COVID-19 rapid test

for antigensSARS-COV-2nasopharyngeal

Product Description
The SARS-CoV-2 Antigen Rapid Test Cassette is a lateral flow immunoassay using colloidal gold for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal and nasopharyngeal swab specimens. Intended for use in individuals with clinical symptoms or epidemiological indications of SARS-CoV-2 infection. Samples should be collected by healthcare professionals; the cassette serves as an aid in diagnostic evaluation.

Components / Included Items

• Single-use test cassette with integrated test strip
• Sample treatment solution, single-use bottle
• Sterile swabs (single use)
• Sample processing tube with cap (single use)

Product Features

• Non-invasive sample types (nasal, nasopharyngeal swabs)
• Simple procedure; no instrumentation required
• Rapid results within 15-20 minutes
• Designed for point-of-care use by trained personnel
• Low-cost, single-use components

Operating Steps

• Read the instruction manual completely before testing and bring reagents and specimens to room temperature.
• Perform hand hygiene, open the test cassette package and place the cassette on a clean, flat surface.
• Collect specimen using the provided sterile swab (nasal or nasopharyngeal) according to collection standards.
• Add 10 drops of sample treatment solution into the processing tube.
• Insert the swab into the tube and rotate approximately 10 times to elute the specimen into the solution.
• Squeeze the tube while rotating the swab to extract liquid, remove and discard the swab safely.
• Cap the processing tube and mix gently.
• Add 3 drops of the processed sample into the sample well (S) of the cassette.
• Start timing and read the result visually within 15-20 minutes.
• Dispose of used materials as medical waste according to local regulations.

Result Interpretation
Observe the test and control zones for the appearance of purple-red bands. Read results visually within 15-20 minutes after applying the sample. Do not interpret results after the specified reading time.

Specifications

• Principle: Colloidal gold lateral flow immunoassay
• Target analyte: SARS-CoV-2 nucleocapsid antigen (qualitative)
• Specimen types: nasal swab, nasopharyngeal swab
• Intended user: specimens collected by healthcare professionals
• Time to result: 15-20 minutes
• Sample volume: 3 drops of processed sample into well (S); process with 10 drops of treatment solution
• Packaging: single-use cassette, sample treatment solution, sterile swabs, processing tube
• Waste handling: dispose as medical waste per local regulations