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

Basic Info

Model NO.	JCH001
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
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 specificityC.Easy to operate, no need equipment, convenient and fastD.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 specificityNasopharyngeal or oropharynx swabRelative 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%)SalivaRelative 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	1X105TCID50/mL	negative
Influenza B virus	1X105TCID50/mL	negative
Chlamydia pneumoniae	1X105TCID50/mL	negative
Adenovirus	1X105TCID50/mL	negative
Mycoplasma pneumoniae	1X105TCID50/mL	negative
Respiratory syncytial virus	1X105TCID50/mL	negative

Packing for Antigen Saliva rapid test kit

Product	Packing Information	Image
Antigen Test Kit	20 test kits packingContent:1) 20 Foil pouches with test cassettes and desiccants2) 20 tubes filled with buffer and dropper dippers3) 20 Sterile swab4) 20 droppers6)1 Instruction for use7) 1 tube holderCollection bag optioanalPacking Size:20 test kits/packing box50 boxes/CartonCarton Size:64*44*39cm
Antigen Test Kit	5 test kits packingContent:1) 5 Foil pouches with test cassettes and desiccants2) 5 tubes filled with buffer and dropper dippers3) 5 Sterile swab4) 5 droppers5)1 Instruction for useCollection bag optioanal
Antigen Test Kit	1 test kits packingContent:1) 1 Foil pouches with test cassettes and desiccants2) 1 tubes filled with buffer and dropper dippers3) 1 Sterile swab4) 1 droppers5)1 Instruction for useCollection bag optioanal

Test producer for Antigen Saliva rapid test kit

Company Profile

Hangzhou Immuno Biotech 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 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.

CertifcationsLogistics
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