CAS-Envision Neutralizing Antibodies Test Kit (Colloidal Gold) (25 Test/Kit)

• Type: IVD Instrument
• Product Name: Antigen Rapid Test
• Accuracy: Over 99%
• Certificate: CE, ISO, Nmpa, FSC, Pei
• Methodolgy: Colloidal Gold
• Shelf Life: 24 Months
• Model NO.: CG201A
• OEM/ODM: Support
• Operation Temperature: 2~30celsius
• After-Sale Service: Return and Replacement
• Fomat: Cassette
• Package: 1,5,25 Test/ Kit
• Application: Home
• Read Time: 15 Mins
• MOQ: 10000 Tests
• Transport Package: Individual Foil Pouch + Box + Carton
• Specification: disposable
• Trademark: CAS-Envision
• Origin: China
• HS Code: 3822009000
• Production Capacity: 500000 PCS/Day

Product Description

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Product Actual Photo

Materials Provided:
1.25Individual sealed pouches, each pouch contains:
 1*Test Cassette
 1*Desiccant Pouch
2.25Disposable plastic droppers
3.25 blood colltctors
4.Sample Diluent Buffer(1*6mL)
5.1*Instructions for Use
6.1*Certifivate of conformity
7.1*Procedure card

Sensitivity and Specificity: The clinical sensitivity of the kit is determined by specimens collected from 116 participants who received the Beijing Institute of Biological Products Vaccine (Vero cell, Inactivated) in China. The clinical specificity of the kit is determined by specimens from 269 uninfected and unvaccinated participants. The reference reagent used in the clinical study is cPass™  Neutralization Antibody Detection Kit manufactured by GenScript USA Inc. The kit showed 97.4% of sensitivity and 99.6% of specificity. The nasal swabs of 161 patients with nucleic acid positive and 185 subjects with nucleic acid negative were tested simultaneously using the product and PCR method to evaluate the sensitivity, specificity, and accuracy of the product; The NP swabs test results were compared with PCR, The sensitivity, specificity, and accuracy were calculated and the 95% confidence intervals were calculated respectively.