Reporting of pre-analytical Processes in Biobanked Biomaterials: A Missed Opportunity to Address the Replicability Crisis in Clinical Biomarker Research

Abstract

Biobanks are crucial for clinical biomarker research, but pre-analytical processing can impact sample suitability. Insufficient reporting of pre-analytical methods can lead to invalid conclusions. This study evaluated the pre-analytical reporting quality in 294 clinical biomarker studies using biobank plasma and serum samples published from 2018 to 2023, based on the SPREC and BRISQ guidelines. The analysis revealed frequent incomplete reporting. Key underreported elements included fasting time (reported in 31% of articles), freeze-thaw cycles (22.8%), internal transport (8.5%), and centrifugation settings (20-35%). Demographic data (96.9%), storage temperatures (81%), and blood tube additives (82.7%) were more consistently reported. No significant correlation was found between reporting quality and journal impact factor. This highlights the need for standardized pre-analytical reporting to improve research replicability and biomarker study quality.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

List of abbreviationsSPRECSample PREanalytical CodeBRISQBiospecimen Reporting for Improved Study QualityISBERInternational Society for Biological and Environmental Repositories

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