Adenovirus Antigen Rapid Test – EZER™ Diagnostic Kit

What is in the Adenovirus Antigen Rapid Test?

The EZER™ Adenovirus Antigen Rapid Test is a CE-marked lateral flow device that uses monoclonal antibodies specific to Adenovirus F-protein antigens. It is designed to detect antigens from multiple Adenovirus serotypes including types 1, 2, 3, 4, 5, 6, 7, 8, 11, 19, 37, and 55.

Kit contents:

• 20 test devices

• 20 sterilized swabs

• 20 extraction tubes with buffer

• 20 nozzles

• 1 package insert

Samples can be tested immediately or stored (2–8°C) for up to 48 hours before processing. No specialized instrumentation is required for test execution or result interpretation.

Role of Adenovirus in Disease

Adenovirus is a DNA virus known for causing a broad spectrum of illnesses, including:

• Upper respiratory tract infections

• Pneumonia

• Gastroenteritis

• Conjunctivitis

• Hemorrhagic cystitis

Infections are more frequent in infants, school-aged children, and immunocompromised patients. Certain serotypes are associated with outbreaks, especially in institutional settings such as military barracks, daycare centers, and hospitals.

Transmission occurs through direct contact, respiratory droplets, or fecal-oral routes. Due to overlapping symptoms with other pathogens (e.g., influenza, RSV), Adenovirus-targeted testing is critical to ensure appropriate isolation, treatment, and infection control measures.

About the EZER™ Adenovirus Antigen Rapid Test

Manufactured by Genesis Biotech, the EZER™ Adenovirus Rapid Test has demonstrated outstanding clinical performance:

• Positive Percent Agreement (PPA): 98.6%

• Negative Percent Agreement (NPA): 99.3%

• Overall Accuracy: 99.0% (n=204 throat swab samples)

• 100% agreement in nasopharyngeal swabs and nasal aspirates (n=50)

The test detects as low as:

• 6.0×10³ particles/mL for Adenovirus type 3

• 1.0×10⁴ particles/mL for types 6 and 7

Cross-reactivity:
No cross-reaction was observed with:

• Influenza A/B, RSV, Parainfluenza, Rotavirus, Chlamydia spp., E. coli, K. pneumoniae, Staph. aureus, or Mycobacterium species.

This specificity ensures high confidence in identifying Adenovirus-positive cases in both mono- and polymicrobial settings.

Principle and Workflow

The test operates on a straightforward immunochromatographic principle:

1. Sample collection

   • NP swab: Insert into nostril to absorb secretions

   • Throat swab: Collect epithelial cells from the posterior pharynx

   • Nasal aspirate: Use suitable suction device

2. Sample preparation

   • Mix collected sample with extraction buffer in tube

   • For aspirates, add 500 μL directly to buffer

3. Test application

   • Add 3 drops of the processed sample into the sample well

   • Read result at 15 minutes (do not interpret after 30 minutes)

4. Result interpretation

   • Two red lines (C + T): Adenovirus-positive

   • One red line at C: Negative

   • No C line: Invalid test

Each test includes internal procedural controls. Visual line intensity may vary based on antigen concentration but still indicates a valid positive.

Clinical Application

The EZER™ Adenovirus Antigen Rapid Test is ideal for:

• Hospital laboratories seeking rapid respiratory panel exclusion

• Pediatric clinics diagnosing acute upper respiratory infections

• Outbreak response teams in schools, daycares, and care facilities

• Diagnostic labs in need of high-throughput, fast-turnaround assays

In combination with clinical symptoms and other laboratory findings, this Adenovirus-targeted test supports timely treatment decisions and reduces unnecessary antibiotic use. It also aids in cohorting patients during outbreaks and minimizing transmission risk in shared healthcare environments.