Ordering Recommendation
Aid in the detection of latent disease among persons at increased risk for tuberculosis (TB). Positive predictive value is less in low-risk populations. May be used in persons who have received BCG vaccine.
Mnemonic
Methodology
Cell Culture/Semi-Quantitative Enzyme-Linked Immunosorbent Assay
Performed
Sun-Sat
Reported
1-4 days
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™ 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
Reference Interval
Components | Reference Interval |
---|---|
QuantiFERON-TB Gold In-Tube | Negative |
QuantiFERON-TB1 minus NIL | 0.34 IU/mL or less |
QuantiFERON-TB2 minus NIL | 0.34 IU/mL or less |
QuantiFERON MITOGEN minus NIL | No reference interval |
QuantiFERON NIL | No reference interval |
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 |
---|---|---|
2006962 | QuantiFERON Mitogen minus NIL | 71774-4 |
2006963 | QuantiFERON NIL | 71776-9 |
3000401 | Quantiferon TB Gold Plus | 71773-6 |
3000402 | Quantiferon Plus TB1 minus NIL | 64084-7 |
3000403 | Quantiferon Plus TB2 minus NIL | 88517-8 |