Medical Supply Rapid Test Diagnostic Antigen Test Kit

• Customization: Available
• Type: IVD Reagent
• Certification: CE/ISO13485/White List
• Classification: Antigen Test Kit
• Group: All People
• Quality Guarantee Period: 2 Years
• Ues for: Detection for Antigen
• Specimens: Nasal/Saliva Swab
• Material: Plastic
• Application: Fast Clear of Infection
• 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: Saliva Swab Test with High Accuracy
• Feature 4: Already Registered in EU
• Transport Package: Carton
• Specification: 20 test kits/packing box
• Trademark: IMMUNOBIO
• Origin: China
• HS Code: 3002150050
• Production Capacity: 200000/Week

Product Description

 Medical supply Rapid Test Diagnostic Antigen Test Kit


Product Description

The IMMUNOBIO CA 19 Rapid Test Diagnostic Nasal Swab Antigen Test Kit is for detection of 2019 vir antigens. Anti-2019 vir il monoclonal antibodies are coated in the test line and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-2019 vir antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with another anti-2019 coil monoclonal antibodies in the test region. The complex is captured and forming a colored line in the Test line region.
The 2019 vir Antigen Testing contains anti-2019 vir monoclonal antibodies conjugated particles and another anti-2019 vir 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 2019 vir antingen testing kits manufacturer

Features for  Antigen Test Kit

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
F. Applicable for Saliva and Nasal swab test


Product Information
 

Test Type	Rapid Test Diagnostic Nasal Swab 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 2019 vir Antigen Rapid Test  has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity

Relative Sensitivity: 95.60% (95%CI: 88.89%~98.63%)
Relative Specificity: 100% (95%CI:98.78%~100.00%)
Accuracy: 98.98% (95%CI:97.30%~99.70%)
2. Cross-reactivity:
The IMMUNOBIO vir Antigen Rapid Test is associated with a panel of proteins of other human  recombinant antigens and other respiratory symptoms relative virus. The results showed in below sheet.

Packing
 

Packing	Image	Package Content
20tests Kit/packing box		1 Instruction for use 20 Test Cassettes 20 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 for Rapid Test Diagnostic Nasal Swab Antigen Test Kit 



Company Profile
 

Hangzhou Immuno Biotech Co., Ltd. is a R&D based company located in Hangzhou. Immunobio is well known as a recombinant protein original designer and supplier in the upstream of in vitro diagnostic field. Immunobio is also a professional rapid test manufacturer who has advanced technology in veterinary diagnostic and human medical diagnostic industries. Immunobio has more than 30 authorized patents in IVD field and more than 20 under review.

To fight against the CA-19 epidemic, Immunobio has developed a series of rapid diagnostic test on CA-19. In early February 2020, we released the  CA-19 IgG/IgM Antibody Rapid Test for the IgG and IgM antibodies testing. Then in September, Immunobio has successfully developed the Antigen Rapid Diagnostic Test Kit (CA-19 Ag) to support the fast screening of antigen test. In December 2020, a novel Neutralizing Antibody Rapid Test (CA-19 Ab) was developed in success, to indicate the protective status of the neutralizing antibodies in people's blood.

Hangzhou Immuno Biotech Co., Ltd. is doing and will continue doing innovative research and development in the IVD medical diagnostic field. Immunobio will keep our promise to provide the innovative and competitive products for a healthy world.

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 for Antigen Test Kit before play batch order?
A: Qulaified sample is available, details please contact with our sales.

Question 2: How about the MOQ for Antigen Test Kit?
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 for Antigen Test Kit?
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