US 11,747,328 B2
Method for measuring the plasma concentration of an analyte directly on a whole blood sample
Sylvie Cheucle, La Tour de Salvagny (FR); Laure Marillet, Lyons (FR); and Aurélie Thollet, Nantes (FR)
Assigned to BIOMERIEUX, Marcy L'Etoile (FR)
Filed by BIOMERIEUX, Marcy l'Etoile (FR)
Filed on Oct. 24, 2018, as Appl. No. 16/169,158.
Application 16/169,158 is a continuation of application No. 14/787,790, granted, now 10,132,800, previously published as PCT/FR2014/051086, filed on May 12, 2014.
Claims priority of application No. 1354276 (FR), filed on May 13, 2013.
Prior Publication US 2019/0056387 A1, Feb. 21, 2019
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/543 (2006.01); G01N 33/68 (2006.01); G16B 40/10 (2019.01); G16B 40/00 (2019.01)
CPC G01N 33/543 (2013.01) [G01N 33/6887 (2013.01); G16B 40/10 (2019.02); G01N 2333/47 (2013.01); G01N 2333/4706 (2013.01); G01N 2333/75 (2013.01); G16B 40/00 (2019.02)] 8 Claims
 
1. A method of performing a calibration of the device for measuring an amount of analyte in a whole blood sample, wherein the method comprises:
providing a plurality of calibration whole blood samples and performing measurements on the calibration whole blood samples, wherein the measurements include, for each of the plurality of calibration whole blood samples:
measuring an haematocrit level in the calibration whole blood sample;
measuring an analyte amount in the calibration whole blood sample; and
measuring an analyte amount in a plasma sample obtained from the calibration whole blood sample; and
calculating polynomial coefficients of a calibrated relation:
DP=Pa(DST,DH)
from values of haematocrit level and analyte amount measured in the plurality of calibration whole blood samples, and values of analyte amount measured in the plasma samples obtained from the plurality of calibration whole blood samples,
where Dp is the measured analyte amount in plasma, DST is the measured analyte amount in whole blood, DH is the measured haematocrit level, and Pa is a non-constant polynomial of a degree greater than or equal to 1 having as indeterminate values the measured analyte amount, DST, and the measured haematocrit level, DH, the polynomial coefficients depending on the analyte,
wherein, after calibration, the device, upon receiving a measurement of a total analyte amount in a whole blood sample, calculates a corrected analyte amount according to the calibrated relation DP=Pa(DST, DH),
where Dp is the corrected analyte amount, DST is the measured analyte amount, and DH is the measured haematocrit level.
 
7. A device for measuring the plasmatic amount of an analyte in a whole blood sample, wherein the device comprises
means for performing measurements on a plurality of calibration whole blood samples, wherein the measurements include, for each of the plurality of calibration whole blood samples:
measuring an haematocrit level in the calibration whole blood sample;
measuring a total analyte amount in the calibration whole blood sample; an
measuring an analyte amount in a plasma sample obtained from the calibration whole blood sample; and
means for calculating polynomial coefficients of a calibrated relation:
DP=Pa(DST,DH)
from values of haematocrit level and analyte amount measured in the plurality of calibration whole blood samples, and values of analyte amount measured in the plasma samples from the plurality of calibration whole blood samples,
where Dp is the measured analyte amount in plasma, DST is the measured analyte amount in whole blood, DH is the measured haematocrit level, and Pa is a non-constant polynomial of a degree greater than or equal to 1 having as indeterminate values the measured analyte amount, DST, and the measured haematocrit level, DH, the polynomial coefficients depending on the analyte,
wherein, after calibration, the device, upon receiving a measurement of a total analyte amount in a whole blood sample, calculates a corrected analyte amount according to the calibrated relation DP=Pa(DST, DH),
where Dp is the corrected analyte amount in plasma, DST is the measured analyte amount, and DH is the measured haematocrit level.