Chlamydia Trachomatis CT Rapid Test Kit Household Medical Devices

Basic Info

Model NO.	CT-C
Name	CT Chlamydia Trachomatis Test Kit
Methodology	Colloidal Gold Immune Chromatographic Assay
Specimen	Secretion
Format	Cassette
Accuracy	More Than 98%
Reading Time	10-15 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

Product Description

Chlamydia Trachomatis Rapid Test Kit

INTENDED USE

One Step Chlamydia Rapid Test Device (Swab/Urine) is a rapid visual immunoassay for the qualitative presumptive detection of Chlamydia trachomatis in female cervical swab, male urethral swab and male urine specimens. This kit is intended for use as an aid in the diagnosis of Chlamydia infection.

FEATURES AND BENEFITS

• Easy to use in simple step.• High accuracy and stability.• Fast results, clear and easy to read.

DIRECTIONS FOR USE

1. Sample extractionA. Extraction-Female Endocervical or the male penile Swab Specimensa) Use an extraction tube (provided) for each specimen to be tested, and label each tube appropriately.b) Add 8~9 drops (about 300ul) of Extraction Buffer A to the extraction tube. Mix liquids by gently swirling the tube. Place the specimen swab in the tube and swirl the swab for ten times. Incubate at room temperature (10°~30°C) for 5 minutes, with the swab in the tube.c) Add 8~9 drops (about 300ul) of Extraction Buffer B to the extraction tube containing the swab.d) Swirl the swab for ten times, then expunge as much liquid as possible from the swab by pressing and rotating the fiber portion against the wall of the tube. Discard the swab. Cap the tube and mix contents by gently swirling. The swab extract can be tested after 5 minutes. B. Extraction - Male Urine Specimensa) Mix the urine specimen by inversion. Transfer 10ml of the urine specimen into a v-based centrifugation tube and add 10ml distilled or deionised water. Centrifuge the specimen at 10000rpm for 10 minutes. Carefully pour off the supernatant and discard.b) Add 8~9 drops (about 300ul) of Extraction Buffer A to the centrifugation tube. Vortex mix well. After 5 minutes, add 8~9 drops (about 300ul) of Extraction Buffer B and vortex mix well. After 5 minutes, transfer the solution to a clean extraction tube (provided). 2. Immunoassay of the Extract 1. Remove the test cassette from its sealed foil pouch by tearing at the notch. Dispense 4 drops (about 100ul) of the above extraction specimen from the extraction tube into the sample well of the test device by inverting and squeezing the tube as shown. 2. Wait for color bands to appear. Read the result at 10~15 minutes.

PACKAGING DETAILS

1. 25 Individual sealed pouches, each containing: Test device,Desiccant pouch2. 25 Extraction tubes.3. 25 Sterile swabs.4. One bottle of buffer A (7.5mL): PBS pH 11.0±0.2 with 1.86%EDTA. 5. One bottle of buffer B (7.5mL): PBS pH 3.0±0.2 with 1.86%EDTA and 0.3% SDS.6. Leaflet with instructions for use.

STORAGE CONDITION

Store at 4C to 30°C. It should avoid light, moisture and cryopreservation.Shelf-life: 24 months from manufacturing date.

Product Name	CT Chlamydia Trachomatis Test
Brand Name	GOLDEN TIME , OEM-Buyer's logo
Specimen	Secretion
Format	Cassette
Relative	97.7%
Reading time	10-15mins
Shelf time	24 months
Storage	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.