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US 2017/0107585 A1Published application
Nucleic acid amplification controls
AssigneeZeptoMetrix Corporation
InventorsJames C.D. Hengst, Gregory R. Chiklis
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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.
Claims8
A method for making a full process positive control material for detection of virus in biological samples comprising:
- a) purifying an intact virus from a source;
- b) exposing the purified intact virus to an aldehyde at a temperature and for a time such that one or more surface proteins are irreversibly modified while leaving the nuclear components substantially intact thereby rendering the purified intact virus non-pathogenic and wherein nucleic acids of the purified intact virus are amenable to amplification;
- and
- c) identifying that the purified intact virus can be used as a full process positive control by confirming absence of active virus and an ability of viral nucleic acids in the purified intact virus to be amplified.
1 more element
Dependencies are inferred from the claim text.