Throat 19 AG Test/ Nasal Antigen Rapid Test/ Saliva Test

• Type: IVD Reagent
• Certification: CE/ISO13485/White List/Pei/Bfarm/Anmat
• Classification: Coil Antigen Test
• Specimens: Nasal Swab/Saliva
• Sensitivity: 95.35%~98.67%
• Specificity: 99.23%~100%
• Model NO.: YM050
• Accuracy: 98.95%~99.65%
• Time: 10-15 Minutes Show Result
• Delivery Time: One Week After Get Payment
• Feature 1: Stock Product, Ready to Ship
• Group: All People
• Quality Guarantee Period: 2 Years
• OEM/ODM: Accepted
• Free Sample: Available
• Transport Package: Carton
• Specification: 20 tests/packing, 5 tests/packing, 1 test/packing
• Trademark: IMMUNOBIO
• Origin: China
• Production Capacity: 200000/Week

Product Description

PEI/bfarm/ANMAT Test Saliva Antigen Rapid Diagnostic Test Ivd Kit Rapid Nasal Swab 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

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