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SARS-CoV-2 Antigen Rapid Test Kit(Fluorescence immunoassay)
SARS-CoV-2 Antigen Rapid Test Kit is a lateral flow immunoassay intended for the quantitative detection of the Nucleocapsid antigen from SARS-CoV-2 in nasopharyngeal swabs from individuals who are suspected of SARS-COV-2 by their healthcare provider within the first 7 days of symptom onset, or for screening of individuals without symptoms, or other reasons to suspect SARS-COV-2 infection, if applicable.
Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
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.
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.
|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.
【Storage conditions and validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.
The production date, batch number and expiration date are shown in the outer package of the product.
Nir-1000 dry fluorescent immunoassay analyzer produced by WWHS Biotech. Inc.
Insert a fresh NMT swab into the patient nostril parallel to the palate. The swab should be inserted less than 1 inch/2cm into the nostril until resistance is met at the turbinate. Rotate the swab several times, then gently remove and repeat the process in the other nostril.
【Interpretation of results】
|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|
About WWHS Biotech Inc
WWHS Biotech. Inc Is A High-Tech Enterprise Incubated By The Research Institute Of Tsinghua University In Shenzhen In 2016. The Company Is Located In The National Biomedical Industrial Base In Pingshan District, Shenzhen, With About 32,000 Square Feet Space For Workshop And Office.
As A Fast-Growing Biotechnology Company, We Dedicate To The Development Of World-Class Bio-Detection Technologies That Meet The Ever-Increasing Demands On Clinical Diagnostics. We Focus On Developing Cost-Effective And Precise Rapid Diagnostic Products Based On Our Unique Near Infrared (NIR) Fluorescence Platform Technologies (PGOLD™ And IR-LF™) With Major Interests In Cardiology, Infectious Diseases, Oncology, Metabolic Diseases And Women And Children’s Health.
About NIR-1000 Dry Fluoroimmunoassay Analyser
It is a fluorescence immunochromatographic analysing system with internal temperature control,
which can help diagnose conditions such as infection, diabetes, cardiovascular diseases, renal injury and cancers, etc.
Testing time less than 15 minutes
Easy-to-use touch-screen platform,multi-language system
Reagents stored at room temperature for 12 months
Q1: Are you trading company or manufacturer?
A1: We are manufacturer.
Q2: Do you provide samples ?
A2: Yes,we do provide samples.If you need it, please contact us.
Q3: How about the quality?
A3: We have the best professional engineer and strict QA and QC system to ensure you get high quality products from us.
Q4: How’s the package?
A4: Normally are cartons, but also we can pack it according to your requirements.
Q5: How’s the delivery time?
A5: It depends on the quantity you need.
Send your inquiry directly to us