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Mpox Monkeypox Virus IgM IgG Antibody Rapid Test Kit Whole Blood Plasma Screening Test
【INTENDED USE OF MONKEYPOX TEST】
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.
【PRINCIPLE OF MONKEYPOX TEST】
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.
【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°C-8°C),
if not tested immediately. The specimens must betested within 24
hours of collection.
【WARNINGS AND PRECAUTIONS】
【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 serum/plasma 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).
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.
【STORAGE AND STABILITY】