What is the product profile of ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab)?
In addition to the PCR test, rapid tests are also often used as an initial examination of COVID-19. As the name implies, rapid test results can be known immediately in a short time, usually only a few minutes or a maximum of 1 hour to wait for the results of the examination to come out. Antigen tests are commonly used in the diagnosis of respiratory pathogens, including the influenza virus. The US Food and Drug Administration (FDA) has granted an Emergency Used Authorization (EUA) for antigen testing that can identify SARS-CoV-2. The antigen test is performed on a nasopharyngeal (inner nose) swab specimen that is placed directly into the extraction buffer or test reagent. There is no age limit for using this COVID-19 rapid antigen test.
The discussion on products that have global CE certification are: ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab), with packaging per box containing 25 tests, 25 extraction tubes and lids, 25 nasopharyngeal swabs, and 1 buffer solution bottle.
ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab) is qualitative with the principle of immunochromatographic assay to detect the presence of SARS-CoV-2 antigen in patients, especially the SARS-CoV-2 nucleocapsid in patient samples using a nasopharyngeal swab sampling method. The nucleocapsid is a protein found in the structure of SARS-CoV-2 and is an ideal target for diagnosis even though it has only been exposed to the virus for 1 day. In this assay, antibodies specific to the SARS-CoV-2 Nucleocapsid (N) protein separately coat the test area of the cassette. During the test, the specimens present reacted with antibodies to the N protein of SARS-CoV-2 coated on the particles. The mixture migrates up the membrane to react with the SARS-CoV-2 N protein antibody on the membrane and produces a single colored line in the test region. The presence of a colored line in the test area (T) indicates a positive/reactive result. A colored line will always appear in the control region (C) if the test was performed correctly.
Features and Benefits of ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab)
Feature
- Use of SARS-CoV-2 N protein antibody attached to the test cassette membrane.
- Sample is taken from nasopharyngeal swab.
- The principle of the tool is an immunochromatographic assay.
- 1 box complete with test cassette, extraction tube and lid, nasopharyngeal swab and buffer.
- Available 1 vial of buffer for 25 tests (Additional buffer solution bottles available if needed).
- Results can be interpreted in 10 minutes (short).
- Products have CE certification.
- The product has a post-production expiration date of 2 years (long enough).
Benefit
- N protein is known as an ideal target for detecting the presence of virus even though it has only been exposed to the virus for 1 day.
- Practical and comfortable for patients because it is non-invasive (doesn't hurt) where the material and shape of the nasopharyngeal swab are according to WHO recommendations.
- Makes it easier for users to read the results through the colored lines that are formed.
- No need for additional tools and materials when using the product (except personal protective equipment and waste containers).
- Practical for use by 1 user in the laboratory.
- The user can determine the next immediate action according to the results that appear.
- Guaranteed quality and according to global recommendations.
- Users can keep a certain amount of stock without worrying about the product quality being reduced.
How to Use ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab):
- Drop 8 drops of buffer on the supplied extraction tube.
- Place the swab specimen in the Extraction Tube. Rotate the swab for about 10 seconds while pressing it against the inside of the tube to maximize sampling.
- Release the swab while pressing the swab head on the inside of the extraction tube to remove as much liquid as possible. Dispose of swabs according to biohazard waste disposal protocol.
- Attach the capping tube and drop 3 drops of the mixture on the test cassette (S). Read the results after 10 minutes. Do not read the results after 20 minutes.
- Interpret the results according to the picture.
Note: it is important to note that the use of the test cassette is maximum 1 hour after removing the package/sealing.
Reference:
- Diao, B, Wen, K., Zhang, J., Chen, J., Hao, C., Chen, Y., Wang, S., Deng, G., Zhou, H. & Wu, Y. 2020. Accuracy of a nucleocapsid protein antigen rapid test in the diagnosis of SARS-CoV-2 infection. Clinical Microbiology and Infection, 2020: 1-14.
- CDC. Guidance for Antigen Testing for SARS-CoV-2 for Healthcare Providers Testing Individuals in the Community.
- Instruction for Use ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab). 2020 by AccuBiotech Co., Ltd.
