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Quick Reference Instructions for Xpert Xpress SARS-CoV-2 ...

302-3752 Rev. B April 20202020 Cepheid For IVD In Vitro Diagnostic Use Only Quick Reference Instructions for Xpert Xpress SARS-CoV-2 and GeneXpert Xpress System (Hub Configuration) I Storage and Handling and WarningsThe user should be trained in the procedure. Wear the appropriate protective attire for your safety when handling patient samples. Clean testing surfaces according to your institution s policy. This test is only for nasopharyngeal swab, nasal swab, and mid-turbinate swab the complete Quick Reference Instructions before performing the test. For assistance, call Cepheid Technical Support at (888) 838 and HandlingWarnings Wear gloves. Change gloves between processing each sample.

SARS-CoV-2 are 15-30°C, 20-80% relative humidity. For use under the Emergency Use Authorization (EUA) only. Sample Chamber . 2020 Cepheid or IVD In Vitro Diagnostic Use Only 02-52 Re Apri 2020 Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 USA Tel: +1 408 541 4191 Fax: +1 408 541 4192 VI Possible Results ...

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Transcription of Quick Reference Instructions for Xpert Xpress SARS-CoV-2 ...

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Xpert Xpress SARS-CoV-2 - Cepheid

www.cepheid.com

Xpert® Xpress SARS-CoV-2 2 Xpert® Xpress SARS-CoV-2 302-3750, Rev. F January 2021 5 Principle of the Procedure The Xpert Xpress SARS-CoV-2 test is an automated in vitro diagnostic test for qualitative detection of nucleic acid from SARS- CoV-2. The Xpert Xpress SARS-CoV-2 test is performed on GeneXpert Xpress System.

  Asrs, Sars cov 2, Sars cov 2 2

Xpert Xpress Nasopharyngeal Sample Collection Kit for Viruses

www.cepheid.com

Transport Medium (3 mL tube with transport media). • Samples can be stored at 15-30 °C for up to 8 hours and at 2-8 °C for up to 7 days before processing with the Xpert Xpress SARS-CoV-2 test. • Proper specimen collection, storag e, and transport are critical to the performance of this test. Specimen Collection Procedure

  Transport, Processing, Collection, Specimen, Specimen collection

Xpert CT/NG Controlled - Cepheid

www.cepheid.com

Xpert® CT/NG 1 301-0234, Rev. K August 2019 Xpert® CT/NG For in vitro diagnostic use only 1 Proprietary Name Xpert® CT/NG 2 Common or Usual Name Xpert CT/NG 3 Intended Use The Xpert® CT/NG test, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro real-time PCR test for the automated detection and differentiation of genomic DNA from …

  Common

Xpert Xpress CoV-2/Flu/RSV plus

www.cepheid.com

Testing of nasopharyngeal swab, anterior nasal swab, or nasal wash/aspirate specimens, run on the GeneXpert Dx and GeneXpert Infinity systems, is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet requirements to perform high or moderate complexity tests.

  Infinity, Genexpert, Genexpert infinity

GeneXpert Maintenance: GeneXpert Dx System

www.cepheid.com

GeneXpert® GX-IV Filter (PN 001-1537) GeneXpert® High Efficiency (HE) Filter Kit (P/N GX-HE-FILTERKIT) GeneXpert® GX-XVI R1 Filter (PN 001-1271) GeneXpert® GX-II (PN 001-1271) GeneXpert® GX-XVI R2 Filter (PN 001-1537) GeneXpert® SystemOptics Cleaning Kit Description and Part Number (PN) (PN 700-6519S) Contains the I-CORE brush and GX-IV ...

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GeneXpert Quality Control Features - Cepheid

www.cepheid.com

2. Reagent Control (Probe Check): Probe Check is performed on every cartridge after onboard sample preparation, reagent mixing, probe integrity, and reaction tube filling, but before initiation of PCR. During Probe Check, fluorescence readings are measured in the reaction tube for each probe and compared to default settings established by Cepheid.

  Control, Reactions

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FACTS AND MYTHS ABOUT THE SARS-COV-2 SEROLOGY …

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responses to SARS-CoV-2, a finding that is known to occur with other viral infections. • Recently, FDA has advocated for a 2-step serologic assay format to improve overall sensitivity and specificity for SARS-CoV-2 sero-surveillance. This would entail initial testing for a more broadly reactive antibody followed by a more specific antibody.

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Updated CLIA SARS-CoV-2 Molecular and Antigen Point of ...

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Updated CLIA SARS-CoV-2 Molecular and Antigen Point of Care Test Enforcement Discretion . What is CMS’s policy regarding laboratories performing SARS-CoV-2 molecular and antigen tests authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for use at the point of care (POC) or in patient care settings

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Novel Coronavirus (SARS-CoV-2) Real-Time Multiplex RT-PCR …

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www.ama-assn.org

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CPT Assistant guide: Coronavirus (SARS-CoV-2); August 2020

www.ama-assn.org

RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected c (For additional PLA code with identical clinical . descriptor, see 0223U. See Appendix O or the most current listing on the AMA CPT website to

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