2021 New Hot Self-Test Mouth Antigen Saliva Rapid Test Kit

• Customization: Available
• Type: Test Strips & Test Tube
• Material: Plastic
• Model NO.: RJ-C-1001
• Quality Guarantee Period: Two Years
• Group: Adult & Chirdren
• Logo Printing: With Logo Printing
• Manufacturer: Self-Owned
• Output: 500, 000
• Lead Time: One Week
• Application: Self-Test
• Accuracy Average: 99%
• Packing: 1test/Bag, 1/25/50 Test/Box
• Mqc: 1000
• Colour: White
• Certificate: CE/ISO
• Product Name: Rapid Reagent Test Kit
• Product Code: Rj-C-1001
• Shelf Life: 1years
• Storage Condition: Normal Temperature
• Usage: Professional Testing
• Transport Package: Carton
• Specification: 5/7/10ml
• Trademark: Renji
• Origin: China
• HS Code: 3822009000
• Production Capacity: 100000000

Product Description

1. Clinical Sensitivity, Specificity, and Accuracy

 Antigen Rapid test Kit has been evaluated with specimens obtained from patients. A commercialized molecular assay was used as the reference method. The results show that the Antigen Rapid  Kit has a high overall relative accuracy.
 

	Antigen Rapid test Kit
PCR	Positive	Negative	Total
Positive	67	1	68
Negative	2	178	180
Total	69	179	248
Relative Sensitivity:	97.1%
Relative Specificity	99.4%
Overall Accuracy	98.8%

 

1. Cross-Reactivity

No false-positive S* test results were observed on 1-13 specimens from the following disease states or specific conditions, respectively:

 

Virus/Bacteria	Result
S* Nucleocapsid (Expressed By 293 Cells)	Negative
MERSS N Protein (Expressed By 293 Cells)	Negative
Human Coro*-NL63 culture	Negative
HAV positive serum	Negative
HBV positive serum	Negative
HCV positive serum	Negative
HEV positive serum	Negative
HIV positive serum	Negative
TB positive serum	Negative
H. pylori-positive serum	Negative
Dengue positive serum	Negative
Influenza A H1N1 culture	Negative
Influenza A H3N2 culture	Negative
Influenza A H5N1 culture	Negative
Influenza A H7N9 culture	Negative
Influenza B culture	Negative
Influenza C culture	Negative
RSV culture	Negative
Human Parainfluenza virus culture	Negative
Herpes simplex virus culture	Negative
Respiratory chlamydia culture	Negative
Mycoplasma Pneumonia culture	Negative
Mycobacteria tuberculosis culture	Negative

 

INTENDED USE

The  Saliva  Antigen  Rapid  Detection  Kit is a  lateral flow immunoassay for the qualitative detection of nucleoprotein from S* in saliva. It is intended to be used by professionals as a test and provides a preliminary test result to aid in the diagnosis of infection with novel Coro*
Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this test.
 

SUMMARY AND EXPLANATION OF THE TEST

Coro*are a large family of viruses that cause illnesses ranging from the common cold to more severe diseases such as  Middle   East   Respiratory   Syndrome and severe acute respiratory syndrome . A novel coro* s a new strain that has not been previously identified in humans and was discovered in 2019. The clinical manifestations are systemic symptoms such as fever and fatigue, accompanied by dry cough and dyspnea, etc., which can rapidly develop into severe pneumonia, respiratory failure, and acute breathing. Distress syndrome, septic shock, multiple organ failure, severe acid-base metabolism disorders, etc. are even life-threatening.
Saliva detection is a common method for the diagnosis of infection with novel coro*. This test is used for detection of S* nucleoprotein antigen.
The Antigen Rapid Detection  Kit detects the nucleoprotein of novel coro* in a human saliva sample. It can be performed within 15-20 minutes by minimally skilled personnel without the use of laboratory equipment.

REAGENTS AND MATERIALS PROVIDED

1. Individually sealed foil pouches containing:
   1. One cassette device
   2. One desiccant
2. Quick Reference Instructions (1)

MATERIALS REQUIRED BUT NOT PROVIDED

1. Clock or timer
2. Vortex
3. 0.2-mL Calibrated Micropipette with pipette tips

WARNINGS AND PRECAUTIONS

GMP workshop 

Certificates

Packing &shipping :

FAQ

Q1. Are you factory or trading company?
 A. We are definitely factory where you could get first source goods 

Q2. How can I visit your factory?
A. Welcome your visit. Our factory is conveinent located in Changsha City, Hunan Province, China .

Q3. Do you have other products about the medical equipments?
A. Renji's main products include: disposable virus specimen collection samplers , Saliva collection kits, Vacuum Blood Collection tubes, pipette tips etc.

Q4:Can I have a sample for testing?
   A:Sure, free sample for you, freight cost to be covered by you . 

Q5:Can I add my logo on the medical products?
   A:Yes,OEM and ODM are available for us.But the trademark authorization letter should be supplied. 

 Q6:What is the delivery time ?
   A: the normal delivery time is in 7 working days once we get your deposit.

 Q7:Will you help me register the products in my country ?
   A:Sure, we will provide all you documents and samples you need for register, but courier cost will be for your accoiunt. 

Q8:Is it possible to be your sole agent in my country/some region ?
   A:Yes. You are welcome to discuss the detail of sole agent agreement .