夏洛克 新冠检测试剂盒说明书 EUA-Sherlock-cris-ifu.pdfVIP

INSTRUCTIONS FOR USE SherlockTM CRISPR SARS-CoV-2 kit Rx Only For Emergency Use Authorization (EUA) only CATALOG NUMBER COMPANY TBD Sherlock Biosciences, Inc. 35 Spinelli Place Cambridge, MA 02138 Phone: (617) 612-8209 LAB-120-0048, rev 00 Effective Date: 5/6/2020 LAB-120-0048, rev 00 Effective Date: 5/6/2020 Table of Contents Intended Use 3 Summary and Explanation 3 Principles of the Procedure4 Components and Storage……………………………………………………………………………………………………………..4 Storage and Handling of Kit Components 5 Materials Required (But Not Provided) 5 Control Material 5 RNA Extraction System 6 Equipment 6 Additional Supplies 7 Warnings and Precautions 7 Specimen Collection, Handling, and Storage 9 Reagent Controls and Preparation 10 Quality Control 11 Nucleic Acid Extraction and Assay Set up 11 Assay Controls and Interpretation of Results 17 Troubleshooting 19 Limitations 21 Conditions of Authorization for the Laboratory 22 Performance Characteristics 23 Disposal 27 Symbols………………………………………………………………………………………………………………………………………27 References 28 Contact Information, Ordering, and Product Support 30 2 Intended Use The SherlockTM CRISPR SARS-CoV-2 kit is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, nasopharyngeal wash/aspirate or nasal aspirate) and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited