Last updated on Apr 24, 2024

How can you standardize immunological and molecular diagnostic tests across different laboratories?

Immunological and molecular diagnostic tests are essential tools for detecting and identifying pathogens, diseases, and immune responses. However, different laboratories may use different methods, protocols, reagents, and equipment, which can affect the accuracy, reliability, and comparability of the results. How can you standardize immunological and molecular diagnostic tests across different laboratories? Here are some tips and best practices to follow.

1 Choose validated tests

The first step to standardize immunological and molecular diagnostic tests is to choose tests that have been validated by independent and reputable sources, such as the World Health Organization (WHO), the US Food and Drug Administration (FDA), or the European Medicines Agency (EMA). Validated tests have been proven to meet certain criteria of sensitivity, specificity, reproducibility, and robustness. They also have clear instructions, quality control measures, and performance indicators.

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Simone Bonecker

PhD in Oncology, Master in Molecular Biology, Precision Medicine Oncology, Molecular Diagnostic, auditor PALC, Business Development
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Whenever possible, you can start with validated tests or IVDs, even then an internal verification must be carried out, a process that is faster and simpler than validation. On the other hand, when it is not possible to acquire validated tests or IVD, depending on the country's legislation, it is possible to carry out LDT and validate in accordance with international guidelines.

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2 Follow standard operating procedures

The second step to standardize immunological and molecular diagnostic tests is to follow standard operating procedures (SOPs) for each test. SOPs are detailed documents that describe the steps, materials, equipment, and conditions required to perform a test consistently and correctly. SOPs should include information on sample collection, storage, transport, preparation, processing, analysis, interpretation, and reporting. SOPs should also specify the frequency and methods of calibration, maintenance, and troubleshooting of the equipment.

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Simone Bonecker

PhD in Oncology, Master in Molecular Biology, Precision Medicine Oncology, Molecular Diagnostic, auditor PALC, Business Development
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Besides the SOPs, you should have internal procedures, such as work instructions, in order to specific some steps in a simpler way and to guarantee the sample traceability.

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3 Use certified reference materials

The third step to standardize immunological and molecular diagnostic tests is to use certified reference materials (CRMs) for each test. CRMs are samples or substances that have a known or assigned value of a specific parameter, such as concentration, identity, or activity. CRMs are used to verify the accuracy and precision of the test results and to monitor the quality and stability of the reagents and equipment. CRMs should be obtained from accredited sources, such as the National Institute of Standards and Technology (NIST), the European Commission Joint Research Centre (JRC), or the WHO.

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Simone Bonecker

PhD in Oncology, Master in Molecular Biology, Precision Medicine Oncology, Molecular Diagnostic, auditor PALC, Business Development
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CRMs are essential during the validation. I understand that sometimes, to reduce costs, many laboratories avoid using this material, but I guarantee, from my experience, working since 2011 with molecular diagnostics, the cost of not using it will be higher.

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4 Participate in external quality assessment

The fourth step to standardize immunological and molecular diagnostic tests is to participate in external quality assessment (EQA) programs for each test. EQA programs are organized by external agencies or networks that provide participating laboratories with unknown samples to test and compare their results with those of other laboratories or with a reference value. EQA programs help to evaluate the proficiency, performance, and comparability of the laboratories and to identify and correct any errors or deviations.

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5 Implement internal quality control

The fifth step to standardize immunological and molecular diagnostic tests is to implement internal quality control (IQC) procedures for each test. IQC procedures are performed by the laboratory staff to check the quality and consistency of the test results and to detect any problems or variations within the laboratory. IQC procedures should include the use of positive and negative controls, blanks, duplicates, standards, and indicators for each test run. IQC procedures should also involve the recording, analysis, and review of the data and the implementation of corrective actions if needed.

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6 Share and communicate data

The sixth step to standardize immunological and molecular diagnostic tests is to share and communicate data with other laboratories and stakeholders. Data sharing and communication can facilitate the exchange of information, knowledge, and best practices, as well as the identification of common challenges and solutions. Data sharing and communication can also enhance the transparency, credibility, and comparability of the test results and the collaboration and coordination among the laboratories and the public health authorities.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Trent Bridge, PharmD

Medical Communications Specialist and Quality Systems Investigator
(edited)
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Results of molecular testing (eg, liquid biopsy) are uploaded into patient charts, often leading to patients accessing reports before their healthcare providers have time to analyze the results. Although the immense clinical utility of liquid biopsy is undeniable and will continue to expand, patient access to this complex medical information before clinicians are able to analyze results adds complexity to the care continuum. Patients often contact care teams with questions relating to their reports that cannot be answered until clinicians have evaluated the findings, potentiating negative outcomes on patient-provider relationships. Patient-friendly reporting is urgently needed.

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How can you standardize immunological and molecular diagnostic tests across different laboratories?

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1 Choose validated tests

2 Follow standard operating procedures

3 Use certified reference materials

4 Participate in external quality assessment

5 Implement internal quality control

6 Share and communicate data

7 Here’s what else to consider

Biotechnology

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