COVID Antigen Test kit Antigen Nasal/Sputum Rapid Test
COVID Antigen Test kit Antigen Nasal/Sputum Rapid Test
INTENDED USE
COVID 19 Antigen Self Test Antigen Nasal/Saliva Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in human throat and nasal secretions, and saliva specimen.This product is intended for self-testing.
Brief Introduction
COVID 19 Antigen Self Test Antigen Nasal/Saliva Rapid Test is for detection of SARS-CoV-2 antigens. Anti-SARS-CoV-2 monoclonal antibodies are coated in the test line and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-SARS-CoV-2 antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with another Anti-SARS-CoV-2 monoclonal antibodies in the test region. The complex is captured and forming a colored line in the Test line region.
COVID 19 Antigen Self Test Antigen Nasal/Saliva Rapid Test contains anti-SARS-CoV-2 monoclonal antibodies conjugated particles and another anti-SARS-CoV-2 monoclonal antibodies are coated in the test line regions.
SPECIMEN COLLECTION AND PREPARATION
The SARS-CoV-2 Antigen Rapid Test (COVID- 19 Ag) can be performed using throat secretions and nasal secretions.
• Throat Secretions: Insert the sterile swab into the throat. Gently scrape the secretions around the wall of pharynx.
• Nasal Secretions: Insert the sterile swab into the deep nasal cavity. Gently rotate swab against wall of turbinate for several times. Make the swab wet as much as possible.
• Saliva: Take a specimen collection container. Make a “Kruuua” noise from the throat, to get out the saliva or sputum from the deep throat. Then spit saliva (about 1-2ml) into the container. Morning saliva is optimal for saliva collection. Do not brush the teeth, eat food or drink before collection the saliva specimen.
• Collect 0.5ml of assay buffer and place into a specimen collection tube. Insert the swab into the tube and squeeze the flexible tube to extrude the specimen from the head of the swab. Make the specimen resolved in the assay buffer sufficiently. Add the crystal tip onto the specimen collection tube. If saliva specimen, suck the saliva from the container and place 5 drops (approx.200ul) of the saliva into the sample collection tube.
The assay should be performed immediately in 2 hours after the specimen preparation.
TEST PROCEDURE
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer.
See illustration below
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.
INTERPRETATION OF RESULTS
- Positive (+): Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the T line region.
*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of SARS-CoV-2 present in the specimen. Therefore, any shade of color in the test line region should be considered positive and recorded as such.
- Negative (-): One colored line appears in the control line region (C). No line appears in the T line region.
- Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Advice: If the result is positive, it is suggested to go to the nearest hospital for a confirmative check.
If the test result is negative or doubtful, it is suggested to consult a professional and repeat the testing under the help of a professional.
False positive or false negative is of low level but might happen occasionally. It is usually caused by improper operation to the assay.
Please go to a professional for help if you could not run the assay properly.
COMPANY PROFILE
Hangzhou Immuno Biotech Co., Ltd. is a R&D based company located in Hangzhou. Immunobio is well known as a recombinant protein original designer and supplier in the upstream of in vitro diagnostic field. Immunobio is also a professional rapid test manufacturer who has advanced technology in veterinary diagnostic and human medical diagnostic industries. Immunobio has more than 30 authorized patents in IVD field and more than 20 under review.
To fight against the COVID-19 epidemic, Immunobio has developed a series of rapid diagnostic test on COVID-19. In early February 2020, we released the Coronavirus COVID-19 IgG/IgM Antibody Rapid Test for the IgG and IgM antibodies testing. Then in September, Immunobio has successfully developed the SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) to support the fast screening of antigen test. In December 2020, a novel SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) was developed in success, to indicate the protective status of the neutralizing antibodies in people’s blood.
Hangzhou Immuno Biotech Co., Ltd. is doing and will continue doing innovative research and development in the IVD medical diagnostic field. Immunobio will keep our promise to provide the innovative and competitive products for a healthy world.
Our services:
1. Your inquiry will be replied within 12 hours
2. Competitive prices, high quality, excellent after-sales services
3. All the test kits will be inspected strictly before out of factory, we have strict management and quality control systems.
4. Try our utmost to support & protect our agents, protection of your sales area, and all your private information.
FAQ
Q:Can I get some samples of Rapid Test kits
A:Yes,sample orders welcomed.
Q2: What is sample ready time?
A2: Usually 3-7 day.
Q3: Can I print own logo on package?
A3: Sure! Customized package and OEM printing are available.
Q4: What is delivery time?
A4: Usually 5-7 days.
Q5:Can I trust you?
A:Absolutely Yes,we are “made-in-china” verified supplier.
Q6:May I visit your factory?
A:Sure,welcome any time.We can also pick you up at airport and station