دورية أكاديمية
High-Throughput CRISPR-Cas13 SARS-CoV-2 Test.
| العنوان: | High-Throughput CRISPR-Cas13 SARS-CoV-2 Test. |
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| المؤلفون: | Manning BJ; R&D Department, Sherlock Biosciences, Boston, MA., Khan WA; Department of Pathology and Laboratory Medicine, The Audrey and Theodore Geisel School of Medicine at Dartmouth College, Hanover, NH.; Laboratory for Clinical Genomics and Advanced Technology, Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Medical Center, Lebanon, NH., Peña JM; R&D Department, Sherlock Biosciences, Boston, MA., Fiore ES; R&D Department, Sherlock Biosciences, Boston, MA., Boisvert H; R&D Department, Sherlock Biosciences, Boston, MA., Tudino MC; R&D Department, Sherlock Biosciences, Boston, MA., Barney RE; Department of Pathology and Laboratory Medicine, The Audrey and Theodore Geisel School of Medicine at Dartmouth College, Hanover, NH., Wilson MK; R&D Department, Sherlock Biosciences, Boston, MA., Singh S; R&D Department, Sherlock Biosciences, Boston, MA., Mowatt JA; R&D Department, Sherlock Biosciences, Boston, MA., Thompson HJ; R&D Department, Sherlock Biosciences, Boston, MA., Tsongalis GJ; Department of Pathology and Laboratory Medicine, The Audrey and Theodore Geisel School of Medicine at Dartmouth College, Hanover, NH.; Laboratory for Clinical Genomics and Advanced Technology, Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Medical Center, Lebanon, NH., Blake WJ; R&D Department, Sherlock Biosciences, Boston, MA. |
| المصدر: | Clinical chemistry [Clin Chem] 2021 Dec 30; Vol. 68 (1), pp. 172-180. |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: England NLM ID: 9421549 Publication Model: Print Cited Medium: Internet ISSN: 1530-8561 (Electronic) Linking ISSN: 00099147 NLM ISO Abbreviation: Clin Chem Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2020- : Oxford : Oxford University Press Original Publication: Baltimore, Md. : P.B. Hoeber, [c1955- |
| مواضيع طبية MeSH: | COVID-19*/diagnosis , CRISPR-Cas Systems*, COVID-19 Testing/*methods, High-Throughput Screening Assays ; Humans ; RNA, Viral/isolation & purification ; SARS-CoV-2/isolation & purification ; Sensitivity and Specificity |
| مستخلص: | Background: The ability to control the spread of COVID-19 continues to be hampered by a lack of rapid, scalable, and easily deployable diagnostic solutions. Methods: We developed a diagnostic method based on CRISPR (clustered regularly interspaced short palindromic repeats) that can deliver sensitive, specific, and high-throughput detection of Sudden Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2). The assay utilizes SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) for the qualitative detection of SARS-CoV-2 RNA and may be performed directly on a swab or saliva sample without nucleic acid extraction. The assay uses a 384-well format and provides results in <1 hour. Results: Assay performance was evaluated with 105 (55 negative, 50 positive) remnant SARS-CoV-2 specimens previously tested using Food and Drug Administration emergency use authorized assays and retested with a modified version of the Centers for Disease Control and Prevention (CDC) quantitative PCR with reverse transcription (RT-qPCR) assay. When combined with magnetic bead-based extraction, the high-throughput SHERLOCK SARS-CoV-2 assay was 100% concordant (n = 60) with the CDC RT-qPCR. When used with direct sample addition the high-throughput assay was also 100% concordant with the CDC RT-qPCR direct method (n = 45). With direct saliva sample addition, the negative and positive percentage agreements were 100% (15/15, 95% CI: 81.8-100%) and 88% (15/17, 95% CI: 63.6-98.5%), respectively, compared with results from a collaborating clinical laboratory. Conclusions: This high-throughput assay identifies SARS-CoV-2 from patient samples with or without nucleic acid extraction with high concordance to RT-qPCR methods. This test enables high complexity laboratories to rapidly increase their testing capacities with simple equipment. (© American Association for Clinical Chemistry 2021.) |
| معلومات مُعتمدة: | Good Venture Foundation in support of this work; Sherlock Biosciences |
| فهرسة مساهمة: | Keywords: infectious disease; molecular diagnostics; viral diseases |
| المشرفين على المادة: | 0 (RNA, Viral) |
| تواريخ الأحداث: | Date Created: 20211031 Date Completed: 20220202 Latest Revision: 20220202 |
| رمز التحديث: | 20221213 |
| DOI: | 10.1093/clinchem/hvab238 |
| PMID: | 34718481 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1530-8561 |
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| DOI: | 10.1093/clinchem/hvab238 |