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 required but not provided
Materials ReMaterials Required but Not provided
quired but Not provided
TEST PROCEDURES
Allow the test device, specimen, buffer, and/or controls to reach room temperature (15 - 30°C) prior to testing.
1.Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
For Serum or Plasma Specimens:
Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10 uL), and transfer the specimen to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 μL) and start the timer. (See illustration below. Avoid trapping air bubbles in the specimen well.)
For Whole Blood (Venipuncture/Fingerstick) Specimens:
To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 2 drops of whole blood (approximately 20 μL) to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 uL) and start the timer. See illustration below.
To use a micropipette: Pipette and dispense 20 μL of whole blood to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 μL) and start the timer.
3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
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.
CERTIFICATIONS
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