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Method for performing an assay with a nucleic acid present in a specimen

  • US 8,569,019 B2
  • Filed: 10/31/2007
  • Issued: 10/29/2013
  • Est. Priority Date: 05/01/1998
  • Status: Expired due to Fees
First Claim
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1. A method for detecting the presence of a nucleic acid in a specimen, the method comprising the steps of:

  • (A) providing a specimen tube containing specimen to a self-contained, standard-alone analyzer;

    (B) performing an automated process within a housing of the analyzer that comprises;

    (1) transferring at least a portion of the specimen from the specimen tube to a receptacle, wherein the transferred portion of the specimen is dispensed into the receptacle with a robotic pipettor, and wherein the transferred portion of the specimen contains a nucleic acid;

    (2) immobilizing the nucleic acid on a solid support within the receptacle, the solid support comprising a magnetically-responsive particle;

    (3) applying a magnetic field to the receptacle and its contents;

    (4) during step (3), purifying the nucleic acid immobilized in step (2) by accessing and removing at least a portion of a fluid component of the specimen from the receptacle while the nucleic acid remains immobilized on the solid support within the receptacle;

    (5) forming a reaction mixture comprising the purified nucleic acid of step (4) and all reagents required to perform a nucleic acid amplification;

    (6) performing a nucleic acid amplification with the reaction mixture formed in step (5), the nucleic acid amplification resulting in the enzymatic synthesis of amplification products, each of the amplification products comprising (i) a target sequence contained in the nucleic acid or (ii) the complement of the target sequence;

    (7) selectively hybridizing a probe having a label to the target sequence or its complement of an amplification product that is one of the amplification products synthesized in step (6), thereby forming a hybrid in a mixture that comprises the probe and the amplification product; and

    (8) in the mixture, detecting [the label as an indication of] the formation of the hybrid, wherein the formation of the hybrid in the mixture is an indication of the presence of the nucleic acid in the specimen.

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