Product Description
REAGEN™ The COVID-19 Real-time fluorescence PCR detection Kit is intended for research and diagnostic applications. The COVID-19 Real-time fluorescence PCR detection Kitis an in vitro Nucleic Acid Test (NAT) based pathogen detection product. The COVID-19 Real-time fluorescence PCR detection Kit is designed to detect N gene and ORF1ab gene of severe acute respiratory syndrome-Coronavirus (COVID-19) nucleic acids in respiratory , alveolar lavage fluid ,serum and blood samples.
The COVID-19 Real-time fluorescence PCR detection Kit can be used in clinical practice and for research purposes for COVID-19 diagnostics.
Procedure Overview
REAGEN™ The COVID-19 Real-time fluorescence PCR detection Kit is based on RNA reverse transcription process and consequential cDNA fragments amplification with polymerase chain reaction (PCR) method. The amplification process lies in repeated cycles: thermal DNA denaturing, primer annealing with complementary sequences and further polynucleotide chains completion by Taq-polymerase.
The COVID-19 Real-time fluorescence PCR detection Kit, DNA probes, each of which contains a fluorescent label and fluorescence quencher, are included in PCR mix. In case of specific сDNA product formation, a probe gets destroyed and that leads to fluorescence level growth registered by special appliances.
DNA probes used for N gene and ORF1ab gene PCR products detection are labeled with Fam and Rox fluorescent probes accordingly. That allows separate severe acute respiratory syndrome coronavirus2 cDNA sample PCR results registration. For PCR products analysis, detecting PCR cyclers should be used.
The COVID-19 Real-time fluorescence PCR detection Kit is based on real-time detection of the target DNA sequence. Real-time PCR technology is based on measurement of the fluorescence at every cycle of reaction. The PCR-mix contains target-specific hydrolyzing probes bearing reporter and quencher molecules. Once hybridized to a target sequence, the probe become activated. As a result of activation fluorescence increases proportionally to target sequence amplification. The intensity of fluorescence is detected with a real-time PCR thermal cycler data collection unit and analyzed with the software provided.
Note: components of different batches can not be used interchangeably. Components in the kit should be fully mixed and centrifuged before use (it is recommended to mix them by flicking or reversing,not by vortex oscillator). Repeated freeze-thaw should be avoided as much as possible!
Warnings and Precautions
The laboratory makeup should comply the requirements regulating work with microorganisms of I-IV classes of pathogenicity.
Handle and dispose all biological samples, reagents and materials used to carry out the assay as if they were able to transmit infective agents. Avoid direct contact with the biological samples reagents and materials used to carry out the assay. Any material coming in contact with the
biological samples must be treated for at least 30 minutes with disinfecting solution or autoclaved
for 1 hour at 121ºC before disposal.
TORAGE AND HANDLING REQUIREMENTS
The kit is stored at - 20 ℃, and its validity is 12 months. Please use within the validity period.
An expired COVID-19 Real-time fluorescence PCR detection Kit must not be used.
We strongly recommend following the instructions to get robust and reliable results. The conformityCOVID-19 PCR Test Kit- RNS92049
of the COVID-19 Real-time fluorescence PCR detection Kit to the prescribed technical requirements is subject to compliance of storage, carriage and handling conditions recommended by manufacturer.
LIMITIONS
1. The sample test results are related to the quality of sample collection, processing, transportation and preservation.
2. If cross contamination occurs during sample processing, false positive results may appear.
3. The gene mutation of the virus in the process of epidemic may lead to false negative results.
4. The test results are only for clinical reference. If you need to confirm the case, please combine the clinical symptoms and other test methods.
SPECIFICATIONS
Sensitivity: 500 copies/ml.
Diagnostic sensivity: 99.8%.
Diagnostic specificity: 100%.
