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Time Sensitive

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.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

QuantiFERON®-TB Gold Plus 1-tube (ARUP Supply #54015) available online through eSupply using ARUP Connect™ 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).

Storage/Transport Temperature

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

Unacceptable Conditions

Clotted specimens.

Remarks

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

Stability

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

Methodology

Cell Culture/Semi-Quantitative Enzyme-Linked Immunosorbent Assay

Performed

Sun-Sat

Reported

1-4 days

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

If the stability requirements cannot be met, please refer to test 3000399, QuantiFERON-TB Gold Plus, 4-Tube.

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

  • Interferon-Gamma Release Assay for Tuberculosis
  • Latent Tuberculosis Infection (LTBI)
  • QFT & M TB
  • QFT-G & M. tuberculosis
  • QFT-TB; QFT-TB Plus
  • QuantiFERON Mitogen and NIL
  • QuantiFERON-TB Gold In Tube
  • QuantiFERON-TB Gold Plus & Mycobacterium tuberculosis Antibody
QuantiFERON-TB Gold Plus, 1-Tube