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

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.

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.

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.

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?