How does an Antigen test work?
The COVID-19 Rapid Antigen Test Kit seeks to detect directly the virus rather than the antibodies produced by the body. It finds specific proteins that are present only in the virus. Once the infection has gone, the antigen disappears.
SARS-CoV-2, the virus that causes COVID-19, has several known antigens, which are the visible protrusions on its surface. Our Antigen test captures the S protein of the new coronavirus, which is extremely sensitive.
How is the COVID-19 Rapid Antigen Test Kit different from Real-Time RT-PCR test?
The RT-PCR test, though it detects the antigens, takes a long time to complete the whole process. Its mechanism to detect the virus is also different. Unlike our rapid antigen test, PCR method looks for the genetic material from the virus. It also requires a complex set-up of machines, which eventually becomes expensive and time-consuming.
In contrast, COVID-19 Rapid Antigen Test Kit can take just 15 minutes to produce as accurate results with a slightly different approach. Our Antigen test kit uses ACE2 latex method to detect a specific protein on the virus, thus leading to early detection of the disease.
What are the limitations of Antigen tests?
- An Antigen test can only reveal if the person is “currently” infected with the SARS-COV-2 virus.
- As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
- If the test result is negative and clinical symptoms persist additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of COVID-19 infection.
Why Do We Need Antigen Testing?
As the Antigen test can detect the virus at early stage of the disease, this can greatly address the issue of further and long-lasting damage caused to one’s health due to SARS-COV-2. If a person knows at the early onset of the infection that they are infected, the disease can caught and treated easily avoiding further risks to one’s health.
One can also contribute in controlling the community spread. You could be infected with SARS-COV-2 virus and you may not be aware of it as you have no symptoms. However, this can be risky for the community you live in. Thus, by becoming aware, you can avoid any kind of community transmission.
What is the limit-of-detection for this assay?
The Limit of detection (LoD) per Virus Strain for this assay is 1.25 X 103 TCID50/mL
Can this test detect variants or mutations of SARS-CoV-2?
The S2 Covid-19 Rapid Antigen Test Kit (swab) can detect both the SARS-Cov-2 nucleoprotein as well as the SARS-Cov-2 spike protein. By ELISA, we determined that the antibody we use binds to amino acids 511-531 of the SARS Cov-2 spike protein. The detectability of genetic SARS-CoV-2 variants was tested by examining the sensitivity toward recombinant SARS-Cov-2 spike proteins (319 to 541aa). In these tests, the Novel Coronavirus (SARS-Cov-2) antigen-rapid test achieved the same values when detecting the B.1.1.7 (UK) and
B.1.351 (SA) variants as when detecting the standard variant.
Why use Nasal Swabs for testing ?
Nasal swabs have similar viral load hence similar sensitivity as NP/OP swabs. They also have longer detection window than OP Swabs. In addition, Nasal Swabs are easy to use and much more comfortable than NP/OP swab and can be used across the age groups including children and infants. The have much lower collection-related hazard for healthcare workers than NP/OP swabs which are aerosol generating collection processes.
What is the difference between the NP Swab based Antigen tests and SensingSelf saliva, sputum and stool based tests?
There are many reasons why SensingSelf Saliva/Sputum/Stool Antigen test is better than NP Swab based traditional antigen test:
- Sensitivity: Sensing Self’s Saliva/Sputum/Stool Antigen test (90%+) offers much higher sensitivity than most of the NP based traditional antigen tests available (50-85%)
- Specificity: Sensing Self’s Saliva/Sputum/Stool Antigen test (100%) offers much higher specificity than most of the NP based traditional antigen tests available (85%-95%)
- SARS-CoV-2 Mutant Strain: Sensing Self’s Saliva/Sputum/Stool Antigen test can identify mutations and strains like D614G unlike NP swab based antigen tests
- Detection of SARS-CoV-2: SensingSelf’s Saliva/Sputum/Stool Antigen test can differentiate between SARS-CoV and SARS-CoV-2 unlike NP swab based antigen tests
- Product Flexibility: Since SensingSelf’s Saliva/Sputum/Stool Antigen test is based on genetically engineered design, there is a scope for continuous optimisation unlike NP swab based antigen tests which are based on traditional monoclonal / polyclonal antibodies.
- Product Extensibility: SensingSelf’s Saliva/Sputum/Stool Antigen test doesn't cross react with MERS, FluA, FluB hence multiplex detection is possible unlike NP swab based Antigen test which cross reacts with MERS and other viruses.
What kind of volume can you supply for these tests?
With current capacity, we can supply 10M tests per month.
Are these tests covered by insurance?
The billing code for non-CDC laboratory tests for SARS-CoV-2/COVID-19 is 86328. The patient's insurance company should be contacted to determine coverage and pricing.
Are the kits CE or FDA approved?
Our kits are CE approved.
Do I need a special analyzer to run the COVID-19 Rapid Antigen Test?
No, this test does not require any other analyser or equipment.
What should I do if I my COVID-19 Rapid Antigen Test is positive?
The COVID-19 Rapid Antigen Test can only be used as a reference, please contact your local physician or hospital.
Is each test packed separately and what components are included?
Yes, each test is packed individually in unit of one. Each test included, One test strip, extraction tube with reagent solution, pipette, Paper Cup and Instruction for use (IFU)
What is the difference between an Antibody test and an Antigen test?
An antibody test detects the antibodies produced by the body when any foreign substance enters it and stimulates a response from the immune system. However, an Antigen test directly detects the foreign substance by identifying a molecule on its surface.
An antibody test looks for the traces of the body's response to the virus. If a person is infected with SARS-COV-2, two specific antibodies can be surely found:
- IgM antibodies against SARS-CoV-2, which develops early on in an infection.
- IgG antibodies against SARS-CoV-2, which are mostly found after someone has recovered from the infection.
An Antigen test reveals if a person is currently infected with a pathogen such as the SARS-CoV-2 virus. Once the infection has gone, the antigen disappears. Unlike the antibody test, antigen tests detect proteins or glycans, such as the spike proteins found on the surface of the SARS-CoV-2.
The novel coronavirus invades human cells by specifically binding of its spike glycoprotein (ligand) to ACE2 (receptor) on human cellular membrane with a high affinity (KD measured as 15 nM for the binding of the S protein to the ACE2 receptor), which is 10-20 times stronger than SARS-CoV. Accordingly, we substituted ACE2 receptor for antibody to establish a novel ligand-receptor chromatography test kit for rapid novel coronavirus detection.