KHB Diagnostic Kit for Antibody to Hepatitis C Virus (Double Antibody Sandwich Enzyme-linked Immunoassay)

• Type: IVD Reagent
• Shelf-Life: 12 Months
• Storage Temperature: 2 to 8 Degrees
• Transport Package: Carton
• Specification: 48 Test/Kit Box; 96 Test/Kit Box
• Trademark: KHB
• Model NO.: Anti-HCV jx (ELISA)
• Origin: China
• HS Code: 3002100000
• Production Capacity: 12000000 Pieces/Year

Product Description

KHB Diagnostic Kit for Antibody to Hepatitis C Virus (Double Antibody Sandwich Enzyme-linked Immunoassay) 
 

Product Description

Branding advantage: First company to launch commercialized Hepatitis C Virus Elisa Tests in China

Performance advantage: Floating cutoff value, more stable result

Quality Control: As GMP-certified   products, HC every batch is nationally quality guaranteed
 

Principle of the Assay

Polystyrene microtiter strip wells have been coated with HCV specific antigens derived from "core" and "ns" regions encoding for conservative immunodominant antigenic determinants. the diluted sample is incubated in such a well; antibodies to HCV are captured, if present, by the antigens during the time of incubating. After washing out the unbound components of the samples, the anti-human IgG antibodies, labeled with peroxidase (HRP) are added to the wells. The enzyme conjugates will bind to the complex and excess unbound enzyme conjugates are removed by washing again. Incubation with enzyme, substrate produces a blue color in the microwell, which turns yellow when the reaction is stopped with sulphuric acid. If the sample contains no antibodies to HCV, the labeled antibody cannot be bound specifically and only alow background color develops.

 
 

Specification

Product	Specification
Anti-HCV jx	96T/8 well
Anti-HCV jx	96T/12 well

 

Applicable Instrument

Automatic Operation Instrument: Fully automatic enzyme immunoassay analyzer

Manual Operation Instrument:

- 37 ºC thermostat or water bath

- Micropore oscillator

- Micropipette 25 μl -200 μl

- Microplate reader: detection wavelength 450nm, reference wavelength 630nm

- Microplate washer or bottle washer

 

Specimen Requirement

1. KHB HCV is an in vitro diagnostic kit for the detection of HCV in human serum or plasma.

2. Human serum and plasma should be stored at 2 to 8ºC. For long term storage, both human serum and plasma should be stored at -20ºC, and avoid repeated-freeze-thaw.

 

Product Brochure

Company Profile

KHB (Kehua Biotech)

_{Shanghai Kehua Bio-engineering Co., Ltd. (hereinafter referred to as KHB, Stock code: 002022.SZ) is an  IVD company that boasts a full line of medical diagnostic products. Since its foundation in 1981, KHB has developed into a hi-tech company that integrates R&D, manufacturing and marketing business operation. In 2004, it was listed in Shenzhen Stock Exchange (SZSE).}
 

_{Headquartered in Shanghai, KHB has set up R&D centers and production bases in a number of countries and regions including Italy, Shenzhen, Xi'an, and Suzhou and 33 subsidiaries. Currently, the company has nearly 2,000 employees, and its subsidiary Tianlong Technology has nearly 1000 employees.}
 

_{Driven by the company's R&D and innovation capability, KHB has built two R&D technology platforms for clinical IVD reagents and full automatic analyzers in order to progressively promote the serial development and integration of reagents and instruments. Focusing on immune diagnosis, biochemical diagnosis, molecular diagnosis and POCT(point-of-care testing), we have 260+NMPA product registration certificates, and more than 80+ CE certified reagent and instrument products. At the same time, Tianlong Technology has 70 domestic medical device registration certificates and 120 international medical device certifications; The Italian subsidiary TGS has more than 80 EU CE certified products.}
 

_{With its business rooted in China, KHB has a global footprint. Customers of KHB cover 12,000+ hospitals, 500+ disease control and prevention centers, blood centers and a number of bio-pharmaceutical enterprises and scientific research institutions across over 30 provinces, municipalities and autonomous regions. It has established long-term partnership with more than a thousand of domestic agents and dozens of international agents. KHB branded products have been exported to 100 foreign countries and regions. AIDS diagnostic reagents in-house developed by KHB that passed WHO PQ have been listed in the purchase catalogs in USAID, UNICEF and many countries.}
 

_{KHB attaches great importance to the integration of industry, education and research. We were selected into Zhangjiang Index in 2020, and successfully developed a highly sensitive infectious disease screening technology platform. At the same time, we worked with Fudan University to deepen the cooperation between industry, education and research, built an enterprise innovation center with Fudan Guanghua Harbor, promoted the technological integration of Kehua Biology and the Biomedical Engineering Center of Fudan Harbor based Industrialization Innovation Platform, and jointly improved the capabilities of scientific and technological innovation and industrial integration. The company has set up a national postdoctoral research workstation, Shanghai Enterprise Technology Center, Shanghai Immunodiagnostic Reagent Engineering Technology Research Center and Shanghai IVD Reagent Technology Innovation Center, etc. It is a high-tech enterprise certified by the competent department of Shanghai.}
 

_{Over the past 41 years, as a member of the China Association For Medical Devices Industry (CAMDI), a high-tech enterprise of the Shanghai Municipal Science and Technology Commission, a demonstration enterprise of intellectual property rights in Shanghai, and one of the top 100 enterprises in Shanghai's manufacturing industry, KHB has successively won such honorary titles as "Shanghai Famous Trademark Certificate", "Shanghai Famous Brand", "Shanghai Science and Technology Award", "Shanghai Innovative Enterprise", and "China's Top 100 SMEs in Innovation".}
 

_{Inspired by its corporate vision -"Care for life, Dedicate to excellence" and with talent and quality at the top of its priority list, KHB is dedicated to improving the health of human beings by focusing on the field of IVD driven by innovation and lean management.}