Covid 19 Rapid Antigen Test Kit Saliva/ Sputum/ Stool
15 Minute Detection Window

COVID-19
SALIVA / SPUTUM / STOOL
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 from Saliva, Sputum or Stool.
    No NP/OP swabs

    Saliva, Sputum and/or Stool has the highest viral load compared to swabbing.

  • We do on the spot results in 15 minutes.
    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
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COVID-19
Rapid Antigen Test Kit

SALIVA / SPUTUM / STOOL

  • Sensitivity   90%+
  • Specificity   100%

Compare.methods
for accuracy, and reasons for its accuracy

Speciality/Tests Traditional Antigen Test Kit sensingSelf Logo
S1 Rapid Antigen Test
Sensitivity Depends on the quality of the antibody (50%-85%) High ~95%+ for Sputum and Stool 90%+ for Saliva
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

S1 Rapid Antigen Test Kit

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S1 Covid-19
Rapid Antigen Detection Kit

Saliva / Sputum / Stool

Advantages:

  • Immediate detection on Day Zero of infection for treatment protocol
  • On the spot results in just 15 minutes
  • No uncomfortable swabbing for NP/OP sampling
  • 100% Accuracy for Specificity, 90%+ Accuracy for Sensitivity No False Negatives
  • Extensible - No cross reactivity to other viruses hence able to detect the novel coronavirus and all its mutant strains

Clinical Validation
of Covid-19 Rapid
Antigen Test Kit

August 2020

S1 Covid-19
Rapid Antigen Detection Kit

Saliva / Sputum / Stool

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Clinical Validation Sample Report
Product Comparison

Product
Comparison

SensingSelf saliva/sputum/stool test is a new method for testing people suspected of SARS-CoV-2 infection. It still relies on a scientific process as other tests, we made it simpler to drive down costs, eliminated the need to use Lab and place less stress on the supply chains.

SensingSelf ANTIGEN test is unique in 3 ways:

  1. We test from Saliva, Sputum or Stool, not NP/OP swabs. Saliva, Sputum and/or Stool has the highest viral load compared to saliva or swabbing. This means the person does not have to go through a painful and uncomfortable process of being subjected to a swab up your nose, which will increase testing compliance. This also shields caretakers, nurses and other healthcare professionals from probable exposure to infected patients and works around inefficiencies of supply availability.
  2. We do on the spot results in 15 minutes. No labs required. Which means this test can be self administered in test facility without storing and sending the samples to the labs. It also means the test does not require extracting the nucleic acid from samples before testing. Nucleic acid extraction is costly and time-consuming, and there have been worldwide shortage and operating inefficiencies for the supply materials for testing and compatibility of test equipments. Even with Salivary tests, samples are required to be sent to labs, and use of heating equipments and reagents are needed to extract the results. Our method shortens the test detection period to 15 minutes while maintaining the accuracy at a very high level.
  3. Our test is extensible for multiple strains. While the world is grappling with current pandemic, on-set of Influenza in flu season has similar symptomatic outburst in the patients. With additional capability to do on the spot testing of multiple virus (SAR COV-19, MERS, Influenza A/B) strands on the same test strip allows our test to be more aligned for future deployments in the community screening, test labs and hospital providers during recurrence of chronic flu to isolate infectious versus chronic patients.
Comparative Matrix
sensingSelf Logo
BinaxNOW Antigen Test
sensingSelf Logo
S1 and S4 Rapid Antigen Test
SARS Vs SARS-CoV-2 No Differentiation between SARS and SARS-CoV-2 Accurate Differentiation between SARS and SARS-CoV-2
Detection of mutations Lack of detection for different strains of virus like D614G Technology is mutation based / strains agnostics
Sensitivity 97.1% 95%
Specificity 98.5% 100%
False Positive Yes Zero
Specimen NP Swabs based Samples No Swabbing Only sample needed is Saliva/Sputum/Stool
Sample Collection Difficult and prone to errors Easy, Error Free
Product Flexibility Uses traditional double antibody sandwich method hence performance depends on the quality of the antibody used. Genetically engineered design, continuous optimization
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 1-7 days only 1 - 15 days in Saliva & Sputum
1 - 30 days in Stool

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

Research on Saliva / Sputum and its implications on COVID-19 Detection

Stanford Science Daily Science Direct Harvard Nature Sage journals
Stanford Sage journals Science Direct Harvard Nature Science Daily

Understanding Antigen Testing

Understanding Multiplex
Antigen Testing

What is the difference between Single Antigen and Multiplex Antigen Test?
Single Antigen test detects only SARS-CoV-2 but Multiple Antigen detects not only SARS-CoV-2 but also MERS/Flu A/Flu B.
Why do we need Multiplex Antigen test versus Single Antigen Test?

Most of the symptoms of SARS-CoV-2 are very similar to symptoms of MERS or FluA or FluB like fever, fatigue, dry cough, nasal congestion, runny nose and sore throat. In such cases, it becomes a very critical to diagnose the condition of patient and really find out whether it is due to SARS-CoV-2 or MERS/FluA/FluB. If the person feels they have FluA/FluB but actually if they have SARS-CoV-2 then its very dangerous as SARS-CoV-2 is much more contagious than FluA/FluB.

By doing a simple multiplex test, health workers or patient can immediately find out if they are infected with MERS/FluA/FluB or SARS-CoV-2.

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 for this assay is 0.06 pM.
What is the limit-of-detection for this assay?
The limit-of-detection for this assay is 1.5pM of S-protein.
Why use Saliva/Sputum/Stool instead of NP/OP Swabs?
Saliva, Sputum and/or Stool has the highest viral load compared to saliva or swabbing. This means the person does not have to go through a painful and uncomfortable process of being subjected to a swab up your nose, which will increase testing compliance. This also shields caretakers, nurses and other health care professionals from probable exposure to infected patients and works around inefficiencies of supply availability.
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.