Factory Freezed PCR Realtime Nucleic Acid Test Kit with CE

China Factory Freezed PCR Realtime Nucleic Acid Test Kit with CE, Find details about China Diagnostic Test Kit, Rapid Diagnostic Test from Factory Freezed PCR Realtime Nucleic Acid Test Kit with CE

Transport Temperature
2-8 Degrees
Trademark
Singuway
Specification
48tests/kit, 96tests/kit
Origin
Shenzhen, China
Transport Temperature
2-8 Degrees
Trademark
Singuway
Specification
48tests/kit, 96tests/kit
Origin
Shenzhen, China
Product Name: Nucleic Acid Detection Kit(PCR Fluorescence Probe)
 
Factory Freezed PCR Realtime Nucleic Acid Test Kit with CE
Features

1. Simple operation and short time consuming

2. Line type standard, obvious amplification curve plateau

3. Strong anti-interference ability

4. Strong compatibility, suitable for a variety of fluorescence PCR instruments
 

Technical Parameters

Detection MethodReal-time PCR fluorescence technology
Sample TypeOral or nasal swab
Test  Virus TypeFluA, FluB and other respiratory tract virus  
Target GeneN, E, and ORF1A/B gene
Sensitivity100 copies/mL
Amplification Time30 min
Validity12months below -20 degrees
Specification48tests/kit, 96tests/kit
 

Product Description

Intended use
This kit is used for qualitative detection of nucleic acid in throat swab or nasopharyngeal swab samples. The test results are only used for clinical reference, and cannot be used as the basis for diagnosis or exclusion of cases alone. 
This kit is based on real-time PCR fluorescence technology to detect the nucleic acid of patients with Flu-like symptoms, patients with severe pneumonia or patients with asymptomatic infection.


Storage conditions and the period of Validity
This kit shall be stored at the temperature below -20ºC in dark and avoid repeated freezing and thawing (if freezing and thawing, must not exceed 4 times), with a validity period of 12 months. 
It can be stored at 4ºC after opening the cover, with a validity period of 30 days. 


Applicable instruments
A real-time PCR instrument containing at least four colors fluorescence channels, such as Singuway Singu9600, Bio rad CFX96, ABI 7500, Roche LightCycle 480.

Test process

Factory Freezed PCR Realtime Nucleic Acid Test Kit with CE

Main Components(48Tests)
Factory Freezed PCR Realtime Nucleic Acid Test Kit with CE

Performance Characteristics
Nucleic Acid Detection Kit (PCR Fluorescence Probe) has been evaluated with specimens obtained from patients.A
commercialized molecular assay was used as the reference method. The results show that the antigen Test Kit has a high overall relative accuracy.
According to the clinical trial protocol, we included 500 samples, which included 187 positive and 313 negative results confirmed by clinical diagnosis judgement. The result of clinical evaluation of the detection kit was as follows:
MethodPCRSum
Nucleic Acid Detection Kit (PCR Fluorescence Probe)RusultPositiveNegative
Positive1851186
Negative2312314
Sum187313500
Percent Positive Agreement = 98.9%
Negative Percent Agreement = 99.6%
Total Percent Agreement = 99.4%
Kappa = 0.987, Z= 22.074, P =0.000
Factory Freezed PCR Realtime Nucleic Acid Test Kit with CE
 

Certifications

 
 
Factory Freezed PCR Realtime Nucleic Acid Test Kit with CE
 
 

Company Profile

Singuway Biotech Inc., founded in 2017, is located at the National Biological Industry Base of Pingshan District, Shenzhen with more than 2000 square meters of GMP standard workshop and production lines. It is a high-tech molecular diagnostic enterprise integrating the research and development, production, marketing and after-sales of clinical medical test reagents and instruments, devoting to provide global customers with high-quality products and molecular diagnostic solutions.

Singuway has accumulated several core technologies such as microfluidic chip technology, RSA constant temperature amplification technology, fluorescent quantitative PCR technology, nucleic acid separation and purification technology, and rapid fluorescent PCR technology, and has passed the ISO9001 and ISO13485 quality system assessments. The company's products cover virus sample collection, nucleic acid extraction systems, nucleic acid detection systems, and are exported to Europe, America, the Middle East, Asia, Africa and other regions, and are widely used in medical inspection, animal disease, food hygiene, environmental testing and other fields.

 
Factory Freezed PCR Realtime Nucleic Acid Test Kit with CE
 
 

Exhibition

 
Factory Freezed PCR Realtime Nucleic Acid Test Kit with CE
 

Packaging & Shipping

Package Size

SpecificationBox Size(L*W*H)Carton TypeCarton BoxCarton Size(L*W*H)
48tests/kit55*50*60mmfoam+Corrugated Carton30 boxes(1440tests)530*450*350mm
48L Cooler Box100 boxes(4800tests)500*500*500mm
91L Cooler Box220 boxes(10560tests)620*620*640mm
96tests/kit55*50*60mmfoam+Corrugated Carton30 boxes(2880tests)530*450*350mm
48L Cooler Box100 boxes(960tests)500*500*500mm
91L Cooler Box220 boxes(21120tests)620*620*640mm
 

Notes:
For this reagents, we use foam box with ice bag or cooler box with ice plate to guarantee the suitable temperature;
The flight keeping cool at 2ºC-8ºC is recommended!

Factory Freezed PCR Realtime Nucleic Acid Test Kit with CE

 

 
Factory Freezed PCR Realtime Nucleic Acid Test Kit with CE
 

FAQ

Q1. Are you factory or trading company?
 A. We have our own factory to make sure our product quality.

Q2. OEM and ODM is available?
 A. Yes,OEM and ODM are available for us. But the trademark authorization letter should be supplied.

Q3. What is the delivery time?
 A. It depends on your order, usually it is under 15 working days once receiving your deposit.

Q4. What kind of payment do you support?
 A. Usually we prefer 100% T/T in advance.

Q5. What's the shipping way?
 A. The flight keeping cool at 2ºC-8ºC is recommended, the express like DHL/Fedex is risky and unsuitable.