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Monkeypox Virus CE Nucleic Acid Detection Kit Fluorescence PCR Method

Basic Information
Place of Origin: China
Brand Name: Dewei
Certification: CE
Model Number: DW
Minimum Order Quantity: 10000 units
Price: $2-2.5/unit
Packaging Details: 24tests/kit, 48tests/kit, 96tests/kit
Delivery Time: in 20 days
Payment Terms: T/T, Western Union, L/C
Supply Ability: 200,000 units/Day
Detail Information
Usage: Monkeypox Virus Collection And Detection Temperature: -20±5 ℃
Stability: 24 Months Recycling: Disposable
Sample: Whole Blood, Serum And Lesion Exudate Samples Instrument: ABI7500, ABI7300, LightCycler480, Bio-Rad CFX96, SLAN-96S And QuantStudio.
High Light:

Fluorescence PCR Nucleic Acid Detection Kit

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CE Nucleic Acid Detection Kit

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Fluorescence PCR Nucleic Acid Test Kit


Product Description

Monkeypox Virus Nucleic Acid Detection Kit ( Fluorescence PCR method )

 

【SPECIFICATION】

24tests/kit, 48tests/kit, 96tests/kit

 

【INTENDED USE】

This kit is used to achieve qualitative detection of Monkeypox viral DNA extracted from whole blood, serum or lesion exudate samples of suspected infected patients and other patients requiring diagnosis.

 

【PRINCIPLE】

This kit uses real-time fluorescent PCR technology to select a relatively conserved region of Monkeypox virus nucleic acid fragment as the amplification target region, design specific primers and different fluorescent probe labels, and use RT-PCR technology to detect whether the sample contains Monkeypox viral DNA.

 

【COMPONENT】

Specification Components Package Ingredients
24tests/kit MPV PCR Reagent A 408μL×1 tube Specific primers, probes, tris-hydrochloric acid buffer, etc.
MPV PCR Reagent B 72μL×1 tube Hot-start Taq enzymes, uracil-N-glycosylase, etc.
MPV Positive Control 400 μL×1 tube DNA sequences containing Target gene
MPV Negative Control 400 μL×1 tube NaCl
48tests/kit MPV PCR Reagent A 816μL×1 tube Specific primers, probes, tris-hydrochloric acid buffer, etc.
MPV PCR Reagent B 144μL×1 tube Hot-start Taq enzymes, uracil-N-glycosylase, etc.
MPV Positive Control 400 μL×1 tube DNA sequences containing Target gene
MPV Negative Control 400 μL×1 tube NaCl
96tests/kit MPV PCR Reagent A 816μL×2 tubes Specific primers, probes, tris-hydrochloric acid buffer, etc.
MPV PCR Reagent B 144μL×d tubes Hot-start Taq enzymes, uracil-N-glycosylase, etc.
MPV Positive Control 400 μL×2 tubes DNA sequences containing Target gene
MPV Negative Control 400 μL×2 tubes NaCl

Note:

Do not mix the components from different batches for detection.

Nucleic acid extraction reagents: Recommend Nucleic Acid Extraction Reagent manufactured by Dewei.

No need nucleic acid extraction when using Positive Control, nucleic acid extraction is required when using Negative Control.

 

【STORAGE AND STABILITY】

The kit can be stored at -20±5 ℃ for 12 months.

Temporarily store at 4 ℃ for 7 day.

Repeated freezing and thawing should not exceed 7 times, opening reagent should not exceed 7 times.

Dry ice to keep low temperature transportation should not exceed 4 days.

 

【INSTRUMENTS】

Real-time PCR instrument such as ABI7500, ABI7300, LightCycler480, Bio-Rad CFX96, SLAN-96S and QuantStudio.

 

【SAMPLING AND HANDLING】

  • Suitable specimen type: serum and lesion exudate samples.
    2. Collection: Specimen should be collected into sterile tubes in accordance with standard
    technical specifications.
    Storage: The collected specimen should be used for detection immediately or frozen at
    ≤-20°C for no more than one month.Repeated freezing and thawing should be avoid.
    3. Transport: The specimen should be transported using sealed foam box with ice.

 

【PROTOCOL】

  • Sample Treatment and Nucleic Acid Extraction (Sample Treatment Area)

It is recommended to take 200μL liquid samples, Positive Control and Negative Control for nucleic acid extraction, according to the corresponding requirements and procedures of viral DNA extraction kits.

  • PCR Reagent Preparation (Reagent Preparation Area)

Put the PCR tubes into the reaction tank and set the names of each reaction well in the corresponding order.

Take out MVP PCR Reagent A and B from the kit, thaw at room temperature, shake and mix, centrifuge at 8,000 rpm for a few seconds before use.

Take N pcs of PCR reaction tubes (N = number of samples to be tested + Negative Control + Positive Control)

The configuration of the MVP single amplification system is as follows:

MPV PCR Reagent A 17μL
MPV PCR Reagent B 3μL
Amplification System 20μL

After mixing the components thoroughly, centrifuge for a short time so that all the liquid on the tube wall is centrifuged to the bottom of the tube, and then dispense 20 µl of the amplification system into PCR tubes.

  • Sampling (Sample Preparation Area)

Add 5µl of each the processed Negative Control, the nucleic acid of the sample to be tested, and the MVP positive Control to the above PCR tubes, tight the tube caps and centrifuge at 8,000 rpm for a few seconds, then transfer to the amplification detection area.

  • PCR Amplification (Amplification Area)

Put the PCR tubes into the reaction tank and set the names of each reaction well in the corresponding order.

Settings of detection fluorescence: (1) Monkeypox virus (FAM); (2)Internal Control (CY5).

Run the following cycling protocol: ABI7500, Bio-Rad CFX96, SLAN-96S and QuantStudio, please refer to instrument user manual for better operation:

  Steps Temperature Time Cycles
1 Pre-denaturation 95 ℃ 2min 1
2 Denaturation 95 ℃ 10 s 45
Annealing, extension, fluorescence acquisition 60 ℃ 30 s
  • Results analysis (please refer to Instrument User Manual)

After the reaction, the results will be saved automatically. Click “Analyze” to analyze, and the instrument will automatically interpret Ct values of each sample in result column. The negative and positive control results shall conform to the following

"5. Quality Control ".

  • Quality Control

Negative Control: No Ct or Ct>40 in FAM channel, Ct≤40 in CY5 channel with normal amplification curve.

Positive Control: Ct≤35 in FAM channel with normal amplification curve, Ct≤40 in CY5 channel with normal amplification curve.

The result is valid if all the above criteria is met. Otherwise, the result is invalid.

 

【INTERPRETATION OF RESULTS】

The following results are possible:

  Ct value of FAM channel Ct value of CY5 channel Interpretation
1# No Ct or Ct>40 ≤40 Monkeypox virus negative
2# ≤40 Any results Monkeypox virus positive
3# 40~45 ≤40 Re-test; if it is still 40~45, report as 1#
4# No Ct or Ct>40 No Ct or Ct>40 Invalid

NOTE: If invalid result occur, the sample needs to be collected and tested again.

 

【DETECTION LIMITATIONS】

The detection result of this kit is only for clinical reference, and it should not be directly used as the evidence for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms, medical history and exposure history.

The detection result can be affected by operations, including specimen collection, storage and transportation. False negative result may occur if there is any mistakes in the operation. Cross contamination during specimen treatment may lead to false positive result.

 

【PERFORMANCE SPECIFICATIONS】

Detection limitation: 500 copies /mL.

Precision: The coefficient of variation (CV, %) of Ct value of within-batch/between-batchprecision is ≤5%.

Accuracy: The conformity rate of negative/positive reference: 100%.

Specificity: no cross-reactivity with human genome and the following pathogens: smallpox virus, sheep pox virus, vaccinia virus, chicken pox virus,hepatitis B virus, hepatitis C virus, human immunodeficiency virus,enterovirus.

 

【ATTENTIONS】

  • This product is only used for in vitro test. Please read this manual carefully before use.
  • Use sterile, DNase-free and RNase-free tubes and tips during the detection.
  • During the detection, it is necessary to avoid cross-contamination, wear appropriate protective equipments, disposable gloves and masks, and complete the operation in the biosafety cabinet to avoid harmful substances entering the respiratory tract.
  • In case of contact with skin and mucous membrane during use, please rinse immediately with flowing water, which will not cause any harm to the operator.

All liquid reagents should be fully melted and mixed at room temperature before use, and centrifuged at 8,000 rpm for a few seconds before use.

After use, the packaging and waste liquid must be uniformly treated as medical waste to prevent pollution.

 

 

Contact Details
Sherry

Phone Number : +8613316305166

WhatsApp : +008615267039708