P743H - SARS-CoV-2 Delta Mutant Nucleic Acid Multiplex Detection Kit
Tianlong
China
1-2 weeks
50000 Test/M
TianLong SARS-CoV-2 RNA and E484Q/P681R Multiplex Detection Kit is intended for the qualitative detection of SARS-CoV-2 RNA and the E484Q/P681R mutant in S gene of SARS-CoV-2 by Real-time Reverse Transcription Polymerase Chain Reaction (Real-time RT-PCR) method. The test results are only for clinical reference, which can not be used as the sole basis for confirming or excluding cases.
SARS-CoV-2 and E484Q/P681R Mutant Nucleic Acid Multiplex Detection Kit (Fluorescence PCR Method)
Intended use:
The TianLong SARS-CoV-2 RNA and E484Q/P681R Multiplex Detection Kit is intended for the qualitative detection of SARS-CoV-2 RNA and the E484Q/P681R mutant in the S gene of SARS-CoV-2 by Real-time Reverse Transcription Polymerase Chain Reaction (Real-time RT-PCR) method.
The test is designed to detect SARS-CoV-2 RNA and the E484Q/P681R mutant in the S gene of SARS-CoV-2 in specimens such as nasopharyngeal or oropharyngeal swabs collected from individual personnel based on clinical and/or epidemiological criteria. Other sample types from the upper and lower respiratory tract (such as sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate), as well as samples collected from the environment, may serve the purpose for virus detection as well if adequate SARS-CoV-2 RNA and the E484Q/P681R mutant in the S gene of SARS-CoV-2 could be extracted from the samples. The potential candidate personnel to be tested could include, but are not limited to patients with symptoms of infection who are suspected of COVID-19 by healthcare providers, or persons with no symptoms from a population for screening test confirmation or exclusion of viral infection or viral carriage status.
Principles of the Assay:
The assay is designed to target the well conserved regions of N protein genes, the mutation sites of E484Q and P681R in the S gene.
The specific primers and probes set are designed, the different fluorophores labels are used to multiplex detection of N gene and the mutation sites of E484Q and P681R in the S gene. Nucleic acids are extracted from designated samples with adequate methods and materials. After reverse transcription, the presented target sequences will be amplified by respective specific primers and detected by TaqMan probes. During the extension phase of each PCR cycle, the Taq polymerase cleave reporter dye off the 5′ end of the probe, separate dye from the quencher, producing fluorescent signals. The increasing fluorescence signals are detected over the PCR course and data analyzed.
A specific primer and probe set is designed for a human housekeeping gene GAPD which serves as the internal control (IC) for this assay. GAPD is consistently expressed in human cells that are present in intended samples for the assay. The occurrence of false negatives due to issues in sample quality and/or extraction process can be monitored and controlled effectively.
Reagent Storage, Shipment, and Handling
All reagents should be stored at the temperature between -25°C to -15°C in a non-frost-free freezer for use before the expiration date. Freeze/Thaw more than three times should be avoided during the kit usage period. The reagents should be shipped at the temperature between -25°C to 8°C.
Product Info.:
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Order Code
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P743H
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Specification
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50 Tests /Kit
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Target
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N gene and the mutation sites of E484Q and P681R in the S gene
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Sensitivity
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200copies/mL
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Specimen
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Human nasopharyngeal swabs, sputum, lower respiratory tract specimens, environment specimens
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Storage
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All reagents must be stored at –25°C to –15°C for 12 months. -25°C and 8°C for shipment.
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Applicable Equipment
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Instruments with with FAM, VIC (HEX), ROX(Texas Red) and Cy5 channels, i.e. TianLong Gentier real time PCR systems.
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FAQ
What is the difference between Gentier96 and Gentier48 ?
1.1 Sample throughout difference: Gentier96 can process maximum 96 samples per run, Gentier48 can process maximum 48 samples per run; 1.2 Fluorescence channel difference: Gentier96 E/R has 6/4 fluorescence channels separately, Gentier48 E/R has 4/2 fluorescence channels; 1.3 Light source location difference : The light source of Gentier96 is on the top,