CRISPR SARS-CoV-2 kit is the first FDA authorized CRISPR-based EUA diagnostic test. The kit is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory tract and bronchoalveolar lavage samples from individuals suspected of COVID-19 by their healthcare provider. This kit provides specific and sensitive identification of SARS-CoV-2.
CRISPR SARS-CoV-2 kit is the first EUA CRISPR-based diagnostic test intended for the qualitative detection of nucleic acid from SARS-CoV-2. This kit provides specific and sensitive detection of the SARS-CoV-2 virus in the upper respiratory tract and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider.
Faster than PCR; approximately 1 hour reaction time
Add hundreds of tests per day to current lab volume
100% specificity and sensitivity in EUA clinical evaluation
Minimal footprint; uses standard laboratory equipment and a microplate reader
CRISPR SARS-CoV2 technology, proven highly sensitive with an LoD of 6.75 cp/uL VTM
CRISPR SARS-CoV-2 kit is designed to detect fragments in the Open Reading Frame (ORF1ab) gene and the Nucleocapsid (N) gene of SARS-CoV-2. Internal control target human RNase P POP7 gene is used for confirmation of clinical sample extraction in the absence of a positive SARS-CoV-2 result.
The assay is comprised of two steps. Step one is RT-LAMP where targeted SARS-CoV-2 genomic RNA is reverse transcribed to DNA then amplified by a strand-displacing DNA polymerase. Step two transcribes the amplified DNA to activate collateral cleavage activity of a CRISPR complex programmed to the target RNA sequence. Cleavage of nucleic acid reporters results in a fluorescent readout detectable by a standard plate reader.
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