Hightop Biotech Coronavirus Antigen Rapid Test (1 Test)
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The Hightop Biotech COVID-19 antigen rapid test remains capable of detecting the mutated omicron coronavirus variant (download manufacturer’s certificate). The coronavirus antigen rapid test is intended for in vitro qualitative detection to SARS-CoV-2 antigen in human nasopharyngeal swab or oropharyngeal swab samples. For professional use.
Product name: SARS-CoV-2 Antigen Rapid Test (Immunochromatography)
Specimen type: nasopharyngeal swab or oropharyngeal swab
Kit size: 1 Test/Box
Manufacturer: Hightop Biotech Co., Ltd.
Expiration date: 2023.11.24.
File number: OGYÉI/23612-3/2021
Registration number: HU/CA01/23612/21
Main components of the Coronavirus Antigen Rapid Test Kit
- Test cassette
- Sample extract
- Sample extraction tube
COVID-19 antigen rapid test sample requirement
Collection method of anterior nasal swab
Insert the swab about 2.5 cm into the nostril and rotate 5 times against the nasal wall.
This should take approximately 15 seconds per nostril. Sample both nostrils with same swab.
Collection method of nasopharyngeal
The operator holds the swab by the right hand and holds the head of the subject fixedly by left hand. Do not overexert to avoid traumatic hemorrhage. When the cusp of the swab touching the paries posterior of the pharyngonasal cavity, letting the swab remain in the place for a few seconds (about 3 seconds) and rotating the swab gently for one cycle, and then remove the swab slowly.
Using the same swab, repeat this process for the other nostril to ensure that an adequate sample is collected from both nasal cavities.
Collection method of oropharyngeal swab
The head of the person to be collected is slightly tilted and his mouth is wide open, exposing the pharyngeal tonsils on both sides. Wipe the swab across the root of the tongue. Wipe the pharyngeal tonsils on both sides of the person to be collected back and forth with a little force for at least 3 times, and then wipe up and down the posterior pharyngeal wall for at least 3 times.
Avoid touching your tongue, cheeks or teeth when sampling. Just after drinking water or beverages, sampling samples cannot be used for testing.
Coronavirus antigen rapid test procedure
Instructions must be read entirely before taking the Covid-19 antigen rapid test. Leave the reagent and sample at room temperature for 30 minutes before use. Return to room temperature. Do not open the inner packing until it is ready. Use it as soon as possible after opening the inner packing.
Add 500μl of sample extraction reagent to the sample extraction tube (add about 20 drops vertically if using a dropping bottle).
Insert the swab after sampling into the solution of the sample extraction tube and rotate vigorously against the inner wall of the tube to squeeze the swab for 10 times to make the sample dissolve in the solution as much as possible.
Squeeze the swab head along the inner wall of the extraction tube to keep the liquid in the tube as much as possible.
Take out and discard the swab, and the twisted liquid is taken as the sample to be tested. Cover the emitter and wait for inspection.
Open the tear hole of the aluminum foil bag, take out the test cassette and lay it flat. Apply 2-3 drops of the treated sample extract solution (60μl-80μl) vertically in to the sample well of the test cassette.
The results are observed after 15 minutes and the results were invalid after 20 minutes.
Results of the coronavirus antigen rapid test
Two distinct red lines appear. One line should be in the control region (C) and the other line should be in the test region (T).
One red line appears in the control region (C). No red line appears in the test region (T). The negative result does not indicate the absence of analytes in the sample, it only indicates the level of tested analytes in the sample is less than cut-off level.
No colored lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.
Performance characteristics of the coronavirus antigen rapid test
• The reagent is a disposable diagnostic reagent in vitro, which is only used for the detection of human nasopharyngeal swab, or oropharyngeal swab. The operation should be carried out strictly according to the instructions. Do not use expired and damaged products.
• The strength of the quality control line does not mean the quality of the reagent, as long as its color is clear and visible, that means the reagent is effective.
• The coronavirus antigen rapid test kit should be sealed and kept away from moisture. Reagents or samples stored at low temperature should be balanced to room temperature before they can be used.
• Reagents should be used as soon as possible after removal from aluminum foil bags, so as to avoid exposure to air for too long and affecting test results due to dampness.
• Do not use samples that have been placed for too long or contaminated.
• Please operate in accordance with the laboratory testing procedures for infectious diseases. Waste after use should be treated in accordance with infectious substances and should not be discarded at will.
• Incorrect operation may affect the accuracy of the results, such as insufficient sample mixing, insufficient amount, inaccurate detection time, etc.
• Components in different batch should not be mixed.
• There should be appropriate biosafety assurance procedures for those substances containing and suspected sources of infection.
• The following are relevant considerations:
Handle samples and reagents with gloves.
Do not suck samples with your mouth.
Do not smoke, eat, drink, cosmetic or handle contact lenses while handling these items.
Disinfect the spilled sample or reagent with disinfectant.
Disinfect and treat all samples, reagents and potential pollutants in accordance with relevant local regulations.
Each component of the reagent remains stable until the expiry date under proper handling and storage conditions. Do not use the expired reagent kit.