KHB Diagnostic Kit for Antibody to Human Immunodeficiency Virus (ELISA) AIDS/HIV Reagent

• Type: IVD Reagent
• Shelf-Life: 12 Months
• Storage Temperature: 2 to 8 Degrees
• Specimen Requirement: Serum and Plasma
• Transport Package: Carton
• Specification: 96 Test/Kit Box
• Model NO.: HIV (ELISA)
• Trademark: KHB
• Origin: China
• HS Code: 3002100000
• Production Capacity: 12000000 Pieces/Year

Product Description

KHB Diagnostic Kit for Antibody to Human Immunodeficiency Virus (ELISA)
 

Product Description

Excellent raw material: Coated with unique HIV antigen, endows reagent with high sensitivity and reduces missed detection

Superior performance: 100%specificity and 100%sensitivity in 2018-2019 CDC clinical performance evaluation 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 antigen. The test sample is incubated in such a well; antibodies specific for HIV-1 and HIV-2, 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 antigen 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 the reaction is stopped with sulphuric acid. If the sample contains no HIV-1 and/or HIV-2 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. Anti-HIV-1 Positive Control	1.0ml/vial
4. Anti-HIV-2 Positive Control	0.5ml/vial
5. Anti-HIV Negative Control	1.0ml*1 vial
6. Washing solution(25* )	80ml/vial
7. Chromogen A	8.0ml/vial
8. Chromogen B	8.0ml/vial
9. Stopping solution	7.0ml/vial
10. Plate sealers	5 pieces
11. 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 HIV-1 and/or HIV-2 in Human serum or plasma.

2. Human serum and plasma should be stored at temperature of 2 to 8ºC.
    For long term storage, both human serum and plasma should be stored at temperature of -20ºC, 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. Set 2 wells for Anti-HIV-1 positive control (100ul per well), 1 well for Anti-HIV-2 positive control ( 100ul per well), 1 well for Anti-HIV negative control (100ul per well), 1 well for blank control ( Not to add sample and conjugate into blank control well but add only zymolyte and stopping solution) per experiment. Pipette 100ul of sample for testing into rest wells. 

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

5. 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 and keep for 30 - 60 seconds with concentration wash solution into each well before spin-dry. 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 and keep for 30 - 60 seconds with concentration wash solution into each well, each well should be absorbed completely, without any residual. Pat dry microplates on clean absorbent tissues after washing.

6. Pipette 100ul of conjugate into the well that contained specimen, positive control and negative control. Cover the microplate with a plate sealer after mixing uniformity. Incubate at 37ºC for 30 minutes.

7. Repeat the procedure 7.

8. Pipette 50ul of Chromogen A and 50ul of Chromogen B into all wells after washing, blend to get uniformity. 

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

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

11. Fill in all wells with 50ul stopping solution, concession the microplate for 5 seconds to get blending uniformity completely. 

12. Use microplate reader to read and select wavelength of 450nm. (Recommendation to use dual wavelength microplate reader to colorimetric, reference wavelength 630nm or close 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. (The value should be read in 10 minutes after adding stopping solution.)

 

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.}