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Quality Assurance, Testing, and Education

Quality Assurance, Testing, and Education

Microbiology Panels for Quality Assurance, Testing, and Education

 

The Meridian Bioscience Proficiency & Controls Business Unit (PCBU) has proven expertise in the development and manufacture of a variety of microbiological specimen panels. Maintaining a standard of excellence for more than 25 years, PCBU products help meet requirements for:

  • Proficiency testing programs
  • Clinical study site qualification
  • Product development and manufacture
  • New product market introductions and evaluations
  • Instruction and training associated with staff performance evaluations and review
  • Reference
  • Education

Our expertise embraces:

  • Virus/Bacteria Culture
  • Virus/Bacteria Serology
  • Molecular Detection of Infectious Agents
  • Diagnostic Immunology
  • Parasitology
  • Autoimmune Serology
  • Enzyme Immunoassay
  • Microscopy

These product formats closely simulate actual analytes encountered in clinical specimens and can be of value in helping laboratorians ensure that regulatory guidelines and compliance with medical quality system regulations are met.

Product Development and Product Manufacturing Services

The PCBU provides product development and manufacturing services to establish the proficiency of participating clinical trial sites in the performance of laboratory analyses associated with vaccines and other biopharmaceutical products.

Our customer-focused product offerings span the spectrum of biological and non-biological materials in a variety of formats:

  • Glass slides
  • Dry swabs
  • Liquids
  • Lyophilized

Custom Development Services

The PCBU also provides custom development and manufacturing services to meet customer specifications and labeling requirements. A dedicated customer focus combined with unparalleled experience enables the PCBU to develop specialized resources at a favorable cost.

PARA-PANEL®

PARA-PANEL® products contain parasitic organisms preserved in human blood or fecal matter. These products are intended for:

  • Educational training
  • Proficiency
  • Reference use

There are 3 types of panels:

  • Blood parasite panels, including malaria, filarial, and trypanosome parasites
  • Intestinal parasite panels containing developmental stages of helminths and protozoan parasites and artifacts
  • Immunoassay panels with formalin-preserved intestinal protozoan parasites

 

Self Assessment Materials

Use of independent materials can be of assistance in monitoring the performance of procedures. These items serve as an aid in identifying errors, trends, and problems within procedures when they occur. External assessment materials serve as an integral component of good laboratory practices in providing a means of assisting in the monitoring of overall laboratory performance.

BACTQUAL®

BACTQUAL® products contain sets of samples intended for self-assessment when performing laboratory procedures.

BACTQUAL® GAS – Streptococcus Group A

  • BACTQUAL® GAS Group A Streptococcus is comprised of both Positive and Negative samples in swab format.
  • Specimens are to be processed in accordance with instructions and standard procedures for handling biological specimens.

BACTQUAL® CD – Clostridium difficile

  • BACTQUAL® CD Clostridium difficile is comprised of both positive and negative samples in liquid suspension.
  • Specimens are to be processed in accordance with instructions and standard procedures for handling biological specimens.

PARAQUAL®
PARAQUAL® products contain sets of samples intended for self-assessment when performing laboratory procedures.

PARAQUAL® FSm – Unassayed Microsporidia

  • PARAQUAL® FSm – Unassayed Microsporidia is comprised of formalin-preserved fecal smear slides for qualitative determinations.

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