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COVID-19 Antigen/Influenza A+B Antigen Combo Rapid Test is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens and Influenza A and B virus antigens in nasal swab specimens from individuals suspected of COVID-19 and Flu A/B.
COVID-19 Antigen/Influenza A+B Antigen Combo Rapid Test
UDXBIO
COVID-19 Antigen/Influenza A+B Antigen Combo Rapid Test
Product Description
Parameter of COVID-19 Antigen/Influenza A+B Antigen Combo Rapid Test | |
Material | pp |
Test type | Nasal Swab |
Test time | 15 minutes |
Test method | Colloidal Gold |
Specimen | Nasal Swab |
Keep temperature | 2-30℃ |
Certification | CE, ISO 13485：2016 |
Shelf-life | 24 months |
Package | Carton Box, 1 test/kit, 5 tests/kit, 20 tests/kit, 25 tests/kit, 50 tests/kit |
Fast. You can read the result within 5-10 minutes, faster than PCR test.
Simple. Easy to use and easy to get the specimen, no equipment required, no PCR lab required.
Convenient. Can be used in many places like station, airport, hospital, school and very convenient.
COVID-19 Antigen/Influenza A+B Antigen Combo Rapid Test is based on colloidal gold immunochromatography assay.
During the test, specimens and detection buffer are applied to the test cartridges. If there are SARS-CoV-2 nucleocapsid antigens or influenza A/B virus in the specimens, they will bind to colloidal gold-labeled antibodies against SARS-CoV-2 N protein or Influenza A and B virus antigens respectively on conjugation pad forming virus antigen-antibody-colloidal gold complexes (complex A for Flu A, complex B for Flu B and complex C for COVID-19 ).
During lateral flow, the complexes move along nitrocellulose membrane toward one end of the absorbent paper. When passing the COVID-19 test line TC (coated with another monoclonal antibody against SARS-CoV-2 N protein), the complex C is captured by capture antibody resulting in coloring on line TC; when passing the Influenza A test line TA (coated with another monoclonal antibody against Influenza A virus N protein), the complex A is captured by capture antibody resulting in coloring on line TA; when passing the Influenza B test line TB (coated with another monoclonal antibody against Influenza B virus N protein), the complex B is captured by capture antibody resulting in coloring on line TB; when passing the line C, residual colloidal gold-labeled control molecule is captured by quality-control antibody resulting in coloring on line C.
1. Test cartridge
2. Pre-filled extraction buffer tube
3. Nozzles to extraction tube
4. Nasal swab
5. Paper rack
6. Instructions for use
1. Carefully insert the entire absorbent tip of the swab in one nostril and rotate at least 5 times. Be sure that the absorbent tip of the swab
scrapes against the nasal wall.
2. Remove swab from nostril and, using the same swab, repeat step 1 in the other nostril.
3. Insert the absorbent tip of the swab into the extraction buffer tube and swirl the swab at least 5 times.
4. Squeeze the tube against the submerged swab several times to facilitate extraction of the specimen. Remove the swab,
place it back in its original wrapping and dispose into the waste bag.
5. Place the nozzle onto the extraction tube and ensure it is attached firmly.
Restore the test devices and specimens to room temperature (15-30°C ) prior to testing.
1. Remove the cassette device from the sealed pouch just prior to testing. Lay the device on a clean, flat surface and label with
specimen ID/name.
2. Invert the sample extraction tube and slowly add 2~3 drops of the extracted specimen into the sample well of the cassette device
by gently squeezing the sample tube.
3. Set the timing device for 15 minutes.
4. Read the results after 15 minutes. Note: The result might be visible after a shorter time, however, it should only be interpreted
between 15-20 minutes after dispensing the sample material onto the cassette device.
5. Collect all used items (swab, cassette, sample extraction tube, foil seal and nozzle, and potentially used gloves) into the waste bag.
Close the bag and dispose in a biohazard trash can.
6. Thoroughly wash or sanitize hands and any used surfaces/tools for the procedure.
RESULTS INTERPRETATION
1. Negative results: coloring on C line appear only.
2. COVID-19 positive results: coloring on both TC line and C line. (Note: Faint line should be regard as coloring)
3. Flu A positive results: coloring on both TA line and C line. (Note: Faint line should be regard as coloring)
4. Flu B positive results: coloring on both TB line and C line. (Note: Faint line should be regard as coloring)
5. Invalid results: no coloring appear on C line regardless of TA, TB and TC line coloring.
Valid results:
Invalid results:
