COVID-19 Antigen Rapid Test Kit
REAGEN This kit is used for in vitro qualitative detection of COVID-19 antigen in human oropharyngeal swabs and nasopharyngeal swab samples.
Mechanism Of Reaction
REAGEN This kit adopts the detection principle of double antibody sandwich method. The binding pad of the detection card contains colloidal gold-labeled mouse N protein monoclonal antibody I; the detection line (T line) of the nitrocellulose membrane is coated with mouse N protein monoclonal antibody Antibody II, quality control line (line C) is coated with goat anti-mouse antibody.
The collected samples are processed by the sample extract and added. During the test, when the extract containing the N protein of the COVID-19 is added to the sample hole of the test card, under the action of chromatography, the sample moves to the end of the absorbent paper and first passes through the binding pad. The N protein and colloidal gold labeled mice The source N protein
monoclonal antibody I specifically binds and continues to move to the absorbent paper end. When the sample moves to the T line, the N protein bound to the labeled antibody specifically binds to the N protein monoclonal antibody II coated in the T line in a double antibody sandwich mode, and stays at the T line; the remaining liquid continues to absorb water The paper end moves. When it moves to the C line, the mouse N protein antibody I labeled with colloidal gold specifically binds to the goat anti-mouse antibody in the C line. The T line shows a red band, indicating that the COVID-19 antigen is positive. No matter whether the T line is colored or not, the C line should show red. If the C line is
not colored, the test is invalid and the sample needs to be tested again.
Kit Contents, Storage And Shelf Life
The REAGEN COVID-19 Antigen Rapid Test Kit has the capacity for 20 and 40 determinations.
The shelf life is 18 months when the kit is properly stored.
Warnings And Precautions
1. This kit is only used for in-vitro auxiliary diagnosis and must be operated in strict accordance with the instructions.
2. Please check the validity period and package integrity of the kit before use. If the package of the test card is damaged or exceeds the validity period, it cannot be used.
3. Must follow the time of determination and judgment result.
4. It is recommended to use it immediately, for one-time use only; the test card should be tested within 30 minutes after being taken out of the package to avoid prolonged exposure of the test card to the air.
5. The kit can be stored at room temperature. Beware of moisture, light, heat, heavy pressure, and freezing.
6. It is recommended that the waste or remaining samples generated during the test be soaked in a lipid solvent such as ether, 75% ethanol, chlorine-containing disinfectant, peracetic acid and chloroform for virus inactivation treatment.
7. The test results of this kit are for clinical reference only. The clinical diagnosis of the disease should be comprehensively considered in conjunction with its symptoms, signs, medical history, other laboratory tests and treatment responses. Sample Requirements
1. Sample collection
Oropharyngeal swabs collection method: the person's head is slightly tilted, the mouth is open, and the pharyngeal tonsils on both sides are exposed. Wipe the root of the tongue with a swab, gently wipe the pharyngeal tonsils on both sides of the collected person back and forth for at least 3 times, and then wipe the posterior pharyngeal wall up and down at least 3 times.Nasopharyngeal swabs collection method: the sampler uses one hand to gently hold the head of the sampled, the sampler holds the swab with the other hand, inserts the swab through the nostril, and then slowly moves back along the bottom of the lower nasal cavity Penetration should be avoided vigorously to avoid traumatic bleeding. When the tip of the swab reaches the back wall of the nasopharyngeal cavity, gently rotate it one round (to prevent reflex cough, stop for one minute), and then slowly remove the swab.
2. Sample processing
Add 7 drops (about 200μL) of sample extraction buffer to the sample extraction tube, immerse the sampled swab in the sample extraction buffer to make the sample extraction buffer completely penetrate the swab, rotate for 10 seconds and squeeze Swab 10 times to keep the liquid in the tube as much as possible, remove and discard the swab, cover the dripper, and shake the extraction tube to
mix the liquid.
Limitations Of Inspection Methods
1. This kit is a qualitative test and is only for in vitro auxiliary diagnosis.
2. Due to the limitation of the antigen detection method, the minimum detection limit (analytical sensitivity) is generally lower than that of nucleic acid detection reagents. Therefore, the test personnel should pay more attention to the negative result of the antigen test, and comprehensive
judgment should be combined with other test results and clinical symptoms. For negative results,nucleic acid testing or virus isolation and culture identification methods are used to assist in the judgment.
3. Unreasonable sampling, transportation, processing, and low virus content in the sample may cause false negatives.
4. The test results of this reagent are for clinical reference only, and should not be used as the sole basis for clinical diagnosis and treatment. The final diagnosis of the disease should be made after comprehensive evaluation of all clinical and laboratory results.
REAGEN The sensitivity of the test kit was 94.5%, the specificity was 96.3%, and the accuracy
was between 90%-97.0%.