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This is the April 2026 issue of clinical chemistry, volume 72, issue 4.
Quantum Machine Learning and Data Re-Uploading Evaluation on Benchmark and Laboratory Medicine
Data Sets by Thomas J. S. Durant at all. Quantum Machine Learning may offer advantages for
biomedical data analysis, but its practical performance remains uncertain. This study found that the
quantum data re-uploading algorithm performs well on low-dimensional data sets, showing potential
for early research applications and laboratory medicine. However, its effectiveness declines
with higher-dimensional data, which has more independent variables. Even after optimization,
it underperforms compared to non-linear classical machine learning models. These findings highlight
the need for further development in quantum algorithms and hardware to realize the full potential
of quantum approaches in biomedical research. Discovery of an artificial intelligence label
feedback loop, how the success of a clinically implemented artificial intelligence algorithm has
created an unforeseen challenge to algorithm retraining by Patrick L. Day at all.
Artificial intelligence or AI augmented laboratory tests can enhance quality,
efficiency, staff satisfaction, and cost effectiveness in laboratory medicine. Retraining
these models with additional data has the potential to further improve the performance of these
tests. However, there is a paucity of literature surrounding the challenges associated with real
world model retraining. This study reports an AI label feedback loop discovered during the
retraining of a clinically developed kidney stone composition test. Continuous human annotation and
robust validation strategies can help attenuate this risk.
Towards clinical integration of deep learning-based classification of urinary sediment particles from
digital microscopy images, a prospective study by Stelianos Musla at all. This study evaluated a
deep learning method for automated classification of urinary sediment particles using digital microscopy
images. An efficient net-based model was trained on annotated data from varied collection schemes
and a tool was developed for laboratory integration. The model achieved high accuracy of around 97%
in controlled tests, but lower performance in perspective evaluation. Interpretability and
calibration analyses investigated robustness and failure modes, offering insights for integrating
artificial intelligence tools into urine microscopy workflows.
Development of a novel liquid chromatography coupled to multiple reaction monitoring,
or LC-MRM assay, for the quantification of neurofilament-light chain and cerebral spinal fluid
and comparison with ultra-sensitive amino assay, a step towards standardization,
by Salome copens at all. To ensure reliable clinical implementation of the neurofilament-light chain
test, a key biomarker for neurodegeneration, standardized measurement procedures, and calibrators
is required. This study presents a validated immunoprecipitation liquid chromatography
mass spectrometry assay using an assay traceable calibrator and compares it with luma pulse and
somoa platforms to assess agreement and bias. Analysis of cerebral spinal fluid samples and pools
by the immuno and mass spectrometry assays were performed. Following the development and validation
of the new SI traceable method, there was close correlation with both available immunosays,
but biases were identified, reinforcing the need for standardization of this test's measurement.
Establishing reference values in healthy participants for the Cardiactroponin T-High Sensitivity Gen 6 assay
ref T-6 Global Reference Study by Laurie B. Daniels at all. In this article, the authors determined 99th
percentile upper reference limits or URLs for the new Cardiactroponin T-High Sensitivity Gen 6 assay
in a prospectively collected global healthy reference range cohort or ref T-6. Sex-specific 99th
percentile URLs were 18 nanograms per liter for females and 32 nanograms per liter for males.
The uniform 99th percentile URL was 27 nanograms per liter. These findings met the International
Federation for Clinical Chemistry and Laboratory Medicine criteria to be designated as a Cardiactroponin T-High
Sensitivity Assay. 89.7% of results were above the limit of detection and the coefficient of
variation was well below 10% at sex-specific and uniform 99th percentile URLs. Going forward,
the 99th percentile URLs determined in ref T-6 will be validated in a clinical performance study.
6.Color Multiplex Digital PCR assays for comprehensive screening and identification
of multiple driver mutations associated with pancreatic carcinogenesis by Chio Maeda at all.
In this article, the authors described the development of two 6-color digital PCR assays,
PlexScreen DPCR for broad mutation screening and PlexID DPCR for identifying 14-specific
K-RAS and G-NAS variants. Upon using synthetic DNA, cell lines and clinical samples, both assays
exhibited high sensitivity, limit of detection 0.02 to 0.05% and strong concordance with standard
methods. The 6-color system exhibited significantly improved a multiplexing efficiency
compared to conventional two-color platforms. These assays represent scalable, cost-effective
tools for early pancreatic cancer detection with the potential for expansion to broader genomic
applications.

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