Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) – Professional Use Only
Intended Use:
SARS-CoV-2 Antigen tests are immunoassays that use highly sensitive monoclonal anti- bodies to detect the presence of virus. With placing nasal/throat swab specimens directly into the assay’s extraction buffer or reagent, antigen tests can be used for screening in high-risk congregate settings in which repeat testing could quickly identify persons with a SARS-CoV-2 infection to inform infection prevention and control measures, thus preventing transmission.
Product Advantages: Highly portable, Prepacked eluent buffer ready to use, Easy to operate, no instrument needed, Good consistency with PCR test, Time Saving Result in 10 Minutes and Storage can be at Room Temperature 4-30 Degree Celsius.
Principle of Detection: The double antibody sandwich method is adopted in the product, and measurement is conducted in the form of solid-phase immune chromatography. The sample to be tested will diffuse upwards at the charging end under capillary action, and then SARS-CoV-2 antigen in the sample will combine with the antibody in the marker pad and form colloidal gold antibody-antigen complex; The complex continues to diffuse to the nitrocellulose membrane with the sample, and then blocked by T-line (test line) packed with antibody, and form colloidal gold labeled antibody-antigen-immune complex packed with antibody. The rest unblocked colloidal gold complex continues to move upwards, and combine with C-line(quality control line), indicating that the reaction is completed.
Specimen Requirements:
- Applicable sample types of the test card include throat swab, Nasal swab.
- Sampling:
1) Nasal Swab: The sampling personnel shall hold the head of the sampled personnel gently with one hand, and the swab with the other hand, put it inside the nostril, and go deep along nose bottom. Given the arced nasal passage, be cautious to act gently, and avoid traumatic bleeding. As the swab top reaches to the rear wall of the pharyngonasal cavity, rotate for a cycle gently (in case of reflective cough, stay for a minute), and then take it out slowly, and put it inside the elution tube.
2) Throat Swab: The sampled personnel shall rinse the mouth with saline solution at first, and then the sampling personnel shall put the swab into sterile saline solution (prevent from putting the swab into the virus preserving fluid, and avoid antibiotics from causing allergies), hold the sampled personnel’s head up slightly, with their mouth open wide, and give out the sound of “Ah”, expose the pharyngeal tonsils at two sides, and then use the swab to pass the root of tongue, and swipe the pharyngeal tonsils at the two sides of the sampled personnel for at least 3 times, and then swipe the rear wall of the throat upwards and downwards for at least 3 times, and then put the swab into the elution tube. - Samples shall be eluted in 1h, and tested as soon as possible afterwards. In case of failing to process immediately, please store under the following conditions: It can be stored for 1 day under 2°C-8°C, and for a long term under -70°C and below.
- Samples shall be fully recovered to the room temperature before test. Cryo-preserved samples can only be used after being fully melted, re-warmed and evenly mixed, and prevent from repeated freezing and thawing.
Test Methods: Read the instructions for use carefully before use.
- The test cassette must be at room temperature before use, and the test must be operated at room temperature.
- Remove the test cassette from the foil pouch and place on a flat, dry table.
- After specimen collection, add the portion of swab where sample was collected to 0.5 mL sample eluent for even elution.
- Cover the upper cover of the elution tube and place it upside down above the sample hole of the reagent card, gently squeeze the elution tube, add 4 drops (about 80 μL) to the charging hole of the reagent card, and start counting.
- Read the results after 10 minutes. The result is invalid after 15 minutes.
Performance: Our Rapid Antigen Test kits have Very High Sensitivity and Very High Specificity.
