Sars-CoV-2 Antigen Rapid Test (Nasal Swab)
INTENDED USE
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.
MATERIALS
Materials Provided
- Foil pouches, each contains one test cassettes, and one desiccant bag
- Assay buffer tubes (0.5ml each)with tips
- Disposable Sampling swabs
- Instruction for use
- Positive control swab and negative control swab
Materials Required But Not Provided
- Specimen collection container
- Timer
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.
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Sensitivity, Specificity and Accuracy
The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity
Method
Gold standard reagent
(PCR)
Total Results
SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag)
Results
Positive
Negative
Positive
103
0
103
Negative
7
100
107
Total Result
110
100
210
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%）
