Collect

QuantiFERON-TB Gold Plus 1-tube (ARUP Supply #54015) available online through eSupply using ARUP Connect(TM) or contact ARUP Client Services at 800-522-2787. For collection and transport instructions, refer to QuantiFERON under Special Handling at https://www.aruplab.com/testing/quantiferon#collection. NOTE: The specimen must be submitted in the ARUP-provided collection tube due to the requirements of the laboratory automation.

Specimen Preparation

Transport 6 mL whole blood. (Min: 5 mL).

Unacceptable Conditions

Clotted specimens.

Storage/Transport Temperature

Refrigerated. Must be collected and shipped directly to ARUP the same calendar day.

Stability (from collection to initiation)

Ambient: 3 hours; Refrigerated: 48 hours; Frozen: Unacceptable

Performed

Sun-Sat

Remarks

Do not collect or ship on holidays or the day before holidays.

Notes

If the stability requirements cannot be met, please refer to ARUP test code 3017562, QuantiFERON-TB Gold Plus, 4-Tube.

Performing Lab

ARUP Laboratories

Ordering Recommendations

Aids in the detection of latent disease among persons at increased risk for tuberculosis (TB). Positive predictive value is decreased in low-risk populations. May be used in persons who have received the bacille Calmette-Guérin (BCG) vaccine.

Methodology

Semi-Quantitative Chemiluminescent Immunoassay (CLIA)/Semi-Quantitative Enzyme-Linked Immunosorbent Assay (ELISA)

Reported

1-4 days

Reference Interval

Components
Reference Interval
QuantiFERON Mitogen minus NIL
No Reference Interval

QuantiFERON NIL
No Reference Interval

Quantiferon Plus TB1 minus NIL
0.34 IU/mL or less

Quantiferon Plus TB2 minus NIL
0.34 IU/mL or less


Interpretive Data

Interferon gamma release is measured for specimens from each of the four collection tubes. A qualitative result (Negative, Positive, or Indeterminate) is based on interpretation of the four values: NIL, MITOGEN minus NIL (MITOGEN-NIL), TB1 minus NIL (TB1-NIL), and TB2 minus NIL (TB2-NIL). The NIL value represents nonspecific reactivity produced by the patient specimen. The MITOGEN-NIL value serves as the positive control for the patient specimen, demonstrating successful lymphocyte activity. The TB1-NIL tube specifically detects CD4+ lymphocyte reactivity, specifically stimulated by the TB1 antigens. The TB2-NIL tube detects both CD4+ and CD8+ lymphocyte reactivity, stimulated by TB2 antigens. An overall Negative result does not completely rule out TB infection.

A false-positive result in the absence of other clinical evidence of TB infection is not uncommon. Refer to: Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection -- United States, 2010 (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5905a1.htm), for more information concerning test performance in low-prevalence populations and use in occupational screening.

CPT Codes

86480
Collection

Collect

QuantiFERON-TB Gold Plus 1-tube (ARUP Supply #54015) available online through eSupply using ARUP Connect(TM) or contact ARUP Client Services at 800-522-2787. For collection and transport instructions, refer to QuantiFERON under Special Handling at https://www.aruplab.com/testing/quantiferon#collection. NOTE: The specimen must be submitted in the ARUP-provided collection tube due to the requirements of the laboratory automation.

Specimen Preparation

Transport 6 mL whole blood. (Min: 5 mL).

Unacceptable Conditions

Clotted specimens.

Storage/Transport Temperature

Refrigerated. Must be collected and shipped directly to ARUP the same calendar day.

Stability (from collection to initiation)

Ambient: 3 hours; Refrigerated: 48 hours; Frozen: Unacceptable

Performed

Sun-Sat

Remarks

Do not collect or ship on holidays or the day before holidays.

Notes

If the stability requirements cannot be met, please refer to ARUP test code 3017562, QuantiFERON-TB Gold Plus, 4-Tube.

Performing Lab

ARUP Laboratories
Ordering

Ordering Recommendations

Aids in the detection of latent disease among persons at increased risk for tuberculosis (TB). Positive predictive value is decreased in low-risk populations. May be used in persons who have received the bacille Calmette-Guérin (BCG) vaccine.

Methodology

Semi-Quantitative Chemiluminescent Immunoassay (CLIA)/Semi-Quantitative Enzyme-Linked Immunosorbent Assay (ELISA)

Reported

1-4 days
Result Interpretation

Reference Interval

Components
Reference Interval
QuantiFERON Mitogen minus NIL
No Reference Interval

QuantiFERON NIL
No Reference Interval

Quantiferon Plus TB1 minus NIL
0.34 IU/mL or less

Quantiferon Plus TB2 minus NIL
0.34 IU/mL or less


Interpretive Data

Interferon gamma release is measured for specimens from each of the four collection tubes. A qualitative result (Negative, Positive, or Indeterminate) is based on interpretation of the four values: NIL, MITOGEN minus NIL (MITOGEN-NIL), TB1 minus NIL (TB1-NIL), and TB2 minus NIL (TB2-NIL). The NIL value represents nonspecific reactivity produced by the patient specimen. The MITOGEN-NIL value serves as the positive control for the patient specimen, demonstrating successful lymphocyte activity. The TB1-NIL tube specifically detects CD4+ lymphocyte reactivity, specifically stimulated by the TB1 antigens. The TB2-NIL tube detects both CD4+ and CD8+ lymphocyte reactivity, stimulated by TB2 antigens. An overall Negative result does not completely rule out TB infection.

A false-positive result in the absence of other clinical evidence of TB infection is not uncommon. Refer to: Updated Guidelines for Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection -- United States, 2010 (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5905a1.htm), for more information concerning test performance in low-prevalence populations and use in occupational screening.

Administrative

CPT Codes

86480

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Disease Topics