NUCLEIC ACID AMPLIFICATION CONTROLS

摘要

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.

主权项

1. 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 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.