QuantiFERON®-TB gold plus collection kit

Note: all collection tubes should be at room temperature (17 - 27 °C) at the time of draw.

• Use of butterfly needles is not recommended.
  If a butterfly needle is used for collection, a discard tube must be collected prior to collecting QFT tubes.
• All four (4) tubes included in the kit must be collected. There is no specific order for blood collection, however, a commonly used fill order is Grey, Green, Yellow, Purple.
• Tubes fill slowly; keep each tube on the needle for 2-3 seconds after the tube appears to have filled completely.
• Fill each tube appropriately. A black mark on each tube indicates the valid range of 0.8 – 1.2 mL of blood needed for testing. If the level of blood is outside of the black indicator line, another specimen should be collected.
• Immediately after filling, shake tubes 10 times, just firmly enough to ensure that the inner surface of the tube is coated in blood. Overly energetic shaking may cause gel disruption and could lead to aberrant results.
• Label each tube appropriately and package for transport to the laboratory.
  • Excellian ordering sites: Each of the four labels is unique and indicates a tube color (purple, grey, green and yellow). Ensure that you are applying the correct label to each corresponding tubes.
• If you are not approved to process specimens on-site, specimens must reach Allina Health Laboratory within 12 hours of collection.

QuantiFERON®-TB gold plus collection kit

Ambient (62 - 80°F) - 12 hours

If you are not approved to process specimens on-site, specimens must reach Allina Health Laboratory within 12 hours of collection.

• Improper labels (unlabeled or mislabeled)
• Hemolysis (some procedures)
• Improper anticoagulant or ratio
• Delay in transport
• Improper storage temperature affecting results
• Improper container
• Leaking container resulting in compromised specimen
• Quantity not sufficient (QNS)

Chemiluminescence immunoassay (CLIA)

Negative

The performance of QuantiFERON^®-TB gold plus has not been evaluated in specimens from:

• Individuals with impaired or altered immune functions (HIV infections, transplant patients, those receiving immunosuppressive drugs such as corticosteroids) and those with other clinical conditions (e.g. diabetes, hematological disorders)
• Individuals younger than 17 years old
• Pregnant women

Indeterminate results are uncommon and may be related to the status of the immune system of the patient. An indeterminate result may also be related to technical factors (e.g., inappropriate storage or handling of the blood collection tubes). Physicians may choose to redraw a specimen or perform other procedures as appropriate.