Abstract
BackgroundThe determination of CA 15-3 is useful for monitoring breast cancer patients. Several retrospective studies determined CA 15-3 levels in frozen samples to evaluate the sensitivity and specificity of novel biomarkers in relation to breast cancer; however, freeze-thaw cycles, as well as preanalytical variables before sample storage, are not always reported. Here, we analyzed the current scientific literature to identify possible critical aspects related to CA 15-3 determination in frozen-stored human serum/plasma samples.MethodsWe obtained data from 4 different bibliographic databases: Web of Science, Embase, PubMed, and Cochrane Library. We followed the PRISMA guidelines to screen and select the eligible articles discussed in the final revision.ResultsInitially, 674 scientific papers were evaluated, and after the application of the screening and eligibility criteria, 18 studies were included in the qualitative synthesis. The analysis reported an important level of heterogeneity concerning the preanalytical phase before sample storage.ConclusionAlthough advances in healthcare have been achieved using certified workflows in medical diagnostics, standardized preanalytical processes are not always applied when referring to frozen-stored biosamples. Biobanks will guarantee the best possible conditions for the storage of human biological samples to be used in clinical research. The use of certified bioresources will favor the optimal development and introduction of new disease biomarkers.
Highlights
The determination of CA 15-3 is useful for monitoring breast cancer patients
Risk of bias We carried out the risk of bias assessment by objectively evaluating the selected publications with the following questions: (1) Can we find confounding factors for sample handling? (2) Can we reproduce the sample freezethaw cycle? (3) Are we confident in the appropriate balance of the sample sizes of the case and control groups? We assessed the risk of bias across studies by using the Newcastle-Ottawa Scale (NOS) for case-control study quality assessment [21]
According to the biospecimen type used for CA 15-3 determination in the 18 included papers, 14 studies used serum samples [22,23,24,25,26,27,28,29,30,31,32, 34, 35, 39], while the remaining 4 were structured as follows: (i) Zajkowska et al used exclusively plasma samples [33], (ii) Christenson et al focused on methodological comparison and assayed CA 15-3 in both serum and plasma samples [36], (iii) Saba et al measured CA 15-3 in both serum and pleural effusion [37]; and (iv) Laidi et al determined CA 15-3 in serum and saliva biosamples [38]
Summary
Several retrospective studies determined CA 15-3 levels in frozen samples to evaluate the sensitivity and specificity of novel biomarkers in relation to breast cancer; freeze-thaw cycles, as well as preanalytical variables before sample storage, are not always reported. Coppola et al Systematic Reviews (2021) 10:102 samples, we decided to evaluate how the preanalytical variables and storage conditions (including freeze-thaw cycles) are correctly reported in the literature for CA 153, a commonly used biomarker for monitoring breast cancer (BC). We selected this marker since it is widely used in clinical practice for patient stratification in retrospective case-control studies as well as for performance comparison with novel introduced biomarkers. Despite its association with BC cells, an increase in CA 15-3 can be detected in some benign conditions, such as liver disease and benign breast, lung, or ovarian disease [9]; it is not considered a specific BC biomarker for diagnostic purposes
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