Gastrointestinal disease assay kit PYLiaGold

for microbiologyfor antigensHelicobacter pylori

Overview
PYLiaGold is an automated turbidimetric assay for the semi-quantitative detection of Helicobacter pylori stool antigen. It delivers fast, traceable results from a single stool sample while minimizing manual pre-analytical handling.

Why it matters
Helicobacter pylori infection is a common chronic infection linked to gastritis, peptic ulcer and gastric cancer. Clinical laboratories require accurate, rapid and non‑invasive diagnostic solutions suited for initial diagnosis and post‑treatment monitoring.

• Urea Breath Test (UBT) — Accurate, but costly and not ideal for pediatric or respiratory‑compromised patients.
• Manual ELISA — Time‑consuming, requires manual steps and increases inter-operator variability.
• Lateral Flow Tests — Convenient but not automatable and provide limited traceability.

What PYLiaGold offers
A solution designed for high‑throughput clinical laboratories:

• Automated assay with no manual pre‑analytical steps
• Hygienic, closed system using the patented pierceTube
• Fast time to result — approx. 10 minutes
• High throughput — up to 270 tests per hour
• Liquid, ready-to-use reagents
• Automated calibration and full sample traceability
• Accurate and sensitive turbidimetric technology
• Workflow consolidation with FOBGold and CALiaGold on the same SENTiFIT platform

How it works
The workflow minimizes handling and maximizes traceability.

1. Sample collection
The patient collects a stool sample at home using the PYLiaGold pierceTube:

• Hygienic dual-cap design
• Standardized sample amount via the grooved stick
• Excess material removed automatically through the funnel
• Suitable for pediatric use

2. Preparation
In the laboratory, the operator simply:

• Vortexes the tube (light-blue cap down)
• Lets it stand for 10 minutes
• Places the tube directly on the analyzer tray

No centrifugation, no sample transfer, no open handling.

3. Automated analysis
With the pierceable cap facing upward, the analyzer reads the barcode and performs all analytical steps, providing semi-quantitative results in minutes.

The PYLiaGold pierceTube
A patented collection tube engineered for safety and efficiency:

• Pre-filled with 1.7 mL extraction buffer
• Colorless pierceable cap for analyzer access
• Light-blue screw-cap with integrated grooved stick
• Single-use, suitable for both patient and laboratory sampling
• Designed to ensure optimal sample collection

Performance & analytical characteristics

• Limit of Detection (LoD): 0.47 ng/mL
• Measuring range: 0.47 – 40.00 ng/mL (0.08 – 6.8 µg/g)
• Prozone effect: none observed up to 4500 ng/mL
• Time to result: approx. 10 minutes
• Throughput: up to 270 tests/hour
• Technology: Automated turbidimetric assay
• Sample type: Human stool
• Stability after collection:
  • 7 days at 2–8°C
  • 5 days at 15–25°C
  • 1 day at 37°C

Consolidated stool-testing workflow
Combine PYLiaGold, FOBGold and CALiaGold on the SENTiFIT platform for:

• Streamlined workflows
• Single sample type
• Harmonized maintenance and training
• Maximum efficiency in high‑throughput laboratories

Characteristics / technical specifications

• Assay type: Automated turbidimetric, semi-quantitative
• Sample: Human stool collected in pre-filled pierceTube
• Extraction buffer volume: 1.7 mL (pre-filled)
• Time to result: approx. 10 minutes
• Throughput: up to 270 tests/hour
• Measuring range: 0.47 – 40.00 ng/mL (0.08 – 6.8 µg/g)
• LoD: 0.47 ng/mL
• Prozone: none observed up to 4500 ng/mL
• Stability after collection: 7 days at 2–8°C; 5 days at 15–25°C; 1 day at 37°C
• Key accessory: Patented pierceTube with pierceable cap and integrated grooved stick