Sars-CoV-2 Antigen Rapid Test
The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV-2 in human nasal swab specimen.
PRINCIPLE
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.
MATERIALS
SPECIMEN COLLECTION AND PREPARATION
The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) can be performed using nasal swab.
Nasal Swab: Insert the sterile swab into one of the patient’s nostrils around 2.5cm. Gently rub against the anterior nasal wall for 5 times. Take out the swab, and repeat the collection into the other nostril. Note: Ask the patient to wipe his/her nose before the swab collection if the secretion is too much
Take out of an assay buffer tube, and tear off the seal of the tube. Insert the swab into the tube and squeeze the flexible tube for 8~10 times to extrude the specimen from the head of the swab. Make the specimen resolved in the assay buffer sufficiently. Add the tip onto the assay buffer 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. Run a quality control testing before using the kit (if necessary) according to the quality control protocols.
- Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
- 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.
- 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.
Relative Sensitivity: 93.64% （95%CI: 87.23%～97.10%）
Relative Specificity: 100% （95%CI：95.56%～100.00%）
Accuracy: 96.67% （95%CI：93.15%～98.51%）
