Bulletin: QuantiFERON Plus Transition
Qiagen, the manufacturer of the QuantiFERON test, will no longer sell their QuantiFERON Gold In-tube test after June 1, 2018. This is significant because their new test, QuantiFERON Plus, requires a four (4) tube draw rather than three tubes. This bulletin is intended to provide information and instructions for product
|When will Warde start SHIPPING the 4-tube Quantiferon Plus tubes?||April 20, 2018On this date, Warde will stop sending out the 3-tube systems and begin providing the 4-tube Quantiferon Plus systems. On April 24th, the laboratory will be able to test both collection systems.|
|When will Warde begin TESTING the 4-tube Quantiferon Plus tubes?||April 24, 2018On this date, the computer system will allow clients to order the Quantiferon Plus tests (test code QFTBP). Any 4-tube collection systems sent to the laboratory prior to this date must be cancelled and re-ordered after April 24th. The laboratory has no way to result the 4-tube data prior to April 24th.|
|Should I use the old Quantiferon code|
(QFGIT) when submitting the 3-tube system?
|YESThe data fields are different for the new and old Quantiferon tests. The fields must match before the results can cross the interface. The old code (QFGIT) will be active until June 1, 2018.|
|When will Warde stop testing the old, 3-tube systems?||June 1, 2018Warde will not accept the current 3-tube collection systems after June 1, 2018.|
All collection sets sent out after March 20, 2018 include informational stickers stating that the tubes will not be tested after this date.
|Do the 4-tube systems have different handling or storage requirements?||NOThe current three-tube and the new four-tube collection systems have the same handling and processing requirements. Both tube sets include a Quick Collection Guide that describes the handling and processing requirements.All four tubes must be filled with whole blood to the black mark on the side of the tube.All four tubes should be shaken ten (10) times to make sure that inner surface of the tubes is coated with blood.All tubes must be transferred to a 37oC ± 1oC incubator within 16 hours of collection. Hold tubes at 22oC ± 5oC until they are placed in the incubator.Remix tubes by inverting ten (10) times immediately prior to placing them in the incubator.Incubate tubes UPRIGHT at 37oC ± 1oC for 16-24 hours. Humidity/CO2 are not required.Centrifuge the tubes for 15 minutes at 2000 to 3000 RCF (xg).Centrifuged QFT-Plus tubes can be stored at 2oC to 8oC for up to 28 days.Send the incubated and centrifuged tubes to our laboratory for testing.|
|What are the Rejection Criteria for the new 4-tube sets?||The following specimens will not be tested:Frozen tubesUnspun collection tubesTubes with fill volumes above or below the markSpecimens not in Quantiferon-Plus collection tubes.|
|What type of pre-analytical events can cause erroneous results?||Under or overfilling tubesRefrigerating whole bloodFailure to shake tubes properlyIncubation is delayed >16 hours.Failure to incubate the tubesIncubation at improper temperatures|
|What are the advantages of the new test?||The current TB collection tube contains peptide antigens from the MTB-complexassociated antigens, ESAT-6 and CFP-10. The new TB1 tube and the TB2 tube contain peptides from ESAT-6 and CFP-10 that are designed to elicit CMI responses from CD4+ T-helper lymphocytes. The TB2 tube also contains an additional peptides that induce CMI responses from CD8+ cytotoxic T lymphocytes. CD8+ cytotoxic lymphocyte responses may be helpful in detecting latent TB infections.|
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