Descripción
The Agilent SARS-CoV-2 qRT-PCR Dx kit is a real-time reverse transcriptase PCR (qRT-PCR) in vitro diagnostic reagent kit for the qualitative detection of SARS-CoV-2 RNA. The CE-IVD marked kit contains a primer and probe mix that targets the N1 and N2 regions of the SARS-CoV-2 nucleocapsid gene and human RNase P, and includes a synthetic SARS-CoV-2 RNA positive control. RNA is isolated and purified from nasopharyngeal, nasal, and oropharyngeal swab specimens obtained from individuals suspected of having COVID-19 by their healthcare provider. The kit is validated for use with multiple automated RNA extraction systems and real-time PCR instruments and allows clinical laboratories to easily generate diagnostic results from this single-tube assay.
• The Agilent SARS-CoV-2 qRT-PCR Dx kit is CE-IVD marked in accordance with the European Union In Vitro Diagnostic Directive 98/79/EC.
• For In Vitro Diagnostic Use
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Características:
• Single-tube qRT-PCR assay includes 3 targets: N1 and N23 viral targets and human RNase P
• Single tube assay minimizes use of consumables and maximizes sample throughput per instrument run
• Available as an optional stand-alone positive control
• Developed using primer and probe sequences published by the U.S. Centers for Disease Control (CDC)2
• Clinically validated and demonstrated with a limit of detection as low as 1.5 copies per µL
• Choose from two automated RNA extraction platforms
• Protocols for established 96-well real-time PCR systems for easy assay adoption on existing instruments
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Especificaciones:
• Kit throughout: Validated protocols for 96 well plate formats
• Platform: CFX96 Touch Real-Time PCR Detection System (Bio-Rad)/Applied Biosystems 7500 Fast Real-Time PCR Instrument (Thermo Fisher Scientific)/AriaDx Real-Time PCR Instrument
• Primary Sample Type: Nasopharyngeal swab specimen/Nasal swab specimen/Oropharyngeal swab specimen
• Primer/Probe Sequences: Published by the U.S. Centers for Disease Control (CDC)
• Qualitative Reaction Speed: Fast Cycling
• Reaction Format: Single tube
• SARS-CoV-2 Viral RNA Controls: In-vitro transcribed N1 RNA/In-vitro transcribed N2 RNA
• SARS-CoV-2 Viral RNA Primer/Probes: N1/N2
• Sample Reaction Internal Control Primer/probe: Human RNAse P
• Sensitivity: Limit of detection (LoD) as low as 1.5 copies per µL ng
• Target Specificity: No cross-reactivity with 20 human respiratory pathogens, based on target sequences
• Technique: qPCR
• Validated RNA Extraction Systems and Reagents: MagMAX Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit with Automated KingFisher Flex system (Thermo Fisher Scientific); QIASymphony DSP Virus/Pathogen Midi Kit with automated QiaSymphony SP (Qiagen).
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