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%.
