March 25, 2009

Military madness - marking time?

Details of the latest military study into Quantiferon are as follows;

to assess the reproducibility of QFT-GIT results when the volume of the blood specimen used is both within- and out-of-range per the FDA approved package insert... specimen volumes to be used per test subject collected at a single point in time are 0.5ml, 0.8ml, 1.0ml, 1.0ml, 1.0ml, 1.2ml, and 1.5ml.

measure inter-assay agreement in QFT-GIT results when the test antigens are mixed with the whole blood specimens using two different mixing conditions:
a. Whole blood specimens shall be mixed with the antigens by shaking to the point at which the blood begins to froth - this procedure is recommended by the QFT-GIT manufacturer and has been FDA approved.

b. Whole blood specimens shall be mixed with the antigens by rolling on a mixing platform (concurrently rocks and rolls tubes to assure full surface coverage) - this procedure is more consistent with the way phlebotomists are taught to handle blood specimens.