Diagnostic test calibration adjustment method
A method is provided for adjusting either the signal measured or activity calculated by an instrument or a predefined calibration curve for a medical diagnostic test, performed on an instrument with pre-calibrated reagents. A calibration adjuster for a blood clotting diagnostic test is further provided.
1. A method for adjusting a signal measured for a blood clotting investigation test that is a dispersed solid phase immunological assay test, performed on an instrument with pre-calibrated reagents, comprising the following steps:
(i) defining a standard signal value, for one or two calibration adjuster(s) comprising a compound under test having a predetermined concentration or activity;
(ii) measuring for said adjuster(s) a difference between the standard signal and the value of the signal measured by the instrument;
(iii) adjusting the value of the signal measured by the instrument such that the value of the signal measured by the instrument is brought back to a signal value identical to the standard signal value determined in step (i) for the single adjuster or for each of the two adjusters; and
(iv) applying the adjustment of step (iii) to each compound under test.
2. The method according to claim 1 , wherein a single adjuster is used.
3. The method according to claim 1 , wherein the difference measured according to step (ii) is not more than 20 to 30%.
4. The method according to claim 1 , wherein at least one of the adjusters comprises stabilised freeze-dried plasma or a stabilised freeze-dried plasma pool.
5. The method according to claim 1 , wherein at least one of the adjusters comprises purified or semi-purified plasma proteins, and further comprises the compound under test, the concentration or activity of the compound under test being predetermined.
6. A method for adjusting a signal measured for a blood clotting investigation test that is a functional investigation test that is a D-Dimer assay test, performed on an instrument with pre-calibrated reagents, comprising the following steps:
(i) defining a standard signal value, for one or two calibration adjuster(s) comprising a compound under test having a predetermined concentration or activity;
(ii) measuring for said adjuster(s) a difference between the standard signal and the value of the signal measured by the instrument;
(iii) adjusting the value of the signal measured by the instrument such that the value of the signal measured by the instrument is brought back to a signal value identical to the standard signal value determined in step (i) for the single adjuster or for each of the two adjusters; and
(iv) applying the adjustment of step (iii) to each compound under test.
7. The method according to claim 1 , wherein the clotting investigation test is an APTT, PT, TT test or an enzymological test.
8. The method according to claim 6 , wherein a single adjuster is used.
9. The method according to claim 6 , wherein the difference measured according to step (ii) is not more than 20 to 30%.
10. The method according to claim 6 , wherein at least one of the adjusters comprises stabilised freeze-dried plasma or a stabilized freeze-dried plasma pool.
11. The method according to claim 6 , wherein at least one of the adjusters comprises purified or semi-purified plasma proteins, and further comprises the compound under test, the concentration or activity of the compound under test being predetermined.