories

Ordering

Performed

Varies

Methodology

Quantitative High Pressure Liquid Chromotography (HPLC)

Reported

In 5 days

Synonyms

  • 6-THIOQUANINE
  • IMURAN METABOLITES
  • 6-METHYLMERCAPTOPURINE
  • 6-MERCAPTOPURINE METABS
  • LAB3067
  • IBD METABS
Result Interpretation

Reference Interval

Therapeutic Range: (6-TGN): 235-400 pmole/8x108 RBC
(6-MMPN): <5,700 pmole/8x108 RBC

Performed by

Prometheus Laboratories

Administrative

CPT Codes

82491 Thioguanine; 82491 6-Methyl-metecaptopurine

IBD - TPMT ENZYME ACTIVITY

LAB8529

 

Collect

5 mL purple top [EDTA] whole blood

Unacceptable Conditions

Frozen samples

Storage/Transport Temperature

Internal: Deliver to lab immediatley
Offsite: Ship whole blood ambient or refrigerated (DO NOT FREEZE)

Stability (from collection to initiation)

Ambient: 24 hours; Refrigerated: 8 days

Remarks

This test is used to determine the level of the enzyme thiopurine methyltransferase activity to determine if treatment with inflammatory bowel disease [Imuran] will be effective.

Performed by

Prometheus Laboratories

Performed

Varies

Methodology

Enzyme activity in peripheral blood cells/Quantitative High Pressure Liquid Chromatography (HPLC)

Reported

In 5 days

Synonyms

  • LAB8529
  • TMPT

Reference Interval

Normal TPMT Activity: >23.6 EU/mL
Intermediate TPMT Avtivity: 6.7 - 23.6 EU/mL
Low TPMT Activity: <6.7 EU/mL

Performed by

Prometheus Laboratories

CPT Codes

82491 6 Methylthioguanine
82657 Thiopurine S-methyltransferase.

Collection

LAB8529

 

Collect

5 mL purple top [EDTA] whole blood

Unacceptable Conditions

Frozen samples

Storage/Transport Temperature

Internal: Deliver to lab immediatley
Offsite: Ship whole blood ambient or refrigerated (DO NOT FREEZE)

Stability (from collection to initiation)

Ambient: 24 hours; Refrigerated: 8 days

Remarks

This test is used to determine the level of the enzyme thiopurine methyltransferase activity to determine if treatment with inflammatory bowel disease [Imuran] will be effective.

Performed by

Prometheus Laboratories

Ordering

Performed

Varies

Methodology

Enzyme activity in peripheral blood cells/Quantitative High Pressure Liquid Chromatography (HPLC)

Reported

In 5 days

Synonyms

  • LAB8529
  • TMPT
Result Interpretation

Reference Interval

Normal TPMT Activity: >23.6 EU/mL
Intermediate TPMT Avtivity: 6.7 - 23.6 EU/mL
Low TPMT Activity: <6.7 EU/mL

Performed by

Prometheus Laboratories

Administrative

CPT Codes

82491 6 Methylthioguanine
82657 Thiopurine S-methyltransferase.

IBD - TPMT GENETIC ASSESSMENT

Effective: 2/1/17
LAB6451

Collect

Lavender (EDTA), pink (K2EDTA), or yellow (ACD Solution A or B).

Specimen Preparation

Transport 3 mL whole blood. (Min: 1 mL)

Unacceptable Conditions

Plasma or serum. Heparinized specimens.

Storage/Transport Temperature

Refrigerated.

Stability (from collection to initiation)

Ambient: 72 hours; Refrigerated: 2 weeks; Frozen: 1 month.

Performed by

Prometheus Laboratories

Performed

Mon, Thu

Methodology

Polymerase Chain Reaction/Fluorescence Monitoring

Reported

5-10 days

Synonyms

  • TMPT GENETICS
  • AZA toxicity
  • Azathioprine
  • S-adenosyl-L-methionine genotype
  • Thiopurine
  • Thiopurine S-methyltransferase genotype
  • TPMT genetics
  • TPMT mutation
  • LAB6451

Ordering Recommendations

Assess risk, due to genetics, for severe myelosuppression with standard dosing of thiopurine drugs. Appropriate for pre- or posttherapeutic assessments. Preferred test for patients with recent heterologous blood transfusion. Can be performed irrespective of thiopurine therapy.

Reference Interval

By report

Interpretive Data

Background Information for Thiopurine Methyltransferase (TPMT) Genotyping, 4 Variants:
Characteristics:
 Thiopurine therapy is used in the treatment of autoimmune diseases, inflammatory bowel disease and acute lymphoblastic leukemia and is also used to prevent rejection after solid organ transplant. Thiopurine drugs (eg, Azathioprine, 6-mercaptopurine, 6-thioguanine) are antimetabolites and must be metabolized to 6-thioguanine nucleotides (6-TGN) for activity. The inactivation of thiopurine drugs is primarily catalyzed by TPMT. Variants in the TPMT gene can lead to low TPMT enzyme activity, resulting in accumulation of cytotoxic metabolites and increased risk for drug-related myelotoxicity with standard doses of thiopurine drugs.
Incidence of TPMT deficiency: In the general population, approximately 0.3 percent of individuals have low TPMT activity and 10 percent have intermediate TPMT activity.
Allele Frequencies:
TPMT *2: African 0.000792, Asian 0.0, Caucasian 0.00190, Mediterranean 0.00408, Mexican 0.00592, Middle Eastern 0.00749
TPMT *3A: African 0.00198, Asian 0.0001118, Caucasian 0.0356, Mediterranean 0.0254, Mexican 0.0533, Middle Eastern 0.0114
TPMT *3B: African 0.0, Asian 0.0, Caucasian 0.000461, Mediterranean 0.00426, Mexican 0.00690, Middle Eastern 0.00562
TPMT *3C: African 0.0495, Asian 0.0157, Caucasian 0.004205, Mediterranean 0.00545, Mexican 0.00888, Middle Eastern 0.00562
Inheritance: Autosomal co-dominant.
Cause: TPMT gene variants resulting in enzyme deficiency.
Variants Tested:
 TPMT deficiency alleles: *2 (c.238G>C; p.Ala80Pro), *3A (c.[460G>A;719A>G]; p.[Ala154Thr;Tyr240Cys]), *3B (c.460G>A; p.Ala154Thr), *3C (c.719A>G; p.Tyr240Cys).
No variants detected is predictive of *1 functional alleles and normal TPMT enzyme activity.
(Variants are numbered according to NM_000367 transcript)
Clinical Sensitivity: 95 percent. 
Methodology: Polymerase chain reaction (PCR) and fluorescence monitoring.
Analytical Sensitivity and Specificity: 99 percent.
Limitations: Only the targeted TPMT variants will be detected by this panel. Because the complex *3A allele contains the variants found in the *3B and *3C alleles, this test cannot distinguish the 3A/Negative genotype (intermediate enzyme activity) from the rare *3B/*3C genotype (no or low enzyme activity). This test does not assess for TPMT variants associated with ultra-high enzyme activity. Genotyping will reflect donor status in patients who have received allogenic stem cell or bone marrow transplants. TPMT enzyme activity, drug metabolism and risk for adverse reactions to thiopurines may be affected by additional genetic and non-genetic factors not evaluated by this test. Diagnostic errors can occur due to rare sequence variations. Genotyping does not replace the need for therapeutic drug monitoring and clinical observation.

Counseling and informed consent are recommended for genetic testing. Consent forms are available online at www.aruplab.com.

Performed by

Prometheus Laboratories

CPT Codes

81401
Collection

Effective: 2/1/17
LAB6451

Collect

Lavender (EDTA), pink (K2EDTA), or yellow (ACD Solution A or B).

Specimen Preparation

Transport 3 mL whole blood. (Min: 1 mL)

Unacceptable Conditions

Plasma or serum. Heparinized specimens.

Storage/Transport Temperature

Refrigerated.

Stability (from collection to initiation)

Ambient: 72 hours; Refrigerated: 2 weeks; Frozen: 1 month.

Performed by

Prometheus Laboratories

Ordering

Performed

Mon, Thu

Methodology

Polymerase Chain Reaction/Fluorescence Monitoring

Reported

5-10 days

Synonyms

  • TMPT GENETICS
  • AZA toxicity
  • Azathioprine
  • S-adenosyl-L-methionine genotype
  • Thiopurine
  • Thiopurine S-methyltransferase genotype
  • TPMT genetics
  • TPMT mutation
  • LAB6451

Ordering Recommendations

Assess risk, due to genetics, for severe myelosuppression with standard dosing of thiopurine drugs. Appropriate for pre- or posttherapeutic assessments. Preferred test for patients with recent heterologous blood transfusion. Can be performed irrespective of thiopurine therapy.
Result Interpretation

Reference Interval

By report

Interpretive Data

Background Information for Thiopurine Methyltransferase (TPMT) Genotyping, 4 Variants:
Characteristics:
 Thiopurine therapy is used in the treatment of autoimmune diseases, inflammatory bowel disease and acute lymphoblastic leukemia and is also used to prevent rejection after solid organ transplant. Thiopurine drugs (eg, Azathioprine, 6-mercaptopurine, 6-thioguanine) are antimetabolites and must be metabolized to 6-thioguanine nucleotides (6-TGN) for activity. The inactivation of thiopurine drugs is primarily catalyzed by TPMT. Variants in the TPMT gene can lead to low TPMT enzyme activity, resulting in accumulation of cytotoxic metabolites and increased risk for drug-related myelotoxicity with standard doses of thiopurine drugs.
Incidence of TPMT deficiency: In the general population, approximately 0.3 percent of individuals have low TPMT activity and 10 percent have intermediate TPMT activity.
Allele Frequencies:
TPMT *2: African 0.000792, Asian 0.0, Caucasian 0.00190, Mediterranean 0.00408, Mexican 0.00592, Middle Eastern 0.00749
TPMT *3A: African 0.00198, Asian 0.0001118, Caucasian 0.0356, Mediterranean 0.0254, Mexican 0.0533, Middle Eastern 0.0114
TPMT *3B: African 0.0, Asian 0.0, Caucasian 0.000461, Mediterranean 0.00426, Mexican 0.00690, Middle Eastern 0.00562
TPMT *3C: African 0.0495, Asian 0.0157, Caucasian 0.004205, Mediterranean 0.00545, Mexican 0.00888, Middle Eastern 0.00562
Inheritance: Autosomal co-dominant.
Cause: TPMT gene variants resulting in enzyme deficiency.
Variants Tested:
 TPMT deficiency alleles: *2 (c.238G>C; p.Ala80Pro), *3A (c.[460G>A;719A>G]; p.[Ala154Thr;Tyr240Cys]), *3B (c.460G>A; p.Ala154Thr), *3C (c.719A>G; p.Tyr240Cys).
No variants detected is predictive of *1 functional alleles and normal TPMT enzyme activity.
(Variants are numbered according to NM_000367 transcript)
Clinical Sensitivity: 95 percent. 
Methodology: Polymerase chain reaction (PCR) and fluorescence monitoring.
Analytical Sensitivity and Specificity: 99 percent.
Limitations: Only the targeted TPMT variants will be detected by this panel. Because the complex *3A allele contains the variants found in the *3B and *3C alleles, this test cannot distinguish the 3A/Negative genotype (intermediate enzyme activity) from the rare *3B/*3C genotype (no or low enzyme activity). This test does not assess for TPMT variants associated with ultra-high enzyme activity. Genotyping will reflect donor status in patients who have received allogenic stem cell or bone marrow transplants. TPMT enzyme activity, drug metabolism and risk for adverse reactions to thiopurines may be affected by additional genetic and non-genetic factors not evaluated by this test. Diagnostic errors can occur due to rare sequence variations. Genotyping does not replace the need for therapeutic drug monitoring and clinical observation.

Counseling and informed consent are recommended for genetic testing. Consent forms are available online at www.aruplab.com.

Performed by

Prometheus Laboratories

Administrative

CPT Codes

81401

IDH1 MUTATION BY PCR

LAB4383

Collect

3 mL EDTA whole blood or bone marrow

Unacceptable Conditions

Serum/plasma. Frozen samples.

Storage/Transport Temperature

Ambient: 5 days

Refrigerated: Acceptable but not preferred.

Performed by

PCL Clinical Laboratory

Performed

1 day a week

Methodology

PCR and direct sequencing

Reported

7-10 days

Synonyms

  • LAB4383
  • IDH1PCR

Reference Interval

No molecular evidence for mutations in codon R132

Performed by

PCL Clinical Laboratory

CPT Codes

81479

Collection

LAB4383

Collect

3 mL EDTA whole blood or bone marrow

Unacceptable Conditions

Serum/plasma. Frozen samples.

Storage/Transport Temperature

Ambient: 5 days

Refrigerated: Acceptable but not preferred.

Performed by

PCL Clinical Laboratory

Ordering

Performed

1 day a week

Methodology

PCR and direct sequencing

Reported

7-10 days

Synonyms

  • LAB4383
  • IDH1PCR
Result Interpretation

Reference Interval

No molecular evidence for mutations in codon R132

Performed by

PCL Clinical Laboratory

Administrative

CPT Codes

81479

IDH2 MUTATION BY PCR

LAB4384

Collect

3 mL EDTA whole blood or bone marrow

Unacceptable Conditions

Serum/Plasma. Frozen specimens

Storage/Transport Temperature

Ambient:  5 days

Refreigerated; Acceptable but not preferred

Performed by

PCL Clinical Laboratory

Performed

1 day a week

Methodology

PCR and direct sequencing

Reported

7-10 days

Synonyms

  • LAB4384
  • IDH2PCR

Reference Interval

No molecular evidence for mutations in codons R140 and R172.

Performed by

PCL Clinical Laboratory

CPT Codes

81479

Collection

LAB4384

Collect

3 mL EDTA whole blood or bone marrow

Unacceptable Conditions

Serum/Plasma. Frozen specimens

Storage/Transport Temperature

Ambient:  5 days

Refreigerated; Acceptable but not preferred

Performed by

PCL Clinical Laboratory

Ordering

Performed

1 day a week

Methodology

PCR and direct sequencing

Reported

7-10 days

Synonyms

  • LAB4384
  • IDH2PCR
Result Interpretation

Reference Interval

No molecular evidence for mutations in codons R140 and R172.

Performed by

PCL Clinical Laboratory

Administrative

CPT Codes

81479

IGF BINDING PROTEIN-1

LAB3840

Collect

Plain red or serum separator tube (SST).

Patient Preparation

Patient should fast overnight (12 hours) prior to collection.

Specimen Preparation

Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.2 mL)

Unacceptable Conditions

Grossly hemolyzed or lipemic specimens.

Storage/Transport Temperature

Frozen. Also acceptable: Refrigerated.

Stability (from collection to initiation)

Ambient: 24 hours; Refrigerated: 1 week; Frozen: 4 weeks

Performed

Varies

Methodology

Quantitative Radioimmunoassay

Reported

3-10 days

Synonyms

  • LAB3840
  • IGFBP-1

Ordering Recommendations

Research interest only. For suspected growth hormone disorders, IGF-1 (Insulin-Like Growth Factor 1) (0070125) and Growth Hormone (0070080) is recommended.

Reference Interval

By report

CPT Codes

83519
Collection

LAB3840

Collect

Plain red or serum separator tube (SST).

Patient Preparation

Patient should fast overnight (12 hours) prior to collection.

Specimen Preparation

Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.2 mL)

Unacceptable Conditions

Grossly hemolyzed or lipemic specimens.

Storage/Transport Temperature

Frozen. Also acceptable: Refrigerated.

Stability (from collection to initiation)

Ambient: 24 hours; Refrigerated: 1 week; Frozen: 4 weeks
Ordering

Performed

Varies

Methodology

Quantitative Radioimmunoassay

Reported

3-10 days

Synonyms

  • LAB3840
  • IGFBP-1

Ordering Recommendations

Research interest only. For suspected growth hormone disorders, IGF-1 (Insulin-Like Growth Factor 1) (0070125) and Growth Hormone (0070080) is recommended.
Result Interpretation

Reference Interval

By report
Administrative

CPT Codes

83519

IGG SUBCLASS 4

LAB1000

Collect

Serum separator tube or green (sodium or lithium heparin).

Specimen Preparation

Separate serum or plasma from cells ASAP or within 2 hours of collection. Transfer 1 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.45 mL)

Storage/Transport Temperature

Refrigerated.

Stability (from collection to initiation)

After separation from cells: Ambient: 2 hours; Refrigerated: 8 days; Frozen: 6 months

Performed

Mon-Sat

Methodology

Quantitative Nephelometry

Reported

1-3 days

Synonyms

  • LAB1000
  • IGG4

Ordering Recommendations

Aids in diagnosis of immunodeficiencies.

Reference Interval

Effective February 16, 2016
Cord blood: 1-47 mg/dL                         5-6 years: 2-116 mg/dL
0-2 months: 1-33 mg/dL                         7-8 years: 0-138 mg/dL
3-5 months: 1-14 mg/dL                         9-10 years: 1-95 mg/dL
6-8 months: 1-16 mg/dL                         11-12 years: 1-153 mg/dL
9-23 months: 1-65 mg/dL                       13-14 years: 2-143 mg/dL
2 years: 0-120 mg/dL                              15 years and older: 1-123 mg/dL
3-4 years: 0-90 mg/dL

CPT Codes

82787
Collection

LAB1000

Collect

Serum separator tube or green (sodium or lithium heparin).

Specimen Preparation

Separate serum or plasma from cells ASAP or within 2 hours of collection. Transfer 1 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.45 mL)

Storage/Transport Temperature

Refrigerated.

Stability (from collection to initiation)

After separation from cells: Ambient: 2 hours; Refrigerated: 8 days; Frozen: 6 months
Ordering

Performed

Mon-Sat

Methodology

Quantitative Nephelometry

Reported

1-3 days

Synonyms

  • LAB1000
  • IGG4

Ordering Recommendations

Aids in diagnosis of immunodeficiencies.
Result Interpretation

Reference Interval

Effective February 16, 2016
Cord blood: 1-47 mg/dL                         5-6 years: 2-116 mg/dL
0-2 months: 1-33 mg/dL                         7-8 years: 0-138 mg/dL
3-5 months: 1-14 mg/dL                         9-10 years: 1-95 mg/dL
6-8 months: 1-16 mg/dL                         11-12 years: 1-153 mg/dL
9-23 months: 1-65 mg/dL                       13-14 years: 2-143 mg/dL
2 years: 0-120 mg/dL                              15 years and older: 1-123 mg/dL
3-4 years: 0-90 mg/dL
Administrative

CPT Codes

82787

IGG SUBCLASSES [1,2,3,4]

LAB1001

Collect

Serum separator tube or green (sodium or lithium heparin).

Specimen Preparation

Separate serum or plasma from cells ASAP or within 2 hours of collection. Transfer 2 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.45 mL)

Storage/Transport Temperature

Refrigerated.

Stability (from collection to initiation)

After separation from cells: Ambient: 2 hours; Refrigerated: 8 days; Frozen: 6 months

Performed

Mon-Sat

Methodology

Quantitative Nephelometry

Reported

1-3 days

Synonyms

  • LAB1001
  • IGGSUB

Ordering Recommendations

Do not order for total IgG measurements. Secondary test in suspected immunoglobulin deficiency. Do not order before IgG, IgA, and IgM measurements are performed.

Reference Interval

Components
Reference Interval
Immunoglobulin G Subclass 1Cord blood: 435-1084 mg/dL                 5-6 years: 330-1065 mg/dL
0-2 months: 218-498 mg/dL                   7-8 years: 225-1100 mg/dL
3-5 months: 143-394 mg/dL                   9-10 years: 390-1235 mg/dL
6-8 months: 190-388 mg/dL                   11-12 years: 380-1420 mg/dL
9-23 months: 288-880 mg/dL                 13-14 years: 165-1440 mg/dL
2 years: 170-950 mg/dL                          15 years and older: 240-1118 mg/dL
3-4 years: 290-1065 mg/dL
Immunoglobulin G Subclass 2Cord blood: 143-453 mg/dL                   5-6 years: 57-345 mg/dL
0-2 months: 40-167 mg/dL                     7-8 years: 42-375 mg/dL
3-5 months: 23-147 mg/dL                     9-10 years: 61-430 mg/dL
6-8 months: 37-60 mg/dL                       11-12 years: 73-455 mg/dL
9-23 months: 30-327 mg/dL                   13-14 years: 71-460 mg/dL
2 years: 22-440 mg/dL                            15 years and older: 124-549 mg/dL
3-4 years: 28-315 mg/dL
Immunoglobulin G Subclass 3Cord blood: 27-146 mg/dL                     5-6 years: 8-126 mg/dL
0-2 months: 4-23 mg/dL                         7-8 years: 9-107 mg/dL
3-5 months: 4-70 mg/dL                         9-10 years: 10-98 mg/dL
6-8 months: 12-62 mg/dL                       11-12 years: 16-194 mg/dL
9-23 months: 13-82 mg/dL                     13-14 years: 12-178 mg/dL
2 years: 4-69 mg/dL                                15 years and older: 21-134 mg/dL
3-4 years: 4-71 mg/dL
Immunoglobulin G Subclass 4Effective February 16, 2016
Cord blood: 1-47 mg/dL                         5-6 years: 2-116 mg/dL
0-2 months: 1-33 mg/dL                         7-8 years: 0-138 mg/dL
3-5 months: 1-14 mg/dL                         9-10 years: 1-95 mg/dL
6-8 months: 1-16 mg/dL                         11-12 years: 1-153 mg/dL
9-23 months: 1-65 mg/dL                       13-14 years: 2-143 mg/dL
2 years: 0-120 mg/dL                              15 years and older: 1-123 mg/dL
3-4 years: 0-90 mg/dL

Interpretive Data

The total IgG (mg/dL) can be derived from the sum of the subclass IgG1, IgG2, IgG3, and IgG4 values. However, a confirmatory and more precise total IgG is available by the nephelometric method of quantitation for total IgG.  Refer to test Immunoglobulin G, Serum (0050350).

CPT Codes

82787 x4
Collection

LAB1001

Collect

Serum separator tube or green (sodium or lithium heparin).

Specimen Preparation

Separate serum or plasma from cells ASAP or within 2 hours of collection. Transfer 2 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.45 mL)

Storage/Transport Temperature

Refrigerated.

Stability (from collection to initiation)

After separation from cells: Ambient: 2 hours; Refrigerated: 8 days; Frozen: 6 months
Ordering

Performed

Mon-Sat

Methodology

Quantitative Nephelometry

Reported

1-3 days

Synonyms

  • LAB1001
  • IGGSUB

Ordering Recommendations

Do not order for total IgG measurements. Secondary test in suspected immunoglobulin deficiency. Do not order before IgG, IgA, and IgM measurements are performed.
Result Interpretation

Reference Interval

Components
Reference Interval
Immunoglobulin G Subclass 1Cord blood: 435-1084 mg/dL                 5-6 years: 330-1065 mg/dL
0-2 months: 218-498 mg/dL                   7-8 years: 225-1100 mg/dL
3-5 months: 143-394 mg/dL                   9-10 years: 390-1235 mg/dL
6-8 months: 190-388 mg/dL                   11-12 years: 380-1420 mg/dL
9-23 months: 288-880 mg/dL                 13-14 years: 165-1440 mg/dL
2 years: 170-950 mg/dL                          15 years and older: 240-1118 mg/dL
3-4 years: 290-1065 mg/dL
Immunoglobulin G Subclass 2Cord blood: 143-453 mg/dL                   5-6 years: 57-345 mg/dL
0-2 months: 40-167 mg/dL                     7-8 years: 42-375 mg/dL
3-5 months: 23-147 mg/dL                     9-10 years: 61-430 mg/dL
6-8 months: 37-60 mg/dL                       11-12 years: 73-455 mg/dL
9-23 months: 30-327 mg/dL                   13-14 years: 71-460 mg/dL
2 years: 22-440 mg/dL                            15 years and older: 124-549 mg/dL
3-4 years: 28-315 mg/dL
Immunoglobulin G Subclass 3Cord blood: 27-146 mg/dL                     5-6 years: 8-126 mg/dL
0-2 months: 4-23 mg/dL                         7-8 years: 9-107 mg/dL
3-5 months: 4-70 mg/dL                         9-10 years: 10-98 mg/dL
6-8 months: 12-62 mg/dL                       11-12 years: 16-194 mg/dL
9-23 months: 13-82 mg/dL                     13-14 years: 12-178 mg/dL
2 years: 4-69 mg/dL                                15 years and older: 21-134 mg/dL
3-4 years: 4-71 mg/dL
Immunoglobulin G Subclass 4Effective February 16, 2016
Cord blood: 1-47 mg/dL                         5-6 years: 2-116 mg/dL
0-2 months: 1-33 mg/dL                         7-8 years: 0-138 mg/dL
3-5 months: 1-14 mg/dL                         9-10 years: 1-95 mg/dL
6-8 months: 1-16 mg/dL                         11-12 years: 1-153 mg/dL
9-23 months: 1-65 mg/dL                       13-14 years: 2-143 mg/dL
2 years: 0-120 mg/dL                              15 years and older: 1-123 mg/dL
3-4 years: 0-90 mg/dL

Interpretive Data

The total IgG (mg/dL) can be derived from the sum of the subclass IgG1, IgG2, IgG3, and IgG4 values. However, a confirmatory and more precise total IgG is available by the nephelometric method of quantitation for total IgG.  Refer to test Immunoglobulin G, Serum (0050350).

Administrative

CPT Codes

82787 x4

IGVH MUTATION ANALYISIS BY SEQUENCING

LAB3740

Collect

Lavender (EDTA) or bone marrow (EDTA).

Specimen Preparation

Transport 5 mL whole blood OR 3 mL bone marrow. (Min: 1 mL whole blood OR 1 mL bone marrow) Specimens must be received within 48 hours of collection due to lability of RNA..

Unacceptable Conditions

Serum or plasma. Frozen or clotted specimens. Specimens collected in anticoagulants other than EDTA. Severely hemolyzed specimens.

Storage/Transport Temperature

Refrigerated.

Stability (from collection to initiation)

Ambient: 1 hour; Refrigerated: 48 hours; Frozen: Unacceptable

Notes

This assay is designed for individuals with a confirmed diagnosis of CLL, and for these individuals testing will include sequencing.  All other diagnoses will terminate after amplification and will not have the sequencing component.

Performed

Varies

Methodology

Polymerase Chain Reaction/Sequencing

Reported

12-14 days

Synonyms

  • V Gene Mutation
  • LAB3740
  • IGHV MUT
  • IGVH MUT

Additional Technical Information

Ordering Recommendations

Determine risk group in newly diagnosed CLL.

Interpretive Data

Refer to report.

CPT Codes

81263
Collection

LAB3740

Collect

Lavender (EDTA) or bone marrow (EDTA).

Specimen Preparation

Transport 5 mL whole blood OR 3 mL bone marrow. (Min: 1 mL whole blood OR 1 mL bone marrow) Specimens must be received within 48 hours of collection due to lability of RNA..

Unacceptable Conditions

Serum or plasma. Frozen or clotted specimens. Specimens collected in anticoagulants other than EDTA. Severely hemolyzed specimens.

Storage/Transport Temperature

Refrigerated.

Stability (from collection to initiation)

Ambient: 1 hour; Refrigerated: 48 hours; Frozen: Unacceptable

Notes

This assay is designed for individuals with a confirmed diagnosis of CLL, and for these individuals testing will include sequencing.  All other diagnoses will terminate after amplification and will not have the sequencing component.
Ordering

Performed

Varies

Methodology

Polymerase Chain Reaction/Sequencing

Reported

12-14 days

Synonyms

  • V Gene Mutation
  • LAB3740
  • IGHV MUT
  • IGVH MUT

Additional Technical Information

Ordering Recommendations

Determine risk group in newly diagnosed CLL.
Result Interpretation

Interpretive Data

Refer to report.

Administrative

CPT Codes

81263

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