Evolution of autoimmune diagnostics over the past 10 years: lessons learned from the UK NEQAS external quality assessment EQA programs.

Objectives: External quality assessment (EQA) programs play a pivotal role in harmonizing laboratory practices, offering users a benchmark system to evaluate their own performance and identify areas requiring improvement. The objective of this study was to go through and analyze the UK NEQAS "Immunology, Immunochemistry and Allergy" EQA reports between 2012 and 2021 to assess the overall level of harmonization in autoimmune diagnostics and identify areas requiring improvement for future actions.

Methods: The EQA programs reviewed included anti-nuclear (ANA), anti-dsDNA, anti-centromere, anti-extractable nuclear antigen (ENA), anti-phospholipids, anti-neutrophil cytoplasm (ANCA), anti-proteinase 3 (PR3), anti-myeloperoxidase (MPO), anti-glomerular basement membrane (GBM), rheumatoid factor (RF), anti-citrullinated protein antibodies (ACPA), mitochondrial (AMA), liver-kidney-microsomal (LKM), smooth muscle (ASMA), APCA, and celiac disease antibodies.

Behind the scenes of EQA - characteristics, capabilities, benefits and assets of external quality assessment (EQA).

External quality assessment (EQA) enhances patient safety through the evaluation of the quality of laboratory-based and point of care testing. Regulatory agencies and accreditation organizations utilize the results and the laboratory's response to them as part of assessing the laboratory's fitness to practice. In addition, where EQA samples are commutable and the assigned value has been determined using reference measurement procedures (RMPs), EQA data contributes to the verification of metrological traceability of assays as part of the post-market surveillance of diagnostic (IVD) medical devices (IVD-MDs).

Harmonization of anti-nuclear antibody testing (ANA) by indirect immunofluorescence assay: Results from ten years of UK NEQAS external quality assessment.

External quality assurance (EQA) programs play a pivotal role in monitoring laboratory practices, allowing each laboratory to evaluate the consistency of results across different methods as well the ability of individual laboratories to compare and improve over time their own performance. The objective of our study was to analyze the UK NEQAS EQA reports for the "Antibodies to Nuclear and Related Antigens" program from 2013 to 2023, to assess the overall level of harmonization of the responses for anti-nuclear antibody (ANA) testing by indirect immunofluorescence (IIF), in terms of both pattern and titer consensus. As a second aim, we analyzed the impact of the introduction in UK NEQAS EQA reports of the International Consensus on ANA Patterns (ICAP) nomenclature and of digital image recognition on the harmonization of the ANA HEp-2 IIF test.

External quality assessment-based tumor marker harmonization simulation; insights in achievable harmonization for CA 15-3 and CEA.

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 simulation of external quality assessment (EQA) data from multiple EQA programs using patient-pool based samples.

Evaluation of cryoprotein investigation using a digital external quality assurance scheme.

Robust preanalytical and analytical processes are critical for the detection of cryoproteins. There is significant variation in practice in the detection, analysis and reporting. A survey in 2018 of 137 laboratories participating in the UK National External Quality Assessment Service (UK NEQAS) (6) quality control program showed significant variation in the laboratory processes which highlighted the need for standardisation of the detection, analysis and reporting of cryoglobulins.

Investigating the Current Harmonization Status of Tumor Markers Using Global External Quality Assessment Programs: A Feasibility Study.

Background: The harmonization status of most tumor markers (TMs) is unknown. We report a feasibility study performed to determine whether external quality assessment (EQA) programs can be used to obtain insights into the current harmonization status of the tumor markers α-fetoprotein (AFP), prostate specific antigen (PSA), carcinoembryonic antigen (CEA), cancer antigen (CA)125, CA15-3 and CA19-9.

Methods: EQA sample results provided by 6 EQA providers (INSTAND [Germany], Korean Association of External Quality Assessment Service [KEQAS, South Korea], National Center for Clinical Laboratories [NCCL, China], United Kingdom National External Quality Assessment Service [UK NEQAS, United Kingdom], Stichting Kwaliteitsbewaking Medische Laboratoriumdiagnostiek [SKML, the Netherlands], and the Royal College of Pathologists of Australasia Quality Assurance Programs [RCPAQAP, Australia]) between 2020 and 2021 were used.

Combined deficient response to polysaccharide-based and protein-based vaccines predicts a severe clinical phenotype.

Objectives: Antibody response on polysaccharide- and protein-based vaccines is useful to test B cell functionality. As only few studies have explored the value of studying immune response to both vaccines, we evaluated the clinical value of anti-polysaccharide and anti-protein Luminex-based multiplex assays in context of primary immunodeficiency (PID) diagnosis.

Methods: A 10-plex Luminex-based assay detecting antibodies to ten pneumococcal polysaccharide (PnPS) serotypes [present in unconjugated Pneumovax, not in 13-valent pneumococcal conjugated vaccine (PCV)] and a 5-plex assay detecting antibodies to five protein antigens (present in DTap/Tdap) were clinically validated in healthy individuals (n=99) and in retrospective (n=399) and prospective (n=108) patient cohorts.

Clients in Uganda accessing preferred differentiated antiretroviral therapy models achieve higher viral suppression and are less likely to miss appointments: a cross-sectional analysis.

Introduction: The Uganda Ministry of Health recommends facility- and community-based differentiated antiretroviral therapy (DART) models to support person-centred care for eligible clients receiving antiretroviral therapy (ART). Healthcare workers assess client eligibility for one of six DART models upon initial enrolment; however, client circumstances evolve, and their preferences are not routinely adjusted. We developed a tool to understand the proportion of clients accessing preferred DART models and compared the outcomes of clients accessing preferred DART models to the outcomes of clients not receiving preferred DART models.

Detection of antinuclear antibodies: recommendations from EFLM, EASI and ICAP.

Objectives: Antinuclear antibodies (ANA) are important for the diagnosis of various autoimmune diseases. ANA are usually detected by indirect immunofluorescence assay (IFA) using HEp-2 cells (HEp-2 IFA). There are many variables influencing HEp-2 IFA results, such as subjective visual reading, serum screening dilution, substrate manufacturing, microscope components and conjugate.

Utilizing a church-based platform for mental health interventions: exploring the role of the clergy and the treatment preference of women with depression.

Background: Training lay people to deliver mental health interventions in the community can be an effective strategy to mitigate mental health manpower shortages in low- and middle-income countries. The healthy beginning initiative (HBI) is a congregation-based platform that uses this approach to train church-based lay health advisors to conduct mental health screening in community churches and link people to care. This paper explores the potential for a clergy-delivered therapy for mental disorders on the HBI platform and identifies the treatment preferences of women diagnosed with depression.

Pharmacotherapy Prescriptions for Relapse Prevention of Psychotic Depression After Electroconvulsive Therapy.

Purpose/background: Electroconvulsive therapy (ECT) is effective in the treatment of acute episodes of psychotic depression. However, no adequately powered studies have directly investigated the efficacy of antipsychotic pharmacotherapy in relapse prevention of psychotic depression after ECT. In the absence of such literature, we reviewed the clinical practice of 4 academic medical centers that have made research contributions in the treatment of psychotic depression over the past 20 years.

High prevalence of undiagnosed hypertension among men in North Central Nigeria: Results from the Healthy Beginning Initiative.

Background: The prevalence of hypertension in Nigeria is high and growing. The burden and risk factor distribution also vary by geographical zone. Information about prevalence, risk factors and disease status awareness are needed to guide evidence based public health response at the national and sub- national levels.

Hepatitis B infection and risk factors among pregnant women and their male partners in the Baby Shower Programme in Nigeria: a cross-sectional study.

Objectives: To determine the population prevalence and determinants of hepatitis B (Hep B) status, and status discordance, among pregnant women and their male partners in Nigeria.

Methods: Cross-sectional study assessing the seroprevalence of Hep B virus in a cohort of 16 920 pregnant women and their male partners in northcentral Nigeria. Rapid HBsAg antibody test was used for Hep B diagnosis.

Opportunities and challenges to integrating mental health into HIV programs in a low- and middle-income country: insights from the Nigeria implementation science Alliance.

Background: In Nigeria, there is an estimated 1.9 million people living with HIV (PLHIV), 53% of whom utilize HIV care and services. With decreasing HIV-related deaths and increasing new infections, HIV with its associated comorbidities continue to be a key public health challenge in Nigeria.

Successful pregnancy following chemotherapy in a survivor of small cell carcinoma of the ovary, hypercalcemic type (SCCOHT): A case report and review of literature.

•Small cell carcinoma of the ovary hypercalcemic type (SCCOHT) is a rare neoplasm that mostly affects young women.•The chances of future fertility in women are limited due to the aggressive nature of SCCOHT and need for adjuvant therapy.•We report the case of a 26y woman with stage IA SCCOHT who had a successful pregnancy following surgery and chemotherapy.

Continued provision of WHO International Standards for total and free PSA: Content and commutability of replacement preparations.

Objectives: Replacements are required for the WHO International Standards (IS) for free PSA, coded 96/668 and total PSA (90:10), coded 96/670, which were established in 1999 to support efforts to harmonise PSA assays and address non-equimolarity. An important consideration is that the introduction of the replacements should have minimal impact on PSA measurements.

Design And Methods: We report the development of a replacement strategy, informed by field assessment of preparations through an external quality assessment scheme and the subsequent evaluation of the candidate ISs in worldwide collaborative studies.

Challenges and Strategies for Improving Training of Mid-Level Research Personnel in Nigeria.

Background: Contextual research evidence is needed to reduce morbidity and mortality due to chronic but preventable diseases in low- and middle-income countries. Nigeria, Africa's most populous country, is particularly burdened by these diseases despite its academic and research infrastructure. A major impediment to developing robust evidence on sustainable disease prevention and treatment strategies is the lack of skilled research personnel.

"PSYCH-PASS": the Development, Adaptation, and Implementation of a Psychiatric Handoff.

Objective: The primary purpose of the study was to develop and implement a psychiatry mnemonic PSYCH-PASS for transitions of care in residency training programs.

Methods: The authors examined areas of improvement in the handoff system with residency training administration, service directors, and psychiatry residents to create PSYCH-PASS, a novel mnemonic that could be integrated in the electronic medical record (EMR). The components of PSYCH-PASS are Patient summary, Situational awareness, "whY" is the patient here, Comorbidities, Hemodynamics, Pharmacology/PRNs, Action list, Specifics, and Synthesis.

Targeted HIV testing for male partners of HIV-positive pregnant women in a high prevalence setting in Nigeria.

Background: Partner HIV testing during pregnancy has remained abysmally low in sub-Saharan Africa, particularly in Nigeria. Males rarely attend antenatal clinics with their female partners, limiting the few opportunities available to offer them HIV testing. In this study, we evaluated the scale-up of the Healthy Beginning Initiative (HBI), a community-driven evidenced-based intervention to increase HIV testing among pregnant women and their male partners.

Determinants of Infant Mortality in Southeast Nigeria: Results from the Healthy Beginning Initiative, 2013-2014.

Background: Neonatal mortality due to preventable factors occurs at high rates throughout sub-Saharan Africa. Community-based interventions increase opportunities for prenatal screening and access to antenatal care services (ANC) services. The Healthy Beginning Initiative (HBI) provided congregation-based prenatal screening and health counseling for 3,047 women in Enugu State.

Developing a Theoretical Framework for a Complex Maternal-Child Health Intervention: Health Beginning Initiative.

A theoretical framework serves as a roadmap for the implementation and application of a complex, health promotion intervention; is used to test hypotheses; and guides analysis and evaluation of the intervention. The purpose of this article is to demonstrate how a theoretical framework was developed and used to guide the implementation of Healthy Beginning Initiative (HBI) to promote uptake of HIV services in a low-income country. We used the guide for developing a theoretical framework published in Health Promotion Practice.

Gaps and strategies in developing health research capacity: experience from the Nigeria Implementation Science Alliance.

Background: Despite being disproportionately burdened by preventable diseases than more advanced countries, low- and middle-income countries (LMICs) continue to trail behind other parts of the world in the number, quality and impact of scholarly activities by their health researchers. Our strategy at the Nigerian Implementation Science Alliance (NISA) is to utilise innovative platforms that catalyse collaboration, enhance communication between different stakeholders, and promote the uptake of evidence-based interventions in improving healthcare delivery. This article reports on findings from a structured group exercise conducted at the 2016 NISA Conference to identify (1) gaps in developing research capacity and (2) potential strategies to address these gaps.

A Patient-Held Smartcard With a Unique Identifier and an mHealth Platform to Improve the Availability of Prenatal Test Results in Rural Nigeria: Demonstration Study.

Background: Community-based strategies to test for HIV, hepatitis B virus (HBV), and sickle cell disease (SCD) have expanded opportunities to increase the proportion of pregnant women who are aware of their diagnosis. In order to use this information to implement evidence-based interventions, these results have to be available to skilled health providers at the point of delivery. Most electronic health platforms are dependent on the availability of reliable Internet connectivity and, thus, have limited use in many rural and resource-limited settings.