Special Feature :
- Licensed by Indian Government for Use in Approved Labs in India by CDSCO
- Endorsed by WHO-FIND Programme
- European CE-IVD Approved
- Room Temperature Stable Kit, No degradation, No need to maintain cold chain transportaion
- Detection Limit of > 10 RNA copies per reaction for ORF1ab and N gene
- Compatible with most Common PCR equipment
- Prefilled Vials (No Techincal Support needed)
- Cost Effective
- Less Time Consuming & Accurate Results
- SARS-Cov-2 8-well strips : 6×8 well strip
- Rehydration Buffer : 1 Blue Vial
- SARS-Cov-2 Positive Control : 1 Red vial
- SARS-Cov-2 Negative Control : 1 Violet Vial
- Water RNAse/DNAse free : 1 White Vial
- Tear Off 8-cap strips : 6×8-cap strip
1. Intended use
VIASURE SARS-CoV-2 Real Time PCR Detection Kit is designed for the specific identification and differentiation of 2019 Novel Coronavirus (SARS-CoV-2) in respiratory samples from patients with signs and symptoms of COVID-19 infection. This test is intended for use as an aid in the diagnosis of SARS-CoV-2 in combination with clinical and epidemiological risk factors. RNA is extracted from respiratory specimens, amplified using RT-PCR and detected using fluorescent reporter dye probes specific for SARS-CoV-2.
2. Principle of the procedure
VIASURE SARS-CoV-2 Real Time PCR Detection Kit is designed for the diagnosis of SARS-CoV-2 in respiratory samples. The detection is done in one step real time RT format where the reverse transcription and the subsequent amplification of specific target sequence occur in the same reaction well. The isolated RNA target is transcribed generating complementary DNA by reverse transcriptase which is followed by the amplification of a conserved region of ORF1ab and N genes for SARS-CoV-2 using specific primers and a fluorescent-labeled probe.
VIASURE SARS-CoV-2 Real Time PCR Detection Kit is based on the 5´ exonuclease activity of DNA polymerase. During DNA amplification, this enzyme cleaves the probe bounded to the complementary DNA sequence, separating the quencher dye from the reporter. This reaction generates an increase in the fluorescent signal which is proportional to the quantity of target template. This fluorescence can be measured on Real Time PCR platforms.
VIASURE SARS-CoV-2 Real Time PCR Detection Kit contains in each well all the components necessary for real time PCR assay (specific primers/probes, dNTPS, buffer, polymerase and retrotranscriptase) in an stabilized format, as well as an internal control to monitor PCR inhibition. ORF1ab gene is amplified and detected in FAM channel, N gene is amplified and detected in ROX channel and the internal control (IC) in HEX channel, VIC or JOE channel (depending on the equipment used select the proper detection channel, see Annex 2).
VIASURE SARS-CoV-2 Real Time PCR Detection Kit has been validated on the following equipments: Applied Biosystems 7500 Fast Real-Time PCR System, Applied Biosystems StepOne™ Real-Time PCR System, Bio-Rad CFX96™ Real-Time PCR Detection System, Agilent Technologies AriaMx Real-Time PCR System, DNA-Technology DTprime Real-time Detection Thermal Cycler, DNA-Technology DTlite Real-Time PCR System, Rotor-Gene® Q (Qiagen), SmartCycler® (Cepheid), Roche Molecular Diagnostics Cobas z480 Analyzer, VIASURE 48 Real Time PCR System and VIASURE 96 Real Time PCR System. When using the Applied Biosystems 7500 Fast with strips it is recommend to place a plate holder to reduce the risk of crushed tube (Ref. PN 4388506).
3. Transport and storage conditions
• The kits can be shipped and stored at 2-40ºC until the expiration date which is stated on the label. • Once the positive control has been re-suspended, store it at -20ºC. We recommend to separate it in aliquots to minimize freeze and thaw cycles. Positive control has been validated as still being stable after 6 freezethaw cycles. • Keep components away from sunlight.
To be Used By Approved Labs By Govt of India
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