RT Monkeypox Virus Real-Time PCR Detection Reagent KIT Freeze-Dried Multiplex

DESCRIPTION

Monkeypox is an infectious disease caused by the monkeypox virus (MPXV), a double-stranded DNA virus, that belongs to the Orthopoxvirus genus of the Poxviridae family. The virus was first discovered in 1958 as the cause of outbreaks of a pox-like disease in monkeys kept for research in Denmark. Human disease was first identified in 1970 in the Democratic Republic of the Congo. Orthopoxviruses can cause disease in humans and other mammals. Symptomatic infection typically results in the formation of lesions, skin nodules or disseminated rash. There are two known clades of MPXV: clade I, mainly found in the Congo Basin region, and clade II, which contains two subclades, IIa and IIb, mainly found in West Africa. Clade IIb is the predominant strain in the ongoing global outbreak, which was recognized in May 2022.

This product is a freeze-dried real-time PCR reagent for in vitro qualitative detection of MPXV. It uses the highly conserved F3L gene of MPXV as the detection target, and human ribonuclease P gene (RNaseP) as the internal positive control (IPC). It is a mastermix containing all necessary ingredients, except for template DNA, for real-time PCR amplification of MPXV, and it is pre-dispensed as single-test in PCR tubes for easy use. This product does not require cold chain for transportation and storage, which significantly reduces shipping cost, and eliminates possible loss due to cold chain failure, repeated freezing and thawing, pipetting errors, and aerosol amplicon contamination.

 LIMITATIONS

1.This reagent is only used for qualitative detection in vitro and cannot be used to determine the content of antibodies. Therefore, the amount or increase of the amount of antibodies cannot be determined by this reagent.

2.This reagent is used for the detection of personal serum, plasma or whole blood samples. Do not use it for the detection of saliva, urine or other body fluids.

3.The test results of this product are interpreted by human eyes, and are susceptible to factors such as visual inspection errors or subjective judgments. Therefore, when the colorr of the band 3 is not easy to judge, it is recommended to repeat the test.

4.This test kit is used as one of the auxiliary methods for diagnosis. The test results are for reference only and should not be used as the sole basis for clinical diagnosis and treatment. Positive results need to be confirmed by other methods.

5.Limited by the detection sensitivity, the negative result may be caused by the absence of antibodies or the titer of the product at the initial stage of infection. Patients should be reminded to review within 7 to 14 days. If the result is still negative, but the clinical symptoms persist, other methods of testing should be recommended. The clinical diagnosis should be combined with clinical examination, medical history and other tests. Negative results cannot at any time rule out the possibility of MPXV infection.

6. Patients with impaired immune function or receiving immunosuppressive therapy have limited reference values for serological antibody testing

SPECIFICATIONS & COMPOSITION

Technical Parameters:

STORAGE AND SHELF LIFE

Store at ambient temperature (4-30°C). It is stable for up to 12 months. Once the vacuum package is open, please store the unused products in the provided re-sealable plastic bag with the desiccants, and in the aluminum foil bag.