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).
|System||E (copies/ml)||RdRP (copies/ml)|
|Target Region||E gene, RdRP gene|
|Sample Type||Human respiratory samples (nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage|
|Extraction Control||RNAseP gene|
|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.
|Product||Test Size||Catalog No|
|Diagnovital SARS-CoV-2 Real-Time PCR Kit||25 Tests||09065025|
|Diagnovital SARS-CoV-2 Real-Time PCR Kit||50 Tests||09065050|
|Diagnovital SARS-CoV-2 Real-Time PCR Kit||100 Tests||09065100|