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QuantiFERON®-TB Gold (Client Incubated)
Test Code183244
CPT Codes
86480
Preferred Specimen
"Whole blood
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Minimum Volume
0.8 mL x three tubes
Instructions
"After incubation, maintain specimen at room temperature (17°C to 27°C). Do not centrifuge, refrigerate, or ship tubes on ice.
Refer to collection instructions included with draw kit. Special specimen collection kit contains three gel-barrier tubes: gray-top/white ring (nil), red-top/white ring (TB antigens), and purple-top/white ring (mitogen). All three tubes are required for a single test result. Each tube is designed to draw only 1 mL and fill time may be longer than other blood collection tubes. Because of the limited vacuum in these tubes, use a needle and holder (not a butterfly) to collect QuantiFERON® specimens. If a butterfly is required, first collect other required tubes or use another Vacutainer® tube to purge the butterfly line of air and then proceed with drawing the “In tubes.” Fill tubes to the black fill line on the tube. If tubes are underfilled or overfilled (see kit insert), immediately redraw a replacement tube.
Following proper fill, label the tubes appropriately, and shake tubes 10 times just firmly enough to ensure the entire surface of the tube is coated with blood cells to solubilize the antigen on the tube walls. After shaking, the volume may fall below the fill line. Do not centrifuge or refrigerate specimens.
Return each of the three properly filled, labeled, and shaken tubes to the box labeled ""QFT kit."" Seal the top by removing tape from adhesive. Tubes should be incubated upright in the box/kit within 16 hours of collection.
Please indicate date and time of venipuncture on the test request form.
Incubation:
If blood is not incubated immediately after collection, remix the tubes by inverting 10 times immediately prior to incubation and within 16 hours of collection.
Within 16 hours of collection, incubate the tubes upright at 37°C +/- 1°C for 16 to 24 hours. The incubator does not require CO2 or humidification.
Following incubation, ship the tubes to laboratory at 17°C to 27°C.
This test is time-sensitive and specimens must be received in the laboratory within 70 hours after incubation by the client (no more than 94 hours from the time of collection). Specimen collection times will vary depending on logistics from the incubating location to a LabCorp lab. This test requires a special collection kit that may not be available at all PSCs. Contact your local LabCorp service representative to find out whether this test is available in your area.
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Refer to collection instructions included with draw kit. Special specimen collection kit contains three gel-barrier tubes: gray-top/white ring (nil), red-top/white ring (TB antigens), and purple-top/white ring (mitogen). All three tubes are required for a single test result. Each tube is designed to draw only 1 mL and fill time may be longer than other blood collection tubes. Because of the limited vacuum in these tubes, use a needle and holder (not a butterfly) to collect QuantiFERON® specimens. If a butterfly is required, first collect other required tubes or use another Vacutainer® tube to purge the butterfly line of air and then proceed with drawing the “In tubes.” Fill tubes to the black fill line on the tube. If tubes are underfilled or overfilled (see kit insert), immediately redraw a replacement tube.
Following proper fill, label the tubes appropriately, and shake tubes 10 times just firmly enough to ensure the entire surface of the tube is coated with blood cells to solubilize the antigen on the tube walls. After shaking, the volume may fall below the fill line. Do not centrifuge or refrigerate specimens.
Return each of the three properly filled, labeled, and shaken tubes to the box labeled ""QFT kit."" Seal the top by removing tape from adhesive. Tubes should be incubated upright in the box/kit within 16 hours of collection.
Please indicate date and time of venipuncture on the test request form.
Incubation:
If blood is not incubated immediately after collection, remix the tubes by inverting 10 times immediately prior to incubation and within 16 hours of collection.
Within 16 hours of collection, incubate the tubes upright at 37°C +/- 1°C for 16 to 24 hours. The incubator does not require CO2 or humidification.
Following incubation, ship the tubes to laboratory at 17°C to 27°C.
This test is time-sensitive and specimens must be received in the laboratory within 70 hours after incubation by the client (no more than 94 hours from the time of collection). Specimen collection times will vary depending on logistics from the incubating location to a LabCorp lab. This test requires a special collection kit that may not be available at all PSCs. Contact your local LabCorp service representative to find out whether this test is available in your area.
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Transport Container
"The QuantiFERON® collection kit contains instructions for the draw of three special QuantiFERON® collection tubes (one each): (1) gray-top (with white ring), uncoated (nil); (2) red-top (with white ring), TB antigen-coated; (3) purple-top (with white rin
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
"Specimen centrifuged, refrigerated, or frozen; specimen more than 94 hours old on receipt by lab
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Methodology
"Mycobacterium tuberculosis antigen-stimulated interferon-? production with detection by enzyme-linked immunosorbent assay (ELISA). Test includes PHA (positive) and nil (negative) controls. QuantiFERON® is a registered trademark of Cellestis Ltd, Melbourne, Australia. "
Limitations
"Spontaneous interferon-? production (independent of TB stimulation) or lack of a response to mitogen (due to anergy or immune suppression) may render the results indeterminate. A negative result should not be used alone to exclude M tuberculosis infection in persons with symptoms or signs suggestive of TB disease. Those who have a negative result, but who are likely to have latent TB infection (LTBI) and who are at greater risk for severe illness or poor outcome if TB disease occurs, might need treatment or closer monitoring for disease.1
The QuantiFERON® TB test has been shown to be accurate in HIV-positive individuals with moderately advanced disease, but in the severely immunocompromised the test may be impaired by T-cell anergy.2,3
Active TB disease may result in a negative test as reduction of in vitro IFN-? release has been described and may be due to suppressive cytokines associated with TB disease.4 Patients with mycobacterial infections, other than tuberculosis, might also be responsive to ESAT-6, CFP-10, and TB7.7, as the genes encoding these proteins are present in M kansasii, M szulgai, and M marinum.5
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The QuantiFERON® TB test has been shown to be accurate in HIV-positive individuals with moderately advanced disease, but in the severely immunocompromised the test may be impaired by T-cell anergy.2,3
Active TB disease may result in a negative test as reduction of in vitro IFN-? release has been described and may be due to suppressive cytokines associated with TB disease.4 Patients with mycobacterial infections, other than tuberculosis, might also be responsive to ESAT-6, CFP-10, and TB7.7, as the genes encoding these proteins are present in M kansasii, M szulgai, and M marinum.5
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