product

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

Short Description:

This product is used for in vitro qualitative detection of the antigen of novel coronavirus in human nasopharyngeal swabs.
COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit is a test and provides a preliminary test result to aid in the diagnosis of infection with novel Coronavirus. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this test.


Product Detail

Test Procedure

OEM / ODM

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.

Product name COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit
Brand Name GOLDEN TIME
Methodology Colloidal gold
Specimen Nasal swab,oropharyngeal swab or nasopharyngeal swab
Clinical sensitivity 96.330%
Clinical specificity 99.569%
Overall agreement 98.79%
Packing 1/5/20 tests/carton ,According to customer requirements.
Reading time 10 mins
Service support OEM/ODM

COVID-19 (SARS-CoV-2) Antigen TestCOVID-19 (SARS-CoV-2) Antigen Test02 COVID-19 (SARS-CoV-2) Antigen TestCOVID-19 (SARS-CoV-2) Antigen Test01

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.


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  • 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.

    COVID-19 (SARS-CoV-2) Antigen TestCOVID-19 (SARS-CoV-2) Antigen Test01 COVID-19 (SARS-CoV-2) Antigen TestCOVID-19 (SARS-CoV-2) Antigen Test02

    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.

    OEM / ODM

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