QINGDAO JIAXIN CO,.LTD

COVID-19 Overview

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. The main symptoms include fever, fatigue, loss of smell and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.SARS viral antigen is generally detectable in upper respiratory specimens during the acute phase of infection. The Coronavirus Ag Rapid Test is a rapid screening tool to detect the presence of SARS viral antigen in the form of a visually interpreted result within minutes.

Product Information

The Coronavirus Ag Rapid Test Cassette (Swab) is an in vitro immunochromatographic

assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in

direct nasopharyngeal (NP) swab specimens directly from individuals who are suspected

of COVID-19 by their healthcare provider within the first ten days of symptom onset. It is

intended to aid in the rapid diagnosis of SARS-CoV-2 infections. Negative results from

patients with symptom onset beyond ten days, should be treated as presumptive and

confirmation with a molecular assay, if necessary, for patient management, may be

performed. The Coronavirus Ag Rapid Test Cassette (Swab) does not differentiate

between SARS-CoV and SARS-CoV-2.

Test Procedure & Interpretation

Specimen collection

Use the nasopharyngeal swab provided in the kit.

1. Carefully insert the swab in the patient’s nostril.

2. Swab over the surface of the posterior nasopharynx and rotate the swab several times.

3. Withdraw the swab from the nasal cavity.

Sample preparation

1. Insert the test extraction tube into the workstation provided in the kit. Make sure that the

tube is standing upright and reaches the bottom of the workstation.

2. Add 300 µL (about 10 drops) of the extraction buffer into the extraction tube.

3. Insert the swab into the extraction tube which contains 300 µL of the extraction buffer.

Roll the swab at least 6 times while pressing the head against the bottom and side of the

extraction tube.

4. Leave the swab in the extraction tube for 1 minute.

5. Squeeze the tube several times from the outside to immerse the swab. Remove the swab.

6. Push the tip which contains the fifilter onto the extraction tube. Ensure the tip has a tight fifit.

Benefifits

• Rapid testing for SARS-CoV-2 antigen within the fifirst ten days of symptom onset

• Rapid results within 15 minutes

• Facilitates patient treatment decisions quickly

• Simple, time-saving procedure

• No instrumentation required

• High sensitivity and specifificity