INFLIXIMAB ACTIVITY + HACA/INFLIXIMAB

LAB5067

Collect

Serum separator tube.

Patient Preparation

Collect specimens before infliximab treatment.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.3 mL)

Unacceptable Conditions

Contaminated, hemolyzed, icteric, or lipemic specimens.

Storage/Transport Temperature

Refrigerated.

Stability (from collection to initiation)

After separation from cells: Ambient: 48 hours; Refrigerated: 4 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)

Notes

This test is performed pursuant to an agreement with Biomonitor.

Performed

Mon, Wed, Thu, Sat

Methodology

Cell Culture/Quantitative Chemiluminescent Immunoassay/ Semi-Quantitative Chemiluminescent Immunoassay

Reported

2-3 days

Synonyms

  • HACA/Infliximab Activity
  • LAB5067
  • INFLI/HACA

Additional Technical Information

Ordering Recommendations

Evaluate response failure to infliximab therapy. Determine and adjust dosage or identify the need for change to another anti-TNF-α inhibitor.

Reference Interval

Available
Separately
Components
Reference Interval
NoInfliximab ActivityNot Detected
NoInfliximab Neutralizing Antibody TiterNot Detected

Interpretive Data

This test measures the capacity of infliximab to neutralize TNF- activity. Additionally, infliximab neutralizing antibodies (NAb) are titered (reporting the highest dilution of patient sera in which NAb activity is detected).

This test is used to evaluate secondary response failures to infliximab therapy. Secondary response failure is defined as loss of clinical response after initial improvement of clinical signs and symptoms. Therapeutic decision should rest on both the clinical response and the knowledge of the fate of the drug including the emergence of immunogenicity in individual patients.
 
Circulating infliximab levels have been shown to vary considerably between patients. These differences relate to route and frequency of administration and patient-related features such as age, gender, weight, drug metabolism, and concomitant medications such as methotrexate and other immunosuppressants.

IF Infliximab
Activity is....
AND Infliximab Neutralizing
Ab. Titer is....
THEN....
Not DetectedNot DetectedA higher dosage of infliximab or shortening the dosing interval may be appropriate.
Not Detected1:20 or greaterA change to another anti-TNF-α drug may be appropriate.
0.65 ug/mL or greaterNot DetectedA change to another type of therapy (not targeting TNF-α) may be appropriate.
0.65 ug/mL or greater1:20 or greaterRepeat testing is suggested to rule out decreasing infliximab activity and/or increasing infliximab neutralizing antibodies.

CPT Codes

86352x2
Collection

LAB5067

Collect

Serum separator tube.

Patient Preparation

Collect specimens before infliximab treatment.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.3 mL)

Unacceptable Conditions

Contaminated, hemolyzed, icteric, or lipemic specimens.

Storage/Transport Temperature

Refrigerated.

Stability (from collection to initiation)

After separation from cells: Ambient: 48 hours; Refrigerated: 4 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)

Notes

This test is performed pursuant to an agreement with Biomonitor.
Ordering

Performed

Mon, Wed, Thu, Sat

Methodology

Cell Culture/Quantitative Chemiluminescent Immunoassay/ Semi-Quantitative Chemiluminescent Immunoassay

Reported

2-3 days

Synonyms

  • HACA/Infliximab Activity
  • LAB5067
  • INFLI/HACA

Additional Technical Information

Ordering Recommendations

Evaluate response failure to infliximab therapy. Determine and adjust dosage or identify the need for change to another anti-TNF-α inhibitor.
Result Interpretation

Reference Interval

Available
Separately
Components
Reference Interval
NoInfliximab ActivityNot Detected
NoInfliximab Neutralizing Antibody TiterNot Detected

Interpretive Data

This test measures the capacity of infliximab to neutralize TNF- activity. Additionally, infliximab neutralizing antibodies (NAb) are titered (reporting the highest dilution of patient sera in which NAb activity is detected).

This test is used to evaluate secondary response failures to infliximab therapy. Secondary response failure is defined as loss of clinical response after initial improvement of clinical signs and symptoms. Therapeutic decision should rest on both the clinical response and the knowledge of the fate of the drug including the emergence of immunogenicity in individual patients.
 
Circulating infliximab levels have been shown to vary considerably between patients. These differences relate to route and frequency of administration and patient-related features such as age, gender, weight, drug metabolism, and concomitant medications such as methotrexate and other immunosuppressants.

IF Infliximab
Activity is....
AND Infliximab Neutralizing
Ab. Titer is....
THEN....
Not DetectedNot DetectedA higher dosage of infliximab or shortening the dosing interval may be appropriate.
Not Detected1:20 or greaterA change to another anti-TNF-α drug may be appropriate.
0.65 ug/mL or greaterNot DetectedA change to another type of therapy (not targeting TNF-α) may be appropriate.
0.65 ug/mL or greater1:20 or greaterRepeat testing is suggested to rule out decreasing infliximab activity and/or increasing infliximab neutralizing antibodies.

Administrative

CPT Codes

86352x2

INFLUENZA A ANTIBODY - IGG

Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.05 mL) Parallel testing is preferred and convalescent specimens must be received within 30 days from receipt of the acute specimens. Mark specimens plainly as "acute" or "convalescent."

Unacceptable Conditions

Plasma. Bacterially contaminated, heat-inactivated, hemolyzed, icteric, lipemic, or turbid specimens.

Storage/Transport Temperature

Refrigerated. Also acceptable: Room temperature or frozen.

Stability (from collection to initiation)

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year

Performed

Mon, Wed, Fri

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Reported

1-4 days

Synonyms

  • Flu A Antibody, IgG
  • INFLUA IGG

Ordering Recommendations

Do not use to diagnose acute influenza infections. Serological testing for influenza should be used for research and public health investigations only.

Reference Interval

0.89 IV or less: Negative - No significant level of influenza A virus IgG antibody detected.
0.90-1.10 IV: Equivocal - Questionable presence of influenza A virus IgG antibody detected.  Repeat testing in 10-14 days may be helpful.
1.11 IV or greater: Positive - IgG antibodies to influenza A virus detected, which may suggest current or past infection.

CPT Codes

86710
Collection

Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.05 mL) Parallel testing is preferred and convalescent specimens must be received within 30 days from receipt of the acute specimens. Mark specimens plainly as "acute" or "convalescent."

Unacceptable Conditions

Plasma. Bacterially contaminated, heat-inactivated, hemolyzed, icteric, lipemic, or turbid specimens.

Storage/Transport Temperature

Refrigerated. Also acceptable: Room temperature or frozen.

Stability (from collection to initiation)

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year
Ordering

Performed

Mon, Wed, Fri

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Reported

1-4 days

Synonyms

  • Flu A Antibody, IgG
  • INFLUA IGG

Ordering Recommendations

Do not use to diagnose acute influenza infections. Serological testing for influenza should be used for research and public health investigations only.
Result Interpretation

Reference Interval

0.89 IV or less: Negative - No significant level of influenza A virus IgG antibody detected.
0.90-1.10 IV: Equivocal - Questionable presence of influenza A virus IgG antibody detected.  Repeat testing in 10-14 days may be helpful.
1.11 IV or greater: Positive - IgG antibodies to influenza A virus detected, which may suggest current or past infection.
Administrative

CPT Codes

86710

INFLUENZA A ANTIBODY - IGM

Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.05 mL) Parallel testing is preferred and convalescent specimens must be received within 30 days from receipt of the acute specimens. Mark specimens plainly as "acute" or "convalescent."

Unacceptable Conditions

Plasma. Bacterially contaminated, heat-inactivated, hemolyzed, icteric, lipemic, turbid specimens.

Storage/Transport Temperature

Refrigerated. Also acceptable: Room temperature or frozen.

Stability (from collection to initiation)

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year

Performed

Mon, Wed, Fri

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Reported

1-6 days

Synonyms

  • Flu A Antibody, IgM

Ordering Recommendations

Do not use to diagnose acute influenza infections. Serological testing for influenza should be used for research and public health investigations only.

Reference Interval

0.89 IV or less: Negative - No significant level of influenza A virus IgM antibody detected.
0.90-1.10 IV: Equivocal - Questionable presence of influenza A virus IgM  antibody detected.  Repeat testing in 10-14 days may be helpful. 
1.11 IV or greater: Positive - IgM antibodies to influenza A virus detected, which may suggest current or recent infection.

CPT Codes

86710
Collection

Collect

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.05 mL) Parallel testing is preferred and convalescent specimens must be received within 30 days from receipt of the acute specimens. Mark specimens plainly as "acute" or "convalescent."

Unacceptable Conditions

Plasma. Bacterially contaminated, heat-inactivated, hemolyzed, icteric, lipemic, turbid specimens.

Storage/Transport Temperature

Refrigerated. Also acceptable: Room temperature or frozen.

Stability (from collection to initiation)

After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year
Ordering

Performed

Mon, Wed, Fri

Methodology

Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Reported

1-6 days

Synonyms

  • Flu A Antibody, IgM

Ordering Recommendations

Do not use to diagnose acute influenza infections. Serological testing for influenza should be used for research and public health investigations only.
Result Interpretation

Reference Interval

0.89 IV or less: Negative - No significant level of influenza A virus IgM antibody detected.
0.90-1.10 IV: Equivocal - Questionable presence of influenza A virus IgM  antibody detected.  Repeat testing in 10-14 days may be helpful. 
1.11 IV or greater: Positive - IgM antibodies to influenza A virus detected, which may suggest current or recent infection.
Administrative

CPT Codes

86710

INHIBIN A [DIMER] LEVEL

LAB3163

 

Collect

Serum separator tube.

Patient Preparation

Fasting specimens are recommended, but not required.

Specimen Preparation

Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.5 mL)

Unacceptable Conditions

Plasma. Hemolyzed or severely lipemic specimens.

Storage/Transport Temperature

Refrigerated.

Stability (from collection to initiation)

After separation from cells: Ambient: 24 hours; Refrigerated: 1 week; Frozen: 1 year (avoid repeated freeze/thaw cycles)

Performed

Sun-Sat

Methodology

Quantitative Chemiluminescent Immunoassay

Reported

1-2 days

Synonyms

  • LAB3163
  • INHIBA
  • INHIBINA

Reference Interval

Effective November 18, 2013
Age/ Phase
Inhibin A (Dimer) pg/mL
Normal Cycling Females:

Early Follicular Phase (-14 to -10)
Mid Follicular Phase (-9 to -4)
Late Follicular Phase (-3 to -1)
Mid Cycle (Day 0)
Early Luteal (1 to 3)
Mid Luteal (4 to 11 )
Late Luteal (12 to 14)
Normal Cycling Females:

1.8-17.3 pg/mL
3.5-31.7 pg/mL
9.8-90.3 pg/mL
16.9-91.8 pg/mL
16.1-97.5 pg/mL
3.9-87.7 pg/mL
2.7-47.1 pg/mL
IVF-Peak Levels
PCOS-Ovulatory
Postmenopausal
354.2-1690.0 pg/mL
5.7-16.0 pg/mL
less than 6.9 pg/mL
Normal malesless than 2.1 pg/mL

Interpretive Data

This assay is performed using the Beckman Coulter Unicel DxI assay. Values may be elevated during normal pregnancy.  Preeclampsia, Down Syndrome, and some cancers may increase Inhibin-A values.

CPT Codes

86336
Collection

LAB3163

 

Collect

Serum separator tube.

Patient Preparation

Fasting specimens are recommended, but not required.

Specimen Preparation

Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.5 mL)

Unacceptable Conditions

Plasma. Hemolyzed or severely lipemic specimens.

Storage/Transport Temperature

Refrigerated.

Stability (from collection to initiation)

After separation from cells: Ambient: 24 hours; Refrigerated: 1 week; Frozen: 1 year (avoid repeated freeze/thaw cycles)
Ordering

Performed

Sun-Sat

Methodology

Quantitative Chemiluminescent Immunoassay

Reported

1-2 days

Synonyms

  • LAB3163
  • INHIBA
  • INHIBINA
Result Interpretation

Reference Interval

Effective November 18, 2013
Age/ Phase
Inhibin A (Dimer) pg/mL
Normal Cycling Females:

Early Follicular Phase (-14 to -10)
Mid Follicular Phase (-9 to -4)
Late Follicular Phase (-3 to -1)
Mid Cycle (Day 0)
Early Luteal (1 to 3)
Mid Luteal (4 to 11 )
Late Luteal (12 to 14)
Normal Cycling Females:

1.8-17.3 pg/mL
3.5-31.7 pg/mL
9.8-90.3 pg/mL
16.9-91.8 pg/mL
16.1-97.5 pg/mL
3.9-87.7 pg/mL
2.7-47.1 pg/mL
IVF-Peak Levels
PCOS-Ovulatory
Postmenopausal
354.2-1690.0 pg/mL
5.7-16.0 pg/mL
less than 6.9 pg/mL
Normal malesless than 2.1 pg/mL

Interpretive Data

This assay is performed using the Beckman Coulter Unicel DxI assay. Values may be elevated during normal pregnancy.  Preeclampsia, Down Syndrome, and some cancers may increase Inhibin-A values.

Administrative

CPT Codes

86336

INHIBIN B

Collect

Serum separator tube or plain red.

Specimen Preparation

Transport 0.5 mL serum. (Min: 0.2 mL)

Unacceptable Conditions

Room temperature specimens. Hemolyzed or lipemic specimens.

Storage/Transport Temperature

Frozen.

Stability (from collection to initiation)

After separation from cells: Ambient: Unacceptable; Refrigerated: 48 hours; Frozen 1 month

Performed

Wed, Fri

Methodology

Quantitative Enzyme-Linked Immunosorbent Assay

Reported

1-8 days

Synonyms

  • INHIBINB
  • LAB4204

Ordering Recommendations

May be used for infertility evaluation. Use to differentiate ovarian tumor with normal CA-125 from stromal or mucinous epithelial tumor. May be used for monitoring recurrence of stromal ovarian tumors.

Reference Interval

Male
Female
0-6 yrs: 40-630 pg/mL
7-10 yrs :35-170 pg/mL
11-18 yrs: 50-475 pg/mL
19-45 yrs: 40-450 pg/mL
Greater than or equal to 46 years: less than 200 pg/mL
0-6 years: less than 73 pg/mL
7-10 years: less than 130 pg/mL
11-12 years: less than 186 pg/mL
13-18 years: less than 360 pg/mL
Pre-menopausal: less than 290 pg/mL
Follicular phase: 10-290 pg/mL
Post-menopausal: less than or equal to 16 pg/mL

Interpretive Data

This test is performed using the Beckman Coulter Inhibin B ELISA kit. Values obtained with different methodologies or kits cannot be used interchangeably.

CPT Codes

83520
Collection

Collect

Serum separator tube or plain red.

Specimen Preparation

Transport 0.5 mL serum. (Min: 0.2 mL)

Unacceptable Conditions

Room temperature specimens. Hemolyzed or lipemic specimens.

Storage/Transport Temperature

Frozen.

Stability (from collection to initiation)

After separation from cells: Ambient: Unacceptable; Refrigerated: 48 hours; Frozen 1 month
Ordering

Performed

Wed, Fri

Methodology

Quantitative Enzyme-Linked Immunosorbent Assay

Reported

1-8 days

Synonyms

  • INHIBINB
  • LAB4204

Ordering Recommendations

May be used for infertility evaluation. Use to differentiate ovarian tumor with normal CA-125 from stromal or mucinous epithelial tumor. May be used for monitoring recurrence of stromal ovarian tumors.
Result Interpretation

Reference Interval

Male
Female
0-6 yrs: 40-630 pg/mL
7-10 yrs :35-170 pg/mL
11-18 yrs: 50-475 pg/mL
19-45 yrs: 40-450 pg/mL
Greater than or equal to 46 years: less than 200 pg/mL
0-6 years: less than 73 pg/mL
7-10 years: less than 130 pg/mL
11-12 years: less than 186 pg/mL
13-18 years: less than 360 pg/mL
Pre-menopausal: less than 290 pg/mL
Follicular phase: 10-290 pg/mL
Post-menopausal: less than or equal to 16 pg/mL

Interpretive Data

This test is performed using the Beckman Coulter Inhibin B ELISA kit. Values obtained with different methodologies or kits cannot be used interchangeably.

Administrative

CPT Codes

83520

INSULIN

LAB527

INSULIN

 

Collect

One 4.5 mL Green top tube with gel separator (PST).

Pediatric Collection

1.5 mL blood.

Unacceptable Conditions

Sample not properly identified; incorrect container; insufficient sample volume; samples that have been thawed and refrozen.

Storage/Transport Temperature

Internal: Deliver to lab immediately.
Offsite: Centrifuge within 30 minutes of collection. Send at 2-8 degrees C.

Stability (from collection to initiation)

Ambient: 8 hours; Refrigerated: 24 hours; Frozen (-20 degrees C): 3 months.

Remarks

Patients on insulin therapy are prone to developing anti-insulin antibodies which may interfere with the assay.

Performed by

PCL Clinical Laboratory - Core

Performed

Daily

Methodology

Chemiluminescent Immunoassay

Reported

Daily

Synonyms

  • LAB527

Reference Interval

2-23 uIU/mL

Performed by

PCL Clinical Laboratory - Core

CPT Codes

83525

Collection

LAB527

INSULIN

 

Collect

One 4.5 mL Green top tube with gel separator (PST).

Pediatric Collection

1.5 mL blood.

Unacceptable Conditions

Sample not properly identified; incorrect container; insufficient sample volume; samples that have been thawed and refrozen.

Storage/Transport Temperature

Internal: Deliver to lab immediately.
Offsite: Centrifuge within 30 minutes of collection. Send at 2-8 degrees C.

Stability (from collection to initiation)

Ambient: 8 hours; Refrigerated: 24 hours; Frozen (-20 degrees C): 3 months.

Remarks

Patients on insulin therapy are prone to developing anti-insulin antibodies which may interfere with the assay.

Performed by

PCL Clinical Laboratory - Core

Ordering

Performed

Daily

Methodology

Chemiluminescent Immunoassay

Reported

Daily

Synonyms

  • LAB527
Result Interpretation

Reference Interval

2-23 uIU/mL

Performed by

PCL Clinical Laboratory - Core

Administrative

CPT Codes

83525

INSULIN ANTIBODIES - HUMAN

LAB649

Collect

Serum separator tube or plain red.

Specimen Preparation

Transfer 0.5 mL serum to an ARUP Standard Transport Tube. (Min: 0.1 mL)

Unacceptable Conditions

Plasma. Hemolyzed or lipemic specimens.

Storage/Transport Temperature

Frozen.

Stability (from collection to initiation)

After separation from cells: Ambient: 24 hours; Refrigerated: 1 week; Frozen: 2 months

Performed

Tue, Wed, Fri

Methodology

Quantitative Radioimmunoassay

Reported

2-5 days

Synonyms

  • Insulin Antibodies, Human
  • Human Insulin Antibodies
  • LAB649
  • INSULINAB

Additional Technical Information

Ordering Recommendations

• Use to determine presence of antibodies to exogenous insulin analogues. Testing not recommended for patients receiving insulin >2 weeks, as insulin antibody formation may occur. • If pursuing antibody testing to dermine autoimmune diabetes mellitus, perform at least 2 antibody tests. In most cases, use glutamic acid decarboxylase antibody in combination with another antibody test. Other antibody tests include Glutamic Acid Decarboxylase Antibody (2001771), IA-2 Antibody (0050202), Islet Cell Cytoplasmic Antibody, IgG (0050138), and Zinc Transporter 8 Antibody (2006196). • Do not use to differentiate type 1 DM from type 2 DM, for most cases.

Reference Interval

Effective May 21, 2012

0.0-0.4 Kronus Units/mL

Interpretive Data

This assay quantitatively measures human serum autoantibodies to endogenous insulin or antibodies to exogenous insulin.
A value of greater than 0.4 Kronus Units/mL is considered positive for Insulin Antibody.
Kronus Units are arbitrary. Kronus Units = U/mL

CPT Codes

86337
Collection

LAB649

Collect

Serum separator tube or plain red.

Specimen Preparation

Transfer 0.5 mL serum to an ARUP Standard Transport Tube. (Min: 0.1 mL)

Unacceptable Conditions

Plasma. Hemolyzed or lipemic specimens.

Storage/Transport Temperature

Frozen.

Stability (from collection to initiation)

After separation from cells: Ambient: 24 hours; Refrigerated: 1 week; Frozen: 2 months
Ordering

Performed

Tue, Wed, Fri

Methodology

Quantitative Radioimmunoassay

Reported

2-5 days

Synonyms

  • Insulin Antibodies, Human
  • Human Insulin Antibodies
  • LAB649
  • INSULINAB

Additional Technical Information

Ordering Recommendations

• Use to determine presence of antibodies to exogenous insulin analogues. Testing not recommended for patients receiving insulin >2 weeks, as insulin antibody formation may occur. • If pursuing antibody testing to dermine autoimmune diabetes mellitus, perform at least 2 antibody tests. In most cases, use glutamic acid decarboxylase antibody in combination with another antibody test. Other antibody tests include Glutamic Acid Decarboxylase Antibody (2001771), IA-2 Antibody (0050202), Islet Cell Cytoplasmic Antibody, IgG (0050138), and Zinc Transporter 8 Antibody (2006196). • Do not use to differentiate type 1 DM from type 2 DM, for most cases.
Result Interpretation

Reference Interval

Effective May 21, 2012

0.0-0.4 Kronus Units/mL

Interpretive Data

This assay quantitatively measures human serum autoantibodies to endogenous insulin or antibodies to exogenous insulin.
A value of greater than 0.4 Kronus Units/mL is considered positive for Insulin Antibody.
Kronus Units are arbitrary. Kronus Units = U/mL

Administrative

CPT Codes

86337

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