COVID-19 Antigen Rapid Infectious Disease Testing Cassette ,Oral Fluid Specimen

INTENDED USE

The COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests. Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens.

An antigen is generally detectable in upper respiratory specimens 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. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. 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.

PRINCIPLE

The COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigens in human oral fluid specimen. SARS-CoV-2 nucleocapsid protein antibody is coated in the test line region. During testing, the specimen reacts with SARS-CoV-2 nucleocapsid protein antibody-coated particles in the test. The mixture then migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2 nucleocapsid protein antibody in test line region. If the specimen contains SARS-CoV-2 Antigens, a colored line will appear in test line region as a result of this. If the specimen does not contain antigens to SARS-CoV-2, no colored line will appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in

the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

DIRECTIONS FOR USE

Allow the test device, collection device, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

Specimen Collection

Important: Before collecting oral fluid, instruct the patients not to place anything in the mouth including food, drink, gum or tobacco products for at least 10 minutes prior to collection. Instruct the patients to deeply cough 3-5 times. It is recommended to collect oral fluid after deep coughing in the morning.

①Remove the collection device and collect oral fluid specimen. If there’s not enough oral fluid collected, repeat the above specimen collection

steps.

Specimen Extraction

②Mix the buffer with the collected oral fluid. Gently shake or squeeze the tube with mixture for 10 seconds to mix well.

NOTE: The storage of the specimen after extraction is stable for 2 hours at room temperature or 24 hours at 2-8°C.

Test Reaction

Remove the test device from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.

③Add Extracted specimen to the Test Device, Wait for the colored line(s) to appear. Read the result at 15 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE:* Two colored lines appear. One colored line should be in the control region (C) and another colored line should be in the Test region (T). Positive result in the Test region indicates detection of SARS-CoV-2 antigens in the sample.

*NOTE: The intensity of the color in the test line region (T) will vary based on the amount of SARS-CoV-2 antigen present in the sample. So any shade of color in the test region (T) should be considered positive.

NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test line region (T) indicates a Negative COVID-19 Antigen test result.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.