QuantiFERON®-TB Gold Plus is an indirect test for M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations. The QuantiFERON®-TB Gold Plus is a test that measures the cell-mediated immune (CMI) responses to peptide antigens that simulate mycobacterial proteins. These proteins, ESAT-6 and CFP-10, are absent from all BCG strains and from most nontuberculosis mycobacteria with the exception of M. kansasii, M. szulgai, and M. marinum. Individuals infected with M. tuberculosis complex organisms usually have lymphocytes in their blood that recognize these and other mycobacterial antigens. This recognition process involves the generation and secretion of the cytokine, IFN-gamma. The detection and subsequent quantification of IFN-gamma forms the basis of this test.
Additional Information
The performance of the QuantiFERON®-TB Gold Plus test has not been extensively evaluated in children younger than 17 years of age. Therefore, there is no published data to document the performance of QFT-G in this age group.
Specimen Type
Blood
Container
Quantiferon Tubes
Collection Instructions
For each patient, collect 1 mL of blood by venipuncture directly into each of the four (4) QFT-Plus blood collection tubes. As the 1 mL tubes draw blood relatively slowly, keep each tube on the needle for 2-3 seconds once the tube appears to have completed filling to ensure that the correct volume is drawn. The black mark on the side of the tubes indicates the required fill volume range of 0.8 to 1.2 mL. If the level of blood in any tube is outside of the indicator mark, a new blood sample should be obtained. Under or overfilled tubes, outside of the 0.8 to 1.2 mL range, will be rejected by the laboratory. If a butterfly needle is being used, a purge tube should be used to ensure that the tubing is filled with blood prior to the QTF-Plus blood collection tubes being used. Immediately after filling the tubes, shake them ten times just firmly enough to make sure the entire inner surface of the tube is coated with blood. Label tubes appropriately. Ensure each tube (Nil, TB1, TB2, and Mitogen) is identifiable by its label or other means once the cap is removed. Deliver tubes to the Laboratory at room temperature. Tubes must be received by the performing laboratory within 16 hours of collection.
Volume
See collection instructions
Minimum Volume
See collection instructions
Storage Temperature
Room Temperature
Stability
Specimen type
Refrigerated (2 - 8°C)
Room Temp (15 - 25°C)
Frozen (-20°C)
Frozen (≤-70°C)
Unspun tube
N/A
16 hours
N/A
N/A
Spun tube
28 days
N/A
Long term
Long term
Special Instructions
To request for the QuantiFERON®-TB Gold Plus collection set: For RRUCLA and SMUCLA patients - Call the laboratory at 310-267-8100 BURL Outreach patients - Call BURL Client Services at 310-267-2680
Shipping and Handling Instructions
Specimens must be received by the testing laboratory within 16 hours of collection. Transport specimens at room temperature Do not refrigerate or freeze blood specimens.
Ambulatory Specimen Processing / Transport
Specimens must be received by the testing laboratory within 16 hours of collection. Transport specimens at room temperature Do not refrigerate or freeze blood specimens.
Causes for Rejection
Specimen collected in wrong container; inadequate specimen volume; improper storage; leaking specimen; specimen not transported at room temperature; specimens not received at performing lab within 16 hours of collection.
Reference Range
Negative
Test Information
CPT Codes
86481
Synonyms
TB, QFT, M. tuberculosis, QuantiFERON
Performing Laboratory / Facility
UCLA Healthcare Clinical Laboratory - Brentwood
Performing Section
Immunoserology
Availability
Daily
Turnaround Time
3 days
Methodology
Immunoassay
Use
QuantiFERON®-TB Gold Plus is an indirect test for M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography, and other medical and diagnostic evaluations. The QuantiFERON®-TB Gold Plus is a test that measures the cell-mediated immune (CMI) responses to peptide antigens that simulate mycobacterial proteins. These proteins, ESAT-6 and CFP-10, are absent from all BCG strains and from most nontuberculosis mycobacteria with the exception of M. kansasii, M. szulgai, and M. marinum. Individuals infected with M. tuberculosis complex organisms usually have lymphocytes in their blood that recognize these and other mycobacterial antigens. This recognition process involves the generation and secretion of the cytokine, IFN-gamma. The detection and subsequent quantification of IFN-gamma forms the basis of this test.
Additional Information
The performance of the QuantiFERON®-TB Gold Plus test has not been extensively evaluated in children younger than 17 years of age. Therefore, there is no published data to document the performance of QFT-G in this age group.
Specimen Collection and Handling
Specimen Type
Blood
Container
Quantiferon Tubes
Collection Instructions
For each patient, collect 1 mL of blood by venipuncture directly into each of the four (4) QFT-Plus blood collection tubes. As the 1 mL tubes draw blood relatively slowly, keep each tube on the needle for 2-3 seconds once the tube appears to have completed filling to ensure that the correct volume is drawn. The black mark on the side of the tubes indicates the required fill volume range of 0.8 to 1.2 mL. If the level of blood in any tube is outside of the indicator mark, a new blood sample should be obtained. Under or overfilled tubes, outside of the 0.8 to 1.2 mL range, will be rejected by the laboratory. If a butterfly needle is being used, a purge tube should be used to ensure that the tubing is filled with blood prior to the QTF-Plus blood collection tubes being used. Immediately after filling the tubes, shake them ten times just firmly enough to make sure the entire inner surface of the tube is coated with blood. Label tubes appropriately. Ensure each tube (Nil, TB1, TB2, and Mitogen) is identifiable by its label or other means once the cap is removed. Deliver tubes to the Laboratory at room temperature. Tubes must be received by the performing laboratory within 16 hours of collection.
Volume
See collection instructions
Minimum Volume
See collection instructions
Storage Temperature
Room Temperature
Stability
Specimen type
Refrigerated (2 - 8°C)
Room Temp (15 - 25°C)
Frozen (-20°C)
Frozen (≤-70°C)
Unspun tube
N/A
16 hours
N/A
N/A
Spun tube
28 days
N/A
Long term
Long term
Special Instructions
To request for the QuantiFERON®-TB Gold Plus collection set: For RRUCLA and SMUCLA patients - Call the laboratory at 310-267-8100 BURL Outreach patients - Call BURL Client Services at 310-267-2680
Shipping and Handling Instructions
Specimens must be received by the testing laboratory within 16 hours of collection. Transport specimens at room temperature Do not refrigerate or freeze blood specimens.
Ambulatory Specimen Processing / Transport
Specimens must be received by the testing laboratory within 16 hours of collection. Transport specimens at room temperature Do not refrigerate or freeze blood specimens.
Causes for Rejection
Specimen collected in wrong container; inadequate specimen volume; improper storage; leaking specimen; specimen not transported at room temperature; specimens not received at performing lab within 16 hours of collection.