Rapid Tests > Norovirus Antigen Assay

Norovirus Antigen Rapid Test – EZER™ Diagnostic Kit

Rapid Tests > Norovirus Antigen Assay

Norovirus Antigen Rapid Test – EZER™ Diagnostic Kit

Product highlights

  • Rapid Norovirus detection — Results in just 15 minutes
  • High accuracy — 97.4% overall agreement vs. PCR
  • No cross-reactivity — Specific to Norovirus GI and GII
  • Easy to use — Ideal for busy clinical laboratories

Norovirus Antigen Rapid Test – EZER™ Diagnostic Kit

About Norovirus Antigen Rapid Test – EZER™ Diagnostic Kit

The EZER™ Norovirus Antigen Rapid Test provides quick and reliable detection of Norovirus antigens in human stool samples. Designed for professional use in clinical laboratories, this in vitro diagnostic test identifies Norovirus-positive specimens in just 15 minutes, enabling faster diagnosis of viral gastroenteritis.

Utilizing a lateral flow immunochromatographic format, the test is simple to use and interpret. It accurately detects both GI and GII Norovirus genogroups with no cross-reactivity observed with pathogens such as Rotavirus, Adenovirus, or E. coli. This makes it an effective tool for outbreak investigations in hospitals, care facilities, and schools.

Each kit contains 20 test cassettes and pre-filled stool collection tubes with extraction buffer, ensuring convenience for high-throughput testing. Built-in procedural controls verify test performance, while the clear visual readout supports confident interpretation. With its high sensitivity, specificity, and rapid turnaround, the EZER™ Norovirus Antigen Rapid Test is a valuable solution for diagnosing and managing viral gastroenteritis.

Specifications of the Norovirus Antigen Rapid Test – EZER™ Diagnostic Kit

What is in the Norovirus Antigen Rapid Test?

The EZER™ Norovirus Antigen Rapid Test is a qualitative, lateral flow assay designed to detect Norovirus antigens in stool specimens. The test utilizes colloidal gold-labeled anti-Norovirus antibodies that react with antigens present in the sample. When the antigen is present, a visible colored line forms in the test region, confirming a Norovirus-positive result. A control line confirms test validity.

Each test kit includes:

  • 20 test devices

  • 20 stool collection tubes with integrated extraction buffer

  • 1 instruction manual (package insert)

All components are designed for single use and should be stored at 2–30°C. The test must be brought to room temperature before use and performed by trained laboratory professionals.

EZER™ Norovirus Antigen Rapid Test device detecting Norovirus in stool samples

Role of Norovirus in Disease

Norovirus is the leading cause of non-bacterial gastroenteritis worldwide, responsible for an estimated 19–42% of acute diarrheal outbreaks. The virus is highly contagious and commonly causes seasonal outbreaks in high-risk environments such as hospitals, long-term care facilities, schools, and cruise ships.

Infections can affect individuals of any age or gender, with particularly severe outcomes in children under 2 and elderly patients. Common symptoms include abdominal cramps, nausea, vomiting, diarrhea, low-grade fever, and general malaise. The rapid identification of Norovirus-positive cases is essential to limit transmission and manage supportive care efficiently.

Routine use of Norovirus-targeted diagnostics enhances infection control and reduces unnecessary use of antibiotics, which are ineffective against viral pathogens.

About the EZER™ Norovirus Antigen Rapid Test

Manufactured by Genesis Biotech, the EZER™ Norovirus Antigen Rapid Test is validated against molecular PCR-based assays. A multicenter clinical study involving 1,231 specimens demonstrated:

  • Positive Percent Agreement: 95.15%

  • Negative Percent Agreement: 98.16%

  • Overall Percent Agreement: 97.40%

The test accurately detects several Norovirus genotypes, including:

  • GI.Pd-GI.3, GI.P4-GI.5

  • GII.2, GII.4, GII.17, GII.P7-GII.6, and others

Crucially, the test does not cross-react with:

  • Bacteria: E. coli, Salmonella, S. aureus, P. aeruginosa, etc.

  • Viruses: Rotavirus, Adenovirus, Enterovirus, Influenza A/B

  • Mycoplasma or Chlamydia species

These validation results ensure that false positives due to other pathogens are extremely unlikely, improving the test’s clinical utility.

Principle and Workflow

The test is based on immunochromatography with a lateral flow format. Here’s how it works:

  1. Sample Collection: Stool is collected using the provided collection tube and mixed with extraction buffer.

  2. Application: Three drops of the mixture are added to the test cassette’s sample well.

  3. Reaction Time: After 15 minutes, results are visually interpreted. A red test line indicates a positive result.

  4. Controls: The appearance of a control line confirms that the test has run correctly.

The test can detect Norovirus concentrations as low as 3.25×10⁴ copies/mL for GI and 3.93×10⁴ copies/mL for GII. It is not affected by common interfering substances such as hemoglobin, bilirubin, or commonly used medications like amoxicillin, levofloxacin, or ribavirin.

Clinical Application

This Norovirus-targeted rapid test is ideal for:

  • Hospital laboratories managing nosocomial infection outbreaks

  • Public health teams performing field diagnostics during community outbreaks

  • Geriatric and pediatric departments requiring fast diagnosis for vulnerable populations

  • School and institutional testing for rapid containment of symptoms

Its fast turnaround, high specificity, and ease of use make it a preferred choice in clinical chemistry, medical microbiology, and diagnostic laboratories under time pressure.

The EZER™ Norovirus Antigen Rapid Test is particularly valuable when paired with molecular confirmatory testing or used as a frontline screening tool. Its robustness and accuracy support rapid decision-making and improve infection control measures.

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