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:
| Product Name | MPVX IgG/IgM Antibody rapid test Monkeypox Virus |
| Package | 48 Tests/kit |
| Sample Type | 1) Skin lesion tissue; vesicle fluid, exudate, or crust; skin
pustule swabs, oral swabs, etc. 2) Serum |
| Test Method | PCR |
| Format | Reagent |
| Type | PCR |
| Shelf Life | 18 Months |
| Storage Temperature | 2-8℃ |
| Detection Limit | High Sensitivity |
| Reading Time | 90-120 Minutes |
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.
CAUTION: The reagent pellet getting smaller is an indication of
moisture seeping into the tube and the reagent is dampened. Any
reagents with significant smaller pellet size than usual should be
discarded or tested with positive control before use for clinical
testing.
