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Descripción
Descripción
- Xpert® Xpress CoV-2 plus, 510K, designed with 3 gene targets for a rapid, robust detection of SARS-CoV-2
- CLIA Waived Environment (GeneXpert Xpress), Moderate Complexity Environment (GeneXpert Dx or Infinity)
- The Xpert Xpress CoV-2 plus test is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab or anterior nasal swab specimen obtained from individuals meeting COVID-19 clinical and/or epidemiological criteria, as well as individuals without symptoms or other reasons to suspect COVID-19 infection
- Results are for the identification of SARS-CoV-2 RNA
- Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
- Positive results do not rule out bacterial infection or co-infection with other viruses
- Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other patient management decisions
- Negative results must be combined with clinical observations, patient history, and epidemiological information
- The Xpert Xpress CoV-2 plus test is intended to be performed by trained users in both laboratory and near patient testing settings
- Fast and accurate results in as early as 20 minutes - with early assay termination for positives, otherwise, the full test runtime is 30 minutes
Especificaciones
Especificaciones
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Product Document(s)
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ApplicationMolecular Reagent
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CLIA ClassificationCLIA Waived for GeneXpert® Xpress System
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CLIA ClassifiedCLIA Waived
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For Use WithFor GeneXpert Xpress System (CLIA Waived) / GeneXpert System with Touchscreen running Cepheid OS (Moderate Complexity)
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Number of Tests10 Tests
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Sample TypeAnterior Nasal Swab / Nasopharyngeal Swab Sample
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SpecialtyMolecular
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Test CategoryRespiratory
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Test FormatCartridge
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Test NameSARS-CoV-2 plus
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Test TypeReal Time RT-PCR
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Time to Results30 Minute Results
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VolumeLysis Reagent: 1 mL, Binding Reagent: 1 mL, Elution Reagent: 2 mL, Wash Reagent: 0.5 mL
Cepheid 510K Status / Software Updates June 2025
Return policy
Return policy
Not loving it? We offer returns for most items within 30 days of delivery for a refund or store credit.
