Intended use

EliGene® Monkeypox RT Kit is intended for detection of Orthopoxvirus causing monkeypox disease (MPXV) from DNA isolated from clinical material.

Principle of the method

This diagnostic kit is based on Real Time PCR (qPCR). For the detection of Monkeypox virus DNA and internal control, primers and fluorescent probes (FAM and HEX) are used. Primers target the region of the TNF receptor gene located in the inverted terminal repeats (ITR) region. To ensure increased specificity of the kit, additional set of primers targeting the conservative region of the DNA polymerase is present.

Compatible instruments

The following list represents instruments on which the above mentioned kits were tested. Please contact us for compatibility with other instruments.

• Roche: LightCycler® 480
• Thermofisher Scientific: Quant Studio 3 a 5
• Bio-Rad: CFX96 Touch Real-Time PCR Detection System
• Bio Molecular Systems: MIC qPCR Cycler

Recommended DNA isolation procedure

Swabs from lesions, blisters, nasopharyngeal and throat swabs

Manual:

• EliGene® Urine Isolation Kit (ELISABETH PHARMACON)
• EliGene® Viral DNA/RNA FAST Isolation Kit
• EliGene® Viral RNA/DNA FAST 96 Vacuum Isolation Kit
• EliGene® Blood DNA Isolation Kit

Automatic:

• Prepito NA Body Fluid Kit (PerkinElmer)

Tissue

Manual:

• EliGene® Tissue DNA Isolation Kit Chemagic DNA Tissue10 Kit (PerkinElmer)

Automatic:

• Prepito DNA Tissue10 Kit (PerkinElmer)

General information

Monkey pox is a zoonotic disease caused by the Orthopoxvirus Monkeypox virus, closely related to the smallpox virus, which causes smallpox disease. Monkeypox virus is a brick-shaped, enveloped DNA virus 200-250 nm in length that replicates in the cytoplasm, not the nucleus. Human cases were first described in 1970 and outbreaks were reported in Africa in the following decades. Mortality is 1-10%, although the mortality rate is lower for infections caused by the West African strain than for the Central African strain. The number of cases and the geographical prevalence of monkeypox have increased in recent years, probably due to weakening immunity to smallpox. DNA isolated from any clinical samples - swabs from lesions, blisters, nasopharynx and throat or affected tissues is suitable for DNA diagnostics.

CE-IVD