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.
Claims39
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.
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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.
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A method of selecting an internal positive control (Ex-IPC) for an assay for the detection of a first virus comprising for testing a vaccine and/or an intermediate in vaccine productions for the presence or absence of a first virus comprising:
- (a) selecting a first virus the vaccine and/or intermediate in vaccine production;
- (b) determining the virus type for the first virus;
- (c) selecting a first or second virus of the same type with a nonoverlapping host range;
- and
- (d) confirming that both the nucleic acids of the first and second viruses can be extracted from a biological sample using the same extraction procedure.
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Dependencies are inferred from the claim text.