Streptococcus Pneumoniae Antigen Rapid Test – EZER™ Diagnostic Kit

What is in the Streptococcus pneumoniae Rapid Test?

The EZER™ Streptococcus pneumoniae Antigen Rapid Test kit includes:

• 40 test cassettes

• 40 sterile transfer pipettes

• 1 package insert with detailed instructions

The device is based on immunochromatographic detection of pneumococcal antigen in urine. It is stable at 2–30°C and does not require refrigeration once opened for immediate use. Results are easy to interpret visually via colored lines on the cassette.

This test detects Streptococcus pneumoniae-positive antigen concentrations as low as 1.25×10⁵ CFU/mL and does not cross-react with other pathogens like E. coli, S. aureus, P. aeruginosa, K. pneumoniae, or Legionella pneumophila.

Role of Pneumococcal Antigen in Disease

Streptococcus pneumoniae is responsible for a broad range of diseases, including:

• Community-acquired pneumonia

• Meningitis

• Bacteremia

• Otitis media

• Endocarditis

• Arthritis

It spreads via respiratory droplets and can rapidly progress from mild respiratory symptoms to life-threatening conditions such as pneumococcal meningitis, which can lead to irreversible brain damage or death.

Children under 5, the elderly, and individuals with chronic illness are most at risk. Pneumococcal antigen is typically excreted in urine within three days of symptom onset, making urine-based Streptococcus pneumoniae-targeted testing a practical method for rapid diagnosis.

About the EZER™ Streptococcus pneumoniae Antigen Rapid Test

Manufactured by Genesis Biotech, the EZER™ test offers unmatched performance:

• Positive agreement: 100% (18/18)

• Negative agreement: 100% (32/32)

• Overall accuracy: 100% (n=50 clinical samples)

• Minimum detection limit: 1.25×10⁵ CFU/mL

The test uses monoclonal antibodies specific to Streptococcus pneumoniae antigens and an internal procedural control for every test. No cross-reactivity was observed in validation studies with over 20 bacteria and fungi, ensuring high specificity.

Compatible with standard midstream urine collection, it avoids the complexity of respiratory specimen processing and supports broad adoption in diverse clinical environments.

Principle and Workflow

This test operates on a classic lateral flow format using gold-labeled antibodies:

1. Collect midstream urine sample

2. Use pipette to apply 3 drops (or 100 μL) onto the sample well

3. Wait 15 minutes

4. Interpret the result visually

Result Interpretation:

• Positive: Red lines appear at both control (C) and test (T) lines

• Negative: Red line at control (C) only

• Invalid: No control line visible – repeat the test

The test must be read exactly at 15 minutes for optimal accuracy. Faint lines are still considered positive if visible.

Clinical Application

The EZER™ Streptococcus pneumoniae Rapid Test is designed for:

• Clinical microbiology labs diagnosing respiratory and systemic infections

• Emergency departments requiring fast, urine-based screening

• Geriatric and pediatric units monitoring high-risk populations

• Triage stations during outbreak response

Its simple operation and high performance make it ideal for use in primary care, outpatient centers, and field settings. The urine-based nature of the test removes invasive sampling and reduces biosafety risks compared to sputum or blood diagnostics.

With increasing antimicrobial resistance, fast and accurate Streptococcus pneumoniae-positive identification enables more precise antibiotic stewardship.