Product Name: Rapid Response COVID-19 Saliva Rapid Antigen Kit, COVID-19 Antigen Rapid Test Kit
Detection type： Qualitative
Method: Colloidal Gold Rapid Test
Certificate: ISO9001/ ISO13485/CE
Format: Strip, Cassette, Midstream
Reading time: 15 minutes
(1) With our company’s Logo
(2) With the natural package
(3) With OEM package
1. Product Description:
NewScen COVID-19 Antigen Rapid Test Cassette is for in vitro qualitative detection of specific antigens to SARS-CoV-2 present in human saliva. It cannot be used as the basis for the diagnosis and exclusion of COVID-19.
2. Intended Use:
This reagent is used to detect cases with suspected symptoms of COVID-19 within 7 days. If suspected symptoms are more than 7 days, it is recommended to test with COVID-19 antibodies or nucleic acid reagents.
The main clinical symptoms of COVID-19 are: Fever, dry cough, fatigue, a few patients will have stuffy noses, runny nose,s, and diarrhea.
This kit uses a double-antibody sandwich immunoassay to detect specific antigens to SARS-CoV-2 in human saliva. The membrane was precoated with SARS-CoV-2 specific antibody on the test zone and goat anti-mouse IgG antibody on the control zone. During the test, the specimen is allowed to react with SARS-CoV-2 specific antibody-colloidal gold particles conjugate, which was predried on the test. The conjugate binds to the SARS-CoV-2 forming an antibody~antigen complex. The complex moves forward on the membrane by the capillary action, then the complex is captured by a specific antibody to SARS-CoV-2 on the test zone to produce a visual red color line. The color of the line is positively correlated with the amount of SARS-CoV-2 in the specimen. Regardless of the presence of SARS-CoV-2, as the mixture continues to move across the membrane to the control zone, the complex is captured by immobilized goat anti-mouse IgG antibodies to form a distinct red line.
COVID-19 Antigen Rapid Test Cassette should be stored in a dark place at 2~30°C for 24 months from the date of manufacture. Keep the test cassette in a sealed pouch until use. Once you have taken the test cassette out of the pouch, use it immediately. Do not use the test beyond the indicated expiration date.
5. Procedure of NewScen Coronavirus COVID-19 Antigen Rapid Test Cassette (Saliva Test):
- Before Collection
Do not place anything in the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection.
- Collection Step
1. Fit the funnel onto the sample collection tube.
2. Deeply cough 3~5 times.
Note: Wear a face mask or cover your mouth and nose with a tissue. When you are coughing and keep your distance from other people.
3. Place the funnel under the mouth, and gently spit saliva secretions into the funnel (Avoid spitting directly). The saliva specimens should just reach the height of the scale line.
Note: If there are not enough saliva secretions collected, repeat the above sample collection steps.
4. Place the used funnel into the plastic Biosafety Bag.
- Sample Storage
Samples should be tested as soon as possible after collection. saliva specimens can be stored at 2~8℃ for up to 8 hours and -20℃ for up to 1 week.
- Sample Preparation
1. Tear to open the sample extraction buffer, then add the entire buffer into the sample collection tube with the saliva specimens.
2. Press the tube tip tightly onto the tube.
3. Gently squeeze the tube 10~15 times to mix well.
- Assay Procedure
1. All samples must be at room temperature before beginning the assay.
2. Open the package, the pouch should be sealed well. If the test reagent store in the refrigerator, it should be restored to room temperature. Then open the pouch and take out the test cassette, place it on the platform.
3. Add 2 drops of sample solution from the tube into S Well, observe the result in 15～20 minutes, interpret the test result after 20 minutes may cause the false result.
6. Interpretation of Result:
1. Positive: One color line in the control zone (C) and one color line in the test zone (T). This indicates that the sample contains SARS-CoV-2 antigen.
2. Negative: Only one color line in the control zone (C). This indicates that no SARS-CoV-2 antigen has been detected.
3. Invalid: If no color line appears in the control zone (C), the test is invalid. Discard the test cassette and perform with a new cassette.
COVID-19 Antigen Rapid Test Cassette has a built-in procedural control that demonstrates assay validity. A color line appeared on the control zone (C) indicates that the test runs correctly.
1. The kit is only used to detect human saliva specimens.
2. The accuracy of the test depends on the process of sample collection. Improper sample collection, improper sample storage, or repeated freezing and thawing of samples will affect the test results.
3. The test results should not be used as the sole basis for clinical diagnosis and treatment. The clinical management of the patient should be considered in combination with other laboratory tests of the patient’s symptoms/signs history and treatment response.