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Authorized Canadian Representatives of Medlink World LLC

FaStep COVID-19 Antigen Rapid Test Device

     (Health Canada approved) Key Features and USPs

  1. Approved by Health Canada and in a total of 17 countries
     

  2. FaStep Antigen Test has 99.1% specificity (which means if the test shows a patient is negative, the patient is truly negative consequently ensuring very miniscule possibility of false negatives).
     

  3. The product can detect Delta Variant which accounts for 95.8% of COVID-19 cases these days. No other rapid antigen test can claim that. Data substantiating this capability is available.
     

  4. The Test has become so reliable that it is being used as a reference given that PCR tests have not been designed to pick up the Delta Variant and are consequently reporting many false negatives.
     

  5. The Test is now approved for the less invasive oral swab and exhibits the same accuracy with this alternative. This is especially significant because it makes it easy to perform on school going children and elderlies.
     

  6. The product shelf life is 12 months unlike some antigen tests where it is only for 6 months which helps in better inventory management and keeping stock piles without the risk of expiration within six months.

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FaStep COVID-19 Antigen Rapid Test Device

Background :
Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the North america. To effectively end the SARS- CoV-2 pandemic, systematic screening and detection of both symptomatic and asymptomatic COVID-19 cases is critical.

Solution :
As an intended point-of-care (POC) designated test with a 10 minutes processing time, FaStep™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.

Unique Features of the Diagnostic Solution.

• No Instrumentation required (Visually read by naked eyes)
• Lateral flow assay
• Rapid results within 15 minutes
• Specimen used is nasal or oral swab
• Intended use at POC setting (i.e., in patient care settings) by trained staff
• Detect SARS-CoV-2 wild type and mutants
• Identify acute infection with high sensitivity of 97.1% and specificity of 99.1%.

  • Medlink World LLC has access to large product lots for immediate delivery of FaStep Antigen Test.
     

  • With COVID-19 Antigen Rapid Point of Care test kits you get results in 15 minutes. For use by healthcare professionals in CLIA waived settings. Very affordable. No separate analyzer or equipment needed. Authorized by Health Canada for emergency use.
     

  • This Antigen tests provide an important service to patients, essential workers, government agencies, educators pharmacy and others who need information relating to their exposure to infection of COVID-19.

  • With the second wave of COVID-19 infections and the Delta variant underway, the demand for antigen testing solutions has never been higher. The FaStep test kit supplied by Medlink World is an important tool in the service of the community.

COVID-19 ANTIGEN RAPID TESTS PRODUCT HIGHLIGHTS

Test
FaStep Antigen
Health Canada Authorization
Yes
FDA Authorization
No
Target
Nucleocapsid Antigen
Point-of-Care
Yes
Analytical Sensitivity (LOO)
1.2X 102 TCID50/mL
Type
Nasopharyngeal or Oropharyngeal
Specificity Specimen
99.1%(Nasal & Oral Swab)
Sensitivity Clinical
97.1% (Nasal & Oral Swab)
Processing Time Clinical
15 minutes
Cross Reactivity
No
Preparation Time Known
None
Instrument Required
No
Technique
Lateral flow chromatographic Immunoassay

The USP of FaStep Antigen Kit

The FaStep antigen test kit outstanding specificity makes it a fit tests for large scale screening program.

All positive cases need to be confirmed with a PCR. Negative test results need not go for RT-PCR tests because the test has 99.1% specificity*

* All diagnosis should be made keeping in mind corroborating patient evidence, symptoms and exposure to COVID-19. No diagnosis should be made on single evidence or in isolation.

Testimonial From Largest Surgery Group

Business Partners Using Our Antigen Test

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