OnSite™ HEV IgM Rapid Test Kit, CE

The OnSite® HEV IgM Rapid Test CE is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibodies to hepatitis E virus (HEV) in human serum, plasma, or whole blood. It provides a fast and convenient method for identifying acute HEV infections, which are often difficult to detect in routine diagnostics.

The test is supplied in individually sealed foil pouches with all required components, making it suitable for point-of-care testing, clinical laboratories, and field screening.

Key Features

• Acute Infection Marker: Detects anti-HEV IgM antibodies as an indicator of recent or acute HEV infection.
• Specimen Flexibility: Works with serum, plasma, or whole blood samples.
• Rapid Results: Results available within minutes for immediate patient management.
• Validated Performance: Evaluated with BBI HEV serum conversion panels and HEV mixed titer performance panels.
• Simple & Portable: Individually packaged with capillary tubes and diluent.
• Convenient Storage: Shelf life of 24 months at 2–30 °C.
• No Equipment Required: Ideal for decentralized or resource-limited settings.

Kit Contents (30 Tests)

• Individually sealed foil pouches with cassette device + desiccant
• 10 µL capillary tubes
• Sample diluent (REF SB-R0095, 5 mL/bottle)
• Package insert (Instructions for Use)

Applications

• Clinical Diagnostics: Screening for acute hepatitis E virus infections.
• Public Health Programs: Surveillance in outbreak-prone regions.
• Field Testing: Suitable for point-of-care and low-resource settings.
• Research & Epidemiology: Monitoring HEV seroprevalence in populations.

The OnSite® HEV IgM Rapid Test CE (R0095C) offers a reliable, simple, and rapid solution for detecting acute hepatitis E infections through IgM antibody identification. With validated performance against recognized HEV reference panels, flexible specimen use, and results available within minutes, it is a valuable diagnostic tool for clinical, public health, and field applications.