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Basic Info.
Product Description
Singclean/OEM Cartons IVD Monkeypox Virus with CE Nucleic Acid (Fluorescence PCR) test
Monkeypox is caused by monkeypox virus. The virus transmitted from animal to human is by direct contact with the blood, bodily fluids, or cutaneous or mucosal lesions of infected animals and from human to human is by close contact with respiratory secretions, skin lesions of an infected person or recently contaminated objects.
Symptons
Monkeypox typically presents clinically with fever, rash and swollen lymph nodes and may lead to a range of medical complications. Severe cases can occur. In recent times, the case fatality ratio has been around 3-6%.
The incubation period (interval from infection to onset of symptoms) of monkeypox is usually from 6 to 13 days but can range from 5 to 21 days.
Product Description
Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR) is used for the detection of nucleic acid from monkeypox virus in serum and human pustular or vesicular rash specimens from individuals suspected of
monkeypox virus infectious. By specifically detecting the nucleic acid fragments of monkeypox virus, monkeypox virus can be quickly identified, which is suitable for rapid diagnosis of related diseases caused by monkeypox
virus infection
Specifications
Specimen Type: serum, human pustular or vesicular rash specimens
Storage: - 20±5°C
Shelf Life: 12 months 
| NO. | Components | 25tests/kit | 50tests/kit | Main Components |
| 1 | MPV-PCR detection Mix | 950μL/tube, 1tube | 950μL/tube, 2 tube | Primers, probes, dNTPs, PCR buffer etc. |
| 2 | MPV-Enzyme mixture | 50μL/tube,1tube | 100μL/tube, 1tube | H-Taq, UNG |
| 3 | MPV-Positive control product | 500μL/tube,1tube | 500μL/tube,1tube | Cloning Plasmids for Target Gene Fragments |
| 4 | MPV-Negative control product | 500μL/tube,1tube | 500μL/tube,1tube | Sterilized saline |
Materials Required but Not Provided
1) 48 or 96-well Polypropylene PCR Microplate. Or 0.2 mL Polypropylene PCR Tube Strips with Flat Cap,
2) Nucleic acid extraction reagents or Preservation solution,
3) Pipettes and Pipetting tips (10μL, 200μL and 1000μL tips with filters),
4) Centrifuge,
5) Desktop vortex mixer,
6) Disposable powder-free gloves and surgical gowns
Applicable Instrument
Recommended PCR instruments include: Applied Biosystems™ 7500 real-time PCR system; ABI 7500 Real-time fluorescence quantitative PCR instrument , SLAN®-96S/96P real-time PCR system, Thermofisher
QuantStudio™5 Real-time fluorescence quantitative PCR, MA-6000 Real-Time Quantitative Thermal Cycler.
Performance Index
1. Specificity: The kit has no cross-reaction with measles virus, rubella virus, parvovirus B19, varicella zoster virus, syphilis virus and herpes simplex virus.
2. Minimum detection limit: 400 copies/mL.
3. Precision: The coefficient of variation (CV %) of the Ct value of the intra-assay precision is less than or equal to 5%.
4. Interfering substances that may exist in the sample: hemoglobin (≤2mg/dL), total bilirubin (≤28mg/dL), triglyceride (≤3g/dL), total IgG (≤40mg/mL) have no effect on the detection. Influence; paracetamol (≤60μg/mL) has no influence on the detection.
Analysis of Results
Positive:
FAM detection Ct value≤40, and the internal standard detection is positive (Ct value≤40)
Negative:
No Ct value or Ct value > 40 in FAM detection, and the internal standard channel detection is positive (Ct value≤40)
Invalid:
There is no Ct value or Ct value >40 in the internal standard test. The cause should be found and eliminated, and the sample should be re-sampled and tested again.
