Liofilchem® Phenoxymethylpenicillin PV Antimicrobial Susceptibility Discs, 10 µg

The Liofilchem® Phenoxymethylpenicillin (Penicillin V, PV) Antimicrobial Susceptibility Discs are used for the qualitative measurement of the susceptibility of bacterial strains to Phenoxymethylpenicillin. These discs are primarily used in clinical and research laboratories for antimicrobial susceptibility testing (AST) by the Kirby-Bauer disc diffusion method.

Features

• Active Ingredient: Phenoxymethylpenicillin (PV) at a concentration of 10 µg per disc.
• High Sensitivity: Designed to detect the susceptibility of beta-lactam-sensitive Gram-positive bacteria, including Streptococcus species.
• Standardized Performance: Manufactured according to EUCAST and CLSI guidelines for reliable and reproducible results.
• Compatibility: Optimized for use on Mueller-Hinton Agar for effective and accurate results.
• Regulatory Compliance: ISO 9001 certified and conforms to EU IVD regulations for in vitro diagnostic use.

Specifications

Testing Procedure

1. Preparation:
   • Use Mueller-Hinton Agar plates with 5% sheep blood if testing Streptococcus species.
   • Prepare the bacterial suspension to match a 0.5 McFarland turbidity standard.
2. Inoculation:
   • Spread the bacterial suspension evenly across the agar surface using a sterile swab.
3. Disc Application:
   • Place the Liofilchem® Phenoxymethylpenicillin discs (10 µg) onto the agar surface using sterile forceps or a disc dispenser.
   • Ensure uniform contact between the disc and agar.
4. Incubation:
   • Incubate the plates at 35±2°C for 18–24 hours in an aerobic atmosphere.
5. Interpretation:
   • Measure the diameter of the inhibition zones around the discs using a calibrated ruler or automated zone reader.
   • Compare results to CLSI or EUCAST interpretative breakpoints to determine susceptibility.

Quality Control

To ensure accuracy, use the following control strains:

Reference Data

• EUCAST Guidelines:
  • Phenoxymethylpenicillin is primarily used to assess susceptibility of Streptococcus pyogenes and other non-beta-lactamase-producing Gram-positive bacteria.
• CLSI Standards:
  • Recommended for disc diffusion testing in clinical diagnostics to guide penicillin-based treatments.
• ISO Validation:
  • Discs conform to ISO 20776-1 for susceptibility testing methods.

Regulatory Information

• IVD Compliance: The discs are CE-marked for in vitro diagnostic use in the European Union.
• Quality Assurance: Manufactured in an ISO 13485 certified facility to ensure consistent quality and performance.
• FDA Status: The product is for research and diagnostic use only and is not approved for therapeutic purposes in the United States.

Applications

• Detection of penicillin sensitivity in:
  • Beta-lactam-susceptible Streptococcus species
  • Other Gram-positive bacteria.
• Monitoring trends in antimicrobial resistance.
• Research in beta-lactamase inhibition studies.

Comparisons with Other Brands

This detailed description ensures a comprehensive understanding of Liofilchem® Phenoxymethylpenicillin PV Discs, emphasizing quality control, testing procedures, and regulatory compliance for effective antimicrobial susceptibility testing.