Ebola Antigen Rapid Test Kit

The Ebola Antigen Rapid Test is a rapid lateral flow chromatographic immunoassay designed for the qualitative detection of Ebola virus antigens in human whole blood (venous or fingertip), serum, or plasma specimens.

Developed for professional in vitro diagnostic (IVD) use, this test provides reliable results in just 15 minutes, supporting rapid clinical decision-making during Ebola outbreak response and emergency screening programs.

Designed for hospitals, laboratories, public health agencies, emergency response teams, and infectious disease surveillance programs, the assay offers a simple workflow with minimal equipment requirements while maintaining high diagnostic performance.

The test should be used as an aid in the diagnosis of Ebola Virus Disease (EVD) in patients presenting compatible clinical symptoms and epidemiological risk factors. Negative results should not be used as the sole basis for diagnosis and should be confirmed by molecular testing such as RT-PCR when clinically indicated.

Ebola Antigen Rapid Test Features

1. Rapid Detection in 15 Minutes

Provides fast qualitative detection of Ebola virus antigen with results available in approximately 15 minutes, enabling timely patient management and outbreak control.

2. Multiple Specimen Types

Compatible with:

• Human fingertip whole blood
• Venous whole blood
• Serum
• Plasma

Offering flexibility for different clinical environments.

3. Simple Point-of-Care Operation

Designed for easy use with a straightforward testing procedure requiring only:

• Blood collection
• Sample application
• Buffer addition
• Visual interpretation

No specialized laboratory equipment is required.

4. High Diagnostic Accuracy

Clinical evaluation against a commercial Real-Time RT-PCR assay demonstrated:

• Sensitivity: 92.08%
• Specificity: 99.53%
• Overall Agreement: 97.12%

Supporting dependable screening performance.

5. Professional In Vitro Diagnostic Use

Intended exclusively for trained healthcare professionals in hospitals, laboratories, emergency medical centers, and public health institutions.

6. Supports Outbreak Response

Ideal for:

• Ebola outbreak surveillance
• Emergency screening
• Infectious disease management
• Border health screening
• Humanitarian medical missions
• Public health programs

7. Easy Visual Interpretation

Clear result interpretation:

• Positive: Control (C) and Test (T) lines visible
• Negative: Control (C) line only
• Invalid: No Control (C) line

Reducing interpretation errors.

8. Convenient Storage

Stable for up to 24 months when stored at 2°C–30°C.

No freezing required.

9. Complete Testing Kit

Each kit includes:

• Test cassette
• Disposable safety lancet
• Sample dropper (20 μL)
• Buffer tube
• Alcohol prep pad
• Collection bag
• Instructions for use

Providing everything required for rapid testing.

10. CE IVD Certified Manufacturing

Manufactured under internationally recognized quality systems with:

• CE Marking
• IVD Compliance
• ISO 13485
• ISO 9001
• GMP Manufacturing

Suitable for international healthcare markets.

 Ebola Antigen Rapid Test Specifications

Item	Specification
Product Name	Ebola Antigen Rapid Test
Detection Target	Ebola Virus Antigen
Test Principle	Lateral Flow Chromatographic Immunoassay
Specimen Types	Whole Blood (Fingerstick & Venous), Serum, Plasma
Sample Volume	Approximately 20 μL
Time to Result	15 Minutes
Intended Use	Professional In Vitro Diagnostic Use
Application	Ebola Virus Disease (EVD) Screening
Result Interpretation	Positive / Negative / Invalid
Storage Temperature	2°C–30°C
Shelf Life	24 Months
Certification	CE, IVD
Recommended Confirmation	RT-PCR when clinically indicated