CE Mark Co-19 AG Antigen Test High Accuracy

• Type: IVD Reagent
• Certification: CE/ ISO13485/White List
• Classification: Saliva Antigen Rapid Test Kit
• Group: All People
• Quality Guarantee Period: 2 Years
• Used for: Fast Detection The Nabs Against 2019 Vir
• Model NO.: JCH002
• Specimens: Saliva Swab or Nasal Swab
• Material: Plastic
• Application: Detection for Angtine
• Time: 10-15 Minutes Show Result
• Delivery Time: One Week After Get Payment
• Ethylene Oxide Sterilization: Without
• Feature 1: Over 95% Sensitivity and Specificity
• Feature 2: Stock Product, Ready to Ship
• Feature 3: Already Registered in EU
• Feature 4: Applicable for Saliva Swab
• Transport Package: Carton
• Specification: 20 test kits/packing box
• Trademark: IMMUNOBIO
• Origin: China
• HS Code: 3002150050
• Production Capacity: 1 Million/Week

Product Description

CE Mark Co-19 AG Antigen Test High Accuracy

Product Description

The IMMUNOBIO CA 19 Saliva Antigen Rapid Test Kit is for detection of CA 19 antigens. Anti-CA 19 monoclonal antibodies are coated in the test line and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-CA 19 antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with another anti-CA 19 monoclonal antibodies in the test region. The complex is captured and forming a colored line in the Test line region.
The CA 19 Antigen Rapid Test contains anti-CA 19 monoclonal antibodies conjugated particles and another anti-CA 19 monoclonal antibodies are coated in the test line regions. 

Authorized certifications

1. CE Approved
2. Approve by German Ministry of Health
3. China's white list approved Antigen CA 19 Tests manufacturer

Features

A.Fast Test, get result within 10-15 minutes.
B.High sensitivity and specificity
C.Easy to operate, no need equipment, convenient and fast
E.Require little Specimens, few Nasal or throat swabs

Product Information
 

Test Type	Antigen Test kit
Test Principle	Colloidal Gold Method
Sample Type	Throat Secretions or Nasal Secretions
Sample Volume	3 Drops of Extracted Solution (about 100µl)
Qualitative/Quantitative	Qualitative
Test time	15mins
Operation Temperature	15-30°C
Storage Temperature	2-30°C

PERFORMANCE CHARACTERISTICS

1. Sensitivity, Specificity and Accuracy
IMMUNOBIO  Antigen Rapid Test  has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity

Relative Sensitivity: 90.00%(95%CI:79.49%~96.24%)
Relative Specificity: 100.00%(95%CI:98.48%~100.00%)
Accuracy: 98.33%(95%CI:96.32%~99.32%)
2. Cross-reactivity:
The IMMUNOBIO CA 19 Antigen Rapid Test t  is associated with parainfluenza virus antigen, influenza A virus antigen, influenza B virus antigen, Chlamydia pneumoniae antigen, Mycoplasma pneumoniae antigen, adenovirus antigen, respiratory syncytial virus antigen, hepatitis B surface antigen, Hepatitis C virus antigen, Treponema pallidum antigen, human immunodeficiency virus antigen, EB virus antigen, cytomegalovirus antigen, enterovirus 71 antigen, mumps antigen, chicken pox-zoster virus positive samples did not cross-react.
3.Interfering Substances:
The following compounds have been tested using the IMMUNOBIO CA 19 Antigen Rapid Test  and no interference was observed.

Packing
 

Packing	Image	Package Content
20tests Kit/packing box		1 Instruction for use 20 Test Cassettes 3 Bottles Antigen Extract Buffer 20 Antigen Extraction tubes and Drop tips 20 Sterilized swap
1 test kit/packing box		1 Test  Cassettes 1 Intsruction for use 1 Sterilized Swap 1 Extractiob Tube 1 Dropper Tip 1 Extration Buffer

Test producer


Company Profile

Hangzhou Immuno Biotechnology Co., Ltd. is an emerging enterprise dedicated to the research and development, service, sales and agency of immunology-related reagent products. Based on technology research and development and product innovation, the Immuno biological team has successfully developed many products that have been well received by the market and customers through continuous technical investment. The various antigen and antibody detection reagents developed by the company have passed the inspections of the Ministry of Health in Germany, South Africa, the Philippines, Argentina and other countries, and have received unanimous praise and recognition.
The company's outstanding technical cooperation, through cooperation with universities, research institutes, technical teams and other objects, continue to expand and enrich our product line, hoping to provide our partners with high-quality and reliable antigen and antibody raw materials and test strip products.
The Immuno Bio team also has good industry and international market experience. The company's head has long been engaged in the in vitro manual diagnostic reagent industry, especially in the market and technical experience in the priority areas of pet disease detection and livestock disease detection. , Has established a long-term cooperative relationship with many domestic and international animal disease diagnosis and food analysis and testing laboratories. It has not only acted part of the international counterparts' products, but also handed over some of our company's antigen and antibody products to the international counterparts.

Certifcations

Logistics


Our Service 

1. Factory price,  reasonable and competitive
2. OEM/ODM service, Not only packaging and brand customization, we have our own laboratory and R&D team, which can develop and customize proprietary products for customers
3. Timly and quickly feedback, anytime and anywhere for customer service.
4. Provide professional training and quality samples to help customers develop the market
5. Flexible trading methods to meet customer and business needs

FAQ 

Question 1: Can I get samples before play batch order?
A: Qulaified sample is available, details please contact with our sales.

Question 2: How about the MOQ?
A: MOQ is more than "0", but our sales team will advise you how much to order based on the products you need, national market conditions, international logistics costs and other factors

Question 3: How about the quality?
A: We already get CE, and also on the white list of Chinese goverment, furthermore, you can find our test result result on the wesite of German Ministry of Health

Question 4: Where is your factory? Can I visit your factory?
A:We are in Hangzhou, Alibaba also located in here, half an hour from Shanghai by high speed train. You are welcomed anytime that you visit us.

Question 5: Do you factory or trading company
A: We are factory, all product we supply is R&D and produce by ourself.

Question 6: How can I pay?
A: You can pay USD, EURO & RMB via T/T, PayPal or Western Union.

Question 7: Which certificate you have:
A: CE/ISO13485