Test Code 6811040359 QuantiFERON-TB Gold
Performing Laboratory
Torrance Memorial Laboratories
Specimen Requirements
Specimen Type: Whole blood
Container/Tube: QuantiFERON (QFT) TB Gold 4 Tube Kit
Specimen Volume: Collect 1 mL of blood into each of 4 tubes,
Tubes may fill slowly. The use of a syringe may ensure correct blood volume. Hold tube on needle for 2-3 seconds after flow ceases. When the tube is upright, blood must be within the black indicator line on the label. (Figure 1)
(Figure 1)
If using butterfly collection device: first collect other required tubes or prime the tubing with a “waste” tube to remove the air and then proceed with collecting the 4 QuantiFERON tubes.
The QuantiFERON tubes are manufactured to draw 1 mL of blood, the black indicator line indicates a range of 0.8 to 1.2 mL. If the level of blood is outside of the black indicator line, another blood specimen must be collected. Over- or under-filling tubes may lead to erroneous results.
Specimens with volumes outside of the black indicator line will be rejected.
Draw order of tubes is as follows:
1. Nil control (grey)
2. TB1-Antigen (green)
3. TB2-Antigen (yellow)
4. Mitogen Control (purple)
Immediately after filling, shake the tubes firmly 10 times (enough to ensure the inner surface of each tube is coated in blood) to solubilize antigens on the tube walls.
Caution: Over-energetic shaking may cause gel disruption and could lead to aberrant results.
Label tubes appropriately. The label should be placed below colored QuantiFERON band so the blood volume and black indicator lines are visible on all 4 collection tubes. (Figure 2)
(Figure 2)
Unacceptable Samples:
- Insufficiently-Filled Sample Tube (Below Indicated Fill Line)
- Overly-Filled Sample Tube (Above Indicated Fill Line)
Volume:
0.8-1.2 mL Per QFT-Plus Blood Collection Tube
Specimen Transport Temperature
Ambient
Maintain tubes between 17–25°C (Room Temperature) at the time of collection until incubation.
Do not refrigerate or freeze.
QFT-Plus Blood Collection Tubes:
- Prior to Incubation: 16 Hours Room Temperature
- After Incubation: 72 Hours (4-28°C) [PERFORMED WHEN RECEIVED AT TMMC LAB]
- After Incubation and Centrifugation: 28 Days Refrigerated [PERFORMED WHEN RECEIVED AT TMMC LAB]
Methodology
Chemiluminescence Immunoassay
Reference Range
Negative. No interferon-gamma response to M. tuberculosis antigens was detected. Latent infection with M. tuberculosis is unlikely. The Reference Range for the ‘TB1 Ag minus Nil Result’ and ‘TB2 Ag minus Nil Result’ is an interferon-gamma level <0.35 IU/mL.
Positive. Interferon-gamma response to M. tuberculosis antigens detected, suggesting infection with M. tuberculosis. Positive results in patients at low-risk for tuberculosis should be interpreted with caution and repeat testing on a new sample should be considered. False positive results may occur in patients with prior infection with M. marinum, M. szulgai, or M. kansasii.
Indeterminate: Results are indeterminate for response to ESAT-6 and/or CFP-10 test antigens.
The NIL tube value reflects the background interferon gamma immune response of the patient’s blood sample. This value has been subtracted from the patient’s displayed TB and Mitogen results.
Lower than expected results with the Mitogen tube prevent false-negative QuantiFERON readings by detecting a patient with a potential immune suppressive condition and/or suboptimal pre-analytical specimen handling.
The TB1 Antigen tube is coated with the M. tuberculosis-specific antigens designed to elicit responses from TB antigen primed CD4+ helper T-lymphocytes.
The TB2 Antigen tube is coated with the M. tuberculosis-specific antigens designed to elicit responses from TB antigen primed CD4+ helper and CD8+ cytotoxic T-lymphocytes
Day(s) Test Set Up/TAT
Performed:
Monday - Friday
Available STAT:
No
TAT:
3 - 5 days
Aliases
QFT
Tb
CPT Code
86480