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US 9,580,761 B2Granted
Exogenous internal positive control
AssigneeNovartis AG
InventorBernhard Roth
Life of this patent
Estimating the term…
Abstract
The present invention provides an internal positive control for contaminating viruses. The invention provides the use of a second virus as an exogenous internal positive control in methods for verifying the reliability of an assay to detect a first virus, in methods of ensuring the absence of the first virus in a biological sample or pharmaceutical sample and in methods of manufacturing a vaccine free from a first virus.
Claims11
A method for verifying the reliability of an assay to detect a first virus comprising the steps of:
- (a) adding an exogenous second virus to a biological sample prior to analysing the viral nucleic acids or polypeptides from the biological sample;
- and
- (b) analysing the viral nucleic acids or polypeptides from the biological sample to detect the first and second virus;
- wherein the first and second virus are the same type of virus and the second virus is an internal positive control;
- and wherein the first virus is an animal virus and the second virus is a plant virus.
2 more elements
A method of confirming that a biological sample is substantially free from a first virus, comprising the steps of:
- (a) adding an exogenous second virus to a biological sample prior to analysing the nucleic acids from the biological sample;
- (b) analysing the nucleic acids from the biological sample to detect the first and second virus;
- and
- wherein the first and second virus are the same type of virus and the second virus is an internal positive control;
- and wherein the first virus is an animal virus and the second virus is a plant virus.
2 more elements
Dependencies are inferred from the claim text.