Place of Origin:
CN
Brand Name:
WWHS
Certification:
CE
Model Number:
Covid-19 Antibody
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【Product name】 Cov-Sars2 Antibody Test.pdf
SARS-CoV-2 Antigen Rapid Test Kit(Fluorescence immunoassay)
【Intended use】
Negative results should be treated as presumptive, and do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with SARS-CoV-2, and confirmed with a molecular assay, if necessary, for patient management.
The SARS-COV-2 Antigen Rapid Test Kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.
【Inspection principle】
The SARS-CoV-2 Nucleocapsid proteins Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of SARS-CoV-2 Nucleocapsid proteins. The SARS-CoV-2 Nucleocapsid proteins in the sample was first bound with the conjugated compound of fluorescent labeled SARS-CoV-2 Nucleocapsid proteins monoclonal antibody, then moved and combined with another SARS-CoV-2 Nucleocapsid proteins monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.
【Components】
Name | Quantity | Component |
Test cards | 25 | It is composed of fluorescent pad (coated with fluorescent labeled SARS-CoV-2 Nucleocapsid proteins monoclonal mouse antibody), nitrocellulose membrane (coated with SARS-CoV-2 Nucleocapsid proteins monoclonal mouse antibody and Goat anti mouse IgG antibody), absorbent paper and backing |
Sample diluent | 25(400μL/tube) | Phosphate buffer |
Nasal Mid-Turbinate (NMT) swabs | 25 | Flocking |
ID card | 1 | With specific stand curve file |
The components in different batches of kits cannot be used interchangeably.
【Note】
WWHS Assay list | Infection | |||||
cat#. | Product Item | Specimen | Reaction Time | Measure Range | Clinical Range | Intended Use |
41 | Covid-19 Antigen | nasal swab, throat swab or nasal wash/aspirate specimens | 15min. | qualitative | qualitative | respiratory tract |
42 | Covid-19 Ab IgG/IgM | WB/Serum/Plasma | 15min. | qualitative | qualitative | respiratory tract |
43 | FluA | nasal swab, throat swab or nasal wash/aspirate specimens | 15min. | qualitative | qualitative | respiratory tract |
44 | FluB | nasal swab, throat swab or nasal wash/aspirate specimens | 15min. | qualitative | qualitative | respiratory tract |
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