Ordering Recommendations

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.

Orderable SIM Number(s)

QUANTIFERON TB GOLD (LAB10118)

Synonyms

  • Quantiferon-TB Gold in Tube
  • Interferon-Gamma Release Assay for Tuberculosis
  • Latent Tuberculosis Infection (LTBI)
  • QFT & M TB
  • QFT-G & M.tuberculosis
  • QFT-TB
  • Quantiferon Mitogen and NIL
  • QuantiFERON-TB Gold In Tube & Mycobacterium tuberculosis Antibody
  • QuantiFERON-TB Gold Plus, 4-Tube
  • LAB10118

Collect

QuantiFERON-TB Gold Plus (Standard) 4-Tube Collection Kit (Lawson #622433).  Contact Aspirus Reference Laboratory for collection kit. 

Collection Instructions:
  1. If drawing with needle, to leave the tubes on the needle for 2-3 seconds once the tube appears to have completed filling.
  2. Recommendation is to draw with a syringe and 1 ml transferred to each of the tubes.
  3. If drawing with butterfly, a “purge” tube should be used to ensure that the tubing is filled prior to the Q-gold tubes.
Fill to between black marks on each tube label (1ml of blood) DO NOT UNDER- or OVER-FILL.

Q-Gold Tubes v2


Specimens may remain ambient for up to 16 hours after collection before being placed in an incubator.

Specimen Preparation

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

Storage/Transport Temperature

Sample processing includes specific incubation and centrifuge timing.  Choose one of the following two options for submitting to Aspirus Reference Laboratory: 

  1. NOT Processed
  • Samples MUST be delivered to the Aspirus Reference Laboratory within 16 hours of collection at Room Temperature.
  1. Processed
  • Samples are incubated for 16 to 24 hours at 37 degrees C and then spun for 15 minutes at 2000-3000 RCF (g).  Samples must be sent to ARL refrigerated.
    ***Indicate that samples have been incubated and spun***

 

Unacceptable Conditions

Whole Blood
Under-filled (<1ml) or Over-filled (>1ml) tubes

Stability (from collection to initiation)

Ambient: 2 hours; Refrigerated: 1 month; Frozen: Unacceptable

Special Handling Instructions

Order of draw: Gray, green, yellow, purple.

Reference Interval

Components Reference Interval
QuantiFERON-TB Gold In-Tube Negative
QuantiFERON NIL No reference interval
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

Interpretive Data

Interferon gamma release is measured for specimens from each of the four collection tubes. A qualitative result (Negative, Positive, or Equivocal) 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

Billable SIM Number(s)

331504

LOINC

  • 71776-9
  • 74774-4
  • 64084-7
  • 88517-8
  • 71773-6
Overview

Ordering Recommendations

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.

Orderable SIM Number(s)

QUANTIFERON TB GOLD (LAB10118)

Synonyms

  • Quantiferon-TB Gold in Tube
  • Interferon-Gamma Release Assay for Tuberculosis
  • Latent Tuberculosis Infection (LTBI)
  • QFT & M TB
  • QFT-G & M.tuberculosis
  • QFT-TB
  • Quantiferon Mitogen and NIL
  • QuantiFERON-TB Gold In Tube & Mycobacterium tuberculosis Antibody
  • QuantiFERON-TB Gold Plus, 4-Tube
  • LAB10118
Specimen

Collect

QuantiFERON-TB Gold Plus (Standard) 4-Tube Collection Kit (Lawson #622433).  Contact Aspirus Reference Laboratory for collection kit. 

Collection Instructions:
  1. If drawing with needle, to leave the tubes on the needle for 2-3 seconds once the tube appears to have completed filling.
  2. Recommendation is to draw with a syringe and 1 ml transferred to each of the tubes.
  3. If drawing with butterfly, a “purge” tube should be used to ensure that the tubing is filled prior to the Q-gold tubes.
Fill to between black marks on each tube label (1ml of blood) DO NOT UNDER- or OVER-FILL.

Q-Gold Tubes v2


Specimens may remain ambient for up to 16 hours after collection before being placed in an incubator.

Specimen Preparation

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

Storage/Transport Temperature

Sample processing includes specific incubation and centrifuge timing.  Choose one of the following two options for submitting to Aspirus Reference Laboratory: 

  1. NOT Processed
  • Samples MUST be delivered to the Aspirus Reference Laboratory within 16 hours of collection at Room Temperature.
  1. Processed
  • Samples are incubated for 16 to 24 hours at 37 degrees C and then spun for 15 minutes at 2000-3000 RCF (g).  Samples must be sent to ARL refrigerated.
    ***Indicate that samples have been incubated and spun***

 

Unacceptable Conditions

Whole Blood
Under-filled (<1ml) or Over-filled (>1ml) tubes

Stability (from collection to initiation)

Ambient: 2 hours; Refrigerated: 1 month; Frozen: Unacceptable

Special Handling Instructions

Order of draw: Gray, green, yellow, purple.
Interpretive

Reference Interval

Components Reference Interval
QuantiFERON-TB Gold In-Tube Negative
QuantiFERON NIL No reference interval
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

Interpretive Data

Interferon gamma release is measured for specimens from each of the four collection tubes. A qualitative result (Negative, Positive, or Equivocal) 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.
Coding

CPT Codes

86480

Billable SIM Number(s)

331504

LOINC

  • 71776-9
  • 74774-4
  • 64084-7
  • 88517-8
  • 71773-6