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US 9,127,048 B2Granted
Nucleic acid amplification controls
AssigneeZeptoMetrix Corporation
InventorsGregory R. Chiklis, James C. D. Hengst
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Abstract
The present invention discloses positive control material for nucleic acid amplification based detection of microorganisms in biological samples. The control material comprises purified microorganism that is rendered non-infectious but is amenable to nucleic acid amplification. Also disclosed is a process for making and using the control material.
Claims11
A method for detection of a microorganism in a biological test sample comprising:
- a) providing a biological fluid test sample suspected of comprising the microorganism;
- b) providing a positive control sample comprising the microorganism in a biological fluid corresponding to the biological fluid of the test sample, wherein the positive control sample is prepared by exposing a purified microorganism to an aldehyde at a temperature of 2-8° C., and quenching the aldehyde exposed microorganism with glycine for at least 2 hours such that the microorganism is in an intact, non-pathogenic, form in which one or more of the surface proteins have been irreversibly modified by covalent attachment to the aldehyde and wherein the nuclear components are substantially intact;
- c) processing the test and the positive control sample to extract the nuclear components of the microorganisms;
- d) amplifying the nuclear components of the microorganisms in the test sample and the positive control;
- and e) comparing the results of nucleic acid amplification in the test sample and the positive control to identify the presence of microorganisms in the test sample.
2 more elements
Dependencies are inferred from the claim text.