Factory Manufacturing Syphilis Test Kit One Step Syphilis Test Plastic Strip
Gaobeidian PRISES Biotechnology Co., Ltd.- Type：Test Strips & Test Tube
- Material：Plastic
- Ethylene Oxide Sterilization：Sterlity Workshop
- Quality Guarantee Period：Two Years
- Group：Adult
- Logo Printing：Without Logo Printing
Base Info
- Model NO.：TP-C
- Name：Tp Syphilis Ab Rapid Test
- Methodology：Colloidal Gold Immune Chromatographic Assay
- Specimen：Serum,Plasma,Wb
- Format：Cassette
- Accuracy：More Than 98%
- Reading Time：1-5 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
TP Syphilis Ab Rapid Test Kit
INTENDED USE
Syphilis Rapid test qualitatively detects for the presence of antibodies IgG and IgM to Treponema Pallidum (TP) in (whole blood), serum, or plasma samples to aid in the diagnosis of Syphilis.
FEATURES AND BENEFITS
• Easy to use in simple step.
• High accuracy and stability.
• Fast results, clear and easy to read.
DIRECTIONS FOR USE
• Step 1: Remove the test cassette from pouch by tearing the foil pouch.
• Step 2: Draw specimen ( serum) into dropper and dispense it into the sample well on the cassette (2-3 drops, approximately 100ul). Be careful not to overfill the absorbent pad.
• Step 3: Read results within five minutes.
• Step 4: Discard the test device after a single use.
Depending on the concentration of Syphilis/TP in the serum sample, positive results may be seen within 40 seconds. Wait the full five minutes to confirm the result. Do not read the Cassette Test after 5 minutes as this may also give an incorrect test result.
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
Syphilis Rapid test qualitatively detects for the presence of antibodies IgG and IgM to Treponema Pallidum (TP) in (whole blood), serum, or plasma samples to aid in the diagnosis of Syphilis.
FEATURES AND BENEFITS
• Easy to use in simple step.
• High accuracy and stability.
• Fast results, clear and easy to read.
DIRECTIONS FOR USE
• Step 1: Remove the test cassette from pouch by tearing the foil pouch.
• Step 2: Draw specimen ( serum) into dropper and dispense it into the sample well on the cassette (2-3 drops, approximately 100ul). Be careful not to overfill the absorbent pad.
• Step 3: Read results within five minutes.
• Step 4: Discard the test device after a single use.
Depending on the concentration of Syphilis/TP in the serum sample, positive results may be seen within 40 seconds. Wait the full five minutes to confirm the result. Do not read the Cassette Test after 5 minutes as this may also give an incorrect test result.
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.