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CoV-2 Test Protocol.pdf

Cepheid-Xpert-Xpress-CoV-2-plus-Verification-Guide-EUA-0920-English.pdf
Preview of CoV-2 Test Protocol
🔗 Source: cepheid.com
📊 Size: 92 KB
📄 Pages: 5 pages
⬇️ Downloads: 310

Summary

The Xpert Xpress CoV-2 plus test is a rapid, real-time RT-PCR test for qualitative detection of SARS-CoV-2 nucleic acid in various specimens, intended for use by healthcare providers and authorized laboratories under the FDA's Emergency Use Authorization. The test is limited to laboratories certified under CLIA, with results indicating active infection requiring clinical correlation and reporting to public health authorities. Negative results do not preclude infection and should be combined with clinical observations and epidemiological information. The verification protocol involves testing known positive and negative samples, with required materials including ZeptoMetrix controls, negative clinical swab specimens, and Xpert Xpress CoV-2 plus cartridges. Precautions include handling reference materials as infectious and following Good Laboratory Practices. The verification procedure involves external controls testing, labeling cartridges and test tubes, and creating dilutions of positive reference material.

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Description

The Xpert Xpress CoV-2 plus test is a rapid, real-time RT-PCR test for qualitative detection of SARS-CoV-2 nucleic acid in various specimens, intended for use...

Technical Information

  • File Format: PDF
  • File Size: 92 KB
  • Pages: 5
  • Language: EN
  • Total Downloads: 310
  • Last Updated: 7 days ago

Document Overview

This PDF document about CoV-2 Test Protocol provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into CoV-2 Test Protocol.

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