Testsealabs Chikungunya IgM Test

Chikungunya IgM Test

1. Target Analyte: This test specifically identifies IgM class antibodies produced by the human immune system in response to Chikungunya virus infection. IgM antibodies are typically the first to appear during an acute infection, usually detectable within 3-7 days after the onset of symptoms and persisting for several weeks to months. Their detection is therefore a crucial indicator of recent or acute CHIKV infection.
2. Specimen Compatibility: The test is validated for use with multiple sample types, providing flexibility for different healthcare settings:

• Whole Blood (Fingerstick or Venipuncture): Enables rapid point-of-care or near-patient testing without the need for complex sample processing.
• Serum: The gold standard sample type for antibody detection in laboratory settings.
• Plasma: Offers an alternative to serum, often readily available in clinical labs.

3. Intended Use & Diagnostic Value: The primary purpose of this test is to aid healthcare professionals in the diagnosis of acute Chikungunya virus infection. A positive IgM result, especially when correlated with clinical symptoms (sudden high fever, severe joint pain, rash, headache, etc.) and epidemiological context (travel to or residence in endemic areas), provides strong supportive evidence for an active or very recent CHIKV infection. It is particularly valuable in the early phase of the illness when IgG antibodies may not yet be detectable.
4. Technology Principle: Based on lateral flow chromatographic immunoassay technology:

• Colloidal Gold Conjugate: The test strip contains a pad with CHIKV antigen conjugated to colloidal gold particles.
• Sample Flow: When the sample (blood, serum, or plasma) is applied, it migrates chromatographically along the strip.
• Antibody Capture: If CHIKV-specific IgM antibodies are present in the sample, they will bind to the gold-conjugated CHIKV antigens, forming an antigen-antibody complex.
• Test Line Capture: This complex continues to flow and is captured by anti-human IgM antibodies immobilized at the Test (T) line region, resulting in a visible colored line.
• Control Line: A Control (C) line, containing antibodies that bind the conjugate regardless of CHIKV antibodies, must always appear to confirm the test has functioned correctly and the sample has migrated properly.

5. Rapid Results: The test provides a visual, qualitative result (Positive/Negative) typically within 10-20 minutes, facilitating prompt clinical decision-making.
6. Ease of Use: Designed for simplicity, requiring minimal training and no specialized instrumentation for result interpretation, making it suitable for various settings including clinics, laboratories, and potentially field use during outbreaks.
7. Important Considerations:

• Qualitative: This is a screening test providing a Yes/No answer for the presence of IgM antibodies, not the quantity (titer).
• Clinical Correlation: Results must be interpreted in conjunction with the patient's clinical history, symptoms, exposure risk, and other laboratory findings. IgM antibodies can sometimes persist or cross-react with related viruses (e.g., O'nyong-nyong, Mayaro), potentially leading to false positives. Conversely, testing too early in the infection (before IgM has risen to detectable levels) can yield false negatives.
• Complementary Testing: In some diagnostic algorithms, a positive IgM may be followed up with more specific tests (like Plaque Reduction Neutralization Test - PRNT) for confirmation, or paired IgG testing (on acute and convalescent samples) may be used to demonstrate seroconversion.