Evanla Inc has partnered with Zhuhai Encode Medical Engineering Co. to develop and distribute a rapid test kit for the detection of Covid-19 antibody. COVID-19 rapid test kits are suitable for the qualitative detection of SARS-CoV-2 IgM/IgG antibodies in human serum, plasma, or whole blood. The test kit acts as an auxiliary and supplementary method for the further diagnosis to the patients with negative result in PCR.
• This test has not been reviewed by FDA
• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in recent contact
with the virus, due to the lag time between exposure and the patient’s antibody response. Follow-up testing
with a molecular diagnostic test should be considered in order 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 of infection status.
• Positive results may be due to past or present infections with non-SARS-CoV-2 coronavirus
strains, such as coronavirus HKU1, NL63, OC43 or 229E.
• This test is for use by licensed laboratories and does not apply to at-home testing.
• Not to be used for blood donor screening
The tests have not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection.
As per FDA’s guidance on March 16th, 2020, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:
COVID-19 Rapid Test Kits are not intended for at home use. If you feel you need to be tested, please reach out to a local clinic or physician and ask them about offering this test. There may also be free local testing sites in your area, please contact your local community directly.
The rapid test kit provides results as quick as 15 minutes, but it should not be used as the sole criterion for a Covid-19 infection. A RT-PCR test is a highly sensitive and specific test, but requires much more time and professional applications to determine the results.
“A sample is collected from parts of the body where the coronavirus gathers, such as a person’s nose or throat. The sample is treated with several chemical solutions that remove substances, such as proteins and fats, and extracts only the RNA present in the sample. This extracted RNA is a mix of a person’s own genetic material and, if present, the coronavirus’ RNA.
The RNA is reverse transcribed to DNA using a specific enzyme. Scientists then add additional short fragments of DNA that are complementary to specific parts of the transcribed viral DNA. These fragments attach themselves to target sections of the viral DNA if the virus is present in a sample. Some of the added genetic fragments are for building DNA strands during amplification, while the others are for building the DNA and adding marker labels to the strands, which are then used to detect the virus.
The mixture is then placed in a RT-PCR machine. The machine cycles through temperatures that heat and cool the mixture to trigger specific chemical reactions that create new, identical copies of the target sections of viral DNA. The cycle repeats over and over to continue copying the target sections of viral DNA. Each cycle doubles the previous amount: two copies become four, four copies become eight, and so on. A standard real time RT-PCR setup usually goes through 35 cycles, which means that by the end of the process, around 35 billion new copies of the sections of viral DNA are created from each strand of the virus present in the sample.
As new copies of the viral DNA sections are built, the marker labels attach to the DNA strands and then release a fluorescent dye, which is measured by the machine’s computer and presented in real time on the screen. The computer tracks the amount of fluorescence in the sample after each cycle. When the amount goes over a certain level of fluorescence, this confirms that the virus is present. Scientists also monitor how many cycles it takes to reach this level in order to estimate the severity of the infection: the fewer the cycles, the more severe the viral infection is.”
Credit of : https://www.iaea.org/newscenter/news/how-is-the-covid-19-virus-detected-using-real-time-rt-pcr
Please contact us at +1(312)883-5522 or our Sales Manager David at dc@evanla.com for stock and availability.
Yes, we do ship globally. Please email us at dc@evanla.com to be forwarded to the local distributor.
Covid-19 rapid test kits should not be used as the sole criterion to determine for a Covid-19 infection. If you are experiencing symptoms, you should contact your local clinic to do a RT-PCR test to confirm your infection status.