Sherlock™ CRISPR SARS-CoV-2

The Sherlock™ 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.

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Sherlock™ CRISPR SARS-CoV-2 Kit

Bringing Speed, Accuracy and Precision to the Fight Against COVID-19.

Sample Prep
Extract RNA from collection device (Upper Respiratory Sample)
Amplification
Loop-mediated isothermal RNA amplification
Detection
CRISPR target-based activation for SARS-CoV-2 ID
Output
Reporter - Cleavage based output
The Sherlock™ 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 upper respiratory tract and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider.
Top 5 Benefits

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 SHERLOCK technology, proven highly sensitive with an LoD of 6.75 cp/uL VTM

The Sherlock™ 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.
  • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens
  • This test has not been FDA cleared or approved
  • This test has been authorized by FDA under an EUA for use by authorized laboratories
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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