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SELF TEST / LAY-USE NASAL SWAB
EC Certificate No. 1434-IVDD-492/2021
CE: 1434

DON'T PUT YOUR HEALTH IN
SOMEONE ELSES HANDS
Accurate, Quick At Home Testing Kits

A VARIETY OF DIFFERENT PACKAGING SIZES
TO SUIT YOUR NEEDS
Packaged In
1, 5, 10, 20, 500 Single Units

SARS-CoV-2 ANTIGEN RAPID TEST (COLLOIDAL GOLD) NASAL SWAB

Our SARS-CoV-2 Antigen Rapid Test is a nasal swab in which a painless and uncomplicated swab is carried out in the anterior nasal cavity. The process of using the nasal swab is uncomplicated and easy to use, giving you accurate results in less than 20 minutes.

A high-performance rapid test enables immediate treatment or isolation measures to minimize transmission. Accessible, easy-to-deploy, large-scale testing helps contain the virus from spreading.

GENERAL INFORMATION

 

This test is intended for the qualitative detection of SARS-CoV-2 Antigen (Nucleocapsid protein) in nasal samples from laypersons with suspected infection within the first seven days after the onset of symptoms in vitro.

 

  • Recognizes All Mutations
  • No Cross-Reactivity
  • Rapid testing for SARS-CoV-2 under 20 minutes
  • Detect 2-3 days after contracting virus
  • Easy sampling method: nasal swab
  • Evaluated and tested by the Paul-Ehrlich-Institut
  • This product has been registered with CE 1434 since November 22, 2021
  • High specificity (100 %) and sensitivity (95.91 %)
premium quality stamp

Verpackungsbeschreibung

Article Number: 500.10

Packaging Unit: 1 Single TEST Kit

Article Number: 500.20

Packaging Unit: 5 Single TEST Kits

Article Number: 500.30

Packaging Unit: 10 Single TEST Kits

Article Number: 500.40

Packaging Unit: 20 Single TEST Kits

Article Number: 500.41

Packaging Unit: 500 Single TEST Kits

Summary of the Performance of the SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) Compared to RT-PCR

SENSITIVITY: 95.91%

This is used to determine whether the virus was detected in people who are sick. If the sensitivity is given as 98% in a test, this means that 98 out of 100 infected people were detected, but the disease was not detected in 2 people.

SPECIFICITY: 100%

The accuracy of a test. if a test has 97% specificity, it means that 97 out of 100 people got a true negative test result. However, three people got a positive result even though they are not infected. It is also known as a false positive.

Precision: 98.37%

The precision of a test is determined by totaling the number of true positives and true negatives and dividing by the total number of samples. This shows how accurate a test is.

EXPLANATION OF TERMS:

C.I.: Confidence Interval
PPA: Positive Percent Agreement= True Positives / (True Positives + False Negatives)
NPA: Negative Percent Agreement= True Negatives / (True Negatives + False Positive)
OPA: Overall Percent Agreement= True Positives + True Negatives) / Total Samples

Quick Guide

Take out the sample extraction solution, unscrew the tube cover from the sample extraction solution tube, and place the sample extraction solution with the tube cover unscrewed into the storage hole in the outer box of the kit.
Insert the disposable swab gently into the nostril at an angle of 70 degrees backward (less than one inch), gently twist the disposable swab five times, and then slowly remove it from the nostril. Repeat and do the same for the other nostril.
When you have finished sampling, insert the swab head (the part containing the cotton swab) into the sample extraction solution at the bottom of the bottle and gently twist the swab clockwise or counterclockwise about 10 times to dissolve the sample in the extraction solution.
Remove the swab along the wall of the sample extraction solution bottle, drain the solution and discard the swab after removal.
Tighten the sample collection tube cap and set it aside.
Remove the test kit and place it horizontally on the platform.
Unscrew the cap from the drop hole of the specimen collection tube.
Invert the sample collection liquid tube vertically and allow 2 drops of the sample extraction mixture to drip vertically into the sample hole of the test card. Do not move the test card until the test is complete.
The test result should be ready within 15-20 minutes. If it exceeds 30 minutes, the interpretation result is invalid.
Close the sampling liquid tube tightly with the drop hole cap of the sampling liquid tube.
The test kit can be disposed of with normal household waster in compliance with the applicable local regulations.
Test result/interpretation.

Interpretation of THE RESULTS

Positive Test Result

The red line in the “C” control line region appears and a red line appears in the “T” test line region. Positive result indicates that the content of the SARS-CoV-2 antigen in the sample is higher than the limit of detection.

Negative Test Result

The red line in the “C” control line region appears. No line appears in the “T” test line regions. A negative result indicates that the content of the SARS-CoV-2 antigen in the sample is below the limit of detection or no antigen.

Invalid Test Result

Once the red line in the “C” control line region doesn’t appear, which will be treated as invalid.

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Xiamen WIZBIOTECH CO in China, specializes in the fields of in vitro diagnostic reagent technologies and rapid diagnostic reagents and instruments. They are continually innovating and improving the detection of diseases, prevention & treatment levels to protect and enhance the general public. WIZBIOTECH is leading the way in these fields and has the highest quality standards for products designed to save lives. WIZBIOTECH’s company culture and long-term vision coincides with SWISSONEMED’s. The management of both companies has decided to create a synergistic partnership under the brand SWISSONEMED by WIZBIOTECH Worldwide.

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