MEDsan - SARS-CoV-2 Ag Duo 1 Box (25 Tests)
MEDsan® SARS-CoV-2 Ag Duo is a solid phase immunochromatographic assay intended for the in vitro qualitative detection of specific severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigens in human oral saliva and nasal swab specimen. The test kit is applicable in healthcare system and the scientific field of research and for professional use only. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in oral saliva or nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19 and confirmed with a molecular assay, if necessary.
If the C band and T band are both present, then the test indicates the presence of SARS-CoV-2 antigens in the specimen. The test result is positive. The purple red test line may vary in shade and intensity depending on the detected antigen concentration. Also, a light or faint test line must be interpreted as a positive result.
If only the C band is present, the absence of any burgundy color in the T band indicates that no SARS-CoV-2 antigens are detected in the specimen. The test result is negative.
Control line C is missing, or control line C and test line T are missing. Incorrect specimen volume or incorrect procedural tech- niques are the most likely reasons for control line failure. Read the instructions carefully again and repeat the test with a new test device. If the problem persists, discontinue using the test device immediately and contact your local distributor.
1. Clinical Studies
Antigen detection in the samples of COVID-19 patients has a high consistency with nucleic acid detection samples. The relative sensitivity for nasal specimen samples is 96.7%. The relative specificity rate is 100% and the accuracy of the product is 99.4%. For oral saliva specimens the relative sensitivity is 92.5%, the relative specificity is 99.8% and the accuracy is 98.4%
Nasal specimen collection
1. Ask the patient to take off the mask and to blow their nose to clear nasal passage of excessive mucus.
2. Tilt the patient’s head back 70 degrees.
3. Carefully insert swab into the nostril until resistance is met at turbinates.
4. Gently rotate the swab several times against the nasal wall to absorb secretions. Repeat in other nostril using the same swab.
5. Place the swab into extraction tube containing the buffer solution.
6. Ask the patient to reapply the mask.
Oral saliva specimen collection
1. Ask the patient to take off the mask.
2. Ask the patient to rinse the mouth with clean water before sampling.
3. Ask the patient to cough up secretions deep in the throat and accumulate it in the oral cavity above the tongue.
4. Insert the specimen collection swab in the mouth and place over the tongue.
5. Rotate the swab to absorb the sample for 10-15 seconds and remove it.
6. Place the swab into extraction tube containing the buffer solution.
7. Ask the patient to reapply the mask.
This test procedure has to be read completely before performing the test.
Allow test device, specimen, buffer and/or controls to equilibrate to room temperature (15-30 °C) prior to testing and use it as soon as possible.
1. Open the extraction tube and insert the swab after specimen collection (refer to section ‘Specimen Collection’) into the extraction tube containing the buffer solution.
2. Rotate the swab constantly and repeat several times.
3. Break the swab at the predetermined breaking point.
4. Cover the extraction tube and incubate for at least 1 minute.
5. Remove the test device from the sealed foil pouch and place it on a clean and even surface. Remove the lower cap of the tube and add 2 drops of the sample solution vertically into the sample well of the test device.
6. Wait 15 minutes to interpret and record the test result. The result is invalid after 20 minutes.
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^ the confirmed delivery date subject to the actual situation (including but not limited to inventory, transportation, logistics, etc.)