INTENDED USE
The COVID- I 9 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 nasopharyngeal secretions collected from individuals suspected of COVID-19 within the first 5 days of symptom onset. 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 (or self-testing). Results are for the identification of SARS-CoV-2 viral nucleoprotein antigen. The antigen is generally detectable in 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 the 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-1 9 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 colour development. Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-CoV-2 antibodies conjugated to coloured 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 the specimen. During testing, the extracted antigens bind to anti-SARS-CoV-2 antibodies conjugated to coloured 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 coloured particles are captured at the internal control zone. The presence of a coloured band in the test region indicates a positive result for the SARS-CoV-2 viral antigens, while its absence indicates a negative result. A coloured 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.
MATERIALS
☞ Individually packed test devices
☞ Extraction tube
☞ Individually packed swabs
☞ Package insert
☞ Negative control(If required)
PRECAUTIONS
☞ For in vitro Diagnostic Use Only.
☞ This test has been authorized only for the detection of proteins from SARS-CoV-2. not for any other viruses or pathogens.
☞ Read the Package Insert prior to use. Directions should be read and followed carefully.
☞ Do not use the kit or components beyond the expiration date.
☞ Specific training or guidance is recommended if operators are not experienced with specimen collection and handling procedures.
☞ Wear protective clothing like laboratory coats, disposable gloves & eye protection when specimens are collected & evaluated.
☞ device contains material of animal origin and should be handled as a potential biohazard. Do not use if pouch is damaged or open
☞ Test devices are packaged in foil pouches that exclude moisture during storage.
☞ Don’t use the Extraction Buffer if it is discoloured or turbid. Discolouration or turbidity may be a sign of microbial contamination.
☞ All patient specimens should be handled and discarded as if they are biologically hazardous
☞ Failure to bring specimens and reagents to room temperature before testing may decrease assay sensitivity.
☞ Inaccurate or inappropriate specimen collection, storage, and transport may yield false-negative test results.
☞ Avoid skin contact with buffer.
STORAGE AND STABILITY
☞ Store The COVID-I 9 Antigen Rapid Test Device at 2-30 when not in use
☞DO NOT FREEZE
☞Kit contents are stable until the expiration dates marked on their outer packaging and containers.
