Manufacturing Companies for Igm Neutralizing Antibody - COVID-19 Antigen test kit – Immuno

The IMMUNOBIO 2019-NCOV Antigen test kit is only used for the in vitro qualitative detection of 2019-ncov antigen from human nasopharyngeal swabs or oropharyngeal swabs specimens.

The IMMUNOBIO 2019-NCOV Antigen test kit is applicable for the auxiliary diagnosis of 2019 2019 novel coronavirus, the results are for clinical reference only and cannot be used as the sole basis for diagnosis and exclusion decision.

Positive test result needs to be further confirmed, negative result does not preclude 2019 Ivd infection.

The IMMUNOBIO 2019-NCOV Antigen test kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.

Features

A. Very Fast Test, result will be showed 10-15 minutes

B. Sensitivity of Immuno 2019 coronavirus rapid test kit: 95.6%

C. Specificity of Immuno 2019 COVID Antigen test rapid test kit: 100%.

D. Applicable for nose and Throat swab

E.Require little Specimens, few Nasal or throat swabs

Authorized certifications

1. With CE Mark, DOC And ISO 13485

2. Approve by German Ministry of Health

3. China’s white list Certified Supplier

Test Producer 

1. Take the test 2019 COVID Antigen test rapid test kit specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

2. Remove the Antigen test kit from the sealed pouch and use it as soon as possible.

3. Place the Antigen rapid test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer. See illustration below.

4. 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 (+): Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the T line region. *NOTE: The intensity of the color in the test line regions may vary depending on the concentration of SARS-CoV-2 present in the specimen. Therefore, any shade of color in the test line region should be considered positive and recorded as such. – Negative (-): One colored line appears in the control line region (C). No line appears in the T line region. – Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor