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

COVID-19(SARS-CoV-2) 항원 테스트 키트

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.
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원칙

 

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.

 

상품명 COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit
상표명 골든 타임
방법론 콜로이드 금
표본 Nasal swab,oropharyngeal swab or nasopharyngeal swab
Clinical sensitivity 96.330%
Clinical specificity 99.569%
Overall agreement 98.79%
포장 고객 요구 사항에 따라 1/5/20 테스트/판지.
독서 시간 10 mins
Service support OEM/ODM

 

covid-19 (sars-cov-2) antigen diagnostic test kit rapid antigen test kit covid 19

 

특징

 

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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