Undisclosed interference in 25-OH-Vitamin D immunoassay on Liaison XL analyzer when using heparin plasma tubes.

This study investigates the impact of sample type on the measurement of 25-OH-vitamin D using the Liaison XL (Diasorin) and Cobas e801 (Roche). This investigation was motivated by the need to optimize sample volume usage, which led us to adopt the use of heparin plasma, an alternative proposed by Diasorin in their specification. Discordant and unexplainable results were observed, prompting us to evaluate the effect of sample type on the accuracy of the 25-OH-vitamin D measurements.

Biological variation of CA 15-3, CA 125 and HE 4 on lithium heparinate plasma in apparently healthy Caucasian volunteers.

Objectives: Tumor markers are well-known for being important tools in the support of diagnosis, monitoring of treatment efficacy and follow-up of cancers. CA 125, CA 15-3 and HE 4 have demonstrated potential efficacy in other clinical indications. The main objective was to evaluate the biological variation of these glycoproteins using two different immunoassays in an apparently healthy Caucasian population.

Short-term biological variation study of plasma hemophilia and thrombophilia parameters in a population of apparently healthy Caucasian adults.

Objectives: Biological variation (BV) data obtained in a standardized way is valuable to assess the analytical requirements and the utility of a reference interval. Our study aimed to determine the short-term BV of thrombophilia (protein S, protein C, activated protein C resistance (APCR) and factor VIII) and hemophilia (factors VIII, IX and XI) parameters in plasma. Coagulation factors V and XII were also evaluated.

Biological variation data and analytical specification goal estimates of the thrombin generation assay with and without thrombomodulin in healthy individuals.

Background: Evaluation of an individual's thrombin-generating capacity enables a global assessment of the coagulation cascade and is therefore thought to better reflect the clotting function of blood. However, the lack of standardization still hampers the use in routine clinical practice.

Methods: Nineteen healthy subjects were sampled once a week for 5 consecutive weeks.

Biological variation and analytical goals of four thyroid function biomarkers in healthy European volunteers.

Background: Interpretation of thyroid function tests by means of biological variation (BV) data is essential to identify significant changes between serial measurements at an individual level. Data on thyroid parameters in adults are limited.

Objectives: We aimed at determining the BV of four thyroid function test (thyroid-stimulating hormone (TSH), free thyroxin (FT4), free triiodothyronine (FT3) and thyroglobulin (Tg)) by applying recent recommendations to acquire BV data on a latest generation of immunoassay.

High clinical performance and quantitative assessment of antibody kinetics using a dual recognition assay for the detection of SARS-CoV-2 IgM and IgG antibodies.

Objectives: Several serological SARS-CoV-2 immunoassays have been developed recently but require external validation before widespread use. This study aims at assessing the analytical and clinical performance of the iFlash® anti-SARS-CoV-2 chemiluminescence assay for the detection of both IgM and IgG antibodies. The kinetics of the antibody response was also evaluated.

Analytical performances and biological variation of PIVKA-II (des-y-carboxy-prothrombin) in European healthy adults.

Background: PIVKA-II (DCP) is increasingly used for the diagnosis and the surveillance of hepatocellular carcinoma (HCC) in at-risk populations. However, to date, few data are available concerning the intra- and inter-individual variability of this marker, which makes the interpretation of serial measurements difficult in the context of monitoring.

Methods: 19 European healthy volunteers (HVs) were taken each week during five consecutive weeks.