SBL’s team of experts have real-world industry experience and are ready to help you at any stage in your workplace testing program. We offer flexible lease and purchase options, tailored to your companies’ needs. Our online administrator certification training programs tracks your team’s training, and we walk you through the non-negative lab/MRO through every step from obtaining a second sample to retrieving your results from the secure online portal.
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COVID-19 Antibody Rapid Test Kit Questions
The Real-Time RT-PCR (nucleic acid test) for SARS-CoV-2 is based on the detection of viral RNA, and it is the gold standard for COVID-19 diagnosis. The results for this nucleic acid test might take up to 3.5 hours, and the increased complexity of viral RNA extractions and PCR reaction setups require highly trained laboratory personnel. The COVID-19 IgM/IgG antibody rapid test is a qualitative test for COVID-19 IgM and IgG antibodies. It is less complex and can provide results in less than 15 minutes. However, it should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
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 have 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. Following-up with molecular diagnostic testing 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.
No, the IgM/IgG rapid test does not require any other equipment. Aurora’s COVID-19 Antibody IgM/IgG Rapid Test Kit provides all the tools you need from sample collection to result reading.
Please refer to the product manual included with the test.
Yes, each test is packed separately in the box. Each test includes a COVID-19 IgM/IgG Rapid Test cassette, disposable pipet, and sample dilution buffer. Each box contains one copy of the product manual.
The minimum order is one box for either of these COVID-19 Antibody Rapid Test. This would be for 25 tests for the non-point of care test, and 20 tests for the point of care, CLIA waived test.
The time for you to receive your order will depend on a number of factors. To receive more information on shipping times and your tracking number, please get in contact with us by email at [email protected], or give us a call at +1-877-373-8948.
The COVID-19 Antibody Rapid Test Cassette will produce results within 10 minutes of placing the sample in the cassette. Results will not be valid after 15 minutes.
COVID-19 IgM/IgG 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
The earliest time for a positive antibody test result (on the IgM line) would be about 7 days after the first clinical symptoms. These first clinical symptoms usually occur about 14 days after the first infection.
The COVID-19 Antibody Rapid Test can only be used as a reference, please contact your local physician or hospital.
COVID-19 Safe Entry Station Questions
The Safe Entry Station uses multispectral thermal imaging cameras and a proprietary artificial intelligence algorithm developed by medical Clinicians and Data Scientists globally. It identifies individuals who are exhibiting symptoms that associate with infectious diseases such as COVID-19.
At the moment, any outbreak associated with the common cold or flu is by default to be associated with COVID-19. Therefore, health agencies are recommending that anyone who is showing associated symptoms stay home.
It typically takes between 1-2 seconds for the scan to process.
Based on WHO report, an asymptomatic laboratory-confirmed case is a person infected with COVID-19 who does not develop symptoms. Asymptomatic transmission refers to transmission of the virus from a person, who does not develop symptoms. There are few reports of laboratory-confirmed cases who are truly asymptomatic, and to date, there has been no documented asymptomatic transmission. This does not exclude the possibility that it may occur. Asymptomatic cases have been reported as part of contact tracing efforts in some countries.
Data from published epidemiology and virologic studies provide evidence that COVID-19 is primarily transmitted from symptomatic people to others who are in close contact through respiratory droplets, by direct contact with infected persons, or by contact with contaminated objects and surfaces. This is supported by detailed experiences shared by technical partners via WHO global expert networks, and reports and presentations by Ministries of Health. As such based on current data, symptomatic transmission is responsible for the spread of COVID-19. Therefore, the key is to identify the majority of symptomatic individuals to prevent transmission which is the purpose of our mass screening technology.
The AI technology monitors and identifies potential presence of COVID-19 associated symptoms such as fever, cough, exhaustion, congestion, sweat gland activation, eye redness and headache, along with other key determinant factors.
The units provided are self-sufficient and only require internet connectivity. Multispectral cameras installed within the units communicate with the cloud servers for analysis.
The PredictMedix technology is different than the other fever scanners on the market that are simply measuring body temperature. The AI looks not only at body temperature, but at 5 specific facial points, which indicate a truly medically induced fever, versus someone who may be hot because of temperature conditions etc. It also measures 6 other known COVID-19 symptoms, before rendering a result.
The technology is currently 95% accurate on a negative predictive analysis for identification of symptoms*. However, because artificial intelligence is continually learning, as more data is collected, that percentage will increase.
The Safe Entry Station is entirely non-invasive and safe; the underlying hardware used for data capture is approved by the FDA and Health Canada.
Typically internet bandwidth of above 25 Mbps is required for a single scan station.
Safe Entry Stations do not store any personal identifiers or contact information. The multispectral camera gathers the data, which is then processed, and the result is displayed in the form of a red or green light. At this point, the data is immediately purged. The algorithms run on dedicated servers with stringent access control. As an additional layer of protection, all camera feeds are anonymous.
Comprehensive training and service support for your testing programs.
We offer comprehensive product training and administrator certification for end-users who have purchased testing products directly or through our partners.