QuantiFERON®-TB Gold Plus

Test ID: 

705866

CPT code:

86480

Synonyms:

Interferon-gamma Release Assay (IGRA) for Mycobacterium tuberculosis
QFT-Plus

Clinical Use:

QuantiFERON-TB Gold Plus is an in vitro diagnostic test using a peptide cocktail of CD4+ and CD8+ T cell antigens to stimulate cells in heparinized whole blood. Detection of interferon-gamma by enzyme-linked immunosorbent assay (ELISA) is used to identify in vitro responses to these peptide antigens that are associated with Mycobacterium tuberculosis infection. 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.

Specimen Type:

Whole blood

Requested Volume: 

1 mL x four tubes in QuantiFERON-TB Gold Plus kit

Minimum Volume: 

1 mL x four tubes in QuantiFERON-TB Gold Plus kit

Container Type: 

The QuantiFERON®-TB Gold Plus collection kit contains the instructions for the collection and handling of (one each): (1) gray-top (with white ring), uncoated (nil); (2) green cap with white ring, TB1 tube; (3) yellow cap with white ring, TB2 tube; (4) purple top with white ring, mitogen-coated. A high-altitude kit is also available for locations between 3350 and 6150 feet; a cap with a yellow ring differentiates the tubes.

Collection:

Blood collection tubes should be at room temperature at the time of collection. Refer to collection instructions included with draw kit. Special specimen collection kit contains four gel-barrier tubes as noted above. All four 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 QuantiFERON tubes. Fill tubes to the black fill line on the tube. If tubes are underfilled or overfilled (see kit insert), immediately collect a replacement tube.

Following proper fill, label the tubes appropriately and shake tubes 10 times 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 four properly filled, labeled, and shaken tubes to the box labeled “QFT kit.” Seal the top by removing tape from the adhesive. To preserve cellular viability, specimens should be collected and sent the same day, at room temperature, so as to arrive at the lab as soon as possible and within 14 hours of collection.

Storage Instructions:

Maintain specimen at room temperature for four tube collection kit. Stability: Kit must be incubated within 16 hours of collection.

Rejection Criteria

Expired collection tubes. Four tube QuantiFERON collection kit: Specimen centrifuged, refrigerated, or frozen; specimen more than 14 hours old on receipt by lab; receipt of three tube collection kit

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