Internal quality control for microbial enumeration assays

C - Chemistry – Metallurgy – 12 – Q

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C12Q 1/06 (2006.01) G01N 33/533 (2006.01) G01N 33/96 (2006.01)

Patent

CA 2400715

A method for calibrating or determining accuracy of a microbial enumeration assay involving providing an internal quality control standard to a sample suspected of containing a microorganism, the standard comprising a defined quantum of a modified form of the microorganism, wherein the modified microorganism comprises a detectable tag such that the modified microorganism can be differentiated from the corresponding unmodified microorganism in a sample being assayed; carrying out the assay so as to detect and determine the number of unmodified microorganisms and the number of modified microorganisms present in the sample; and comparing the number of modified microorganisms detected by the assay with the defined quantum of modified microorganisms provided to the sample so as to calibrate or determine the accuracy of the assay, wherein the ratio of the number of detected modified microorganisms to the defined quantum of modified microorganism added to the sample is indicative of the accuracy of the assay for the microorganism.

L'invention concerne des procédés qui consistent à prévoir une population de bioparticules, à modifier les bioparticules pour le marquage permanent et détectable de chaque bioparticule, de manière que des bioparticules marquées soient produites, à former un échantillon de contrôle de qualité constitué de quantités de bioparticules marquées dans un volume défini de véhicule, à ajouter l'échantillon de contrôle à un échantillon à analyser, pour la détection desdites bioparticules, à mener à bien ladite analyse et à déterminer ensuite la proportion de bioparticules marquées ainsi détectées dans l'échantillon d'analyse, de manière que la précision de l'analyse soit mesurée. L'invention porte également sur des procédés de mise en oeuvre d'un contrôle de qualité interne dans l'analyse de bioparticules dans des fluides potables, et sur des normes de contrôle de qualité interne.

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