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DNA RNA Nucleic Acid Testing Kit With Real Time Fluorescent Quantitative PCR

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DNA RNA Nucleic Acid Testing Kit With Real Time Fluorescent Quantitative PCR

DNA RNA Nucleic Acid Testing Kit With Real Time Fluorescent Quantitative PCR
DNA RNA Nucleic Acid Testing Kit With Real Time Fluorescent Quantitative PCR DNA RNA Nucleic Acid Testing Kit With Real Time Fluorescent Quantitative PCR DNA RNA Nucleic Acid Testing Kit With Real Time Fluorescent Quantitative PCR DNA RNA Nucleic Acid Testing Kit With Real Time Fluorescent Quantitative PCR

Large Image :  DNA RNA Nucleic Acid Testing Kit With Real Time Fluorescent Quantitative PCR

Product Details:
Place of Origin: CHINA
Brand Name: Renji Medical
Certification: CE, SGS, SDS, MA, YBTC
Model Number: RJ-PC-1001
Payment & Shipping Terms:
Minimum Order Quantity: 5000 Pieces
Price: Negotiable
Packaging Details: 50 sets per box or 200 sets per box
Delivery Time: 5-8 working days
Payment Terms: T/T
Supply Ability: 200K pieces per day

DNA RNA Nucleic Acid Testing Kit With Real Time Fluorescent Quantitative PCR

Description
Method: Real-time RT-PCR Method Storage Conditions: Stored At 4-30℃ Protect From Light
Advantages: Fast, High-capacity Testing Sensitivity: Positivity Rate Of >95%
Workflow: Less Than 60 Min. Store Tempreture: -20±5℃
LOD: The Limit Of Detection Is 200 Copies/ml Specificity: No Cross Reaction
Certification: CE, SGS, ISO13485 Packing: 50 Tests/kit & 200 Tests/kit
High Light:

DNA RNA Nucleic Acid Testing Kit

,

Fluorescent Quantitative Nucleic Acid Testing Kit

Nucleic acids in two natural forms of Deoxyribonucleic acid

(DNA) and Ribonucleic acid (RNA) and Sars-Cov2 testing technology

 

››› Low cost, easy, convenient kit!

››› Perfect for remote or mobile testing!

››› FAST: Complete results in 40-90 mins, from start to finish!

 

【Product Name】

 

Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit

(Real-time RT-PCR Method)

 

【Package Specification】

50 tests/kit & 200 tests/kit

DNA RNA Nucleic Acid Testing Kit With Real Time Fluorescent Quantitative PCR 0

 

【Intended Use】

 

This kit is used for the detection of COVID-19(ORF1ab/N Gene) Nucleic Acid and

assisted diagnosis and epidemiological surveillance of COVID-19.

 

【Test Principle】

The kit adopts the principle of real-time fluorescent quantitative PCR technology,

designs specific primers and probes for COVID-19(ORF1ab/N gene) ,

and combines them with real-time fluorescent quantitative PCR instrument to

detect the nucleic acid of COVID-19 virus. So as to realize the qualitative detection

of COVID-19 virus nucleic acid.

In addition, the PCR detection system uses the positive internal control,

which monitors the presence of PCR inhibitors in test specimens by detecting

whether the internal control signal is normal,to avoid a false negative result.

 

【Components of the Diagnostic Kit】

No. Reagent Name Spec. & Qty.  
    50T 200T
1 COVID-19 PCR Mix 750µl x 1 tube 750µl x 4 tube
2 COVID-19 Enzyme Mix 250µl x 1 tube 250µl x 4 tube
3 COVID-19 Negative Control 100µl x 1 tube 100µl x 4 tube
4 COVID-19 Positive Control 100µl x1tube 100µl x4tube
5 Instructions 1 serving 1 serving

 

Note:

1. Do not mix or exchange components from different kit lots.

2. The COVID-19 Negative Control is sterile nuclease-free water, and the COVID-19

Positive Control is transcribed RNA invitro which contains target genes ORF1ab,

N gene, and Internal Control gene.

 

 

【Applicable Instrument】

 

The diagnostic kit is applicable to MA-6000,ABI series, Bio-Rad series, Roche

LightCycler R480, Cepheid SmartCycler, Rotor-Gene series and other multi-channel

real-time quantitative PCR instruments.

 

【Specimen Requirements】

 

1. Sample types:Upper respiratory tract specimens(including throat swabs,

nasal swabs, nasopharyngeal extracts deep cough sputum), lower respiratory tract

specimens(including respiratory tract extracts, bronchial lavage fluid alveolar lavage

fluid, lung tissue biopsy specimens) , Tissue culture and other samples.

2.Storage conditions:The collected specimens should be submitted for inspection

in a timely manner, and the specimens should be stored at 4℃ within 24 hours.

It is best to store at-70℃ for more than 24 hours, and avoid repeated freeze-thaw

cycles.

 

【Storage and Stability】

 

1. The diagnostic kit should be stored in a sealed pouch at-20±5℃.The expiry date

is 12 months.

2. Please refer to the date of manufacture and expiry date on the outer package.

3. The reagent keep valid and stable within the expiry date if not used. The kit should

not be frozen and more than 5 times.

 

【Test Method】

 

1.Reagent Preparation (performed at “reagent preparation region”)

1.1 Takeout each component from the diagnostic kit and place them at room temperature.

Allow the reagents to equilibrate at room temperature, then vortex each of them

respectively for later use.

1.2 According to the quantity of test specimens, COVID-19 Positive Control and

COVID-19 Negative Control,pipette appropriate quantity of COVID-19 PCR Mix

and COVID-19 Enzyme Mix (COVID-19 PCR Mix 15 µl/test+COVID-19 Enzyme

Mix 5 µl /test) mix them thoroughly to make a PCR-Master mix centrifuge it

instantaneously for later use.

Reagent name 1 Sample 10 Samples 25 Samples 50 Samples 100 Samples 200 Samples
COVID-19PCR Mix(µl) 15 150 375 750 1500 3000

COVID-19 Enzyme

Mix(µl)

5 50 125 250 500 1000

PCR-Mastermix

 

20 200 500 1000 2000 4000
Note:The above configuration is just you’re your reference and to ensure enough volume of the PCR-Mastermix, more volume of the actual pipetting may be required.

1.3 Transfer the above-prepared reagents to the "specimen processing region" for

later use.

 

2.Processing and loading of specimens (performed at "specimen

processing region")

2.1 This diagnostic kit does not include Viral RNA&DNA Extraction Kit. It is

recommended to use Viral RNA&DNA Extraction Kit produced by Changsha Renji

Medical Equipment Co, Ltd. to extract viral RNA. The specific operation is in

accordance with its instructions.

2.2 Add 20 µl PCR-Mastermix into PCR reaction tube with 5µl above processed sample,

COVID-19 Positive Control and COVID-19 Negative Control and cap the tube. Carry

out fluorescence quantitative PCR detection on fluorescence PCR instrument.

 

3.PCR Amplification (performed at "nucleic acid amplification area")

3.1 Place PCR reaction tubes into the specimen wells of the amplification equipment

Setup COVID-19 Positive Control COVID-19 Negative Control and specimens to be

tested in the corresponding sequence and input specimen name.

3.2 Set cycle parameters according to the following table for PCR amplification.

Steps Temperature Time Cycles
1 50°C 10min 1
2 95°C 3min 1
3 95°C 10s 40
55°C 30s
 

Note:

1) The fluorescence collection is set at "Step3:55°C, 30s". Selection of detection

channels:FAM, HEX and Cy5, where FAM channel is ORF1ab gene and HEX

channel is N gene. Cy5 channel is the internal control gene, and the reaction system

s set to 25 µl.

2) ABI series fluorescent PCR instruments do not select ROX calibration and select

None for the quenching group.

 

【Positive Judgement Value and Reference Interval】

 

1. Condition Setting for Result Analysis

The adjustment principle of Baseline and Threshold is generally based on the results

of the automatic analysis of the instrument. When the overall slope of the curve

appears, the Start, End,and Threshold values of the Baseline can be adjusted

according to the image. Usually, the user can adjust it according to the actual

situation. The Start value can be set to 3-15, and the End value can be set to 5-20.

Adjust the amplification curve of the negative control to make it straight or below

the thresh hold line.

 

2. The Validity of The Kit

2.1 The COVID-19 Positive Control:FAM, HEX and Cy 5 channels have typical

S-type amplification curves and Cts≤32.

2.2 The COVID-19 Negative Control:FAM, HEX and Cy 5 channels have no

Ct or Ct>38.

2.3 Note:The above conditions must be met at the same time, otherwise this

experiment is invalid and needs to be repeated.

 

3.The Positive Judgment Value

Through the study of reference values, it was determined that the Ct reference value

of the target gene and the internal control gene detected by this kit was both 38.

 

【The Sample Result Judgment】

 

1.If the test sample detects atypical S-type amplification curve in the FAM, HEX

and Cy 5 channels and the Ct is≤38, the sample can be judged to be COVID-19

positive.

2.If the test sample has no Ct or Ct>38 in the FAM and HEX channels, and there

is atypical S-type amplification curve in the Internal Control channel(Cy 5) , Cts≤38,

the sample can be judged to be COVID-19 negative.

3.If the test sample only has a Ct values 38 in a single channel of the FAM or HEX

channel, and there is atypical S-type amplification curve in the Internal Control

channel(Cy 5) , Ct≤38, the results need to retest. If the results repeated are

consistent the sample can be judged as COVID-19 positive, the results repeated

are negative except for the typical S-type amplification curve of the Internal Control

channel(Cy 5) , Ct≤38, which could be judged as COVID-19 negative.

4.If no typical S-type amplification curve(No Ct value) or Ct value>38 is detected in

the FAM, HEX, and Cy 5 channels of the test sample, it means that there is a

problem with the quality of the sample or a problem with the operation. If the result

is invalid, you should find and eliminate the cause, collect the sample again,

and repeat the test(if the test result is still invalid, please contact the company) .

 

【Limitations of Detection Method】

1.Test results of the diagnostic kit can be used only for clinic reference. The clinical

diagnosis and treatment of patients should be considered in conjunction with their

symptoms, signs, medical history and other related conditions.

2.False negative results may occur when the concentration of the detected nucleic

acid in the test sample is below the minimum detection limit of this kit.

3.Improper handling of the tested sample during collection, transportation,

storage, and processing can easily result in RNA degradation and false negative

results.

4.When samples are cross-contaminated during collection, transportation, storage,

and processing, it is easy to get false positive results.

 

【Product Performance Index】

1.LOD:The limit of detection is 200 copies/ml.

2.Precision:Coefficient of variation (CV%] of precision Ct value within batch≤3%.

3.Specificity:There is no cross reaction between the kit and positive samples, such

as Human Coronavirus HCoV-NL63, Human Coronavirus HCoV-OC43, SARS

Coronavirus, MERS Coronavirus, Influenza A Virus, Influenza B Virus Yamagata,

Victoria, H1N1 Influenza Virus, H3N2 Influenza Virus, H5N1 Influenza Virus,

H7N9 Influenza Virus, Respiratory Syncytial Virus A, Adenovirus(type 2) ,

Adenovirus(type 2) , Mycoplasma Pneumoniae, Chlamydia Pneumoniae,

Pertussis, Streptococcus Pneumoniae, Rhinovirus(Type A) etc.

 

【Precautions】

1.The entire detection process should be performed strictly in accordance with the

requirements of this manual in the reagent preparation area, sample processing area,

and PCR amplification area, and the experimental clothes, instruments,

and consumables in each area should be used independently and cannot be mixed.

2.To avoid RNA degradation, the sample processing process should be operated at

0-4℃, and the test should be performed immediately after the experiment is

completed. Utensil consumables used in sample processing should be nuclease-free.

3.Negative and positive controls should be set for each experiment.

4.All reagents in the kit should be fully thawed and mixed at room temperature and

centrifuged immediately before use.

5.All negative and positive controls in the kit should be transferred to the sample

preparation area and stored separately before the first use.

6.To prevent fluorescence interference, avoid touching the PCR reaction tube

directly with bare hands, and avoid any marking on the PCR reaction tube.

7.The instrument amplification related parameters should be set in accordance with

the relevant requirements of this manual and different batches of reagents cannot

be mixed.

8.The product waste during the experiment should be detoxified before being

discarded.

 

【What is Nucleic Acid?】

 

Nucleic acids are essential for all forms of life, and it is found in all cells. Nucleic acids

come in two natural forms called deoxyribonucleic acid (DNA) and ribonucleic acid (RNA).

Nucleic acids are made of biopolymers, which are naturally-occurring, repeated sets of

monomers (making polymers) that then create nucleotides, which form nucleic acids.

To understand the structure of nucleic acid, it is important to understand the structure

of the nucleotides that make up nucleic acid.

INDEX OF SYMBOL

DNA RNA Nucleic Acid Testing Kit With Real Time Fluorescent Quantitative PCR 1

EXPORTER

 

Magnus International Limited

 

F12, New City International Mansion A, 234 Huapao Ave.

Liuyang, Hunan Province 410300 China

 

Contact: Goodwellmedical@gmail.com

 

MANUFACTURER

 

Changsha Renji Medical Equipment Co., Ltd.

 

No.18 Xiangtai Road, Liuyang Jingkai District,

Changsha City, Hunan Province 410300 China

 

AUTHORIZED REPRESENTATIVE

 

Lotus NL B.V.

Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.

 

FACTORY VIEW

 

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Sterile Pipette Tips, Filtered, DNAse and RNAse Free, Autoclavable - 200 µl 4

 

FACTORY WORKSHOP

 

Sterile Pipette Tips, Filtered, DNAse and RNAse Free, Autoclavable - 200 µl 5

 

Sterile Pipette Tips, Filtered, DNAse and RNAse Free, Autoclavable - 200 µl 6

 

PRODUCT AND STANDARDS

 

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【CERTIFICATIONS】

 

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Sterile Pipette Tips, Filtered, DNAse and RNAse Free, Autoclavable - 200 µl 10

 

【FAQ

 
1. Q: How about your healthcare and medical product quality?
 
A: Quality is our top priority. We have a professional quality control team to ensure the
quality with a high standard and regulated with the pro certifications. The QC team is
responsible for quality checking in each process and inspect every batch of our production
and ship them only after QC approval.
 
2. Q: What is your order MOQ?
 
A: Please contact the customer service, and the price is negotiable for large quantity.
 
3. Q: How about your product packing for shipment or mailing?
 
A: We prepared well neutral package for our products. We could also make OEM package,
OEM/ODM Custom Package/Multi-packing package/Cartons with well protective wrapping.
 
4. Q: What level of your product price?
 
A: We are the factory and direct manufacturer and offer competitive prices. We also offer
the volume pricing with more benefits depend on your order quantity level. Please let us know
your ordering volume while you make the inquiry to us to help you obtaining better benefits.
 
5. Q: What's the price terms?
 
A: The price is based on FOB of Hunan, China with exchange rate at RMB6.40 for USD$1.00.
If the exchange rate floating sharply lower than 6.3 or higher than 6.5, we should adjust the
price with real-time exchange rate.
 
6. Q: What's the payment terms?
 
A: We accept T/T wire transferring, PayPal, Western Union, etc. 50% down payment after
signing the contract and rest 50% before shipping confirmation.
 
7. Q: How could I get some samples?
 
A: We are able to deduct your samples expense once your orders confirmed with us.
The shipping fee will be calculated with the sample volume what you demand.
 
8. Q: Could you accept OEM order?
 
A: Yes, we could. We have professional designers who can design the logo or artwork and offer
best solution & styles for your OEM product choices.
 
9. Q: How long will the shipping or express take?
 
A: (1) For the international expresses such as DHL, UPS, FedEx, TNT, or EMS, etc., it usually
takes 5-7 working days to your location or destination.
(2) If shipping with containers, they will take about 30-60 days to process depending on
the vary ports or door locations.
(3) We will arrange your products delivery or shipping within 1-3 days after full payment
has been confirmed. We may not ship your products out until your payments arrive to
our bank account successfully.
 
10. Q: How do you deliver the goods to us?
 
A: If the order of small volume package, we could deliver by courier such as DHL, UPS, FedEx,
TNT, EMS. For the large volume order, we could ship with bulk cargo containers by sea.
We will provide you cost-saving recommendations for your product shipping.
 
11. Q: What is the warranty time.
 
A: One year f each product.
 
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SHIPPING
 
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We are the trusted healthcare and medical supplies from China.
Be free to contact us at any time!

You are very welcome to email us today at:
Goodwellmedical@gmail.com for the inquiry!

We are excited to build a reliable and long-term business with you
at our best!

Contact Details
MAGNUS INTERNATIONAL LIMITED

Contact Person: Marx Wu

Tel: +8613507415915

Send your inquiry directly to us (0 / 3000)