Postpartum maternal and infant haematological effects of second-trimester ferric carboxymaltose versus standard-of-care oral iron in Malawi: longitudinal follow-up of a randomised controlled trial.

Background: Anaemia is common in mothers and infants in the first year postpartum, especially in sub-Saharan Africa. We evaluated whether treating anaemia in the second trimester of pregnancy with a single dose of intravenous iron, ferric carboxymaltose, compared with standard-of-care oral iron could alleviate anaemia in postpartum women and their infants.

Methods: REVAMP (ACTRN12618001268235), an open-label, individually randomised, controlled trial done across nine urban and five rural health centres in Malawi, recruited women if they were in the second trimester of singleton pregnancy, had a capillary haemoglobin concentration of less than 10·0 g/dL, and had a negative malaria rapid diagnostic test.

Age-Specific Reference Intervals for Thyroid-Stimulating Hormones and Free Thyroxine to Optimize Diagnosis of Thyroid Disease.

Thyroid-stimulating hormone (TSH) and subsequent free thyroxine (FT4) concentrations outside the reference interval (RI) are used to diagnose thyroid diseases. Most laboratories do not provide age-specific RIs for TSH and FT4 beyond childhood, although TSH concentrations vary with age. Therefore, we aimed to establish TSH and FT4 age-specific RIs throughout life and aimed to determine whether using these RIs would result in reclassification of thyroid disease diagnoses in adults.

The choice of serum-free light chain analysis method could potentially have clinical consequences for myeloma patients.

Multiple myeloma (MM) is a disease, that at times poses diagnostic and monitoring challenges. Over the last decades laboratory methods have been expanded with serum free light chain (FLC) analysis. Alerted by two index cases with clinical impact due to failure of the FLC analysis to indicate a disease progression, we aimed to identify any clinical consequences due to known differences between FLC analysis methods.

Are we ready for widespread implementation of lactate POCT in fetal blood sampling? An analytical and clinical verification of the novel statstrip POCT analyzer.

Objectives: Currently, pH values are used in fetal scalp blood sampling as a parameter to rule out fetal distress during the delivery. Due to a high number of pre-analytical errors in pH measurements, lactate measurement is already extensively examined as an alternative. Our objectives were to confirm the analytical performance of the StatStrip lactate POCT analyzer and to compare pH and lactate as a marker of fetal distress.

When bias becomes part of imprecision: how to use analytical performance specifications to determine acceptability of lot-lot variation and other sources of possibly unacceptable bias.

ISO 15189 requires laboratories to estimate the uncertainty of their quantitative measurements and to maintain them within relevant performance specifications. Furthermore, it refers to ISO TS 20914 for instructions on how to estimate the uncertainty and what to take into consideration when communicating uncertainty of measurement with requesting clinicians. These instructions include the responsibility of laboratories to verify that bias is not larger than medically significant.

Protocol and statistical analysis plan for a randomized controlled trial of the effect of intravenous iron on anemia in Malawian pregnant women in their third trimester (REVAMP - TT).

Background: Anemia affects 40% of pregnant women globally, leading to maternal mortality, premature birth, low birth weight, and poor baby development. Iron deficiency causes over 40% of anemia cases in Africa. Oral iron supplementation is insufficient for Low-and-Middle-Income-Countries (LMICs) to meet current WHO targets.

Cost-effectiveness of home-based screening of the general population for albuminuria to prevent progression of cardiovascular and kidney disease.

Background: Chronic kidney disease (CKD) is often detected late, leading to substantial health loss and high treatment costs. Screening the general population for albuminuria identifies individuals at high risk of kidney events and cardiovascular disease (CVD) who may benefit from early start of preventive interventions. Previous studies on the cost-effectiveness of albuminuria population screening were inconclusive, but were based on survey or cohort data rather than an implementation study, modelled screening as performed by general practitioners rather than home-based screening, and often included only benefits with respect to kidney events.

Should we depend on reference intervals from manufacturer package inserts? Comparing TSH and FT4 reference intervals from four manufacturers with results from modern indirect methods and the direct method.

Objectives: Correct interpretation of thyroid function tests relies on correct reference intervals (RIs) for thyroid-stimulating hormone (TSH) and free thyroxine (FT4). ISO15189 mandates periodic verification of RIs, but laboratories struggle with cost-effective approaches. We investigated whether indirect methods (utilizing historical laboratory data) could replace the direct approach (utilizing healthy reference individuals) and compared results with manufacturer-provided RIs for TSH and FT4.

Lipid profile and NT-proBNP changes from pre-clinical to established rheumatoid arthritis: A 12 years follow-up explorative study.

Objectives: The aim of the current study was to explore the changes in lipid and NT-proBNP levels in rheumatoid arthritis (RA) patients through different phases of the disease: from the pre-clinical stage and RA onset up to the treatment phase with biological disease-modifying anti-rheumatic drugs (bDMARDS).

Methods: Thirty-eight consecutive patients, initially with arthralgia and rheumatoid factor and/or anti-citrullinated protein antibodies without arthritis, who later developed RA and eventually started treatment with bDMARDs, were included. Lipid spectrum and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels were measured longitudinally from several months before diagnosis through treatment with bDMARDs.

Defining trimester-specific reference intervals for carbohydrate deficient transferrin in pregnant women.

Objectives: Extensive consumption of alcohol during pregnancy can lead to severe complications for the unborn child. Carbohydrate-deficient transferrin (CDT) levels in serum have become a common biomarker for excessive alcohol intake. However, during pregnancy CDT levels can rise to levels above commonly used cut-off values, for reasons unrelated to alcohol intake.

APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data.

Objectives: According to ISO 15189:2022, analytical performance specifications (APS) should relate to intended clinical use and impact on patient care. Therefore, we aimed to develop a web application for laboratory professionals to calculate APS based on a simulation of the impact of measurement uncertainty (MU) on the outcome using the chosen decision limits, agreement thresholds, and data of the population of interest.

Methods: We developed the "APS Calculator" allowing users to upload and select data of concern, specify decision limits and agreement thresholds, and conduct simulations to determine APS for MU.

Parasitic, bacterial, viral, immune-mediated, metabolic and nutritional factors associated with nodding syndrome.

Nodding syndrome is a neglected, disabling and potentially fatal epileptic disorder of unknown aetiology affecting thousands of individuals mostly confined to Eastern sub-Saharan Africa. Previous studies have identified multiple associations-including , antileiomodin-1 antibodies, vitamin B deficiency and measles virus infection-yet, none is proven causal. We conducted a case-control study of children with early-stage nodding syndrome (symptom onset <1 year).

Participation rate and yield of two home-based screening methods to detect increased albuminuria in the general population in the Netherlands (THOMAS): a prospective, randomised, open-label implementation study.

Background: Chronic kidney disease (CKD) has a rising global prevalence and is expected to become the fifth leading cause of death by 2030. Increased albuminuria defines the early stages of CKD and is among the strongest risk factors for progressive CKD and cardiovascular disease. The value of population screening for albuminuria to detect CKD in an early phase has yet to be studied.

Albumin determined by bromocresol green leads to erroneous results in routine evaluation of patients with chronic kidney disease.

Objectives: Measurement of plasma albumin is pivotal for clinical decision-making in patients with chronic kidney disease (CKD). Routinely used methods as bromocresol green (BCG) and bromocresol purple (BCP) can suffer from aselectivity, but the impact of aselectivity on the accuracy of plasma albumin results of CKD-patients is still unknown. Therefore, we evaluated the performance of BCG-, BCP- and JCTLM-endorsed immunological methods in patients with various stages of CKD.

Prognostic Value of C-Reactive Protein in SARS-CoV-2 Infection: A Simplified Biomarker of COVID-19 Severity in Northern Ethiopia.

Purpose: To evaluate the role of C-reactive protein (CRP) in predicting severe COVID-19 patients.

Methods: A prospective observational cohort study was conducted from July 15 to October 28, 2020, at Kuyha COVID-19 isolation and treatment center hospital, Mekelle City, Northern Ethiopia. A total of 670 blood samples were collected serially.

Cytomegalovirus seronegativity rate in pregnant women and primary cytomegalovirus infection during pregnancy in rural Germany.

Background: Congenital cytomegalovirus (CMV) infection is the most common congenital infection worldwide and one of the leading causes of congenital hearing loss in newborns. The aim of this study was to determine the seroprevalence rate for cytomegalovirus in pregnant women and the rate of CMV serological testing utilised during pregnancy in a rural region in Germany.

Methods: Retrospective data on the prevalence of CMV IgG and IgM antibodies were obtained from 3,800 women, identified in the study group of 19,511 pregnant women from outpatient settings whose samples were collected between 1 and 2014 and 30 April 2018.

Ferric carboxymaltose versus standard-of-care oral iron to treat second-trimester anaemia in Malawian pregnant women: a randomised controlled trial.

Background: Anaemia affects 46% of pregnancies in Africa; oral iron is recommended by WHO but uptake and adherence are suboptimal. We tested a single dose of a modern intravenous iron formulation, ferric carboxymaltose, for anaemia treatment in Malawian pregnant women.

Methods: In this open-label, individually randomised controlled trial, we enrolled women with a singleton pregnancy of 13-26 weeks' gestation in primary care and outpatient settings across two regions in southern Malawi.

The first trimester plasma copper-zinc ratio is independently related to pregnancy-specific psychological distress symptoms throughout pregnancy.

Objectives: High plasma copper (Cu) and low zinc (Zn) levels have been associated with depression. However, most studies used low sample sizes and a cross-sectional design, and perinatal data are scarce. We investigated the possible association between pregnancy-specific psychological distress and the plasma CuZn ratio using a prospective design.

Vitamin D deficiency and associated factors among antenatal care attending pregnant women in Sodo town, South Ethiopia: A facility-based cross-sectional study.

Background: Vitamin D deficiency is an emerging public health problem globally, with devastating health consequences. Pregnant women are most susceptible for Vitamin D deficiency, and black women particularly are under double burden of the problem. Therefore, this study aimed to determine the prevalence of Vitamin D deficiency and identify associated factors among antenatal care attending pregnant women.

Effectiveness and tolerability of lacosamide in children with drug resistant epilepsy.

We retrospectively studied the efficacy and tolerability of lacosamide (LCM) in children with drug-resistant epilepsy in a tertiary care centre in the Netherlands, from 2013 till 2019, with a follow-up of two years. 79 children, aged < 18 years, were included. Retention rate, effectiveness, reason for termination, and side-effects were analysed.