INTENDED USE
The Monkeypox virus IgG Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Monkeypox virus in human whole blood, serum, or plasma as an aid in the diagnosis of Monkeypox infections.
INTRODUCTION
Monkeypox is used to be a viral zoonosis with symptoms very similar to those in smallpox patients, caused by by infection with Monkeypox virus. It is an enveloped double-stranded DNA virus that belongs to the Orthopoxvirus genus of the Poxviridae family. Human monkeypox was first identified in humans in 1970 in the Democratic Republic of the Congo in a 9-year-old boy in a region where smallpox had been eliminated in 1968. Since then, most cases have been reported from rural, rainforest regions of the Congo Basin, particularly in the Democratic Republic of the Congo and human cases have increasingly been reported from across Central and West Africa. In humans, the symptoms of monkeypox are similar to but milder than the symptoms of smallpox. Monkeypox begins with fever, headache, muscle aches, and exhaustion. The main difference between symptoms of smallpox and monkeypox is that monkeypox causes lymph nodes to swell (lymphadenopathy) while smallpox does not. The incubation period (time from infection to symptoms) for monkeypox is usually 7−14 days but can range from 5−21 days.
The Monkeypox virus IgG Rapid Test is a rapid test that utilizes a combination of Monkeypox antigen coated colored particles for the detection of IgG Monkeypox antibodies in human whole blood, serum, or plasma.
MATERIALS
Materials Prov
Materials
Materials Provided
- Individually packed test devices
- Disposable pipettes
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Materials ReMaterials Required but Not provided
quired but Not provided
INTERPRETATION OF RESULTS
POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
NOTE:
- The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
- Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
QUALITY CONTROL
An internal procedural control is included in the test. A colored band appearing in the control region (C) confirming sufficient buffer volume and adequate membrane wicking.
Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
Monkeypox Disease Overview
Monkeypox is a rare viral zoonotic disease caused by the monkeypox virus, a member of the Orthopoxvirus genus, which also includes smallpox. Originally discovered in monkeys, the virus primarily affects rodents and other small mammals. It was first identified in humans in 1970 in the Democratic Republic of Congo.
Key Features:
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Transmission: Monkeypox can be transmitted to humans through contact with infected animals, such as rodents or primates, or through contact with bodily fluids or lesions of infected individuals. Human-to-human transmission can occur through respiratory droplets, skin contact, or contaminated materials.
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Symptoms: The disease typically presents with flu-like symptoms, including fever, headache, muscle aches, and swollen lymph nodes, followed by a distinctive rash. The rash progresses from macules to papules, vesicles, and pustules, eventually scabbing over.
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Incubation Period: The incubation period for monkeypox ranges from 7 to 14 days, but symptoms can appear anywhere from 5 to 21 days after exposure.
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Diagnosis: Diagnosis is confirmed through laboratory tests, such as polymerase chain reaction (PCR) assays, which detect the presence of the virus or viral DNA.
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Treatment: There is no specific treatment for monkeypox. Management focuses on supportive care, including hydration, pain relief, and control of secondary infections. In severe cases, antiviral medications and vaccines may be considered.
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Prevention: Preventive measures include avoiding contact with animals that may harbor the virus, practicing good hygiene, and using personal protective equipment (PPE) when caring for infected individuals. Smallpox vaccination may offer some protection against monkeypox.
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Prognosis: Monkeypox is generally less severe than smallpox, with most patients recovering within a few weeks. However, complications can arise, particularly in individuals with weakened immune systems or those who experience severe symptoms.