Home Nasopharyngeal Rapid Antigen Swab Self Test Device Kit

15mins Reading One Step Covid POCT Covid-19 2019-NCoV Antigen Rapid Test Kit

A. Rapid POCT

• ·Our CE marked in vitro diagnostic kits can be used directly at the point of care testing (POCT)
• ·Test result shows in just 15 minutes

B. Easy to Operate

• ·No lab setting is required for operation
• ·No instrument or analyzer is needed

C. Multiple Accurate

• ·Test gives qualitative result also on Influenza A and B antigens
• ·Highly accurate: independent clinical trials show precision of more than 80%

D. Cost Efficient

• ·The cost is much less than nucleic acid test (PCR) with expensive labs
• ·Test kit is lightweight and small in dimension, thus freight and handling cost is low

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.
• Extraction Reagent.
• Nasal/Oral Swab.
• Working Holder.

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.