KHB Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) Anti-TP Reagent

Product Details
Customization: Available
Type: IVD Reagent
Usage: Professional Testing
Manufacturer/Factory & Trading Company

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  • KHB Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) Anti-TP Reagent
  • KHB Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) Anti-TP Reagent
  • KHB Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) Anti-TP Reagent
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  • Overview
  • Product Description
  • Principle of the Assay
  • Kit Contains
  • Applicable Instrument
  • Specimen Requirement
  • Operation Procedure
  • Product Brochure
  • Company Profile
Overview

Basic Info.

Model NO.
Anti-TP (ELISA)
Shelf-Life
12 Months
Storage Temperature
2 to 8 Degrees
Certification
Nmpa; ISO
Transport Package
Carton
Specification
96 Test/Kit Box
Trademark
KHB
Origin
China
HS Code
3002100000
Production Capacity
12000000 Pieces/Year

Product Description

KHB Diagnostic Kit for Antibody to Treponema Pallidum (ELISA)
 
Product Description

KHB is the only supplier of rapid plasma reagents for Syphilis in China

Good Performance: Excellent clinical result in CDC report

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

 
Principle of the Assay

Polystyrene microtiter strip wells have been coated with the recombinant T. pallidum antigens (TP-47 KDa and other antigens) which constitutes the solid-phase antibody. The test sample is incubated in such a well; T. pallidumspecific antibodies, if present in the sample, will bind to the antigen fixed onto the microplate wells. The wells are washed to remove unbound components and the antigens labeled with horseradish peroxidase are added to the wells. The enzyme conjugates will bind to the antigen-antibody complex and excess unbound enzyme conjugates are removed by washing again. Incubation with enzyme, substrate produces a blue color in the microwelll, which turns yellow when reaction is stopped with sulphuric acid. If the sample contains no T. pallidum specific antibodies, the labeled antibody cannot be bound specifically and only a low background color develops.
 

Kit Contains
  96 Test/kit
1. Coated Microplate 96 Wells
2. Conjugate  12 ml/vial
3. Positive Control 1.0ml/vial
4. Negative Control 1.0ml/vial 
5. Washing solution(25* ) 80ml/vial
6. Chromogen A 8.0ml/vial
7. Chromogen B 8.0ml/vial
8. Stopping solution 7.0ml/vial
9. Plate sealers 5 pieces
10. Instruction manual  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. This immunoassay kit is an in vitro diagnostic for the detection of Treponema Pallidum in Human serum or plasma.

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

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 sample, negative control and positive control separately at volume of 100ul into each related reaction holes. (5 holes are suggested to be reserved as comparison hole. There are: 2 holes for negative comparison, 1 hole for positive control, 1 hole for chromogen blank comparison. User can adjust themselves as well.)

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

5. Take out microplate and tear plate sealer, wash each hole with wash solutions for 5 times. If washed manually, discard liquid in every holes, fill in each hole with concentration wash solution mentioned in Step 1 and keep for 30 - 60 seconds with concentration wash solution into each hole before spin-dry. After 5 times repeating, pat dry microplates on clean absorbent tissues. If washed by microplate washer, select 5 times' washing procedure, fill in each hole with concentration wash solution mentioned in Step 1 and keep for 30 - 60 seconds with concentration wash solution into every hole, every hole should be absorbed completely, without any residual. Pat dry microplates on clean absorbent tissues after washing.

6. Pipette 100ul of conjugate into those holes with specimen, positive control and negative control added.

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

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

9. Take out microplate and tear plate sealer, wash every hole with wash solutions for 5 times. The washing procedure is same as the procedure mentioned in Step 5.

10. Pipette 50ul of Chromogen A and 50ul of Chromogen B into every hole, blend to get uniformity. 

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

12. Cover the microplate with a plate sealer. Incubate at 37ºCfor 30 minutes.

13. Fill in every hole with 50ul stopping solution, Shake the microplate for 5 seconds to get blending uniformity completely. 

14. Use microplate reader to read and select wavelength at 450nm. (Recommendation to use dual wavelength microplate reader to colorimetric, reference wavelength 630nm or close to wavelength at 630nm.) If need to deduct chromogen blank, the chromogen blank control well needs to be zero correction firstly before reading OD value of each well.
 

Product Brochure
KHB Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) Anti-TP ReagentKHB Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) Anti-TP ReagentKHB Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) Anti-TP ReagentKHB Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) Anti-TP ReagentKHB Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) Anti-TP ReagentKHB Diagnostic Kit for Antibody to Treponema Pallidum (ELISA) Anti-TP 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 Antibody to Treponema Pallidum (ELISA) Anti-TP Reagent

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