Accurate Rapid Device Test Kit Aids HIV Test in Vitro Diagnostic
Gaobeidian PRISES Biotechnology Co., Ltd.- Type：Test Strips & Test Tube
- Material：Plastic
- Ethylene Oxide Sterilization：Without Ethylene Oxide Sterilization
- Quality Guarantee Period：Two Years
- Group：Adult
- Logo Printing：With Logo Printing
Base Info
- Model NO.：HIV-4-C
- Name：HIV 1+2 Rapid Test
- Methodology：Colloidal Gold Immune Chromatographic Assay
- Specimen：Serum,Plasma,Wb
- Format：Cassette
- Accuracy：More Than 98%
- Reading Time：1-20 Minutes
- Shelf Life：24 Months
- Certification：ISO, Nmpa, FSC
- Service Support：OEM,ODM
- Transport Package：20,25PCS,Box
- Specification：3.0mm,4.0mm
- Trademark：GOLDEN TIME
- Origin：Hebei Province, P. R. China
- HS Code：3002150090
- Production Capacity：3000, 000 Pieces,Month
Description
HIV1+2 Test Kit
INTENDED USE
The HIV 1+2 Ab Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of anti-HIV-1 and anti-HIV-2 antibodies (IgG, IgM or IgA) in human serum, plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HIV-1 or HIV-2.
FEATURES AND BENEFITS
• RESPONSIVE:
High accuracy and stability,double antigen sandwich assay.
• QUICK CHECK:
Easy to use in simple step,10 minutes out of results.
• CLEAR RESULTS:
The detection board is divided into two lines, the result is clear and easy to read.
DIRECTIONS FOR USE
• Step 1: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
• Step 2: Dispense 1drop (about 20 µL )of the specimen into the sample well. Then add 2 drops (about 70-100 µL) of Sample Diluent immediately.
• Step 3: Set up timer.
• Step 4: Results can be read in 20 minutes. Positive results can be visible in as short as 1 minute.
PACKAGING DETAILS
1. Each box contains 25 test devices, each sealed in a foil pouch with three items inside: one cassette device , one desiccant and one 5 µL mini plastic droppers.
2. buffer (1 bottle, 10 mL)
3. 25 blood lancets
4. One package insert (instruction for use).
STORAGE CONDITION
Store at 4C to 30°C. It should avoid light, moisture and cryopreservation.
Shelf-life: 24 months from manufacturing date.
4ºC to 30ºC
PRISES Biotechnology, is a R&D based manufacturer, engaged in development, manufacturing and trading of in vitro Diagnostic Reagents (IVD) and Medical Equipment, which approved for manufacturing and trading IVD products from NMPA(CFDA) and operated under quality system of ISO 13485, most of products have been certified with CE mark.
Our factory is founded in 2012 and located in Gaobeidian City, which is near Xiongan New Area and Beijing. It covers an area of 3,000 square meters, including class 1000,000 clean workshop with 700 square meters, class 10 thousands of microbiological testing room with 200 square meters, well-equipped quality inspection rooms, research and development laboratories, etc.
PRISES Biotechnology is producing highly sensitive urine Fertility tests, such as pregnancy test, ovulation test or FSH tests for professional use and self-testing under brand name of Golden Time, as well as OEM/ ODM basis. It is also providing an extensive range of Immunochromatography based one-step rapid tests for infectious diseases & Respiratory diseases for HBsAg, Anti-HBs, HCV, HIV 1/2, Syphilis, Malaria P.f/P.v, Dengue IgG/IgM, Dengue NS1, H.Pylori,19 Antigen test,19 Antibody test,19 Neutralizing Antibody test, and other unique rapid tests, mask, Disposable Virus Sample Tube, condoms, etc.
Our products are sold well in China market, they are also exported to clients in such countries as Poland, United Kingdom, Germany, Portugal, France, Bulgaria, Turkey, Ireland, Egypt, South Africa, Madagascar, South Korea, Peru etc. Adhering to the business principle of mutual benefits, we have had a reliable reputation among our customers because of our professional services, quality products and competitive prices. We are glad to work with you for common success and bring you the satisfied products.
Q1: How can i distinguish a good test kit ?
A1: U can judge from the 4 facts:
Technical data: Such as the accuracy, specificity and sensitivity.
Pouch sealing: Tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of antibodies labeled on NC membrane. Shelf life will be shorten down.
Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. U can refer to the instruction for more accurate time.
Background: Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice.
Q2:Can I have a sample for our testing?
A2: Yes, free samples are available by freight collected. And we will return the freight in the first order.
Q3:What is sample ready time?
A3: Usually 1-7 days, since it was produced against specific demands to guarantee most freshness.
Q4:What about the order payment methods and delivery time?
A4: 1) 30~70% T/T advance, balance before delivery, Irrevocable L/C at sight.
Delivery time usually 1-45 days after receiving the deposit. Our brand package takes 15 days, OEM package takes around 35 days.(Due to factors such as the power limit of the factory and the surge in demand for 19 test kits, in order to ensure the delivery date, we have reserved several production lines to ensure the normal production of conventional kits and both regular customer orders and new orders will not be affected.)
Q5:Can I print our logo on the package?
A5: Yes, as a manufacturer, we can according to your requirements, the size of the product, the appearance of the design of the program, colleagues can sample order,official authorization will be required. We do not accept orders for imitation brand. We do not do business that harm other brands and companies, as were victims once.
Q6. Will you help me register the products in my country ?
A6: Sure, we will provide all you documents and samples you need for register, but express cost will be paid by your company.
Q7:How to deal with the products regarding the quality and quantity?
A7: PRISES Biotechnology is a professional supplier for the medical products for many years. It is of great importance for the quality issues, QC department will arrange the checking every lot, also we have the spot checking at random, we keep high concentration of quality issues, also quantity issues , which is the life of a company, we carry out all our technique skills according to CE mark , FSC , EU declaration conformity, ISO 13485 and so on .
Q8:Can i have a phone call directly with your sales if some urgent questions?
A8: Yes, of course, that is wonderful to save the time and catch the key point easily. If you have any questions, you can call us or send us by email.
INTENDED USE
The HIV 1+2 Ab Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of anti-HIV-1 and anti-HIV-2 antibodies (IgG, IgM or IgA) in human serum, plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HIV-1 or HIV-2.
FEATURES AND BENEFITS
• RESPONSIVE:
High accuracy and stability,double antigen sandwich assay.
• QUICK CHECK:
Easy to use in simple step,10 minutes out of results.
• CLEAR RESULTS:
The detection board is divided into two lines, the result is clear and easy to read.
DIRECTIONS FOR USE
• Step 1: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
• Step 2: Dispense 1drop (about 20 µL )of the specimen into the sample well. Then add 2 drops (about 70-100 µL) of Sample Diluent immediately.
• Step 3: Set up timer.
• Step 4: Results can be read in 20 minutes. Positive results can be visible in as short as 1 minute.
PACKAGING DETAILS
1. Each box contains 25 test devices, each sealed in a foil pouch with three items inside: one cassette device , one desiccant and one 5 µL mini plastic droppers.
2. buffer (1 bottle, 10 mL)
3. 25 blood lancets
4. One package insert (instruction for use).
STORAGE CONDITION
Store at 4C to 30°C. It should avoid light, moisture and cryopreservation.
Shelf-life: 24 months from manufacturing date.
4ºC to 30ºC
PRISES Biotechnology, is a R&D based manufacturer, engaged in development, manufacturing and trading of in vitro Diagnostic Reagents (IVD) and Medical Equipment, which approved for manufacturing and trading IVD products from NMPA(CFDA) and operated under quality system of ISO 13485, most of products have been certified with CE mark.Our factory is founded in 2012 and located in Gaobeidian City, which is near Xiongan New Area and Beijing. It covers an area of 3,000 square meters, including class 1000,000 clean workshop with 700 square meters, class 10 thousands of microbiological testing room with 200 square meters, well-equipped quality inspection rooms, research and development laboratories, etc.
PRISES Biotechnology is producing highly sensitive urine Fertility tests, such as pregnancy test, ovulation test or FSH tests for professional use and self-testing under brand name of Golden Time, as well as OEM/ ODM basis. It is also providing an extensive range of Immunochromatography based one-step rapid tests for infectious diseases & Respiratory diseases for HBsAg, Anti-HBs, HCV, HIV 1/2, Syphilis, Malaria P.f/P.v, Dengue IgG/IgM, Dengue NS1, H.Pylori,19 Antigen test,19 Antibody test,19 Neutralizing Antibody test, and other unique rapid tests, mask, Disposable Virus Sample Tube, condoms, etc.
Our products are sold well in China market, they are also exported to clients in such countries as Poland, United Kingdom, Germany, Portugal, France, Bulgaria, Turkey, Ireland, Egypt, South Africa, Madagascar, South Korea, Peru etc. Adhering to the business principle of mutual benefits, we have had a reliable reputation among our customers because of our professional services, quality products and competitive prices. We are glad to work with you for common success and bring you the satisfied products.
Q1: How can i distinguish a good test kit ?
A1: U can judge from the 4 facts:
Technical data: Such as the accuracy, specificity and sensitivity.
Pouch sealing: Tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of antibodies labeled on NC membrane. Shelf life will be shorten down.
Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. U can refer to the instruction for more accurate time.
Background: Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice.
Q2:Can I have a sample for our testing?
A2: Yes, free samples are available by freight collected. And we will return the freight in the first order.
Q3:What is sample ready time?
A3: Usually 1-7 days, since it was produced against specific demands to guarantee most freshness.
Q4:What about the order payment methods and delivery time?
A4: 1) 30~70% T/T advance, balance before delivery, Irrevocable L/C at sight.
Delivery time usually 1-45 days after receiving the deposit. Our brand package takes 15 days, OEM package takes around 35 days.(Due to factors such as the power limit of the factory and the surge in demand for 19 test kits, in order to ensure the delivery date, we have reserved several production lines to ensure the normal production of conventional kits and both regular customer orders and new orders will not be affected.)
Q5:Can I print our logo on the package?
A5: Yes, as a manufacturer, we can according to your requirements, the size of the product, the appearance of the design of the program, colleagues can sample order,official authorization will be required. We do not accept orders for imitation brand. We do not do business that harm other brands and companies, as were victims once.
Q6. Will you help me register the products in my country ?
A6: Sure, we will provide all you documents and samples you need for register, but express cost will be paid by your company.
Q7:How to deal with the products regarding the quality and quantity?
A7: PRISES Biotechnology is a professional supplier for the medical products for many years. It is of great importance for the quality issues, QC department will arrange the checking every lot, also we have the spot checking at random, we keep high concentration of quality issues, also quantity issues , which is the life of a company, we carry out all our technique skills according to CE mark , FSC , EU declaration conformity, ISO 13485 and so on .
Q8:Can i have a phone call directly with your sales if some urgent questions?
A8: Yes, of course, that is wonderful to save the time and catch the key point easily. If you have any questions, you can call us or send us by email.