COVID-19 RAPID ANTIGEN TEST 

MADE IN THE UK  - CLINICALLY TESTED - MHRA COMPLIANT - USED WITHIN THE NHS

 

COVID-19 Coronavirus Rapid Test Cassette 
 

Our COVID-19 Antigen rapid Test Cassette identifies COVID-19 present in a swab sample and gives a qualitative yes/no result within 15 minutes.  

Experts are now in agreement  the only way to win the war against COVID-19 is mass testing, this has begun in UK in Liverpool and will soon be Nationwide. Most of Europe are also becoming engaged in mass testing.

The test is perfect for businesses and communities who need to find the asymptomatic employees / people who unknowingly are silently spreading the virus in the workplace, team and community. 

Implementing rapid screening for COVID-19 has huge time and cost savings when compared to, laboratory screening, and will help to control the spread of the virus by identifying active infection rapidly and accurately including asymptomatic cases which account for over 75% of all positive tested people.

A swab is used to sample from either the nose or throat (nasopharyngeal or oropharyngeal sample) and introduced into the test cassette by suspension in a buffer solution.

Now being used by the NHS throughout the West Midlands

 

4 Easy steps - 15 minute result 

Step 1

Ensure all devices and reagent are between 15-30 degrees or room temperature. Insert throat swab ensuring it makes contact with the tonsils or tonsil area.

step 2

Insert swab into the top of the nasal passage and rotate 2 or 3 times. Prepare extraction tube with pateints name and stand in the holder provided.

step 3

Insert 10 drops of buffer fluid into the extraction tube then introduce both swabs one at a time into the tube and stir gently pressing the swab head against the walls of the tube. Stand for 2 minutes

step 4

Insert extraction nozzle into the tube then upend the tube and squeeze 2 drops of the fluid into the cassette well and wait 15 minutes. Result reading = 1 band appears at the C marker this confirms the test is valid and if a second line appears below next to the T marker this is a positive test, if no second line appears its a negative test.    

         
 
 
           Benefits of our COVID-19 Rapid Test Cassette

•       Significant time and cost-saving over lab methods

•        Identifies even in mild or asymptomatic cases

•        Screen anywhere

•        Results within 15 minutes

•        Assists in the control of viral transmission throughout the workplace and society

•        Ideal as a triage and screening tool

•        Easy to use and read, with no specialist equipment required

     
 
     Clinical Studies Results

 

           How accurate is the test?

 

          • Relative Sensitivity: 94.55%
          • Relative Specificity: 97.1% - 100%
          • Overall agreement 98.61% 
           Confidence interval 95%
 

          Our several clinical studies are evidence of the usability and effectiveness of the test.

          For full clinical trial data please contact out technical team on info@workwear-direct.com

 

 

 

 

 

           

          Our Pricing

Our test kits are sold in boxes of 25, each test kit is individually packaged and includes swabs, cassette, and extraction tube,together with enough buffer fluid for 25 tests.
 
 
 
For wholesale and volume pricing please contact your representitive, please note that demand is very high at this time and we are serving everyone on a first come first serve basis. 
 
 
 
 
 
 
   
Please  Contact us for Clinical Studies & White Papers 
FAQs

How does the test work?

 

Diagnostics COVID-19 Antigen Rapid Test detects SARS-CoV-2 viral antigens through visual interpretation of color development. Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-CoV-2 antibodies conjugated to colored particles are immobilized on the conjugated pad. This test is also reffered to as a laterall flow test.

 

A sample is added to the extraction buffer which is optimized to release the SARS-CoV-2 antigens from specimen. During testing, the extracted antigens bind to anti-SARS-CoV-2 antibodies conjugated to colored particles. As the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by the anti-SARS-CoV-2 antibodies at the test region.

 

Excess colored particles are captured at the internal control zone.  The presence of a colored band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking is working.  

 

Is the test CE marked? Does it have IVD certification?

 

Yes, the COVID-19 test is CE marked for professional use and is therefore a registered IVD device.

Has the test been accredited?

 

The COVID-19 test is CE marked for professional use and is therefore suitable and ready for use by a healthcare professional. In addition to our clinical evaluations already completed on the product, we are currently working with a number of independent laboratories and Departments of Health across Europe to further validate the product and gain best practice approvals.

Do the NHS use this test ?

 

Yes the NHS were the first to use in the UK and started in November 2020 

Do you have a confirmation lab test for Coronvirus to confirm positive samples?

 

This screening test is designed to be used alongside a robust screening protocol with laboratory confirmations. We would recommend you work within your healthcare institution to ensure the correct protocols are being followed when using this product.

What is the test procedure ?

 

Bring devices, reagents, and specimens and/or controls to room temperature (15~30℃) before use.

1.  For each specimen, open the foil pouch just before testing and remove the test device, and put it on a clean, level surface. Label the tube with the patient                identification. For best results, the assay should be performed within one hour.
2. Gently mix extraction buffer. Add 10 drops into the extraction tube.
3. Insert the swab into the extraction tube. Mix well and squeeze the swab 10-15 times by compressing the walls of the tube against the swab. Stand for 2                      minutes.

4. Roll the swab head against the inner wall of the tube as you remove it. Try to release as much liquid as possible. Dispose of the used swab in accordance with         your biohazard waste disposal protocol.  

5.  Insert nozzle into sample extraction tube. Invert the tube and add 2 drops of solution into the sample well by gently squeezing the tube.

6.  Read results at 15 minutes.

So can the test detect asymptomatic patients?

 

Yes, the test will be able to detect COVID-19 in asymptomatic people, as they will have an immune response even though they don’t display symptoms. The timeline of infection will be the same as someone displaying symptoms.

What is the shelf-life of the test cassette?

 

The shelf-life is 18 months from the date of manufacture. The product expiry is printed onto the packaging for reference. Do not use after the expiry date.

How should I store the test?

 

The recommended storage temperature is 2 – 30°C, however, we do not recommend you store them in the fridge, unless there is a risk of them overheating. Do not freeze the test cassettes or buffer solution. Tests should be performed at room temperature (15 – 30°C), so if you have stored tests in the fridge, you should allow them to reach room temperature before performing a test.

Do any medications, drugs or other proteins in the blood affect the test result?

 

To date we have tested numerous common pharmaceuticals, none of which have interfered with the test, hence we currently see no cross-reactivity issues. We are looking at more drugs and will update customers accordingly.

Can babies and young children be tested?

 

Yes, there are no issues with testing babies and young children.

Can pregnant or breast feeding women be tested?

 

Yes, there is no harm to the mother or baby when performing a test.

 

 

Please note our tests are CE marked for professional use only, and is not for sale to the general public..

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