Mastering Quality: New Method Validation, QC Standards and PT - a rapidmicrobiology Special Focus

Microbiologics QC Portfolio Includes Culture based and Molecular Methods
Microbiologics Portfolio Includes Culture-based and Molecular Methods

Why Microbiology Labs Fail Without QC and Proficiency Testing
How do labs get results wrong? Test result inaccuracies in microbiology laboratories happen for several reasons:

  • Sample collection issues: sample/specimen rejections happen due to wrong sample/specimen types, insufficient quantities, or incorrect containers.
  • Transport problems: sample/specimens take too long to reach the lab, allowing unwanted organisms to grow, which leads to misleading results
  • Test Protocol issues: test protocols are either not validated correctly for analyte or not followed correctly, or equipment and reagents used are faulty under conditions in the lab.

Financial Impact of Laboratory Errors
Errors in microbiological testing can trigger a chain of commercial and legal issues. Incorrect lab results can lead to poor decisions that impact product safety, patient care, and business sustainability. The accuracy and reliability of testing procedures depend on following laboratory best practices. Labs can also face extra expenses from repeated sampling, additional testing, staff overtime and investigating root causes.

Quality Control Organisms: How QC Organisms Ensure Test Validity
Quality control organisms are the foundations of reliable microbiological testing. These specialized materials provide the measurements needed to ensure accurate and repeatable test results in routine laboratory testing. QC strains are normally well-characterized microorganisms with defined profiles, they serve as verified standards with predictable biochemical reactions, which makes them perfect for testing applications of all types.


QC organisms, whether from a type culture collection or from in-house isolates, play a key role in confirming test validity in pharmaceutical, food, and clinical testing labs. These materials help:

  • Validate testing methodologies
  • Monitor test methodologies to verify instrument, operator and reagent quality
  • Validate culture media through growth promotion testing
  • Support new test method validation
  • Serve as positive controls for diagnostic procedures

In this rapidmicrobiology special focus we enable labs to discover products to help reduce laboratory errors. Starting with collecting and transporting a clinical specimen - is your current system M40-A2 compliant? Discover from Medical Wire why it matters that it is!

For over five decades, Microbiologics has been a global leader in providing user-friendly and reliable microbial controls designed to simplify compliance and streamline QC testing. Their extensive portfolio includes trusted solutions for both culture-based and molecular methods, as well as supporting laboratories in clinical, pharmaceutical, and food microbiology.

In recent years, using in-house isolates and other objectionable microorganisms in various microbiological quality test methods has gained significant importance in meeting regulatory expectations and ensuring product quality. BioMerieux's BIOBALL® Custom Services helps you simplify the process of using your own in-house microbial strains for QC. 

Zeptometrix's Microgel-Flash™ pellet is designed for use with Petrifilm™ and other rehydratable film methods. Each dehydrated pellet contains a known CFU of multiple microorganisms that can be used to test all at once.

Ensuring M40-A2 compliance in specimen transport is key to accurate diagnostics. Learn how validated systems uphold quality, reduce risks, and meet regulatory standards. Visit us at ESCMID 2025 to discover why M40-A2 matters for your lab.
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For 50+ years, Microbiologics has been a trusted leader in microbial control solutions, helping laboratories simplify compliance and validation. With a broad portfolio of ready-to-use microbial controls, reference standards, and custom manufacturing solutions, we make QC testing easier and more reliable.
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BIOBALL® Custom Services simplifies microbiological quality control by preserving and manufacturing in-house isolates in ready-to-use formats. It offers accurate, cost-effective, and efficient solutions, ensuring compliance with regulatory standards and enhancing product quality.
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Quantitatively certified to reliably culture a known CFU of multiple organisms all in one pellet. Our ISO 17034 CRMs are designed for use with Petrifilm™ and other rehydratable film methods. 
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Introducing LabAiQ: Next Generation Reporting that Elevates Industry Standards
Join Confience's Joseph Reynoso, Senior Director of Revenue Marketing, Brian Zarske, Lead Data Engineer, and Jenna Robinson, Product Manager, for an insightful discussion on LabAiQ - a powerful tool that simplifies KPI tracking and turns data into actionable insights.
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Microbiology Method Evaluation and Verification
This course introduces recognised approaches for method validation and practical guidance for in-house method verification using ISO16140 part 3.
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The use of Environmental Isolates in routine quality control testing has been gaining momentum over the years. Most recently, the EU GMP Annex 1 focuses on minimizing risk with continuous environmental monitoring. With increased monitoring comes increased QC testing.
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NSI by ZeptoMetrix provides ISO-accredited CRMs and Proficiency Test Standards, designed to ensure accurate data, support accreditation, and streamline laboratory testing. Their solutions include pre-measured, single-use materials, ready-to-use CRMs, and multi-parameter CRMs for efficient testing.
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