Rotavirus Antigen Rapid Test – EZER™ Diagnostic Kit

What is in the Rotavirus Antigen Rapid Test?

The EZER™ Rotavirus Antigen Rapid Test is a qualitative lateral flow assay used to detect rotavirus antigens in stool specimens. It is CE-marked and intended for professional use in clinical laboratories. Each kit contains:

• 20 test cassettes

• 20 stool collection tubes pre-filled with extraction buffer

• 1 package insert

All components are single-use and should be stored at 2–30°C. The assay must be conducted at room temperature, and results are visually interpreted 15 minutes after sample application.

Role of Rotavirus in Disease

Rotavirus is the most common viral cause of acute gastroenteritis in infants and young children worldwide. Nearly every child contracts the virus by age five. Transmitted via the fecal-oral route, the virus primarily infects the epithelial cells of the small intestine, causing enterotoxin production, fluid loss, and intestinal inflammation.

Symptoms typically include:

• Watery diarrhea

• Vomiting

• Fever

• Abdominal pain

• Dehydration

In vulnerable populations, such as children under five or the elderly, Rotavirus-positive cases can lead to severe outcomes, including hospitalization or even death from dehydration. Therefore, early detection with a Rotavirus-targeted assay is essential for timely intervention.

Group A rotaviruses are responsible for over 90% of human infections. Other groups (B–G) are far less common and usually affect animals or cause localized outbreaks. Identification of Group A is sufficient for clinical diagnostics in nearly all patient cases.

About the EZER™ Rotavirus Antigen Rapid Test

Manufactured by Genesis Biotech, the EZER™ Rotavirus Antigen Rapid Test was clinically evaluated using 395 stool samples from pediatric and young adult patients. Compared to a reference antigen detection panel, the test achieved:

• Relative Sensitivity: 99.53% (95% CI: 97.42%–99.99%)

• Relative Specificity: 98.90% (95% CI: 96.07%–99.87%)

• Overall Accuracy: 99.24%

The assay reliably detects Rotavirus antigen concentrations as low as 0.17 µg/mL, with no cross-reactivity observed with:

• Norovirus

• Adenovirus

• E. coli

• Candida albicans

• Influenza, Enterovirus, Coronavirus, and others

This high specificity makes the test suitable for use even in patients with polymicrobial diarrhea, without risk of false positives due to co-infections.

Principle and Workflow

The test is based on immunochromatography. When a sample is added to the cassette:

1. Sample Preparation: Stool is collected using the supplied tube with buffer.

2. Immune Complex Formation: The sample reacts with colloidal gold-labeled anti-Rotavirus antibodies.

3. Capillary Flow: The immune complex moves along the membrane and binds to fixed anti-Rotavirus antibodies at the T-line.

4. Visual Detection: A red-purple line at the test region (T) indicates a positive result. A control line (C) must always appear.

Test procedure:

• Add 3 drops of the prepared sample to the sample well

• Wait 15 minutes

• Interpret results visually

A missing control line indicates an invalid test.

Clinical Application

The EZER™ Rotavirus Antigen Rapid Test is ideal for:

• Clinical chemistry and microbiology labs needing quick diagnostics during diarrhea outbreaks

• Pediatric hospitals and neonatal care units, where Rotavirus is a common threat

• Outbreak control in childcare centers, schools, and long-term care facilities

• Public health agencies seeking reliable point-of-care screening tools

This Rotavirus-targeted assay supports accurate and timely decision-making in both routine diagnostics and emergency outbreak response scenarios. Its speed, accuracy, and ease of use make it a dependable frontline tool in the clinical setting.