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TB Gold, Quantiferon
MessagePerforming Lab: Regions
Test Code
4626
Alias/See Also
Sunquest: TBGLD; Quantiferon Gold for Tuberculosis
CPT Codes
86480
Preferred Specimen
1 QuantiFERON-TB Gold Blood Collection Kit. Kit includes 1-Nil tube (gray), 1-Antigen tube (red), 1-Mitogen tube (purple)
Minimum Volume
Filled to 1.0 mL fill volume
Other Acceptable Specimens
none
Instructions
Collection:
All tubes must be filled to 1.0 mL with blood. If using a vacutainer, prime the line with a waste tube. After filling, invert the tubes ten (10) times which will lead to frothing of blood.
Processing:
Keep at room temperature (17-27 C). Do not refrigerate or freeze. See TB Gold Specimen Processing procedure for additional information if incubating in collecting facility
Shipping:
Samples must be incubated and processed at Regions within 8 hours of collection. Clinics (other than St. Cloud): Send specimens via STAT courier if collection occurs after last courier pickup
All tubes must be filled to 1.0 mL with blood. If using a vacutainer, prime the line with a waste tube. After filling, invert the tubes ten (10) times which will lead to frothing of blood.
Processing:
Keep at room temperature (17-27 C). Do not refrigerate or freeze. See TB Gold Specimen Processing procedure for additional information if incubating in collecting facility
Shipping:
Samples must be incubated and processed at Regions within 8 hours of collection. Clinics (other than St. Cloud): Send specimens via STAT courier if collection occurs after last courier pickup
Transport Temperature
Unprocessed: Room Temperature
Processed: Refrigerated
Processed: Refrigerated
Specimen Stability
Room Temperature & Unprocessed: 8 hours
Refrigerated & Processed: 28 days
Refrigerated & Processed: 28 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Overfilled or underfilled containers
Methodology
ELISA
Setup Schedule
Monday - Friday
Report Available
Within 3 business days
Limitations
The following mycobacterium may cause false positive results: M. kansasii, M. szulgai and M. marinum.
Performance of this assay has not been extensively evaluated with specimens from the following groups of individuals: Impaired immune function, such as individuals with HIV, AIDS, transplantation managed with immunosuppressive treatments or others who receive other immunosuppressant drugs (e.g. corticosteroids, methotrexate, azathioprine, cancer chemotherapy). Individuals who have other clinical conditions: diabetes, silicosis, chronic renal failure, hematological disorders and other malignancies. Individuals younger than 17 years of age or Pregnant women.
Performance of this assay has not been extensively evaluated with specimens from the following groups of individuals: Impaired immune function, such as individuals with HIV, AIDS, transplantation managed with immunosuppressive treatments or others who receive other immunosuppressant drugs (e.g. corticosteroids, methotrexate, azathioprine, cancer chemotherapy). Individuals who have other clinical conditions: diabetes, silicosis, chronic renal failure, hematological disorders and other malignancies. Individuals younger than 17 years of age or Pregnant women.
Reference Range
Negative (Cutoff: 0.35 IU/mL)
Clinical Significance
QuantiFERON®-TB Gold is an indirect test for M. tuberculosis infection and disease and is intended for use in conjunction with risk assessment, radiography and other medical and diagnostic evaluations
