China Singclean Ivd Reagent Rapid Virus Diagnosis Antigen Diagnostic Monkeypox Test Kit

Customization: Available
Type: IVD Reagent
Shelf Life: 1 Year

Product Description

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Basic Information

Storage Condition 4° C to 30°C
Transport Package Box, Carton
Specification 1 test/box, 5 tests/box, 20 tests/box
Production Capacity 50,000 / Day

Monkeypox Virus IgG/IgM Test Kit

Monkeypox virus IgG/IgM Test Kit (Immunochromatography) is a solid-phase immunochromatographic assay designed for the rapid, qualitative detection of IgG/IgM antibodies to Monkeypox virus in human blood. This test serves as a preliminary screening tool.

Key Features: Hyaluronic Acid, high quality, rapid detection, solid-phase assay, clinical accuracy.

Packaging Specifications

Available in 1 test/box, 5 tests/box, and 20 tests/box. Each pouch contains a test cassette, desiccant, dropper, buffer, and package insert.

Introduction & Principle

Monkeypox is a viral zoonosis with symptoms similar to smallpox. This kit uses the principle of immunochromatography, utilizing anti-human IgM and IgG antibodies immobilized on a nitrocellulose membrane. When a specimen and buffer are added, the antibodies bind to conjugates, migrating through the membrane to form visible bands if reactive.

Test Method

1
Equilibrate the test cassette, specimen, and buffer to room temperature.
2
Place the test device on a clean, level surface.
3
For Serum/Plasma: Add 1 drop of specimen to the sample well (S), followed immediately by 2 drops of buffer.
4
For Whole Blood: Add 1 drop of whole blood to the sample well (S), followed immediately by 2 drops of buffer.
5
Wait for colored lines to appear. Read results at 10 minutes; do not interpret after 15 minutes.
Test Procedure Diagram
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Interpretation of Results

Negative

Only the C band is present. No burgundy color in IgG or IgM bands.

IgM Positive

Presence of C band and IgM band indicates IgM anti-Monkeypox antibodies.

IgG Positive

Presence of C band and IgG band indicates IgG anti-Monkeypox antibodies.

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Frequently Asked Questions

What is the required storage temperature for the kit?
The test kit should be stored in a sealed aluminum foil bag at temperatures between 4°C and 30°C.
How long are the results valid for reading?
Results should be interpreted exactly at 10 minutes. Do not interpret the result after 15 minutes as it may lead to false readings.
What specimen types can be tested?
The kit is compatible with human serum, plasma, and whole blood specimens.
What is the shelf life of the test kit?
The validity period is 24 months from the date of manufacture when stored in the original sealed pouch.
What does a single "C" band mean?
If only the Control (C) band appears, the result is negative, meaning no Monkeypox antibodies were detected in the specimen.
What is included in the package?
Each sealed pouch contains a test cassette, a desiccant, a dropper, buffer, and a detailed package insert.

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