Primerdesign’s genesig®Coronavirus (COVID-19) CE IVD Compatibility Statement:PrimerDesign Cat no: Z-Path-COVID-19-CEUnited States Biological Cat No: 532176
Performance testing of the COVID-19 CE-IVD kit has been validated using the stipulated components detailed in the IFU (sample type, CE-IVD extraction process, qPCR machine software/hardware). Use of the CE-IVD kit with alternative qPCR machines (software or hardware) is described as off-label use as the performance data is no longer appropriate. There is no evidence to suggest that the COVID-19 CE-IVD kit would not be compatible with other qPCR machines and/or other CE-IVD or RUO extraction kits. Any alternative equipment would need to be validated by the end user. However, as these have not been tested by Primerdesign to meet current CE-IVD regulations for the validation of the COVID-19 CE-IVD kit, they cannot be endorsed by Primerdesign.
The COVID-19 CE-IVD kit was validated on the Applied Biosystems® 7500, the Biorad CFX96 and Roche Lightcycler® 480 II Real-Time PCR machines, as detailed in the IFU for COVID-19 CE-IVD kit
Issue number 01 Reference MM064
Kit Description:Severe Acute Respiratory Syndrome Coronavirus (SARS CoV) is a positive-sense, singlestranded RNA virus of the Coronaviridae family. The genome of this virus is around 30K nucleotides in length arrange in a linear formation. Infection with this virus causes Severe Acute Respiratory Syndrome (SARS), an infectious respiratory tract infection. It was most recently brought to prevalence in a near pandemic in 2003 where it spread from China to more than 30 countries within a matter of weeks. The virus is transmitted by droplet transmission as well as suspected airborne transmission. Upon infection, which is by membrane fusion, the host translation machinery translates Open Reading Frames 1a and 1b into the viral replicase protein, the Coronavirus Main Protease (Mpro or 3CLpro). This protease is used in the synthesis of the viral replication complex which allows synthesis of the full length negative strand of RNA. The RNA is then transcribed to mRNA in a series of nested transcripts for each of the viruses major ORF’s which all contain identical leader sequences. The SARS-CoV genome contains five major ORFs that encode the replicase polyprotein, the Spike(S), Envelope(E), and Membrane(M) glycoproteins and Nucleocapsid (N) protein. As the proteins required for the formation of a new virus particle are now present, the new virion is assembled and released from the cell by exocytosis. The initial symptoms presented appear flu-like and the typical symptoms include fever, lethargy, muscle pains, cough and sore throats, nasal congestion as well as other nonspecific symptoms. The symptom specific to all patients is a fever above 39°C. In some cases, as the disease progresses, the patient may encounter shortness of breath as well as chest pains. Diagnosis is usually made by chest X-rays as well as laboratory tests such as ELISA and IFA. Due to the fact that the disease is caused by a virus, there is no specific treatment and typically symptomatic treatment is recommended.
Product Features:
Rapid detection and exclusive to the COVID-19 strain
Does not detect other related coronavirus strains
High priming efficiency
Accurate controls to confirm extraction, and assay validity
Lyophilized components for ambient shipping
Highly specific detection profile
The genesig Real-Time PCR COVID-19 (CE) is CE-IVD marked and intended for in vitro diagnostic use in Europe.
