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Open research questions in Clinical Laboratory Practices and Quality Control

229 gap statements mined from Clinical Laboratory Practices and Quality Control papers in our 7.9M-paper local library, which holds 1,987 papers on the topic — drawn mostly from each paper's own stated research gap, future-work, challenge and limitation notes, and its abstract. The ones listed below are a selection still marked open; each names the study that raised it, with a DOI link where the paper has one.

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What the literature leaves open

  • There is a need for increasingly precise and accurate laboratory and diagnostic methods for rabbits. Preventive healthcare measures, including vaccination and early disease detection, are not consistently applied.

    Leukocyte Differentiation and Scattergram Abnormalities in Rabbits Using the Mindray BC-60R Hematology Analyzer · 2026 · DOI

  • There is a lack of effective power and inadequate cold chain in resource-limited laboratory settings. There is a need for ongoing education and systematic improvements in pre-analytical error prevention.

    Pre-Analytical Errors In Full Blood Count Analysis: A Comprehensive Review · 2026 · DOI

  • Lack of matrix effect verification. Ambiguous residual interference mechanisms. Insufficient long-term stability data.

    Cryoprotective strategies for frozen erythrocytes in POCT whole blood reference materials progress and challenges · 2026 · DOI

  • User-friendly tools for exploratory data analysis to identify such technical effects in large datasets are lacking.

    CytoScan: Automated Detection of Technical Anomalies for Cytometry Quality Control · 2026 · DOI

  • Spurious technical effects resulting from a lack of standardization can affect marker distributions and further complicate multi-sample analyses.

    CytoScan: Automated Detection of Technical Anomalies for Cytometry Quality Control · 2026 · DOI

  • Although direct oral anticoagulants (DOACs) do not usually require monitoring and clinical cut-off values are not well established yet, measurement of apixaban is often requested in emergency settings and may be requested for patients with suspected variable pharmacokinetics.

    Long-term analytical performance of apixaban measurements based on external quality assessment data · 2026 · DOI

  • Flow cytometric enumeration of peripheral blood lymphocyte subsets (EPBLS) is essential for disease management, yet standardized validation criteria are lacking.

    Performance characteristics for flow cytometric enumeration of peripheral blood lymphocyte subsets under harmonized laboratory conditions: a multicenter study · 2026 · DOI

  • To provide better-quality care, further studies evaluating the differences in staffing and blood collection processes on weekends and weekdays are warranted.

    Weekend effect on blood culture contamination: an observational study at a university hospital in Japan · 2025 · DOI

  • There was little correlation found between H&E intensity and assessor score, however, the H&E intensity ratio indicated a trend with assessor score suggesting there may be an optimal stain relationship that should be investigated further.

    An international study of stain variability in histopathology using qualitative and quantitative analysis · 2025 · DOI

  • To date the reliability of haemoglobin levels obtained by point-of-care testing (POCT) analysis if compared to standard blood cell count remains controversial.

    Optimizing haemoglobin measurements in VLBW newborns: Insights from a comparative retrospective study · 2024 · DOI

  • Approaches to dealing with method- or collective-related differences in reference ranges are not considered in this position paper, nor are standardisations at the level of test design and test implementation. Approaches to reporting laboratory results, e.g. in the form of dimensionless relative values instead of specific substance quantities, volumes or activity data, are also not considered here.

    Unity among the units – a position paper by the DGKL · 2026 · DOI

  • The current strategies to solve the problem of inappropriate prescriptions are not adequate. There is a need for a structural solution through the Health Information Technology.

    Designing Efficient Healthcare Systems: A Comparative Analysis of Decision Support Systems in Laboratory Medicine · 2026 · DOI

  • The adoption of AI in low-resource settings is hindered by constraints such as inadequate infrastructure and limited technical expertise. AI models trained on high-income population datasets may underperform in underrepresented regions. The lack of comprehensive local data and limited access to standardized laboratory procedures can reduce the accuracy and generalizability of AI outputs.

    Artificial Intelligence in Medical Laboratory Medicine: Clinical Applications, Ethical Challenges, and the Evolving Role of Laboratory Professionals in Low-Resource Settings · 2026 · DOI

  • Examination of the challenges and limitations of AI adoption in low-resource settings and development of strategies to address them.

    Artificial Intelligence in Medical Laboratory Medicine: Clinical Applications, Ethical Challenges, and the Evolving Role of Laboratory Professionals in Low-Resource Settings · 2026 · DOI

  • The study identified that preanalytical and systemic causes played only a minor role in deviations, with predominantly analytical/quantitative deviations observed; future work should systematically characterize the specific preanalytical variables (specimen handling, transport conditions, storage duration) that do occur and their threshold effects on EQA performance across different test categories.

    Structured Error Analysis and Corrective Actions in Clinical Laboratory Practice: An Analysis of 7226 External Quality Assurance Participations · 2026 · DOI

  • The manufacturer's recommended 2-hour equilibration time may be insufficient for sodium measurement. Clinical observations suggest that sodium results may be sensitive to equilibration time.

    Determination of optimal equilibration time for sodium measurement using Johnson Vitros dry chemistry analyzer · 2026 · DOI

  • There is a need to consider the limitations of Milan model 1b when setting APS. The current approach to setting APS may not fully account for the complexities of clinical decision-making.

    Limitations to the development of Milan model 1b analytical performance specifications · 2026 · DOI

  • There is a need for a more efficient approach to reduce unnecessary dilutions in clinical chemistry tests. Prior work has focused on automating laboratory processes, but there is a lack of studies on revising validation rules to report results above predefined thresholds.

    A model to increase automation and support reliable interpretation of clinical chemistry tests · 2026 · DOI

  • The lack of harmonization in laboratory medicine, particularly in CBC testing. The need for standardized reporting and personalized reference intervals.

    The complete blood count: data or clinical information? · 2026 · DOI

  • There is relatively little research on EQA in individual clinical laboratories. Current scientific evidence on EQA focuses primarily on the analyses carried out by EQA providers.

    Structured Error Analysis and Corrective Actions in Clinical Laboratory Practice: An Analysis of 7226 External Quality Assurance Participations · 2026 · DOI

  • Finally, the data analysis requires complex bioinformatic pipelines for which no standards exist, and which are also often developed in a non-commercial environment of specialty laboratories.

    EFLM position statement on the proposed 2025/0404(COD) IVDR Amendment of Article 5.5 · 2026 · DOI

  • Developing low-residue, user-friendly, human-erythrocyte-adapted cryoprotective techniques - Strengthening commutability validation - Industrializing freeze-dried whole blood reference…

    Cryoprotective strategies for frozen erythrocytes in POCT whole blood reference materials progress and challenges · 2026 · DOI

  • The study was conducted in a specific region (mid-to-high-altitude areas of Yuxi City, southwestern China), - The study had a limited sample size of females compared to males, - The study excluded certain groups…

    A cross-sectional study of routine hematological and biochemical parameters with age- and sex-specific analyses in mid-to-high-altitude regions of southwestern China · 2026 · DOI

  • Further studies are needed to explore the mechanisms underlying the sex differences in CBC and biochemical indicators, - Studies should investigate the effects of high-altitude exposure on human physiological functions in different populations, - Research should focus on developing sex-specific reference ranges for CBC and biochemical…

    A cross-sectional study of routine hematological and biochemical parameters with age- and sex-specific analyses in mid-to-high-altitude regions of southwestern China · 2026 · DOI

  • Analytical errors can lead to inaccurate test results, - Certain analytes are prone to high error rates, - Quality control measures are needed to improve test result…

    Factors associated with analytical errors in blood chemistry tests · 2026 · DOI

Most-cited papers in Clinical Laboratory Practices and Quality Control

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Open questions raised by papers listed on this page include: (1) There is a need for increasingly precise and accurate laboratory and diagnostic methods for rabbits (“Leukocyte Differentiation and Scattergram Abnormalities in Rabbits Using the…”, 2026); (2) There is a lack of effective power and inadequate cold chain in resource-limited laboratory settings (“Pre-Analytical Errors In Full Blood Count Analysis: A Comprehensive Review”, 2026); (3) User-friendly tools for exploratory data analysis to identify such technical effects in large datasets are lacking (“CytoScan: Automated Detection of Technical Anomalies for Cytometry Quality…”, 2026); (4) Flow cytometric enumeration of peripheral blood lymphocyte subsets (EPBLS) is essential for disease management, yet standardized validation criteria are lacking (“Performance characteristics for flow cytometric enumeration of peripheral blood…”, 2026); (5) There is a need for a structural solution through the Health Information Technology (“Designing Efficient Healthcare Systems: A Comparative Analysis of Decision…”, 2026). 229 gap statements have been mined from Clinical Laboratory Practices and Quality Control papers in our 7.9M-paper local library, which holds 1,987 papers on the topic; the gaps come from whichever of those papers state one. They are mostly the research gaps the authors state and the papers' abstracts, plus future-work, limitations and challenges passages. The ones listed below are a selection still marked open; each names the study that raised it, with a DOI link where the paper has one, so you can read the original claim in context.

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