Specimen Type & Test Selection

Important

This section is relevant to SOPs involving the direct use of specimens, which will predominately consist of laboratory procedures or sample reception/triage.

The ‘Specimen Type & Test Selection’ section of an SOP should describe the types of specimens for which the procedure has been validated. It must also outline the acceptance criteria that determine whether the specimen is suitable for analysis. In cases where multiple workflows or test options are available, this section should also provide clear criteria for selecting the appropriate test option.

Key points to cover include:

  • Validate specimen types: List the specimen types that have been approved for use with the procedure (e.g. blood, urine, tissue, swabs, serum etc).

  • Acceptance criteria: Define the minimum requirements for specimen quality, volume, labelling, and storage conditions to ensure sample integrity and confirm sample origin.

  • Test Selection: Provide clear guidance on how to choose between different testing workflows or assays based on specimen type received or clinical indications.

Example content:

🧬 Bioinformatics QC Procedure

This section is not relevant for this example as the procedure does not involve the use of specimens.

👩‍🔬 Staff Training Procedure

This section is not relevant for this example as the procedure does not involve the use of specimens.

🌌 Galaxy Training Procedure

This section is not relevant for this example as the procedure does not involve the use of specimens.

🧪 Laboratory Procedure

Example content from a wet-lab SOP outlining the procedure for preparing sequencing libraries using the Illumina DNA Prep kit.

Specimen Type & Test Selection

This procedure is applicable to sequencing workflows using microbial DNA or cDNA generated from RNA, including but not limited to viral and bacterial samples, where the Illumina DNA Prep Library Preparation Kit has been validated for use.

Selection of samples for library preparation must be performed in accordance with assay-specific criteria and laboratory testing policies. Only samples that meet defined quality and quantity requirements may be processed using this SOP.

💻 Code Update & Review Procedure

This section is not relevant for this example as the procedure does not involve the use of specimens.

✅ Validation Procedure