By ZellBio GmbH
ZELLX® COVID-19 Coronavirus assays
The novel coronavirus, officially termed 2019-nCoV and more commonly known as COVID-19, causes pneumonia and is genetically different from other common human coronaviruses such as 229E, NL63, OC43 and HKU1 that cause seasonal acute respiratory illnesses. It is also genetically distinct from the two newer human coronaviruses, MERS-CoV and SARS-CoV.
The resulting global coronavirus pandemic that spread outwards from Wuhan has created intense demand for real-time SARS-CoV-2 detection and rapid genetic extraction from samples. Accordingly, ZELLX® has introduced a portfolio of COVID-19 Coronavirus assays, including new diagnostic and analytical kits that use quantitative polymerase chain reaction (qPCR) technology for real-time detection, as well as viral RNA extraction and Covid-19 ELISA IgG enzyme-linked immunosorbent assay.
ZELLX® SARS‐CoV-2 Real Time-qPCR Detection Kits
The ZELLX® SARS-CoV-2 RT-qPCR assay design is based on US Center for Disease Control (CDC) guidelines, allowing specific detection of SARS-CoV-2 in less than two hours using real time RT-PCR in respiratory specimens, including sputum, nasopharyngeal, oropharyngeal aspirates, washes or swabs, and tracheal aspirates.
ZELLX® RT-qPCR technology allows efficient cDNA synthesis and Real-Time PCR in a single tube. The qPCR Master Mix provided in the kits contains all the reagent (except PCR primers, probe and template) needed for running PCR reactions. To prevent the degradation of viral RNA by RNases, the kit comes with a vial of Ribonuclease (RNAse) inhibitor.
The kit is offered in two versions:
- ZX-22100-100: SARS‐CoV-2 Real Time-qPCR Detection Kit for 100 test reactions (RXNS)
- ZX-22102-250: SARS-CoV-2 RT-qPCR Detection kit (N&RP) for 250 reactions
Both kits contain one set of primers and fluorescent probe designed according to target region of the virus nucleocapsid (N) gene and to detect the human RNase P used as a control to assess specimen quality. The probes have readout in different channels. Coronavirus SARS-CoV-2 RNA targets are amplified and detected in the FAM channel, while human RNase P RNA targets are amplified and detected in the HEX, VIC or JOE channel (depending on equipment).
The 250 test version includes a positive control (PC), needed to demonstrate that the PCR amplification is working efficiently with the supplied components. To confirm absence of contamination, a non-template (negative) control reaction should be included every time the kit is used. The 250-test kit additionally includes a separate Reverse Transcriptase.
ZELLX® ZX-55109-96 SARS-CoV-2 IgG ELISA Kit
The SARS-CoV-2 virus is a positive-sense single stranded RNA virus, and has four structural proteins, known as the S (spike), E (envelope), M (membrane), and N (nucleocapsid) proteins. The N protein holds the RNA genome, while the S, E, and M proteins together create the viral envelope. The S protein mediates viral entry into host cells by initial binding to the host ACE2 receptor through the receptor-binding domain (RBD) in the S1 subunit and then fusing the viral and host membranes through the S2 subunit. The RBD residues 331 to 524 of the S1 protein elicits the production of antibodies in the host.
A coronavirus ELISA serological assay allows the study of the immune response to SARS-CoV-2 in a qualitative and quantitative manner, to determine the precise rate of infection in an affected area, a prerequisite for accurately determination of infection fatality rate. Serological assays also allow identification of individuals with strong antibody responses, who could serve as donors for the generation of serum antibody-based therapeutics, as well as permitting health authorities to determine who may be immune and who is not.
The ZELLX® SARS-CoV-2 ELISA 96-well kit allows measurement of SARS-CoV-2-specific IgG (N&S Proteins) response within 90 minutes from serum samples, with 100% sensitivity and greater than 96% specificity. The kit provides materials for 46 tests in duplicate.
ZX-22101-500 Viral RNA extraction Kit (500 rxns)
The ZELLX® Viral RNA extraction Kit is designed for the quick purification of viral RNA from cell-free samples such as serum, plasma, urine, and other body fluids, cell culture supernatants and rinse liquid from swabs samples.
The viral RNA molecules bind to the silica-based membrane, and impurities such as proteins and nucleases are removed by thorough washing with Wash Buffer. The RNA is then eluted in sterile, RNase-free water.
The Extraction Kit provides sufficient materials for 500 test reactions (rxns) and can be used in RT-PCR and qRT-PCR for viral detection, viral load monitoring, and viral genotyping. The kit additionally contains carrier RNA that improves binding and recovery of low-concentrated viral RNA.
The procedure can be used for isolation of viral RNA from a broad range of viruses with 100% specificity and sensitivity above 98%. However, performance cannot be guaranteed for every virus species and must be user validated.
The isolated viral RNA is ready to use and should be stored at -70°C. The quantity of purified viral RNA depends on different parameters, including sample type, virus titer, sample source, transport, storage, and age.
Click on ZX-22100-100 (100 RXNS) Coronavirus (SARS‐CoV-2) Real Time-qPCR Detection Kit for product details.
Click on ZX-22102-250 (250 RXNS) SARS-CoV-2 – RT-qPCR Detection kit (N&RP) for product details.
Click on ZX-55109-96 SARS-CoV-2 (COVID-19) IgG ELISA Kit for product details.
Click on ZX-22101-500 Viral RNA extraction Kit (500 rxns) for product details.