Pei/Bfarm Immunobio Coil Antigen Self Test Kit Antigen Saliva/Nasal Swab Rapid Diagnostic Test

• Type: IVD Reagent
• Used for: Coil Antigen Test
• Certification: CE/ISO13485/White List/Pei/Bfarm/Anmat
• Feature 1: Over 98% Sensitivity and Specificity
• Feature 2: Bfarm for Self/Professional Test
• Feature 4: Stock Product, Ready to Ship
• Model NO.: JCH001
• Specimens: Saliva/Sputum or Nasal Swab
• Delivery Time: 3-5days After Get Payment
• Time: 10-15 Minutes Show Result
• OEM/ODM: Accepted
• Free Sample: Supply
• Quality Guarantee Period: 2 Years
• Group: All People
• Transport Package: Carton
• Specification: 20 tests/packing, 5 tests/packing, 1 test/packing
• Trademark: IMMUNOBIO
• Origin: China
• HS Code: 3002150050
• Production Capacity: 1 Million/ Week

Product Description

PEI/Bfarm Immunobio Coil Antigen Self Test Kit Antigen Saliva/Nasal Swab Rapid Diagnostic Test

Product Description 

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

Features for  Antigen Test

Authorized certifications for Antigen Test

1. CE/ISO13485
2. PEI/Bfarm 

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

Product Information
 

Test Type	Antigen Test
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 For Antigen Rapid Test

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

Nasopharyngeal or oropharynx swab
Relative Sensitivity: 98.13% (95%CI: 93.02%~99.90%)
Relative Specificity: 100% (95%CI:97.73%~100.00%)
Accuracy: 99.35% (95%CI:97.50%~99.98%)
Nasal Swab:
Relative Sensitivity: 93.64% (95%CI: 87.23%~97.10%)
Relative Specificity: 100% (95%CI:95.56%~100.00%)
Accuracy: 96.67% (95%CI:93.15%~98.51%)
Saliva
Relative Sensitivity: 91.06% (95%CI: 84.55%~95.08%)
Relative Specificity: 99.00% (95%CI:94.01%~99.99%)
Accuracy: 94.62% (95%CI:90.74%~96.99%)


2. Cross-reactivity:
The IMMUNOBIO Rapid Antigen Test  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 Rapid Antigen Test  and no interference was observed.

substance	concentration	result
alpha-interferon	3millionIU	No interference
Purified Mucin	1000ng/mL	No interference
Parainfluenza virus	^1X105TCID50/mL	negative
Influenza A virus	1X10^5TCID50/mL	negative
Influenza B virus	1X10^5TCID50/mL	negative
Chlamydia pneumoniae	^1X105TCID50/mL	negative
Adenovirus	^1X105TCID50/mL	negative
Mycoplasma pneumoniae	1X10^5TCID50/mL	negative
Respiratory syncytial virus	1X10^5TCID50/mL	negative

Packing for Antigen Saliva rapid test kit

Product	Packing Information	Image
Antigen Test Kit	20 test kits packing Content: 1) 20 Foil pouches with test cassettes and desiccants 2) 20 tubes filled with buffer and dropper dippers 3) 20 Sterile swab 4) 20 droppers 6)1 Instruction for use 7) 1 tube holder Collection bag optioanal Packing Size: 20 test kits/packing box 50 boxes/Carton Carton Size:64*44*39cm
Antigen Test Kit	5 test kits packing Content: 1) 5 Foil pouches with test cassettes and desiccants 2) 5 tubes filled with buffer and dropper dippers 3) 5 Sterile swab 4) 5 droppers 5)1 Instruction for use Collection bag optioanal
Antigen Test Kit	1 test kits packing Content: 1) 1 Foil pouches with test cassettes and desiccants 2) 1 tubes filled with buffer and dropper dippers 3) 1 Sterile swab 4) 1 droppers 5)1 Instruction for use Collection bag optioanal

Test producer for Antigen Saliva rapid 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 Vir , Immunobio has developed a series of rapid diagnostic test . In early February 2020, we released the   IgG/IgM Antibody Rapid Test for the IgG and IgM antibodies testing. Then in September, Immunobio has successfully developed the Antigen Rapid Test  to support the fast screening of antigen test. In December 2020,  Neutralizing Antibody Rapid Test  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 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