COVID-19 RAPID TESTING
HEALTH CANADA APPROVED.
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
Rapid Antibody Testing
Additional Information
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
RAPID ANTIGEN TESTING
Additional Information
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.
