Clinical chemistry and laboratory medicine最新文献

Objectives: Atypical cells (Atyp.C), as a new parameter determined by an automated urine analyzer, can be suspected of being malignant tumor cells. We evaluated the extent to which the Atyp.C can predict the existence of malignant tumor cells.

Methods: A total of 3,315 patients (1,751 in the training cohort and 1,564 in the testing cohort) were recruited and divided into five groups, namely, primary bladder cancer (BCa), recurrent BCa, post-treatment monitoring of BCa, other urological tumors, and controls. Urine Atyp. C, bacteria, white blood cell, and red blood cell were measured by a Sysmex UF-5000 analyzer. We compared the Atyp.C values across the different groups, sexes, and tumor stages. The diagnostic performance of Atyp.C alone and in combination with other parameters for detecting BCa was evaluated using receiver operating characteristic (ROC) curve analysis.

Results: The Atyp.C value of the primary BCa group was significantly higher than that in the other groups, except recurrent BCa group. The Atyp.C value was closely related to tumor staging. Atyp.C combined with bacteria had the highest diagnostic performance for primary BCa [training cohort AUC: 0.781 (95 % CI: 0.761-0.801); testing cohort AUC: 0.826 (95 % CI: 0.806-0.845)]. The AUC value of diagnosed recurrent BCa by Atyp.C plus bacteria for the training cohort was 0.784 (95 % CI: 0.762-0.804).

Conclusions: Atyp.C was high in primary BCa patients and the combination of bacteria and Atyp.C showed high predictive value for primary BCa, suggesting that Atyp.C may be a useful objective indicator for the early detection of BCa.

Objectives: Fecal immunochemical tests (FIT) for hemoglobin are currently considered the screening investigation of choice for colorectal cancer and are worldwide recommended. Similarly, fecal calprotectin is a widely used test for monitoring intestinal inflammation. The pre-analytical issues regarding stool samples have hardly been dealt with and are difficult to solve. Currently, there are no reference analytes available which allow to correct test results for the variable water content of the stool sample. Studies on preanalytics of stool samples have generally focused on sample preparation and sample storage, but generally have paid little attention to the variability in sample hydration and sample composition.

Methods: Stercobilin is a stable heme metabolite which is abundant in stool. Stercobilin concentration can be simply assayed in stool extracts using colorimetry (determination of the I index). Serum indices (H, I and L) and bilirubin concentration of fecal extracts were determined on a Atellica Platform (Siemens).

Results: The inter-individual variation of stercobilin was found to be high. Assaying stercobilin allows to correct for stool sample dilution. The median value of the I-index was used as a reference for correcting the data. Correcting fecal blood results for sample dilution resulted in a significant increase in positive tests (from 9.3 to 11.7 %). For calprotectin, correction resulted in 3.1 % extra positive results and 7.7 % negative results.

Conclusions: Except in the case of obstructive jaundice, this correction can be applied. Correcting test results of common fecal analytes like FIT and calprotectin may result in a better tailored test interpretation.

The biotechnology company Grail developed a non-invasive blood test (Galleri test) which is claimed to detect 50 types of cancer at early and potentially curable stages. The initially promising results from prospective studies, and the anticipated financial success of Grail led the sequencing giant Illumina to purchase Grail for $8 billion (2021). Following this event, Grail collaborated with the UK National Health System to further clarify the test's capability, in a 3-year prospective trial, along with the standard of care. At the end of the first year, UK-NHS announced that they will suspend the trial due to unsatisfactory clinical performance and until they analyze the data for the first year (which already enrolled 140,000 participants). Legal and financial issues between the interested parties are currently in flux. We previously expressed concerns about the sensitivity and specificity of the Galleri test. In this opinion paper, we revisit the hyped technology, and we provide new suggestions on the use of this test.

Objectives: CA 15-3 and CEA are tumor markers used in routine clinical care for breast cancer and colorectal cancer, among others. Current measurement procedures (MP) for these tumor markers are considered to be insufficiently harmonized. This study investigated the achievable harmonization for CA 15-3 and CEA by using an in silico simulation of external quality assessment (EQA) data from multiple EQA programs using patient-pool based samples.

Methods: CA 15-3 and CEA data from SKML (2021), UK NEQAS (2020-2021) and KEQAS (2020-2021) were used. A harmonization protocol was defined in which MPs that were considered equivalent were used to value assign EQA samples, and recalibration was only required if the MP had a bias of >5 % with value assigned EQA. Harmonization status was assessed by determining the mean level of agreement and residual variation by CV (%).

Results: Only MPs from Abbott, Beckman, Roche and Siemens were available in all EQA programs. For CA 15-3, recalibration was proposed for Beckman MP only and for CEA, recalibration was proposed for Siemens MP only. When the harmonization procedures were applied, for CA 15-3 the pre-harmonization mean bias range per MP was reduced from -29.28 to 9.86 %, into -0.09-0.12 % after harmonization. For CEA, the mean bias range per MP was reduced from -23.78 to 2.00 % pre-harmonization to -3.13-1.42 % post-harmonization.

Conclusions: The present study suggests that a significant improvement in the harmonization status of CA 15-3 and CEA may be achieved by recalibration of a limited number of MPs.

Objectives: To assess the variations and diagnostic performance of serum biomarkers of neurodegenerative diseases.

Methods: In this monocentric prospective study, neurofilament light (NFL), T-tau, p-tau181, p-tau217, Aβ40, and Aβ42 were measured in serum collected from orthopedic patients (control group, n=114) and patients in the neurology department (n=69) previously diagnosed with Alzheimer's disease (AD, n=52), parkinsonian syndromes (n=10), and other etiologies of neurodegeneration (non-AD, n=7).

Results: In the control group, serum NFL, T-tau, p-tau181, p-tau217, and Aβ40 significantly increased with age, independently of sex. NFL (p=0.0078), p-tau217 (p<0.001) were significantly increased with neurodegeneration when compared to controls, with only p-tau217 significant in the multivariate analysis (p<0.001). Multivariate regression analysis accounting for age highlighted a significant increase of p-tau217 (p<0.001) in the AD subgroup. NFL was significantly increased in the non-AD patients (p<0.001), and in the parkinsonian syndromes subgroup (p=0.016) when compared to negative controls. Serum p-tau181 and p-tau217 were significantly correlated with CSF p-tau181 (Spearman's coefficients of 0.43 and 0.48 respectively, n=40). Areas under the ROC curves for the identification of patients with neurodegenerative diseases were 0.62 (0.54-0.70) for NFL, 0.62 (0.54-0.71) for T-tau, 0.83 (0.76-0.89) for p-tau217, and 0.66 (0.58-0.74) for Aβ40.

Conclusions: Serum biomarkers can help identify patients with neurodegenerative disease and may be a valuable tool for care and orientation. Phosphorylated tau p-tau217 is a promising blood biomarker for AD and NFL for other etiologies.