Description

The STANDARD Q HAV IgM Test is a rapid diagnostic test (RDT) that detects IgM antibodies specific to the hepatitis A virus (HAV) in human serum, plasma, or whole blood. It is designed for point-of-care testing, offering quick and accurate results to support the diagnosis of acute hepatitis A infections.

Key Features:

• Fast Results: Provides results within 15–20 minutes.
• Sample Types: Compatible with serum, plasma, or whole blood samples.
• Ease of Use: Simple, one-step lateral flow assay, suitable for use in various clinical settings, including remote or resource-limited environments.
• No Special Equipment Required: The test can be performed without the need for specialized laboratory instruments.
• High Sensitivity and Specificity: Designed to minimize false-positive and false-negative results.

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Test Procedure:

1. Sample Collection: Collect a serum, plasma, or whole blood sample.
2. Test Setup: Place the test device on a flat surface and apply the sample to the sample well.
3. Buffer Addition: Add the provided buffer to facilitate the reaction.
4. Incubation: Allow the test to develop for 15–20 minutes.
5. Result Interpretation:
   • Positive: A control line (C) and a test line (T) both appear, indicating the presence of IgM antibodies to HAV.
   • Negative: Only the control line (C) appears.
   • Invalid: No control line appears, indicating a faulty test.

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Result Interpretation:

• Positive Result: Indicates a recent or ongoing hepatitis A infection.
• Negative Result: Suggests no current acute HAV infection or early stage before detectable IgM antibodies.
• Invalid Result: Requires retesting with a new kit.

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Applications:

• Clinical Diagnosis: Useful for early detection of hepatitis A in symptomatic individuals.
• Epidemiological Surveillance: Supports monitoring of HAV outbreaks.
• Travel Clinics and Emergency Settings: Ideal for quick screening in travel-related and emergency diagnostic contexts.

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Storage and Stability:

• Store at 2–30°C (35.6–86°F).
• Keep away from direct sunlight and moisture.
• The test should remain sealed until use to ensure optimal performance.

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Limitations:

• A negative result does not rule out early infection.
• Cross-reactivity with other infections can occur; further testing may be needed for confirmation.
• The test is intended for professional use only.