PEI/Bfarm listed COVID 19 Antigen Nasal Swab/Saliva Rapid Test Kit

PEI/Bfarm listed COVID 19 Antigen Nasal Swab/Saliva Rapid Test Kit

SHORT INTRODUCTION

THE IMMUNOBIO COVID – 19 RAPID ANTIGEN Rapid Test Kit used to detect coronavirus Antigens.

Anti-new coronavirus monoclonal antibody packages are antigen detection lines and are linked to colloidal gold couples.During the test, the specimen reacts with the anti-covid-19 antibody conjugate in the test strip.The mixture then migrates upward on the membrane through capillary tube action and reacts with another anti-new coronavirus monoclonal antibody in the test area.

The complex is captured and a colored line is formed in the test line area. The new coronavirus rapid antigen detection contains anti-2019 coronavirus monoclonal antibody conjugate particles, and another anti-2019 vir monoclonal antibody is encased in the antigen detection line area.

Features

A.High  Sensitivity and Specificity
B. With PEI certified and Bfarm Listed
C. Fast deliverr

D. Applicable for nasal swab and Saliva collection Bag

Authorized certifications

1. CE/ISO13485/White List/PEI Bfarm Listed

Test Method

Allow the test kits, sample, buffer and/or controller to be balanced to room temperature (15-30 degrees C) prior to testing.

1.Leave the package at room temperature before opening it. Remove the test Kit from the sealed bag and use it as soon as possible.

2.Place the test kits on a clean level surface.Flip the specimen collection tube, squeeze the prepared specimen out of 3 drops into the specimen hole (S) of the test box, and start the timer.

See the instructions below.

3. 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 sign: Two colored lines appear.

A colored line should always appear in the control line area (C) and the other line should appear in the T-line area.

Note: The color intensity of the test line area may vary depending on the concentration of SARS-CoV-2 in the sample, Therefore, shadows of any color in the test line area should be considered positive and recorded.

- Negative (-): A colored line appears in the control line area (C) and no lines appear in the T-line area.

- Invalid: Control lines cannot be displayed. Insufficient sample capacity or incorrect operating techniques are the most likely causes of control line failures.Review the process and repeat it with a new test. If the problem persists, stop using the test kit immediately and contact your local dealer.

LIMITATIONS
1. The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) is for in vitro diagnostic use only. This test should be used for the detection of

SARS-CoV-2 antigens in human throat and nasal secretions. If salivaspecimen, the loading of virus is usually lower. If negative found in saliva but symptoms like COVID-19, it is suggested to repeat the assay by throat or nasal swab.

2. The SARS-CoV-2 Antigen Rapid Test (COVID-19 Ag) will only indicate the presence to SARS-CoV-2 in the specimen and should not be used as the sole criteria for the diagnosis of SARS-CoV-2 infections.

3. If the symptom persists, while the result from COVID-19 Rapid Test is negative or non-reactive result, it is recommended to re-sample the patient few days late or test with PCR.

4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

5. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of COVID-19 infection.

6. The potential impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have not been evaluated in the test.

7. Due to inherent differences between methodologies, it is highly recommended that, prior to switching from one technology to the next, method correlation studies are undertaken to qualify technology differences. One hundred percent agreement between the results should not be expected due to differences between technologies.

8. Performance has only been established with the specimen types listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay.