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
QFT-4
Methodology

Cell Culture/Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Performed

Sun-Sat

Reported

1-2 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

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://aruplab.com/testing/specimen/quantiferon.

Specimen Preparation

Transport plasma in the original containers. (Min: 0.8 mL per container)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Whole blood.

Remarks
Stability

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.

Compliance Category

FDA

Note
Hotline History
N/A
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
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
QuantiFERON-TB Gold Plus, 4-Tube