COVID-19 (SARS-CoV-2) Antigen Test Kit

Principle

This kit uses immunochromatography for detection. The test strip consists of: 1) a burgundy colored conjugate pad containing mouse anti-novel coronavirus nucleoprotein monoclonal antibody conjugated with colloidal gold , 2) a n  itrocellulose membrane strip containing one test lines (T lines) and a control line (C line) . The T line is pre-coated with antibodies for the detection of novel coronavirus nucleoprotein, and the C line is pre-coated with a control line antibody.

Features

Easier: No special equipment needed; Easy to use; Intuitive visual interpretation.
Rapid: Results in 10 minutes.
Accurate: Results were validated by PCR and Clinical diagnosis.
Diversity: Works with oropharyngeal swab, nasal swab and nasopharyngeal swab.

Components

1.Individually sealed foil pouches containing:

a. One device
1) Novel coronavirus monoclonal antibody and rabbit IgG antibody for Recombined pad
2) Novel coronavirus monoclonal antibody for T line
3) Goat-anti-rabbit IgG antibody for C line

b. One desiccant
1)Sample Tubes (20) : Sample buffer（0.3ml/bottle)
2)Nasopharyngeal Swabs (20)
3) Quick Reference Instructions (1)

Storage and Stability

Store at 2℃~ 30℃ in a dry place and avoid direct sunlight. Do not freeze. It is valid for 24 months from date of manufacturing.
After the aluminum foil bag is unsealed, the test card should be used as soon as possible within one hour.

Test Procedure

1.Please read the instruction manual carefully before testing.

2.Take out the test cassette, specimen dilution buffer, etc., and use it after returning to room temperature. When everything is ready, tear off the aluminum foil bag, take out the test cassette and place it on the platform.After opening the aluminum foil bag, the test cassette should be used as soon as possible within 1 hour.

3.Aspirate the plasma/serum specimen with the pipette, add 1 drop (approximately 20ul) of specimen to the sample well of the test cassette.and then open the specimen dilution buffer drop bottle, add 2 drops (about 80ul) of specimen dilution buffer to the well.

4.Timing observation: judge the result 15 minutes after specimen adding, do not observe the result 20 minutes later.

Positive: Only the quality control line (C line) has a red line, and the test line (T line) has no red line. It indicate the presence of SARS-CoV-2 neutralizing antibodies above the detection limit of the test kit in the specimen.

Negative: The red lines appear on the quality control line (C line) and the test line (T line) . It means that no SARS-CoV-2 neutralizing antibodies in the specimen or SARS-CoV-2 neutralizing antibodies level is below the detection level.

Invalid: No red line appears on the quality control line (C line) , indicating failure. It may be due to improper operation or test cassette is invalid and should be retried.