Quick COVID-19 Antigen Tests: SARS-2 Rapid Test Kit

Product Description

The SARS-CoV-2 Antigen 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. 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.

SPECIMEN COLLECTION AND PREPARATION

The SARS-CoV-2 Antigen Rapid Test (COVID- 19 Ag) can be performed using nasopharyngeal or oropharynx swab, nasal swab and saliva.
Nasopharyngeal Swab: Insert the sterile swab into the deep nasal cavity until the nasopharynx. Gently rub and rotate the swab against wall of turbinate for several times.
Oropharynx Swab: Insert the sterile swab into the throat. Gently scrape the secretions around the wall of pharynx and tonsil.
Nasal Swab: Insert the sterile swab into one of the nostrils around 2.5cm. Gentally rub against the anterior nasal wall and repeat the actions into the other nostril.
Saliva: Prepare 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.
Take out of an assay buffer tube, and tear off the head of the tube. Extrude all the liquid (around 0.5ml) 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 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. If the assay could not be carried immediately, the prepared specimen should be kept no more than 24 hours at 2-8°C or 7 days at -20°C. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly for more than two times. If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.

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.

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.

Limitation

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.