Covid 19 antigen rapid test is used for the qualitative detection of novel coronavirus (SARS-CoV-2) antigen in sample, only for in vitro diagnostic use. The novel coronaviruses belong to the β genus. SARS-CoV-2 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. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.
15 minutes fast detection Friendly to use Nasopharyngeal swab collection or saliva collection the virus CE mark
Performance Characteristics of Covid 19 Antibody Test Kit
A total of 301 speichel samples included 118 positive samples and 183 negative samples. All samples were compared with ABI 7500 real-time PCR detection results, with BGI Europe A/S and Real-time fluorescent RT-PCR kit for detecting SARS-COV-2.The results are as follows:
Sensitivity 97.46%, 95% confidence interval 92.19% to 99.34%, specificity 99.45%, 95% confidence interval 96.53% to 99.97%, total coincidence rate 98.46%.
Principle of COVID-19 Antigen Rapid Test
The covid 19 antigen rapid test is based on the principle of highly specific antibody-antigen reaction and colloidal gold labeling immunochromatographic analysis technology. The reagent contains SARS-CoV-2 monoclonal antibody prefixed in the test area (T) on the membrane and the SARS-CoV-2 monoclonal antibody coated on the label pad-colloidal gold mixture. The sample is dripped into the sample well and reacts with the SARS-CoV-2 monoclonal antibody which is bound to the pre-coated colloidal gold particles when testing. Then the mixture is chromatographed upwards with capillary effects. If it is positive, the antibody labeled by colloidal gold particles will first bind to the SARS-CoV-2 virus in the sample during chromatography. Then the conjugates are bound by the SARS-CoV-2 monoclonal antibody fixed on the membrane, and a red line appears in the test area (T). If it is negative, there's no red line in the test area (T). Whether the sample contains SARS-CoV-2 antigen or not, a red line will appear in the quality control area (C). The red line appearing in the quality control area (C) is the standard for judging whether there are enough samples and whether the chromatographic process is normal, and it also serves as the internal control standard for the reagent.
COVID-19 Antigen Test Procedure
The swab type: 1. Specimen collection Nasopharyngeal Swab Sample Insert minitip swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the minitip is saturated with fluid from the first collection. If a deviated septum or blockage creates difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.
Nasal Swab: 1. Carefully insert a disposable swab, provided with your kit, into one nostril. Using gentle rotation, push the swab up to 2.5cm (1 inch) from the edge of the nostril. 2. Rotate the swab 5 times against the mucosa inside the nostril to ensure sufficient specimen collection. 3. Using the same swab, repeat this process in the other nostril to ensure that an adequate amount of sample is collected from both nasal cavities. 4. Withdraw the swab from the nasal cavity. The speciment is now ready for preparation using the extraction buffer tubes.
Oropharyngeal Swab Sample Insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsillar pillars and posterior oropharynx and avoid touching the tongue, teeth, and gums
2. Specimen extraction (1) Unscrew the lid of an extraction buffer. Add all of the extraction buffer into a reaction tube with 0.5~1mL sample. (2) Shake evenly, and keep the still in the reaction tube for 1 minute. (3) Shake the reaction tube again before performing the assay.
3. Detection operations (1) Bring the sample, test kit and other controls to recover to room temperature prior to testing. (2) Open a pouch containing a test cassette. Place the test cassette on a dry, horizontal work surface. (3) Hold the dropper vertically and transfer 3 drops of specimen to the sample well of the test cassette. (4) Observe the results showed within 10-15 minutes, and the results showed after 15 minutes have no clinical significance.
The Saliva Type 1. Specimen collection (1)Before collecting saliva, relax your cheeks and massage them gently with your fingers for 15-30 seconds, spit saliva gently in the collection pouch. (2)Transfer extraction buffer solution into extraction tube. (3)Transfer saliva into extraction tube (4)Shake extraction tube 10 second
2.Test Procedure (1) Bring the sample, test kit and other controls to recover to room temperature prior to testing. (2) Open a pouch containing a test cassette. Place the test cassette on a dry, horizontal work surface. (3) Hold the dropper vertically and transfer 3 drops of specimen to the sample well of the test cassette. (4) Observe the results showed within 10-15 minutes, and the results showed after 15 minutes have no clinical significance.
Interpretation of Covid 19 Antigen Test Results
Negative : Only a red line appears in the quality control area (C), and no line appears in the test area (T). Positive : Two red lines appear. One is in the test area (T) and the other is in the quality control area (C). Invalid : No red line displays in the quality control area (C). This indicates that the incorrect operation or the test cassette has deteriorated or damaged. Repeat the test with a new kit. If the problem persists, stop using this lot number immediately and contact your local supplier.
Note: Invalid samples should be treated as infectious pollutants, and samples should be collected again.
Covid 19 Antigen Test Kit FAQs
Q: What's difference between covid 19 PCR test and covid 19 antigen test kit? A: Two different detection method. Detection time covid 19 PCR test take much time to finish assay, covid 19 antigen rapid test usually means colloidal gold method, it’s short time assay, less than 15 minutes.
Q: Can I use covid 19 antigen test kit at home? A: Yes, there are professional test and home test kit
Q: What's lead time for covid 19 antigen test kit? A: It depends on quantity per order.
Q: How many tests can supply per day? A: From 100,000 tests to 3,000,000 tests daily capacity
Q: Do you provide private label service or uncut sheet? A: Yes, we provide OEM / private label test kit.
Q: If it's available sale in European? A: Yes, CE mark
Q: Can you sell covid 19 antigen test kit in US? A: No.