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

Features

  • 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

Test Procedure

  • 1

    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.

  • 2

    Insert the swab into an extraction buffer tube and stir the swab more than 10 times.

  • 3

    Remove the swab while squeezing the well of the tube and close the nozzle cap

  • 4

    Apply 5 drops of extracted specimen to the specimen well of the test device.

  • 5

    Read the results in 10~20 minutes.

Test Result

  • Negative
    A pink colored band appears only at the control region (C), indicating a negative result for COVID-19 infection.

    Negative

    Negative

  • Positive
    A clear pink colored band (C) and a detectable test band (T) appears, indicating a positive result for COVID-19 infection.

    Positive

    Positive

  • Invalid
    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.

    Invalid

    Invalid

C” Control Line

T” Test Line

Clinical Performance

Total eighty-three of human nasopharyngeal and eight of nasal swab specimens from asymptomatic and symptomatic patients were analyzed.

Clinical Study I – Nasopharyngeal swab

Nasopharyngeal swab RT-PCR
Positive Negative Total
Wemed
COVID-19 Antigen (Ag) Kit
Positive 31 31
Negative 2 50 52
Total 33 50 83
Positive Percent Agreement (PPA) 93.94% (31/33)
Negative Percent Agreement (NPA) 100% (50/50)

Clinical Study II – Nasal swab

Nasal swa RT-PCR
Positive Negative Total
Wemed
COVID-19 Antigen (Ag) Kit
Positive 3 3
Negative 5 5
Total 3 5 8
Positive Percent Agreement (PPA) 100% (3/3)
Negative Percent Agreement (NPA) 100% (5/5)

Order Information

Cat.No. SRK-003
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


Specimen Preparation

  • 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.
  • 1

    Tilt patient’s head back 70 degrees.

  • 2

    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

  • 3

    Slowly remove swab while rotating it. (Swab both nostrils with same swab.)