US 12,065,694 B2
Kits for single-step analyte detection with process control
Sunghae A. Joo, San Diego, CA (US); and Janel M. Dockter, Oceanside, CA (US)
Assigned to GEN-PROBE INCORPORATED, San Diego, CA (US)
Filed by GEN-PROBE INCORPORATED, San Diego, CA (US)
Filed on Jul. 29, 2021, as Appl. No. 17/388,410.
Application 17/388,410 is a continuation of application No. 16/657,749, filed on Oct. 18, 2019, granted, now 11,104,935.
Application 16/657,749 is a continuation of application No. 15/729,128, filed on Oct. 10, 2017, granted, now 10,487,353, issued on Nov. 26, 2019.
Application 15/729,128 is a continuation of application No. 13/173,558, filed on Jun. 30, 2011, granted, now 9,822,397, issued on Nov. 21, 2017.
Claims priority of provisional application 61/360,296, filed on Jun. 30, 2010.
Prior Publication US 2021/0355528 A1, Nov. 18, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. C12Q 1/6816 (2018.01); C12Q 1/6844 (2018.01)
CPC C12Q 1/6816 (2013.01) [C12Q 1/6844 (2013.01)] 22 Claims
OG exemplary drawing
 
1. A kit for determining the presence or absence of analyte polynucleotides in a sample, the kit comprising:
an internal control polynucleotide;
one or more amplification reagents to co-amplify a first analyte polynucleotide and the internal control polynucleotide in a nucleic acid amplification reaction to produce an internal control amplicon, and, if the sample contains the first analyte polynucleotide, a first analyte amplicon; and
a first hybridization probe having a first label, the first hybridization probe being capable of forming a first detectable hybrid with the first analyte amplicon, but incapable of forming a detectable hybrid with the internal control amplicon,
a second hybridization probe having a second label, the second hybridization probe being capable of forming a second detectable hybrid with the internal control amplicon, but incapable of forming a detectable hybrid with the first analyte amplicon,
a negative calibrator comprising the internal control polynucleotide, wherein the negative calibrator does not comprise the first analyte polynucleotide, and
one or more standards, each standard comprising the internal control polynucleotide and a known amount of the first analyte polynucleotide,
wherein the first and second labels comprise identical labels.