Beright™ Zika IgG/IgM Rapid Test Cassette, 25 Tests

The Beright™ Zika IgG/IgM Rapid Test Cassette is a lateral flow immunochromatographic assay designed for the qualitative detection of IgG and IgM antibodies to Zika virus in human whole blood, serum, or plasma samples. The test enables simultaneous differentiation between recent (IgM) and past (IgG) Zika virus exposure, supporting clinical diagnosis, epidemiological surveillance, and outbreak investigations.

This rapid test delivers clear, easy-to-interpret results within 15 minutes, making it highly suitable for point-of-care testing, field diagnostics, and routine laboratory screening, especially in regions where Zika virus infection is endemic or suspected.

Intended Use

• For in vitro diagnostic (IVD) use only
• For professional use in clinical and laboratory settings
• Intended as an aid in the diagnosis of Zika virus infection
• Results should be interpreted in conjunction with:
  • Clinical symptoms
  • Patient history
  • Epidemiological information
  • Other laboratory findings

Test Principle

The Beright™ Zika IgG/IgM Rapid Test Cassette operates on a lateral flow immunoassay principle:

• Zika virus antigens are conjugated to colored particles.
• Anti-human IgM and anti-human IgG antibodies are immobilized on the test membrane.
• When a specimen containing Zika-specific antibodies is applied:
  • IgM antibodies bind to the IgM test line (indicating recent or acute infection)
  • IgG antibodies bind to the IgG test line (indicating past or later-stage infection)
• A control line (C) confirms proper sample flow and test validity.

Sample Types

• Fingerstick whole blood
• Venipuncture whole blood
• Serum
• Plasma

Result Interpretation

Performance Characteristics

• Demonstrates high sensitivity and specificity when compared with ELISA reference methods
• Independent performance data provided for:
  • IgM detection
  • IgG detection
• Reported accuracy values in the high-90% range
• Confidence intervals included to support diagnostic reliability

Quality Control

• Built-in internal procedural control (control line)
• Confirms:
  • Adequate sample volume
  • Correct membrane migration
  • Proper test performance
• No external control reagents required for routine testing

Test Procedure (Summary)

1. Allow test cassette and specimen to reach room temperature (15–30 °C).
2. Add the specified volume of sample to the specimen well.
3. Add the provided buffer according to instructions.
4. Read results at 15 minutes.
5. Do not interpret results after 20 minutes.

Kit Components

• Zika IgG/IgM Rapid Test Cassettes
• Assay Buffer
• Sample Droppers
• Package Insert (Instructions for Use)

Materials not provided: lancets, centrifuge, timer, specimen collection tubes.

Storage & Stability

• Store at 2–30 °C
• Do not freeze
• Use immediately after opening the sealed pouch
• Stable until the stated expiration date when stored as recommended

Precautions & Limitations

• For professional use only
• Not intended as the sole basis for diagnosis
• Cross-reactivity studies conducted with related pathogens
• Early infections may yield negative results due to low antibody levels
• Positive results indicate exposure, not necessarily active infection

Key Advantages

• Rapid results in 15 minutes
• Simultaneous IgG and IgM detection
• Multiple sample type compatibility
• Minimal equipment required
• Ideal for point-of-care and laboratory use
• Clear visual interpretation

Applications

• Clinical diagnostics
• Zika outbreak response and surveillance
• Public health screening programs
• Travel and epidemiological testing
• Research and reference laboratories

The Beright™ Zika IgG/IgM Rapid Test Cassette is a reliable, easy-to-use serological diagnostic tool that supports fast identification of Zika virus exposure. Its dual IgG/IgM detection capability, rapid turnaround time, and flexible sample compatibility make it an excellent choice for both routine diagnostics and outbreak response settings.