Wemed COVID-19 Antigen (Ag) Kit
The Wemed COVID-19 Antigen (Ag) Kit Test is a rapid convenient immune-chromatographic assay for the qualitative detection of specific antigens to SARS-CoV-2 present in human nasopharynx.
The Device is designed to aid in the rapid differential diagnosis of COVID-19 Virus infection
- Rapid and Reliable Result within 30 minutes
- Can be stored at room temperature (2~30 °C)
- Simple and easy to use
- No Additional specific equipment needed
- Good correlation with PCR test
Insert a sterile swab into the nostril of the patient, swab over the surface of the posterior nasopharynx. Withdraw the swab from the nasal cavity.
Insert the swab into an extraction buffer tube and stir the swab more than 10 times.
Remove the swab while squeezing the well of the tube and close the nozzle cap
Apply 5 drops of extracted specimen to the specimen well of the test device.
Read the results in 10~20 minutes.
- A pink colored band appears only at the control region (C), indicating a negative result for COVID-19 infection.
- A clear pink colored band (C) and a detectable test band (T) appears, indicating a positive result for COVID-19 infection.
- No visible band at the control region (C). Repeat with a new test device. If test still fails, please contact the distributor with the lot number.
“C” Control Line
“T” Test Line
Total eighty-three of human nasopharyngeal and eight of nasal swab specimens from asymptomatic and symptomatic patients were analyzed.
Clinical Study I – Nasopharyngeal swab
COVID-19 Antigen (Ag) Kit
|Positive Percent Agreement (PPA)||93.94% (31/33)|
|Negative Percent Agreement (NPA)||100% (50/50)|
Clinical Study II – Nasal swab
COVID-19 Antigen (Ag) Kit
|Positive Percent Agreement (PPA)||100% (3/3)|
|Negative Percent Agreement (NPA)||100% (5/5)|
|Package Unit||25 tests/kit|
|Kit Component||Test cassette, Reagent tube, Sterilized Nasal Swab, Filter cap, IFU|
|Storage Temperature||2~30 ℃(36-86℉)|
|Specimen||Nasopharyngeal / Nasal swab sample|
- Freshly collected specimens should be processed as soon as possible, but no later than one hour after the specimen collection, it is essential that correct specimen collection and preparation method be followed.
- Reagent, specimens and devices must be at room temperature (15-30℃) for test.
Tilt patient’s head back 70 degrees.
Insert swab into nostril. (Swab should reach depth equal to distance from nostrils to outer opening of the ear.) Leave swab in place for several seconds to absorb secretion
Slowly remove swab while rotating it. (Swab both nostrils with same swab.)