COVID-19 Rapid Antigen Self test kits

COVID-19 Rapid Antigen Self test kits

Product Description

The COVID-19 Rapid Antigen Self test kits  is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in nasal secretions specimen collected from the anterior nasal cavities. This product is intended for self- testing.

The COVID-19 Rapid Antigen Self test kit 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.
The SARS-CoV-2 Antigen 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.

Features

• Fast results in 10-15 minutes
•Help patients make treatment decisions quickly
•Simple and time-saving procedures
•Small sample, only a few swabs from the nose or throat
•Provide all necessary reagents, no equipment is required
• High sensitivity and specificity

Certificates

1.CE/ISO13485

2. Bfarm listed for professional and self Test kits

3. PEI

4. Registered in Germany/Italy/Austra/Poland/Argentina/Malaysia/Indonesia and etc.

Packing detailes for Covid 19 ag Antigen Rapid Test kits we supply 

Product	Packing Information	Image
COVD -19 Rapid Antigen test	20 test kits packing Content: 1) 20 Foil pouches with test cassettes and desiccants 2) 20 tubes filled with buffer and dropper dippers 3) 20 Sterile swab 4) 20 droppers 6)1 Instruction for use 7) 1 tube holder Collection bag optioanal
COVD -19 Rapid Antigen test	5 test kits packing Content: 1) 5 Foil pouches with test cassettes and desiccants 2) 5 tubes filled with buffer and dropper dippers 3) 5 Sterile swab 4) 5 droppers 5)1 Instruction for use Collection bag optioanal
COVD-19 Rapid Antigen test	1 test kits packing Content: 1) 1 Foil pouches with test cassettes and desiccants 2) 1 tubes filled with buffer and dropper dippers 3) 1 Sterile swab 4) 1 droppers 5)1 Instruction for use Collection bag optioanal

SPECIMEN COLLECTION AND PREPARATION

The COVID-19 Rapid Antigen Self test kits can be performed using throat secretions and nasal secretions.
• Nasal Swabs: insert the sterile swab into one of the nostrils around 2.5cm. Gently rub against the anterior nasal wall and repeat the actions into the other nostril. Make the swab wet as much as possible.
• 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.
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.                                                                                                       3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minute

Interpreted results

-Positive (+): Two colored lines appear. A colored line should always appear in the control line area (C), and the other line should appear in the T area.
*Note: The color intensity of the detection line area may vary with the concentration of SARS-CoV-2 in the specimen. Therefore, any shade of color in the test line area should be considered positive and recorded.
-Negative (-): A colored line appears in the control line area (C), and the T area is wireless.
—Invalid: The control line does not appear. Insufficient sample volume or incorrect programming technique is the most likely cause of control line failure. Review the process and repeat the test with a new test. If the problem persists, stop using the test kit immediately and contact your local dealer.

Limitation

1. SARS-CoV-2 antigen rapid test (COVID-19 Ag) is only used for in vitro diagnosis. This test is used to detect SARS-CoV-2 antigen in human throat and nasal secretions. In the case of saliva specimens, the viral load is usually low. If it is found to be negative in saliva but has symptoms of COVID-19, it is recommended to repeat the test with a throat swab or nasal swab. 2. The rapid SARS-CoV-2 antigen test (COVID-19 Ag) only indicates the presence of SARS-CoV-2 in the specimen and should not be used as the only criterion for the diagnosis of SARS-CoV-2 infection. 3 shown. If the symptoms persist and the rapid COVID-19 test result is negative or no response, it is recommended to delay re-sampling or PCR testing for a few days. 4 shown. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the doctor. 5. If the test result is negative and the clinical symptoms persist, it is recommended to use other clinical methods for additional testing. At any time, a negative result cannot rule out the possibility of contracting COVID-19. 6. The potential impact of vaccines, antiviral therapies, antibiotics, chemotherapy or immunosuppressive drugs has not been evaluated in trials. 7 shown. Due to the inherent differences between methods, it is strongly recommended to conduct method correlation studies to determine technical differences before switching from one technology to another. Due to the difference in technology, you should not expect the results to be 100% consistent. 8. Performance is only determined based on the sample types listed in the intended use. Other specimen types have not been evaluated and should not be used in this test.

QUALITY CONTROL

Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
LIMITATIONS
1. The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) is for in vitro diagnostic use only. This test should be used for the detection of SARS-CoV-2 antigens in human throat and nasal secretions. If saliva specimen , the loading of virus is usually lower. If negative found in saliva but symptoms like COVID-19, it is suggested to repeat the assay by throat or nasal swab.
2. The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) will only indicate the presence to SARS-CoV-2 in the specimen and should not be used as the sole criteria for the diagnosis of SARS-CoV-2 infections .
3. If the symptom persists, while the result from COVID-19 Rapid Test is negative or non-reactive result, it is recommended to re-sample the patient few days late or test with PCR.
4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
5. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of COVID-19 infection.
6. The potential impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have not been evaluated in the test.
7. Due to inherent differences between methodologies, it is highly recommended that, prior to switching from one technology to the next, method correlation studies are undertaken to qualify technology differences. One hundred percent agreement between the results should not be expected due to differences between technologies.
8. Performance has only been established with the specimen types listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay.