CE Approved Singclean Rapid Monkeypox Virus Nucleic Acid Detection Test Kit for Quick Results

• Type: IVD Reagent
• Shelf Life: 1 Year
• Storage Condition: 4° C to 30°c
• Transport Package: Box, Carton
• Specification: 1test/box, 5tests/box, 20tests/box
• Trademark: Singclean
• Origin: Hangzhou, China
• Production Capacity: 50000/Day

Product Description

 

What is Monkeypox?
Monkeypox is a rare disease caused by infection with the Monkeypox virus which is part of the same family of viruses as smallpox.

How is Monkeypox Transmitted?
1. The virus transmitted from animal to human is by direct contact with the blood, bodily fluids, or cutaneous or mucosal lesions of infected animals.
2. From human to human is by close contact with respiratory secretions, skin lesions of an infected person, or recently contaminated objects.
3. Most reported cases so far have been identified through sexual health or other health services in primary or secondary healthcare facilities and have involved mainly men who have sex with men.

Symptoms of Monkeypox can include:
Is it Important to Have Monkeypox Testing?
Early detection and early diagnosis are crucial for taking measures and then curbing Monkeypox outbreak. As a leading in vitro diagnostic products manufacturer with 20 years of experience, Singclean has rapidly developed Monkeypox Virus Test Kit Series to help with the massive testing.

Singclean® Monkeypox Virus Nucleic Acid Detection Kit
 

Intended Use
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
 

Technology	Polymerase chain reactor-fluorescent probe technology
Specification	25 tests/box, 50tests/box
Specimen Types	Serum and human pustular or vesicular rash specimens
lnternal Control	Exogenous internal control, not limited to human clinical samples
PCR turnaround time	36 mins
Limit of Detection	400 copies/mL
Precision	CV≤5%
Storage Temperature	-20±5ºC
Shelf Life	12 Months
Applied PCR Machine	1.Applied BiosystemsTM 7500 real-time PCR system;
	2.ABI 7500 Real-time fluorescence quantitative PCR instrument;
	3.SLAN®-96S/96P real-time PCR system;
	4.Thermofisher QuantStudioTM5 Real-time fluorescence quantitative PCR;
	5.MA-6000 Real-Time Quantitative Thermal Cycler

Kit Components

*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
 

Instruction For Use
Interpretation of Test Result

Preconditions:
Negative control products: FAM curve has no Ct value or Ct>40; and monkeypox virus internal standard detection (HEX/VIC) has no Ct value or Ct>40. Positive control products: FAM curve Ct≤35; and monkeypox virus internal standard detection (HEX/VIC) is positive, Ct≤35.

Sample Test Result
*Limitations
a)The test results need to be combined with other clinical and laboratory data, and if the test results do not match the
clinical assessment, further testing is required.
b)Recent or remote vaccination with a vaccinia-based vaccine (e.g. anyone vaccinated before smallpox eradication, or more recently vaccinated due to higher risk such as orthopoxvirus laboratory personnel) might lead to false positive results.
c)Other factors, including technical reasons, operational errors and other sample factors, may also cause errors in test
results.

*Precautions
1. This kit is for professional use only.
2. Standard precautions should be followed. All patient samples and positive controls should be considered potentially infectious and handled accordingly.
3. Handle hazardous or bio-contaminated materials in accordance with your institution's practices.
4. Please read the instructions carefully before the operation. This kit is only for emergency use in in vitro diagnostic testing. During the experiment, from specimen collection and storage to laboratory testing, each step of the operation should be strictly in accordance with relevant biosafety regulations and molecular experiments.
5. A separate laboratory area is required for the execution of predetermined procedures. a) Area 1: preparation area-preparing detection reagents b) Area 2: sample processing area-processing samples and controls c) Area 3:amplification area-PCR reaction area.
6. All test samples must be treated as infectious substances. Change lab coats and disposable gloves to avoid cross-contamination between samples. Disposal of samples and waste must comply with local, state, and national regulations.

 

Detailed Photos