COVID-19 (SARS-Cov-2) Antigen Rapid Test Cassette (swab)
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.
The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to Novel coroinavirus.
The test device is composed of the following three parts, namely sample pad, reagent pad and reaction membrane. The whole strip is fixed inside a plastic device. The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coroinavirus;the reaction membrane contains the secondary antibodies for Novel coroinavirus, and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane.
When the sample is added into the sample window,conjugates dried in the reagent pad are dissolved and migrate along with the sample. If Novel coroinavirus is present in the sample, a complex formed between the anti- Novel coroinavirus conjugate and the virus will be caught by the specific anti- Novel coroinavirus monoclonal coated on the T region.
Whether the sample contains the virus or not, the solution continues to migrate to encounter another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thereby producing a red line on the region C.
The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies against Novel coroinavirus; the reaction membrane contains the secondary antibodies for Novel coroinavirus,and the polyclonal antibodies against the mouse globulin, which are pre-immobilized on the membrane.
【STORAGE AND STABILITY】
Store the Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) at room temperature or refrigerated (2-30°C). Do not freeze. All reagents are stable until the expiration dates marked on their outer packaging and buffer vial.
【SPECIMEN COLLECTION AND PREPARATION】
1. Specimen collection:
It is applicable to the diagnosis of the Novel coroinavirus from the samples of Nasopharyngeal swab.Use freshly collected samples for optimal test performance. Inadequate sample collection or improper sample handling may yield a false-negative result.
For nasopharyngeal swab completely insert the sterilized swab supplied in this kit into the nasal basin, and swab several times to collect the epidermal cells of the mucus.
For oropharyngeal swab completely insert the sterilized swab supplied in this kit into the posterior pharynx, tonsils and other inflamed areas. Avoid touching the tongue, cheeks and teeth with the swab.
It is recommended to collect sample from Nasopharyngeal for more accurate results.
2. Specimen preparation:
1) Take out 1 bottle of Sample Extraction Buffer, remove the bottle cap, add all the extraction buffer into the extraction tube.
2) Nasopharyngeal and oropharyngeal Swabbing
Insert the swab into the extraction tube which contains Sample Extraction Buffer. Rotate the swab inside the tube using a circular motion to roll the side of the extraction tube so that liquid is expressed and reabsorbed from the swab, remove the swab. The extracted solution will be used as test sample.
【COMPONENTS OF THE TEST KIT】
· Test Device
· Package Insert
· Sterilized Swab
· Nozzle with Filter
· Extraction Tube
· Sample Extraction Buffer
· Tube Stand
【DIRECTIONS FOR USE】
Allow the test, specimen, extraction buffer to equilibrate to room temperature (15-30°C) prior to testing.
1.Remove the test device from the sealed foil pouch and use it as soon as possible. Place the test device on a clean and level surface. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2. Unscrew the whole cap of the specimen collection tube,
3. Take out 1 bottle of Sample Extraction Buffer, remove the bottle cap, add all the extraction buffer into the extraction tube.
4.Place the sterilized swab specimen in the sample extraction buffer. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab.
5.Remove the sterilized swab while squeezing the sterilized swab head against the inside of Buffer as you remove it to expel as much liquid as possible from the swab. Discard the sterilized swab in accordance with your biohazard waste disposal protocol.
6. Screw on and tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the sample extraction buffer. See illustration 4.
7.Add 3 drops of the solution (approx.80ul) to the sample well and then start the timer. Read the result at 10~20 minutes. Don’t interpret the result after 20 minutes.
● Specimen types: Nasopharyngeal swab/ Oropharyngeal swab
● Testing time: 10-20 minutes
● Sensitivity: 96.17 %
● Specificity: ＞99.9%