COVID-19 Antigen Rapid Tests
COVID-19 Antigen Test Kit (Colloidal Gold)
Catalog No.: BG1904C
1 tests/kit; 5 tests/kit; 25 tests/kit
The COVID-19 Antigen Test Kit is used for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in human nasal swab samples from individuals suspected of COVID-19, only for in vitro diagnostic use.
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are found in a few cases.
Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.
1. Components of the test strip in the cassette:
Sample pad: contains buffered salts and detergents.
Label pad: contains gold-labeled mouse anti-COVID-19 monoclonal antibody.
Control area: contains Goat anti-mouse IgG polyclonal antibody and buffer.
Test area: contains mouse anti-COVID-19 monoclonal antibody and buffer.
2. Sample extraction buffer: 1 bottle (1pc/box,1ml/bottle), 1 bottle (5pcs/box,3ml/bottle), 2 bottles (25pcs/box,7ml/bottle).
3. 1/5/25 Extraction tube(s) and dropper tip(s)
4. 1/5/25 nasal Swab(s)
【MATERIAL REQUIRED BUT NOT PROVIDED】
1. Clock or Timer
【STORAGE AND SHELF LIFE AFTER FIRST OPENING】
1. Store at 2℃ to 30℃ in the sealed pouch up to the expiration date (24 months).
2. Keep away from sunlight, moisture, and heat.
3. DO NOT FREEZE.
4.When the humidity is below 60%, use it within 1 hour after opening. When the humidity is above 60%, use it immediately after opening. Production date, expiry date will be in the label.
【PRIMARY SAMPLE COLLECTION,HANDING AND STORAGE】
Use the nasal swab supplied in the kit.
1. Nasal secretions collection
a)Carefully insert the swab into the nostril of the patient, reaching nasal cavity. that presents the most secretion under visual inspection.
b)Swab over the surface of the nasal cavity. Rotate the swab several times.
c)Withdraw the swab from the nasal cavity.
2. Throat secretions collection:
a)Insert the swab completely from the mouth into the throat, centering on the red part of the throat wall and maxillary tonsils.
b)Rub the bilateral throat tonsils and throat wall moderately.
c)Avoid touching the tongue and remove the swab.
The samples should be treated with the virus sampling solution or the sample extraction solution provided with this kit as soon as possible after collection. The collected extracts should be detected within 2 days or stored at 2-8 ℃ after sealing and detected within 4 days.
1. Specimen extraction
a)Add 0.5mL (about 10 drops) of the sample extraction buffer into the extraction tube.
b)Insert the swab into the extraction tube which contains 0.5mL of the extraction buffer. Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube.
c)Leave the swab in the extraction tube for 1 minute.
d)Squeeze the tube several times with fingers from outside of the tube to immerse the swab. Remove the swab. The extracted solution will be used as test sample.
e)Fit the dropper tip with filter on top of the extraction tube tightly.
2. Detection operations:
Open a pouch containing a test cassette. Place the test cassette on a dry, horizontal work surface.
Add 2 drops (about 60μl) of sample solution extract to the sample well of the test cassette.
Observe the results showed within 10-15 minutes, and the results showed after 15 minutes have no clinical significance.
【INTERPRETATION OF RESULTS】
Negative: Only a red line appears in the quality control area (C), and no line appears in the test area (T).
Positive: Two red lines appear. One is in the test area (T) and the other is in the quality control area (C).
Invalid: No red line displays in the quality control area (C). This indicates that the incorrect operation or the test cassette has deteriorated or damaged. Repeat the test with a new kit. If the problem persists, stop using this lot number immediately and contact your local supplier.
Note: Invalid samples should be treated as infectious pollutants, and samples should be collected again.Note: Invalid samples should be treated as infectious pollutants, and samples should be collected again.