IP Library Granted Patent US 12,037,638
Granted Patent B2
US 12,037,638 · App. 17/783,231 · Granted Jul 16, 2024

Quantification of polynucleotide analytes from dried samples

Inventors: Sangeetha Vijaysri Nair (San Diego, CA); Xianqun Wang (San Diego, CA)
Assignee: GEN-PROBE INCORPORATED
C12Q1/6865G16B20/00G16B40/00C12Q1/703
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Quick Facts
Patent No.
US 12,037,638
App. No.
17/783,231
Granted
Jul 16, 2024
Kind
B2
Abstract

Presented are methods, systems, and software products useful for determining the concentration of an analyte in a fluid specimen used to produce a dried sample, where the dried sample serves as a source of the analyte in a detection and quantification procedure. Particularly illustrated is the use of dried blood spots for quantifying a polynucleotide analyte.

Claims (12)

1. A computer programmed with software instructions for quantifying a polynucleotide analyte present in a fluid blood sample that dried to produce a dried blood spot (DBS) test sample, wherein the computer is operably linked to a nucleic acid analyzer, and the software instructions, when executed by the computer, cause the computer to:

(a) receive a measured result from a real-time nucleic acid amplification reaction carried out by the nucleic acid analyzer using the DBS test sample as a source of templates to produce and quantify amplification products;

(b) solve a non-linear equation to determine a correction factor,

wherein the non-linear equation specifies the correction factor as a function of measured results from real-time nucleic acid amplification reactions carried out using only DBS samples other than the DBS test sample, said DBS samples having known quantities of the polynucleotide analyte, and the non-linear equation specifies higher correction factor values at lower concentrations of the polynucleotide analyte in the DBS;

(c) quantify the polynucleotide analyte present in the fluid blood sample that dried to produce the DB S test sample by multiplying the measured result of (a) by the correction factor of (b) to calculate a corrected result; and (d) record the corrected result in a non-transitory form.

2. The computer of claim 1 ,

wherein the measured result of (a) indicates a concentration or an amount of the polynucleotide analyte.

3. The computer of claim 2 , wherein the measured result of (a) and the corrected result of (c) are both expressed in concentration units.

4. The computer of claim 1 , wherein the non-linear equation comprises coefficients optimized in a mathematical curve fitting procedure to define a fitted curve.

5. The computer of claim 4 , wherein the non-linear equation comprises four coefficients.

6. The computer of claim 1 , wherein the non-transient form comprises storage on a computer-readable memory device.

7. The computer of claim 1 , wherein the fluid blood sample comprises whole blood.

Assignments (3)
SECURITY INTEREST Recorded Apr 8, 2026
From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 075462/0440 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 23, 2024
From: WANG, XIANQUN; NAIR, SANGEETHA VIJAYSRI
To: GEN-PROBE INCORPORATED
Reel/Frame 067196/0409 →
SECURITY INTEREST Recorded Oct 11, 2022
From: HOLOGIC, INC.; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 061639/0513 →