US 11,781,174 B2
Calibration method, apparatus and computer program product
Sangeetha Vijaysri Nair, San Diego, CA (US); Xianqun Wang, San Marcos, CA (US); and Susan K. Yamagata, Encinitas, CA (US)
Assigned to GEN-PROBE INCORPORATED, San Diego, CA (US)
Filed by Gen-Probe Incorporated, San Diego, CA (US)
Filed on Apr. 17, 2018, as Appl. No. 15/955,401.
Application 15/955,401 is a continuation of application No. 14/211,565, filed on Mar. 14, 2014, granted, now 9,976,175.
Claims priority of provisional application 61/792,409, filed on Mar. 15, 2013.
Prior Publication US 2018/0298432 A1, Oct. 18, 2018
This patent is subject to a terminal disclaimer.
Int. Cl. C12Q 1/6844 (2018.01); G16B 40/00 (2019.01); C12Q 1/6851 (2018.01); G16B 40/10 (2019.01)
CPC C12Q 1/6844 (2013.01) [C12Q 1/6851 (2013.01); G16B 40/00 (2019.02); G16B 40/10 (2019.02)] 19 Claims
 
1. A method of calibrating a local instrument that quantifies an analyte polynucleotide using results from a real time nucleic acid amplification reaction, the method comprising the steps of:
(a) obtaining an adjustment calibrator comprising a known amount of the analyte polynucleotide and a fixed amount of an internal calibrator;
(b) coamplifying the analyte polynucleotide and the internal calibrator of the adjustment calibrator with the local instrument to determine a normalized indicia of amplification; and
(c) establishing a linear calibration curve that comprises first and second data points, each of the data points being defined by a pair of coordinates specifying an amount of the analyte polynucleotide and a normalized indicia of amplification,
wherein the pair of coordinates of the first data point comprises the known amount of the analyte polynucleotide of the adjustment calibrator and the normalized indicia of amplification from step (b), and
wherein the second data point is a fixed-point determined using an instrument other than the local instrument, thereby calibrating the local instrument, and
wherein the linear calibration curve established in step (c) is used to quantify the analyte polynucleotide present in a test sample that comprises an unknown amount of the analyte polynucleotide.