One Step Sealed Pouch Covid 2019-NCoV Covid-19 Antigen Rapid Test Strip Cassette

INTEND USE  

The rapid test kit is used for qualitative determination of novel coronavirus (SARS-CcV-2) antigen in human nasal swab samples in vitro.. This kit is offered to clinical laboratories and healthcare workers for point-of-care testing, and not for at home testing, in compliance with Section IV.D. of the FDA’s Policy for COVID-19 Diagnostic Test.

MAIN COMPONENTS  

• Test Cassette.

• Extraction Tube.

• Buffer.

• Nasal/Oral Swab.

• Working Holder.

• Instruction Manual.

STORAGE & STABILITY

•  Store at 39 ~ 86 º F (4 ~ 30 º C) in the sealed pouch up to the expiration date.

•  Keep away from direct sunlight, moisture and heat.

•  DO NOT FREEZE.

HOW TO PERFORM THE TEST?

1. Remove a Test Device from the foil pouch by tearing at the notch and place it on a level surface.

2. Holding Extraction Reagent bottle vertically, add 10 drops (400μL) to the Extraction tube.

3. Insert the nasopharyngeal (and oropharyngeal) swab sample(s) into the extraction solution, then, mix the swab 10 times.

4. Remove the swabs while pressing against the solution tube in order to extract most of the specimen

5. Place the dropper cap and drop 3 drops (60~70μl) into the sample well.

6. Read the result in 10-15 minutes. Do not read results after more than 20 minutes.

REANDING RESULTS

Negative :

Only one color line appears on the control region.

Positive :

Two bands are appeared in the test line (T) and control line (C).

Invalid:

No visible line at all, or there is a visible line only in the test region and not in the control region. Repeat with a new test kit.