Agilent SARS-CoV-2 qRT-PCR Dx Kit

SARS-CoV-2 qRT-PCR Dx Kit

CE-IVD

The Agilent SARS-CoV-2 qRT-PCR Dx kit is a real-time reverse transcriptase PCR (qRT-PCR) in vitro diagnostic test for qualitative detection of SARS-CoV-2 RNA. Viral RNA is isolated and purified from nasopharyngeal, nasal and oropharyngeal human swab specimens^¹ obtained from individuals suspected of having COVID-19 by their healthcare provider.

Positive results from these upper respiratory specimens are indicative of the presence of SARS-CoV-2 viral RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.

The Agilent SARS-CoV-2 qRT-PCR Dx kit has been designed for flexibility across the entire workflow. The open system has been validated with two commercially available RNA extraction products and three real-time PCR systems, including the AriaDx Real-Time PCR System.⁴

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.

SARS-CoV-2 Detection Kits

Features

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 1.0 copy 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

Specifications


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 1.0 copy per µL
Target Specificity	No cross-reactivity with 20 human respiratory pathogens, based on target sequences³
Technique	qPCR
Validated RNA Extraction Systems & 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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Featured References

Publications

The performance of the Agilent SARS-CoV-2 qRT-PCR Dx kit assay was established using nasopharyngeal swab specimen type collected in UTM or VCM transport media. Oropharyngeal swabs, nasal swabs, and mid-turbinate nasal swabs are considered acceptable specimen types for use with the Agilent SARS-CoV-2 qRT-PCR Dx kit assay but performance with these specimen types has not been established.
Centers for Disease Control and Prevention, Division of Viral Diseases. CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. CDC/DDID/NCIRD/ Division of Viral (2020), DiseasesCDC-006-00019, Revision: 06. Learn More
N1 and N2 primer and probe target sequences are identical to CDC protocol. These primer sequences are tested by CDC do not react with related pathogens, disease agents, and normal or pathogenic flora likely to be encountered in a clinical specimen. Cross reactivity and not impacted by mutations circulating virus.
The SARS-CoV-2 qRT-PCR Dx kit can be used with the AriaDx or AriaMx Real-Time PCR System. For countries requiring the use of In Vitro Diagnostic instruments, the AriaDx System must be used.

SARS-CoV-2 qRT-PCR Dx Kit

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Frequently Asked Questions: SARS-CoV-2 qRT-PCR Dx kit

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