Intended Use
This product is used for the qualitative detection of SARS-CoV-2
(COVID-19) the S and Ngenes in the throat swab and sputum sample. This
kit is applicable to qualitatively test of the novel
coronavirus(COVID-19,also known as SARS-CoV-2) in a suspected case of
pneumonia infected with a Novel Coronavirus,a suspected case of a
cluster,other patients who need to be diagnosed with a novel coronavirus
infectin or differential diagnosis.
Principle
This kit uses One-Step Real-Time PCR and TaqMan-MGB fluorescent probe
technology. Primers and probes are designed in the highly conserved
regions of the S and N gene sequences of COVID-19, and human RNase P
gene as internal control. This kit has been validated on samples
extracted from sputum, nasopharyngeal and throat swabs. Three
fluorescent reporters are incorporated into this test: FAM measures the
COVID-19 S gene; VIC measures the COVID-19 N gene; CY5 measures human
RNase P gene as internal control.
Sample requirements
The nucleic acids extraction in throat swabs or and sputum sample
from individual suspected of COVID-19 infection by their health provider
is required for the detection. Specimen collection should avoid
possible contamination in collection, storage, and transportation.
Samples can be inactivated at 56¡æ for 30 minutes. Following extraction,
RNA samples should be used immediately or stored at -70¡ãC for use later.
Avoid and minimize repeated sample freezing and thawing.
Performance Characteristics
Analytical sensitivity (limit of detection) is defined as the lowest
concentration at which the detection rate of at least 95% for 20
samples. The analytical sensitivity of the assay was determined by
analyzing a dilution series of in vitro transcribe (Pseudovirus) RNA
from 20 to 500 copies/mL for S gene and N gene. The testing was carried
out in either 5-replicates (for concentrations¡Ý200 copies/mL) or
10-replicates (for concentrations<200 copies/mL).
Storage and validity
The kit reagents should be stored at -20¡À10¡æ in the dark in a
freezer. When properly stored, the reagents are stable for 12 months
when sealed and 2 months after initial use. Avoid and reduce repeated
freezing and thawing. The reagents should be discarded after 5 times of
freezing and thawing. If reagents will be used intermittently, it is
suggested to keep the reagents frozen in aliquots.
