INTENDED USE
The Monkeypox Virus Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Monkeypox antigen in human skin lesion swab, or mucous membrane swab specimen in individuals who are suspected of monkeypox-like symptoms or recent contact with monkeypox infected patients.
INTRODUCTIONMonkeypox 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. Recently in 2022, the monkeypox virus is spreading across the world, with reports of cases in the U.K., Spain, Portugal, the U.S and some more countries. 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 incubation period (time from infection to symptoms) for monkeypox is usually 7−14 days but can range from 5−21 days. The virus enters the body through broken skin (even if not visible), respiratory tract, or the mucous membranes (eyes, nose, or mouth). Animal-to-human transmission may occur by bite or scratch, bush meat preparation, direct contact with body fluids or lesion material, or indirect contact with lesion material, such as through contaminated bedding. Human-to-human transmission is thought to occur primarily through large respiratory droplets. Respiratory droplets generally cannot travel more than a few feet, so prolonged face-to-face contact is required. Other human-to-human methods of transmission include direct contact with body fluids or lesion material, and indirect contact with lesion material, such as through contaminated clothing or linens.
The Monkeypox Virus Antigen Rapid Test is designed as a simple tool in detection of Monkeypox for regular clinical diagnosis.
MATERIALS
Materials Prov
Materials
Materials Provided
- Foil pouches, each contains one test cassette, and one disposable dropper with desiccant bags
- Assay buffer tubes (0.8ml each)
- Disposable sampling swabs
- Paper tube holder
- Instruction for use
Materials Required But Not Provided
- Timer
Materials Required 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 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.