Use of reference strains: from selection to application

Use of reference strains: from selection to application

The Online Meeting was presented by Julia Baruque, Bachelor in Microbiology and Immunology (UFRJ), Master in Biochemical Process Engineering (UFRJ), and Technical Analyst at Controllab.

The session covered the importance of reference strains, the regulatory requirements for their use, criteria for selection and preservation, as well as the main errors in laboratory routine and good biosafety practices.

With updated content, the training helped participants enhance their internal processes, promoting more reliable results and greater safety in conducting microbiological procedures.

Questions & Answers

The following questions were not addressed during the Online Meeting.

Anaerobic microorganisms, such as C. perfringens — in addition to incubation in an anaerobic jar, what additional precautions should be taken to ensure proper culture preservation? Do culture plates and tubes containing cryoprotective medium require different storage conditions?

For anaerobic microorganisms like C. perfringens, beyond using an anaerobic jar, it is essential to handle samples quickly to avoid oxygen exposure, incubate immediately after plating, and ensure the entire process occurs in a minimally oxidizing environment. Plates should be stored in the refrigerator only for short periods and always sealed, while cryovials with cryoprotective medium must be kept exclusively at –80°C, as they are intended for long-term preservation and must not be stored under the same conditions as plates.

Significant differences are not expected, as both NCTC and ATCC are highly standardized and internationally recognized reference collections. When discrepancies occur, they usually stem from internal laboratory factors—such as culture conditions, inoculum preparation, medium integrity, incubation parameters, equipment performance, or handling issues. Therefore, upon detecting any difference, the laboratory should immediately activate its internal verification processes, review procedures, check records, and conduct additional controls to ensure compliance.

The chart in the book provides general guidance on optimal storage conditions and estimated stability periods for each microorganism type. However, these are broad technical recommendations. The validity that must be strictly followed is the one provided by the producer, recorded in the certificate or official documentation. This certified validity reflects specific stability tests, logistics, batch characteristics, and actual production conditions. Therefore, despite the book offering general references, the supplier’s official validity must be followed to ensure compliance and traceability.

Validity updates and retest results are published directly on the suppliers’ official websites, usually on each strain’s individual page. Some producers offer newsletters, but there is no standardized channel that automatically distributes these updates. Therefore, it is the laboratory’s responsibility to periodically check the collection’s website or contact the supplier directly.

Streptococcus pneumoniae and Haemophilus influenzae are highly sensitive organisms and require –80°C stocks with cryoprotectant, very fresh subcultures, incubation in enriched atmospheres (e.g., CO₂ for S. pneumoniae), and minimal time at either refrigerator or room temperature. These strains lose viability quickly outside optimal conditions, which explains the difficulty in maintaining them under milder environments.

Yes. This workflow is effective regardless of the supplier. The only crucial point is that the laboratory must follow the supplier’s instructions precisely when reconstituting the strain. Once the microorganism is reconstituted on a plate, the laboratory may proceed with the workflow that was presented.

If the autoclave becomes unavailable, microorganism disposal should follow a contingency plan that includes placing waste in red biohazard bags, storing it temporarily in a secure area, and sending it to the municipality’s licensed waste treatment service. All steps must be documented until routine operations resume.

There are reports of partial or complete loss of the SCCmec element or decreased mecA expression in S. aureus NCTC 12493, especially after repeated subculturing or stress conditions. Such loss or phenotypic silencing can lead to larger-than-expected inhibition zones, representing a “functional loss” of resistance.

Excess moisture usually results from placing plates in the refrigerator while still warm, which leads to condensation, or from temperature fluctuations, inadequate sealing, or media with high water content. High-humidity refrigerators also contribute to this problem.

You may use a strain from a non–ISO 17034-accredited culture collection as long as the test does not formally require a Certified Reference Material (CRM). However, for accredited assays, ISO 17025 mandates the use of CRMs from an accredited producer.

CRMs for growth promotion tests and inoculum standardization must always be handled using freshly hydrated or freshly thawed cultures, avoiding aged cultures or repeated subculturing. Maintaining traceability, recording the lot and characterizations, and ensuring that the inoculum meets the method’s specifications are essential.

Yes. For quantitative applications, the laboratory may enumerate the microorganism (e.g., plate count), adjust the concentration to the desired range, and then use it in the quantitative process.

If the extra round fails to meet expected results, the laboratory should review inoculation conditions, media quality, equipment, and procedures, and initiate an internal investigation to address the inconsistency.

After freezing, each pearl should be removed individually with a sterile tool, without allowing the tube to thaw. Only one pearl should be used at a time, and the cryovial must be returned to –80°C immediately.

Although commercially supplied TSB/glycerol is sterile, autoclaving after aliquoting is recommended not due to the product’s quality but to the laboratory’s internal process-control requirements. Autoclaving ensures sterility under the lab’s specific handling conditions—after opening, manipulation, and dispensing into cryovials. This eliminates any contamination introduced during handling and maintains the standardization required by quality and biosafety norms such as GMP, ISO 17025, and GLP.

PCA is useful for total aerobic bacterial counts but is not ideal for all reference strains, particularly fastidious organisms or those used for susceptibility testing. In general, TSA, BHI, chocolate agar, or Mueller–Hinton provide better conditions for most strains. However, the medium recommended in each supplier’s certificate must always be followed.

Even if the laboratory can store the lyophilized strain for extended periods, the certificate’s validity must be followed because the manufacturer only guarantees stability and analytical attributes up to that date. After expiration, neither genotypic nor phenotypic profiles are assured, and only the manufacturer can revalidate the product.

You may conduct an internal study showing that the strain remains stable beyond the manufacturer’s date; however, these results do not replace the certificate’s validity and cannot justify using the strain in accredited assays. They serve only as internal technical evaluation. Using expired products is prohibited in Brazil and considered a serious violation of the Consumer Protection Code (CDC), potentially constituting a public health offense.

Campylobacter is extremely sensitive. To maintain viability, daily subculturing under microaerophilic conditions is required, using specific and always fresh media, maintaining frozen stocks at –80°C with cryoprotectant, and never leaving cultures at room temperature or in the refrigerator. Even small environmental variations may compromise viability.

  • Julia Baruque

    Bachelor in Microbiology and Immunology (UFRJ), Master in Biochemical Process Engineering (UFRJ), and Technical Analyst at Controllab.

  • Dr. José Antônio Tesser Poloni

    Pharmacist-Biochemist graduated from PUCRS, with a Master’s and PhD in Health Sciences from UFCSPA, educational manager, and consultant in Urinalysis at Controllab.

Other Meetings

Inflammation in Gynecologic Cytology: How to Recognize Reactive Changes and Avoid Diagnostic Pitfalls in the Pap Test
The Phantom Threat: Phytobacter and the Crisis of Laboratory Identification
Paraproteinemias and Monoclonal Gammopathies: A Practical Laboratory Approach
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PRM 0009

Certified Reference Material Producer

Accredited by Coordenação-Geral de Acreditação do Inmetro

Controllab has been accredited as a Certified Reference Material (CRM) Producer since 2016 by Cgcre, under number PMR 0009. The conformity assessment is carried out in accordance with the requirements established in ABNT NBR ISO 17034 and Inmetro standards, ensuring competence for the production of CRMs, as defined in the Scope of Accreditation.

This accreditation attests to Controllab’s technical competence in producing CRMs according to international requirements and enables it to be recognized in other countries, under mutual recognition agreements, thereby reducing technical barriers between Brazil and other countries across continents.

Materiais de Referência Certificados - PMR 0009 - ABNT NBR ISO 17034-Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

CAL 0214

Calibration Laboratory

Accredited by Coordenação-Geral de Acreditação do Inmetro

In December 2002, the Calibration Laboratory was accredited by Cgcre. With this recognition, it became part of the Brazilian network of accredited laboratories, under number 214. Since then, it has been periodically evaluated for the maintenance and/or extension of its accreditation.

The Inmetro seal attests to Controllab’s technical competence, credibility, and operational capability for calibration services, in accordance with the requirements of ABNT NBR ISO/IEC 17025.

Calibração de Instrumentos - CAL 0214 - ABNT NBR ISO/IEC 17025 - Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

PEP 0003

Proficiency Test Provider

Accredited by Coordenação-Geral de Acreditação do Inmetro

In September 2011, Controllab was accredited by Cgcre as a proficiency test provider, under nº PEP0003. Initially as part of a pilot project by Inmetro, this accreditation was based on ILAC G13: 2007 and included several clinical and hemotherapy tests. In the periodic evaluations of this accreditation, new segments and tests are included and the evaluation is now conducted according to ABNT NBR ISO/IEC 17043.

This accreditation attests to Controllab’s technical competence to develop and conduct proficiency tests in accordance with international requirements and enables it to be recognized in other countries, in accordance with mutual recognition agreements signed by Brazil in Mercosur, the Americas and Europe.

PEP 0003 - ABNT NBR ISO-IEC 17043 - Controllab

Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).