Reagents and instruments for immunology, cell biology and molecular biology.

genesig Real-Time PCR Detection Kit for Coronavirus (Strain 2019-nCoV) FDA EUA (US Only)

Print

Cat# 544138-1Kit

Size : 1Kit

Brand : US Biological

544138 genesig Real-Time PCR Detection Kit for Coronavirus (Strain 2019-nCoV)|FDA EUA (US Only)

Clone Type

Polyclonal

Shipping Temp

Storage Temp

-20°C

The genesig Real-Time PCR COVID-19 is approved for FDA-EUA use.||96-Test Kit includes: oasig Lyophilized qPCR Master Mix, Primer & Probe Mix, Positive Control, Internal Extraction Control, No Template Control, Resuspension Buffers.||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.||The genesig Real-Time PCR COVID-19 is approved for FDA-EUA use.||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||Instrumentation Requirements:|For Use with:|Sample Types Extraction Platforms PCR Platform|Nasopharyngeal Swabs CE IVD Extraction System* AB! 7500, BioRad CFX, Roche 480**|Oropharyngeal Swabs CE IVD Extraction System* AB! 7500, BioRad CFX, Roche 480**|Sputum CE IVD Extraction System* AB! 7500, BioRad CFX, Roche 480**| |*Suitable for the directed sample types ||**|Applied Biosystem® 7500 Real-Time PCR System|Bio-Rad CFX ConnectTM Real-Time PCR Detection System|Roche® LightCycler 480 II

Applications

FDA-Emergency Use Only (EUA)||The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARSCoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal aspirates from individuals who are suspected of COVID19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.|Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.||Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.||Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.||The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is intended for use by qualified, trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is only for use under the Food and Drug Administration’s Emergency Use Authorization (EUA).