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Diagnovital SARS-CoV-2 Real-Time PCR Kit

Diagnovital SARS-CoV-2 Real-Time PCR Kit is a Real-Time Qualitative RT-PCR-based test used for the detection of SARS-CoV-2 intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal and oropharyngeal swabs and BAL specimens from individuals suspected of COVID-19 by their healthcare provider. The test is based on conventional RT-PCR technology including extraction and purification of the nucleic acid genome of SARS-CoV-2 followed by PCR amplification and detection.

selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers and probes specific to the SARS-CoV-2 envelope gene (E-gene) and the polymerase gene (RdRP). The RdRP gene target is detected by one probe, unique to SARS-CoV-2. Additionally, a conserved region in the structural protein envelope E-gene was chosen also for the pan-Sarbecovirus detection. The pan-Sarbecovirus detection sets will also detect SARS-CoV-2 virus.

selective amplification of Internal Control is achieved by the use of non-competitive, sequence specific forward and reverse primers and a probe for the endogeneous human RNAseP gene which have no homology with the coronavirus genome. A thermostable DNA polymerase enzyme is used for amplification.

Diagnovital SARS-CoV-2 Real-Time PCR Kit has been validated for use with RTA Viral Nucleic Acid Isolation Kit or RTA Viral RNA Isolation Kit for its best performance.

Diagnovital Real Time PCR Kits are certified and marked with CE-IVD to meet specific quality and purity requirements of in-vitro diagnostic use.

The kit follows CDC’s and WHO’s latest detection guidelines (04/2020).

Sensitivity

SYSTEM E (COPIES/ML) RDRP (COPIES/ML)
Bio-Rad CFX96-IVD 38 38
ABI 7500 12.8 12.6
Rotorgene 27 16
Quant Studio

Other Features

TARGET REGION E gene, RdRP gene
SAMPLE TYPE Human respiratory samples (nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage
EXTRACTION CONTROL RNAseP gene
STORAGE -20°C

Validated Extraction Methods and Instruments

COMPATIBLE EXTRACTION METHODS

BioMérieux NucliSens ® systems

QIAamp ® Viral RNA Mini Kit

QIAamp ® MinElute Virus Spin Kit or RNeasy ® Mini Kit

(QIAGEN) EZ1 DSP Virus Kit (QIAGEN)

Roche MagNA Pure Compact RNA Isolation Kit

Roche MagNA Pure Compact Nucleic Acid Isolation Kit

Roche MagNA Pure 96 DNA and Viral NA Small Volume Kit

Invitrogen ChargeSwitch ® Total RNA Cell Kit

 

VALIDATED EXTRACTION METHODS

RTA Viral NA Isolation Kit

RTA Viral RNA Isolation Kit

VALIDATED INSTRUMENTS

QuantStudio 5 DX Real Time PCR Detection System

BioRad CFX96™ Real-Time PCR Detection System

Applied Biosystems 7500 Real-Time PCR System

Rotor Gene 3000/6000

*The kit is CE-IVD compatible with Real Time PCR instruments indicated above noting that it can be run on any system that has FAM channel.

 

Documents

A1 Life Sciences-Diagnovital Sars-CoV-2 Product Catalog
RTA SARS-CoV-2 EC-Declaration of Conformity
Diagnovital SARS-CoV-2 Specifications
RTA SARS-CoV-2 Real Time PCR Kit IFU (ENG)
R&D CENTER RTA ISO 13485 CERTIFICATE
R&D CENTER RTA QUALITY SYSTEM CERTIFICATE