Covid 19 Rapid Antigen Test Kit Saliva/ Sputum/ Stool

Nasal / NP Swab/ OP Swab

15 Minute Detection Window

COVID-19
S2 Rapid Antigen Test Kit

Why we need
Antigen Test?

Compared with antibody detection, antigen detection can detect the virus in the incubation period, acute phase or early stage of the disease.

It is especially suitable for scenarios where nucleic acid detection equipment and professionals are lacking to support the pace and scale of infected population.

Unique.
Solution

  • We test using Nasal/NP/OP swabs.

    Throat and Nose Swabbing has been most prevalent method of testing globally.

  • We do on the spot results in 15 minutes. With Mobile AI App. Integrated for National Use. No labs required.

    Which means this test can be self administered in test facility without storing and sending the samples to the labs.

Current
model

Current Model

Rapid Test.
Model

Rapid Test Model

COIVD-19
Rapid Antigen Test Kit

Nasal Swab / NP Swab / OP Swab

  • Sensitivity     97%+
  • Specificity     100%
  • Order Now

Differentiated
Swabs

Rapid Test Model

Compare.methods
for accuracy, and reasons for its accuracy

Speciality/Tests Traditional Antigen Test Kit sensingSelf Logo
S2 Covid-19 Rapid Antigen Test
Sensitivity Depends on the quality of the antibody (50%-85%) High ~97%+
Specificity Severe cross-reaction (80%-95%) Very High, No cross reaction ~100%
SARS-CoV-2
Mutant Strain
Does not work and is not effective in identifying strains Valid identification, has higher sensitivity to evolutionary strains
Product Flexibility No flexibility Genetically engineered design, continuous optimisation
Product Extensibility Cross with MERS and other viruses, cannot be distinguished Combined with MERS, Influenza A/B Virus for detection as multiple virus detection kit

Detection.
Window

Detection Window

Innovative
Detection Method

The Detection method is an innovative detection method that uses Colloidal Gold as a conjugate.

Viral antigen detection is a candidate strategy to achieve early diagnosis of SARS-CoV-2 infection. Nucleocapsid protein (NP) is one of the predominantly expressed structural proteins and has been confirmed as an ideal target for early diagnostic detection of SARS-CoV-2

The N gene is more conserved and stable, with 90% amino acid homology and fewer mutations over time. N proteins of many coronaviruses are highly immunogenic and are expressed abundantly during infection

This is one of the most powerful method that is widely used today in clinical testing.

Why Nucleocapsid Protein based
Antigen Test method for accuracy, and
reasons for its accuracy.

ACE-2 Receptor Latex Method Antigen Test

Regarding high sensitivity: Our antigen detection method uses the Nucleocapsid protein as target to capture the new coronavirus, which is extremely sensitive.

Regarding 100% specificity: Our antigen detection method has very high specificity, no cross-reactivity, and can identify all mutant strains. And the more infectious the mutant strain, the better our sensitivity.

Clinical Validation Sample Report

Clinical Validation
Sample Report
Covid-19

S2 Covid-19 Rapid Antigen Test Kit

Nasal Swab / NP Swab/OP Swab

S2 Covid-19

Rapid Antigen Detection Kit

Nasal Swab / NP Swab/OP Swab

Rapid Antigen Detection Kit

Advantages:

Immediate detection on Day Zero of infection for treatment protocol
On the spot results in just 15 minutes
100% Accuracy for Specificity, 97%+ Accuracy for Sensitivity
No False Negatives
Extensible - No cross reactivity to other viruses hence extensible to other viruses like IFV A and IFV B

Clinical Validation of
S2 Covid-19 Rapid
Antigen Test Kit
Nasal/NP/OP Swabs

August 2020

Covid 19 Rapid Antigen Test Kit Saliva/ Sputum/ Stool
Sensitivity97.1%
Specificity100%
Accuracy99.1%

Covid-19 Mutations

Mutations / Strains.
Detection

At present, there are many variants of the Novel coronavirus (SARS-CoV-2), and the N501Y mutation and its approximate variants have attracted attention because their mutation position is located in the spike glycoprotein's receptor-binding domain of the virus, thereby changing the virus infected efficiency. In Silico analysis demonstrated that the N501Y mutation did not alter the primary and tertiary protein structure of the spike protein RBD domain. Therefore, its antigenicity remains unchanged.

The detectability of genetic SARS-CoV-2 variants was tested by examining the sensitivity toward recombinant SARS-Cov-2 spike proteins (319 to 541 aa). In these tests, the Sensing Self’s S2 Covid-19 Rapid Antigen Test Kit achieved the same values when detecting the B.1.1.7 (UK) and B.1.351 (SA) variants as when detecting the standard variant.

S2 Covid-19

Rapid Antigen Detection Kit

Nasal Swab / NP Swab / OP Swab

Order Now
Antigen S2

Multiple Virus Detection

Benefits

Rapid Antigen Test

  1. Exponentially faster
  2. No Queues, No Wait time for results
  3. Exponentially more cost effective
  4. Early Detection & Elimination
  5. Effort less, and accessible to everyone
    nationwide, instantly
  6. Viable precautionary step
  7. Cost Effective
  8. Return to Work solution
  9. High effective for early detection and scaling
  10. Order Now

Understanding Antigen Testing

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?
  1. An Antigen test can only reveal if the person is “currently” infected with the SARS-COV-2 virus.
  2. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
  3. 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.