Rapid infectious disease test

for antibodiesIgGIgM

Product overview
This product is an in vitro qualitative lateral flow immunoassay for the detection of IgG and IgM antibodies to Monkeypox virus in human whole blood, serum or plasma. CE certified.

Introduction
The Monkeypox virus IgG/IgM Rapid Test provides a rapid qualitative result to aid in the serological assessment of suspected Monkeypox infections. The assay is intended for professional use in clinical laboratories and point-of-care settings.

Benefits

• Results available within 10–15 minutes
• Supports rapid clinical decision-making
• Simple procedure requiring no instrumentation
• All reagents supplied; ready-to-use test devices
• Designed for high sensitivity and specificity

Principle
The test is a membrane-based immunoassay with two test regions (IgG and IgM). Specimen is applied to the sample well and migrates along the membrane. If Monkeypox-specific IgG or IgM antibodies are present, they bind to antigen-coated particles and form a visible colored line at the corresponding test region (G for IgG, M for IgM). A separate control line verifies proper sample addition and membrane migration.

Components

• Individual test devices (sealed pouch)
• Disposable droppers
• Single-use buffer solution
• Package insert / instructions for use

Procedure
Bring test device, specimen and buffer to room temperature (15–30°C) before testing.

• 1. Open pouch and place device on a clean, level surface. Use immediately.
• 2. For serum or plasma: using the dropper, collect ~10 µL (to the fill line) and dispense into the specimen well (S), then add 2 drops of buffer (~80 µL) and start timer.
• 3. For whole blood (venipuncture or fingerstick): using the dropper, collect ~20 µL (2 drops) and dispense into the specimen well (S), then add 2 drops of buffer (~80 µL) and start timer. A micropipette dispensing 20 µL may be used as alternative.
• 4. Observe colored lines. Read results at 10 minutes. Do not interpret after 20 minutes.

Interpretation of assay result

• Colored line at G = presence of Monkeypox IgG antibodies.
• Colored line at M = presence of Monkeypox IgM antibodies.
• Colored line at control (C) only = negative for Monkeypox IgG/IgM.
• No control line = invalid test; repeat with a new device.

Characteristics / technical specifications

• Test type: Rapid chromatographic immunoassay for qualitative detection of IgG and IgM antibodies to Monkeypox virus
• Intended specimens: Human whole blood, serum, plasma (some materials reference saliva—primary validated samples are blood/serum/plasma)
• Sample volume: Serum/Plasma ~10 µL; Whole blood ~20 µL (2 drops)
• Buffer: 2 drops (~80 µL) per test
• Time to result: Read at 10 minutes; do not interpret after 20 minutes
• Storage/operating temperature prior to testing: 15–30°C
• Contents supplied: Test devices, droppers, single buffer, package insert
• Regulatory: CE marked
• Performance: Manufacturer reports high sensitivity and specificity