INTENDED USE
The Monkeypox Virus IgM/IgG Antibody Rapid Test Kit is used for the qualitative detection of Monkeypox Virus IgM/IgG antibody in human serum, plasma or whole blood sample. It is intended for in vitro diagnostic use, and for professional use only.
| Storage |
2~30 º C |
| Specimen |
Whole Blood/Serum/Plasma |
| Component |
Rapid Test + Buffer + Pipettes |
| Principle |
Colloidal gold rapid tests |
| Reading |
Within 15mins |
| Package |
40tests/box |
| Trademark |
Dewei |
| Origin |
China |
PRINCIPLE
The Monkeypox Virus IgM/IgG Antibody Rapid Test Kit is designed to simultaneously detect and differentiate IgG and IgM antibodies to monkeypox virus in human serum, plasma, whole blood. The Monkeypox Virus IgM/IgG test device has 3 pre-coated lines, "G" (Monkeypox IgG Test Line), "M" (Monkeypox IgM Test Line) and "C" (Control Line) on the surface of the membrane. The "Control Line" is used for procedural control. When a specimen is added to the sample well, anti-Monkeypox IgGs and IgMs in the specimen will react with recombinant Monkeypox virus envelope proteins conjugates and forms antibody-antigen complex. As the complex migrates along the test device via capillary action, it will be captured by the relevant anti-human IgG and or anti-human IgM immobilized in two test lines across the test device and generate a colored line.
To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
WARNINGS AND PRECAUTIONS
Immunoassay for in vitro diagnostic use only.
Do not use after expiration date.
The test should remain in the sealed pouch until use.
The used test should be discarded according to local regulations.
SPECIMEN COLLECTION
The Monkeypox Virus IgM/IgG Antibody Rapid Test Kit (Lateral Chromatography) can be performed on plasma, serum, or whole blood.
Serum and plasma:
Test specimens as soon as possible after collecting. Store specimens at 2°C -8°C if not tested immediately. Specimens can be stored at 2°C -8°C for up to 5 days.
The plasma and serum specimens should be frozen at -20°C for longer storage.
Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently.
Specimens containing visible particulatematter should be clarified by centrifugation before testing.
Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.
Whole Blood:
Whole blood can be obtained by either fingertip puncture or venipuncture.
Whole blood specimens should be stored in refrigeration (2°C8°C), if not tested immediately. The specimens must betested within 24 hours of collection.
STORAGE AND STABILITY
The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
OPERATION
Read the instructions thoroughly before testing and bring the card pouch and specimen to room temperature.
1. Bring the specimen and test components to room temperature if refrigerated or frozen. Once thawed, mix the specimen well prior to performing the test.
2. When ready to test, open the pouch at the notch and remove the device. Place the test device on a clean, flat surface.
3. Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense 10µL of serumasma or 20µL of whole blood into the sample well, making sure there are no air bubbles.
4. Immediately add 3 drops (about 100 µL) of sample diluent to sample well with the bottle positioned vertically.
5. Wait for colored line(s) to appear. Interpret the test results in 15 minutes. Do not read results after 20 minutes.
INTERPRETATION OF RESULTS
Preliminary positive (+)Only one colored band appears, in the control region (C). No colored band appears in the test region (T).Negative (-)Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).InvalidControl 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.
PRODUCT IMAGES
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PRODUCTION LINE
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