SARS-CoV-2 Test (for the COVID-19 Coronavirus)
For use under the Emergency Use Authorization (EUA) only
10 MINUTE RESPONSE
Results can be
obtained within 10 minutes
(when a strongly positive
sample is tested, a
positive result can
appear in 1-3 minutes.)
can be avoided
by using single
POINT OF CARE
It can reduce the
exposure risk of
health care workers
and facilitate early
diagnosis and exclusion
of suspicious cases
Through statistical analysis,
the sensitivity is 96.88%,
the specificity is 100%,
the false positive rate is 0%,
the false negative rate is 3 .12%,
and the total conformity rate is 99%.
IMPORTANT PRODUCT INFORMATION
COVID-19 Rapid Response Test Kit
At present, there are available mainly nucleic acid detection (RT-PCR) and colloidal gold immunochromatography (GICA) for the detection of COVid-19. Compared with nucleic acid detection, the rapid diagnostic kit for COVid-19 is suitable for samples of serum, plasma and whole blood.
According to independent research, sensitivity of the assessed kits is 96.88%, the specificity is 100%, the false positive rate is 0%, the false negative rate is 3.12%, and the total conformity rate is 99%.
The test kit uses immunochromatography and the principle of Capture ELISA to qualitatively detect 2019-nCoV IgG/IgM antibodies. Compared with nucleic acid detection, the rapid diagnostic kit for 2019-nCoV is suitable for samples of serum, plasma and whole blood.
The test is convenient, rapid, highly sensitive, and suitable for large-scale screening. Results can be obtained within 10 minutes. At the same time, cross contamination between samples can be avoided by using single reagent strips. In addition, the rapid response test can reduce the exposure risk of health care workers, and can facilitate early diagnosis and exclusion of suspicious cases.
The clinical report shows that this kit is reliable, accurate, convenient, and has high clinical application value.
Coronaviruses are a large family of viruses which may cause illness in animals or humans. In humans, several coronaviruses are known to cause respiratory infections ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The most recently discovered coronavirus causes coronavirus disease COVID-19.
COVID-19 is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. (World Health Organization)
The Food and Drug Administration (FDA or Agency) is issuing this guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency.
In light of this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency’s good guidance practices.
This test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43,or 229E. (Guidelines)