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Providing Correct Estimates of Biological Variation—Not an Easy Task. The Example of S100-β Protein and Neuron-Specific Enolase

2018/08/01 by Anna Carobene, Elena Guerra, Massimo Locatelli +7 · 5 citations
Biochemistry, Genetics and Molecular Biology · Medicine · #S100 Proteins and Annexins #Sepsis Diagnosis and Treatment

paper · pdf · doi:10.1373/clinchem.2018.292169

Abstract

To the Editor: To obtain reliable estimates of biological variation (BV)1, studies must conform to a standardized approach and be adequately powered and properly documented. The recently published Biological Variation Data Critical Appraisal Checklist (BIVAC) aims to assess whether BV studies contain all elements necessary for the associated BV estimates to be reliable and fit for purpose (1). We here present European Biological Variation Study (EuBIVAS) results for S100-β (S100B) and neuron-specific enolase (NSE) proteins to illustrate the importance of study designs following the BIVAC checklist to ensure the validity of results. NSE and S100B are used in the diagnosis and follow-up of NSE-secreting tumors and melanoma, respectively, and may aid in the diagnosis of brain damage such as concussion and neurological disease. The EuBIVAS results are compared with a recently published study performed in amateur mixed martial arts athletes (2). Briefly, EuBIVAS samples were collected weekly from 91 healthy volunteers (53 females and 38 males; age range, 21–69 years) for 10 weeks. Samples, stored at −80 °C, were measured with a Roche Cobas e801 electrochemiluminescence immunoassay using Roche reagents, calibrators, and control materials, with simultaneous analysis of the hemolysis index because hemoglobin falsely increases NSE concentrations. All samples from the same participant were analyzed in duplicate within a single run. Trend analysis was performed to ensure steady state. The protocol was approved by the …

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