Basic Info.
Model NO.
RJ-C-1001
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
- Clinical Sensitivity, Specificity, and 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% | ||
- Cross-Reactivity
| 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
- Individually sealed foil pouches containing:
- One cassette device
- One desiccant
- Quick Reference Instructions (1)
MATERIALS REQUIRED BUT NOT PROVIDED
- Clock or timer
- Vortex
- 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 . |