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One Step Chikungunya Virus (ChikV) IgG IgM Antibody Rapid Test Kit
INTENDED USE
Chikungunya Virus (ChikV) IgG/IgM Rapid Test is a rapid
immunochromatographic assay for the simultaneous detection of IgG
and IgM antibodies to Chikungunya virus in human whole blood, serum
or plasma. The assay is used as a screening test for Chikungunya
viral infection.
PRINCIPLE
ChikV rapid test utilizes the principle of Immuno-chromatography.
Mouse anti-human IgM and human IgG antibodies are immobilized on
the nitrocellulose membrane respectively, as two individual test
lines (IgM line and IgG line) in the test window of the test
device. The IgG line in the test window is closer to the sample
well and followed by IgM line. As the test sample flows through the
membrane within the test, the colored-chikungunya specific
recombinant antigencolloidal gold conjugate complexes with specific
antibodies (IgM and/or IgG) of chikungunya virus, if present in the
sample. This complex moves further on the membrane to the test
region where it is captured by the anti-human IgM and/or human IgG
antibodies coated on the membrane leading to formation of a colored
band, which indicates a positive test results. Absence of this
colored band in the test window indicates a negative test result. A
built-in control line will always appear in the test window when
the test has performed properly, regardless of the presence or
absence of anti- ChikV antibodies in the specimen.
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
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.
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.