KHB Diagnostic Kit for HIV (1+2) Antibody (Colloidal Gold) V2 HIV Reagent Rapid Test with CE IVDR & WHOPQ Professional Use

• Customization: Available
• Type: IVD Reagent
• Reads The Result Within: 15-25 Minutes
• Model NO.: HIV (Colloidal Gold)
• Sample Type: Whole Blood, Serum and Plasma
• Usage: Professional Use
• Certificate: CE Ivdr; Who Pq; Nmpa; ISO
• Transport Package: Carton
• Specification: 1 test/kit; 50 tests/kit
• Trademark: KHB
• Origin: China
• HS Code: 3006300000
• Production Capacity: 12000000 Pieces/Year

Product Description

KHB Diagnostic Kit for HIV (1+2) Antibody (Colloidal Gold) V2
 

Product Description

Features and Benefits
Superior Raw Material
Our HIV 1+2 rapid test who utlized superior gp 160 antigens as the major raw material, which is expressed in  mammalian cells in our labs. Unlike the antigen expressed in E. Coli, this antigen has great solubility in Water, high sensitivity, and very low cross-reactivity. With this superior ntigen, the sensitivity and specificity of the kit  is ensured.

"Sandwich" Testing Principle

Easy to Use
Small Sample Size: 40μL
Reads the result within 15-25 minutes
No equipment required

Suitable for whole blood, serum, and plasma samples


Kit Compoment

Component (product code)	50 tests R-401-50-C-2	50 tests R-401-50-C-3	50 tests KH-R-02	50 tests KH-R-02	50 tests KH-R-02-CE	1 tests R-401-1-C-CE	25 tests R-401-25-C-1-CE	Accessories kit A-GOLD-01
HIV(1+2) antibody test cassette	50	50	50	50	50			N/A
Sample diluent	4ml x 1 bottle	4mlx 2 bottle	4mlx 1 bottle	4mlx 2 bottle	4mlx 1 bottle	0.5mlx 1 bottle	4mlx1 bottle	N/A
Safety lancet	50	50	N/A	N/A	N/A		25	50
Alcohol pad	50	50	N/A	N/A	N/A	1	25	50
Disposable transfer pipette	50	50	N/A	N/A	N/A	1	25	50
Instruction for use	1 pcs	1 pcs	1 pcs	1 pcs	1 pcs	1 pcs	1 pcs	1 pcs

Principle of the Procedure
The Diagnostic Kit for HIV (1+2) Antibody (Colloidal Gold) V2 from KHB adopts the solid phase colloidal gold immunochromatographic technology for the qualitative detection of antibodies against HIV-1/HIV-2.
The gold HIV-1 gp160 conjugate and the gold HIV-2 gp 36 conjugate are coated to the conjugate pad in advance. The test line (recombinant gp 36 and gp 41 antigens) and the control line (monoclonal antibody against gp 160) are pre-coated on the surface of Nitrocellulose (NC) membrane. When the specimen is added to the sample pad, it migrates through the conjugate pad, reconstitutes and mixes with the colloidal gold-antigen complex and moves on till the end of the strip. A reddish-purple test line will be visible in the strip if there are enough antibodies against HIV-1/HIV-2 in the specimen.If the specific antibodies are absent, or present at a very low level, no test line appears.

Test Procedure
Equilibrate all specimens and the devices to room temperature (18-28ºC) before testing.
Sample diluent from different batches can not be mixed.
· Take out a test cassette from the foil pouch, and place it on a horizontal surface.
· Use the specimen of either serum/plasma or whole blood: Add 40μl of specimen to the specimen area firstly (Figure 1), then slowly add 1 drop of sample diluent vertically to the same area (Figure 2). Please avoid direct contact of the diluent bottle with the specimen area.
· Incubate the cassette at room temperature (18-28C) and read the result after 15 minutes but not more than 25 minutes. Reading the test before 15 minutes or after 25 minutes may cause false result.
 

Result Interpretation

Positive result - Clear visible reddish-purple bands appear both at the C-line and the T-line of the cassette.

Negative result - A reddish-purple band appears only at the C-line of the cassette.

Invalid result - A reddish-purple band appears only at the T-line of the cassette. Repeat the test and contact KHB supplier if the C-line remains invisible.

Invalid result - Reddish-purple band appears at neither the C-line nor the T-line of the cassette. Repeat the test of the sample. If the result remains the same, then the result is invalid and contact KHB supplier.
 

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.}