• KHB Diagnostic Kit for Hepatitis B Surface Antigen (ELISA) HBsAg Reagent
  • KHB Diagnostic Kit for Hepatitis B Surface Antigen (ELISA) HBsAg Reagent

KHB Diagnostic Kit for Hepatitis B Surface Antigen (ELISA) HBsAg Reagent

Type: IVD Reagent
Shelf-Life: 12 Months
Principle of The Assay: Sandwich Principle
Transport Package: Carton
Specification: 48 Test/Kit Box; 96 Test/Kit Box
Trademark: KHB
Customization:
Manufacturer/Factory & Trading Company

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Shanghai, China
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  • Overview
  • Product Description
  • Kit Contains
  • Applicable Instrument
  • Specimen Requirement
  • Operation Procedure
  • Product Brochure
  • Company Profile
Overview

Basic Info.

Model NO.
HBsAg (ELISA)
Origin
China
HS Code
3002100000
Production Capacity
12000000 Pieces/Year

Product Description

KHB Diagnostic Kit for Hepatitis B Surface Antigen (ELISA)
 
Product Description

High Sensitivity: adr subtype ≤0.1IU/ml, adw subtype ≤0.1IU/ml, ay subtype ≤0.2IU/ml

Strong detection ability

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

 
Kit Contains
 
48 Test/kit
96 Test/kit
1. Coated Microplate:
48 test 96 test
2. Conjugate 3.ml*1 vial 6.2ml*1 vial
3. Positive Control 0.5ml*1 vial 1.0ml*1 vial
4. Negative Control 0.5ml*1 vial 1.0ml*1 vial
5. Washing solution(25* ) 20ml*1 vial 40ml*1 vial
6. Chromogen A 4.0ml*1 vial 8.0ml*1 vial
7.Chromogen B 4.0ml*1 vial 8.0ml*1 vial
8. Stopping solution 3.5ml*1 vial 7.0ml*1 vial
9. Plate sealers 5 pieces 5 pieces
10. Instruction manual
1 copy
1 copy
 
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 HBsAg is an in vitro diagnostic kit for the detection of hepatitis B surface antigen (HBsAg) in human serum or plasma.

2. Human serum: the whole sample should be kept at room temperature for 1-2 hours until blood clotting and retraction after blood taken, centrifuge at Round per minute for 15 minutes, aspirate serum for use.

3. Plasma: the blood sample and anticoagulants should be blended gently upside down for 6-8 times after blood taken, fully centrifugation until isolation of the plasma and hemocyte, aspirate plasma for use.

4. 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 freezing and thawing of samples.

 
Operation Procedure

1. Dilute the concentrated wash solution 1:25 with purified water. ( For example: 480ml purified water add with 20ml wash solution fully blended to get 500ml working concentration detergent for use.)

2. Open the aluminum bag and take out the microplate with the required number of strips.

3. Pipette 75ul of each specimen, negative control, and positive control into the wells (reserve 3 wells for negative control, 1 well for positive control and 1 well for blank).

4. Cover the microplate with a plate sealer. Incubate at 37ºC for 60 minutes.

5. Take out the microplate and tear the plate sealer, add 50ul conjugate into those wells with samples, negative control and positive control.

6. Concussion for 10 seconds on microporous oscillator or gently concussion for 10 seconds manually.

7. Cover the microplate with a plate sealer. Incubate at 37ºC for 30 minutes.

8. Take out microplate and tear plate sealer, wash each well with wash solutions for 5 times. If washing manually, discard liquid in wells, fill in each well with concentration wash solution mentioned in Step 1, dry strips after 30 to 60 seconds holding. After 5 times repeating, pat dry microplates on clean absorbent tissues. If washing by microplate washer, select 5 times' washing procedure, fill in each well with concentration wash solution mentioned in Step 1 to make sure no residual every time, pat dry microplate 
on clean absorbent tissues after every washing. 

9. Pipette 50ul of Chromogen A and 50ul of Chromogen B into each well, blend to get uniformity. 

10. Concussion for 10 seconds on microporous oscillator or gently concussion for 10 seconds manually.

11. Cover the microplate with a plate sealer. Incubate at 37ºC for 30 minutes.

12. Fill in each well with 50ul stopping solution, concession the microplate for 5 seconds to get blending uniformity completely. 

13. Use microplate reader to read, wavelength 450nm. (Recommendation to use dual wavelength microplate reader to colorimetric, reference wavelength 630nm or similar as 630nm.) If need to deduct chromogen blank, the chromogen blank control well needs to be zero correction firstly, and then read each well's OD value.

 
Product Brochure

 

KHB Diagnostic Kit for Hepatitis B Surface Antigen (ELISA) HBsAg ReagentKHB Diagnostic Kit for Hepatitis B Surface Antigen (ELISA) HBsAg ReagentKHB Diagnostic Kit for Hepatitis B Surface Antigen (ELISA) HBsAg ReagentKHB Diagnostic Kit for Hepatitis B Surface Antigen (ELISA) HBsAg ReagentKHB Diagnostic Kit for Hepatitis B Surface Antigen (ELISA) HBsAg ReagentKHB Diagnostic Kit for Hepatitis B Surface Antigen (ELISA) HBsAg Reagent
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.

KHB Diagnostic Kit for Hepatitis B Surface Antigen (ELISA) HBsAg Reagent

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Diamond Member Since 2023

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Manufacturer/Factory & Trading Company
Number of Employees
893
Year of Establishment
1981-11-22