HEALTH CANADA OTC (Over the counter)

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COVCLEAR RAPID OVER THE COUNTER ANTIGEN TESTS

INTENDED USE 

The CovClear™ COVID-19 Rapid Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens that are self-collected by an individual 18 or older or are collected by an adult from an individual aged 2 years of age and older. This test is intended for use in individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. Persons who test positive with the CovClear™ COVID-19 Rapid Antigen Test should seek follow-up care with their physician or healthcare provider as additional testing and public health reporting may be necessary in accordance with local, regional and federal requirements. Positive results do not rule out bacterial infection or co-infection with other viruses. Persons who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider. The CovClear COVID-19 Rapid Antigen Test is intended for over-the-counter use at home and other non-laboratory sites. 

PRINCIPLES OF THE TEST 

The CovClear™ COVID-19 Rapid Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasal swab specimens directly collected. The CovClear™ COVID-19 Rapid Antigen Test is comprised of five components: polyester swab, lateral flow test strip, polypropylene vials, locking caps, and chase buffer solution. Each test strip contains a nitrocellulose membrane coated with antibodies against the SARS-CoV-2 nucleocapsid protein at the test line. A green-colored line will appear at the test line in the presence of the SARS-CoV-2 nucleocapsid protein. The nitrocellulose membrane is also coated with a printed control line that will appear as a ‘blue’ line until the test strip has been exposed to the swab sample where it will then appear ‘red.’ This color change from ‘blue’ to ‘red’ will indicate that the test was run successfully. Nasal swabs require a sample preparation step in which the sample is eluted from the swab and into the chase buffer solution. The CovClear™ COVID-19 Rapid Antigen Test strip is then placed into the chase buffer solution. When the swab sample migrates into the test strip the gold nanoparticles labeled with anti-SARS-CoV-2 antibodies will bind the SARS-CoV-2 viral antigens to form an antibody antigen immune complex. The immune complex is then captured by the test line on the nitrocellulose membrane as it migrates through the strip. Test results are interpreted at 20 minutes. The presence of two-colored lines, red at the control line and green at the test line, indicates a COVID-19 positive sample. The presence of one red colored line indicates a COVID-19 negative sample. A blue colored line or no line at 20 minutes after running the assay indicates an invalid test. 

MediGuard Systems of Canada is an authorized Distributor and Onsite Rapid Testing Service Provider for the Health Canada Approved BD Veritor Plus system and components. 

The BD Veritor™ Plus System enhances point-of-care testing for  SARS-CoV-2,* Flu A+B, RSV,† and Group A Strep assays in an easy to use point of care instrument based rapid testing solution. 

Time is limited. Staff are busy. Results are critical. Now is when your team needs clear test results, streamlined workflows, simple training, and clear documentation. The BD Veritor™ Plus System through MediGuard is designed to address these needs.

To Purchase the BD Veritor system, or to have MediGuard Systems of Canada conduct onsite testing for your establishment, contact us at 1-888-240-1110 or Info@mediguard.ca 

 MEDIGUARD SYSTEMS IS AN AUTHORIZED DISTRIBUTOR OF THIS DEVICE . BEWARE OF COUNTERFEIT PRODUCTS! 

The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals. Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds that cause respiratory, enteric, hepatic and neurological diseases. Four viruses – 229E, OC43, NL63, and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV, and SARS-CoV-2 (COVID-19) are can be transmitted from between non-human vertebrates to humans.Warning

• This test has been authorized by the FDA under a EUA for professional use. on Labratory and Point of Care .
• This test has been Authorised by Health Canada for Point of Care Professional Use Only.
• This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
• This test includes a buffer in separate vials for each test.
• This product is intended for professional use and not for home use.

THESE TESTS CAN NOT BE SOLD TO THE PUBLIC. POINT OF CARE USE ONLY! , FOR ON SITE TESTING PLEASE CONTACT US DIRECTLY HERE

BUY TESTS HERE

The COVID-19 Antigen Rapid Test Device is an in vitro immunoassay. The assay is for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from nasal and nasopharyngeal secretions collected from individuals with (within the first 5 days of symptom onset) or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours but not more than 36 hours between tests.

The COVID-19 Antigen Rapid Test Device is intended for use by trained healthcare professionals. For laboratory and point of care use. This assay is not intended for home testing. However Canadian regulations may allow for self-testing utilizing this product in some circumstances. 

Results are for the identification of SARS-CoV-2 viral nucleoprotein antigen. Antigen is generally detectable in nasal and nasopharyngeal secretions during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories are required to report all positive results to the appropriate public health authority.

Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary for patient management.

SUMMARY AND EXPLANATION OF THE TEST

Coronaviruses are a large family of viruses that are common in many different species of animals, including camels, cattle, cats, and bats.

The virus is transmitted mainly via respiratory droplets that people sneeze, cough, or exhale. The incubation period for COVID-19 is currently estimated at between 2 and 14 days. Common symptoms of COVID-19 infection include fever, cough and respiratory symptoms such as shortness of breath and breathing difficulties. More serious cases develop severe pneumonia, acute respiratory distress syndrome, sepsis and septic shock that can lead to the death of the patient. People with existing chronic conditions seem to be more vulnerable to severe illness.

If people with COVID-19 are tested and diagnosed in a timely manner and rigorous infection control measures are applied, the likelihood of sustained human-to-human transmission in community settings is low.

PRINCIPLE

The COVID-19 Antigen Rapid Test Device 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. 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.