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US 12,338,463 B2Granted
Sindbis control virus
AssigneeLGC Clinical Diagnostics, Inc.
InventorsRussell Garlick, Catherine Huang, Bharathi Anekella, Jonathan Li
Life of this patent
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Abstract
Disclosed are compositions and methods related to replication deficient Sindbis viruses that are able to function as controls for nucleic acid diagnostic assays (e.g., nucleic acid sequencing based assays and/or nucleic acid amplification based assays).
Claims11
A method of testing a diagnostic assay, comprising performing the diagnostic assay on a control comprising replication deficient recombinant Sindbis virus particles comprising an RNA genome comprising:
- an open reading frame (ORF) encoding functional Sindbis non-structural proteins;
- and
- a heterologous RNA sequence comprising a non-Sindbis RNA virus sequence or a retrovirus sequence;
- wherein the non-Sindbis virus sequence is an Ebolavirus sequence, a SARS virus sequence, a West Nile virus sequence, a Zika virus sequence, a poliovirus sequence or a measles virus sequence;
- wherein the diagnostic assay is a nucleic acid amplification based diagnostic assay or a nucleic acid sequencing based diagnostic assay comprising:
- a) performing a lysis step and/or a nucleic acid extraction step on the composition comprising the replication deficient recombinant Sindbis virus particles;
- and
- b) performing a nucleic acid amplification step or performing a nucleic acid sequencing step on RNA extracted from the replication deficient recombinant Sindbis virus particles;
- and
- wherein the diagnostic assay detects the presence or amplification of an RNA virus or a retrovirus;
- and the diagnostic assay is valid if the heterologous RNA sequence or its amplification is detected.
8 more elements
Dependencies are inferred from the claim text.