QuantiFERON TB-Gold Plus, 4-Tube
Ordering Recommendation
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.
New York DOH Approval Status
Specimen Required
QuantiFERON-TB Gold Plus (Standard) 4-Tube Collection Kit (ARUP Supply #54012) or QuantiFERON-TB Gold Plus (HIGH ALTITUDE) 4-Tube Collection Kit (ARUP Supply #54010) available online through eSupply using ARUP Connect(TM) or contact ARUP Client Services at 800-522-2787. Specimens may remain ambient for up to 16 hours after collection before being placed in an incubator. For collection and transport instructions refer to QuantiFERON under Special Handling at https://www.aruplab.com/testing/quantiferon#collection.
Transport plasma in the original containers. (Min: 0.8 mL per container)
Refrigerated
Whole blood
Ambient: 2 hours; Refrigerated: 1 month; Frozen: Unacceptable
Methodology
Semi-Quantitative Chemiluminescent Immunoassay (CLIA)/Semi-Quantitative Enzyme-Linked Immunosorbent Assay (ELISA)
Performed
Sun-Sat
Reported
1-4 days
Reference Interval
Test Number |
Components |
Reference Interval |
|
---|---|---|---|
QuantiFERON Mitogen minus NIL |
|
||
QuantiFERON NIL |
|
||
Quantiferon Plus TB1 minus NIL |
|
||
Quantiferon Plus TB2 minus NIL |
|
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 (https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5905a1.htm), for more information concerning test performance in low-prevalence populations and use in occupational screening.
FDA
Note
Hotline History
Hotline History
CPT Codes
86480
Components
Component Test Code* | Component Chart Name | LOINC |
---|---|---|
3017623 | QuantiFERON Mitogen minus NIL | 71774-4 |
3017624 | QuantiFERON NIL | 71776-9 |
3017625 | Quantiferon Plus TB1 minus NIL | 64084-7 |
3017626 | Quantiferon Plus TB2 minus NIL | 88517-8 |
3017627 | Quantiferon TB Gold Plus | 71773-6 |