Is the 99th Percentile Cutoff Still Relevant? A Single-Center Assessment of Different Thresholds for Diagnosing Antiphospholipid Syndrome.

Background: The 2023 American College of Rheumatology and modified Sapporo criteria for antiphospholipid syndrome (APS) recommend ELISA to detect anticardiolipin (aCL) and anti-β2-glycoprotein I (aβ2GP1) IgG/IgM antibodies, focusing on moderate to high levels or exceeding the 99th percentile. This study aims to establish the 99th percentile threshold for anti-phospholipid (aPL) antibodies and compare the diagnostic accuracies of these thresholds with manufacturer cutoffs using 2 methodologies.

Methods: The 99th percentile cutoffs for aPL antibodies from 305 healthy donors were established using Aptiva, Particle-Based Multi-Analyte Technology (PMAT), and QUANTA Lite (QL) ELISA, following nonparametric reference interval estimation.

Method validation of an inductively coupled plasma mass spectrometry (ICP-MS) assay for the analysis of magnesium, copper and zinc in red blood cells.

Background: Laboratory measurements of trace elements such as magnesium (Mg), copper (Cu), and zinc (Zn) in red blood cells (RBCs) are essential for assessing nutritional status and diagnosing metal toxicity. The purpose of this study was to develop and validate an ICP-MS method for quantifying these elements in RBCs.

Methods: Packed RBCs were aliquoted and diluted in an alkaline diluent solution containing internal standards, 0.

The incidence of transfusion-related acute lung injury using active surveillance: A systematic review and meta-analysis.

Background: Transfusion-related acute lung injury (TRALI) is a leading cause of transfusion-related mortality. A concern with passive surveillance to detect transfusion reactions is underreporting. Our aim was to obtain evidence-based estimates of TRALI incidence using meta-analysis of active surveillance studies and to compare these estimates with passive surveillance.

Meta-analysis of bacterial growth characteristics in platelet components: Refining the inputs of a simulation analysis comparing the relative safety of testing strategies.

Background: The relative safety of bacterial risk control strategies for platelets that include culture with or without rapid testing has been compared using simulation analysis. A wide range of bacterial lag and doubling times were included. However, published data on growth rates are available and these data have not been synthesized.

Precision quality control: a dynamic model for risk-based analysis of analytical quality.

Objectives: There is continuing pressure to improve the cost effectiveness of quality control (QC) for clinical laboratory testing. Risk-based approaches are promising but recent research has uncovered problems in some common methods. There is a need for improvements in risk-based methods for quality control.

Risk Analysis for Quality Control Part 1: The Impact of Transition Assumptions in the Parvin Model.

Background: Setting quality control (QC) limits involves balancing the risk of false-positive results and false-negative results. Recent approaches to QC have focused on the assessment of false-negative results. The Parvin model is the most-used model for risk analysis.

Risk Analysis for Quality Control Part 3: Practical Application of the Precision Quality Control Model.

Background: We developed a theoretical framework (Precision Quality Control [PQC]) to minimize the cost of quality, but it is not known whether the method can be applied in practice.

Methods: We used data for 2 analytes, cadmium and carbohydrate-deficient transferrin (CDT), and applied the PQC framework to find the optimal control limits. These analytes were selected because they differed with respect to sigma values that are major determinants of control limits.

The Fading of Protective Roots: A Multivariate Analysis of the Risk of Hypertension among Hispanics by Nativity.

Objective: To examine the effects of Hispanic nativity on the risk and severity of hypertension relative to US-born non-Hispanic whites.

Methods: The analytic sample ( = 34,007) was comprised of cross-sectional data drawn from twenty years of the National Health and Nutrition Examination Survey, 1999-2018.

Results: Foreign-born Hispanics aged 65 years and older had a greater risk of severe hypertension compared to non-Hispanic Whites.

Impact of assay stability on the false negative and false positive rates in quality control.

Background: The dynamic Precision QC (PQC) model can be used to evaluate the performance of quality control (QC) monitoring systems. The model depends on inputs that describe the intrinsic shift behavior (i.e.

The epidemiology of transfusion-related acute lung injury: A scoping review and analysis.

Background: The purpose of this scoping review was to identify available sources of evidence on the epidemiology of transfusion-related acute lung injury (TRALI) and whether meta-analysis on the incidence of TRALI is feasible. TRALI is a serious complication and the second leading cause of death related to blood transfusion. Estimates of the incidence of TRALI would provide a useful benchmark for research to reduce TRALI.

Bacterial culture time to detection in platelet components: An evidence synthesis and estimation of detection failures.

Background: Non-pathogen reduction platelet bacterial risk control strategies in the US FDA guidance include at least one culture. Almost all of these strategies have a culture hold time of ≥12 h. Studies have reported time to detection (TTD) of bacterial cultures inoculated with bacteria from contaminated platelets, but these data and estimates of risk associated with detection failures have not been synthesized.

Performance of MPO-ANCA and PR3-ANCA immunoassays for the stratification of specific ANCA-associated vasculitis: A systematic review and meta-analysis.

Objective: To determine the impact of myeloperoxidase (MPO) and proteinase 3 (PR3) antigen-specific immunoassays in the stratification of patients at-risk for anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitides (AAV) at diagnosis.

Methods: A Medline search was conducted to identify diagnostic accuracy studies using PR3-ANCA or MPO-ANCA for the evaluation of granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA). Studies estimates were pooled using the bivariate method.

Platelet Component False Positive Detection Rate in Aerobic and Anaerobic Primary Culture: A Systematic Review and Meta-Analysis.

Septic reactions from platelet transfusions are one of the leading causes of transfusion-associated mortality. The FDA guidance for platelet bacterial risk control includes bacterial culture using both aerobic and anaerobic bottles. Several studies have reported false positive rates (FPR) of culture, but these data have not been summarized or influencing factors analyzed.

The incremental benefit of anaerobic culture for controlling bacterial risk in platelets: a systematic review and meta-analysis.

Background And Objectives: Septic transfusion reactions are a principal cause of transfusion-related mortality. The frequency of detectable bacterial contamination is greater in platelets compared to other blood components because platelets are stored at room temperature. Most strategies outlined in the September 2019 FDA guidance require both aerobic culture (AC) and anaerobic culture (AnC) testing.

Residual bacterial detection rates after primary culture as determined by secondary culture and rapid testing in platelet components: A systematic review and meta-analysis.

Background: Primary culture alone was a bacterial risk control strategy intended to facilitate interdiction of contaminated platelets (PLTs). A September 2019 FDA guidance includes secondary testing options to enhance safety. Our objective was to use meta-analysis to determine residual contamination risk after primary culture using secondary culture and rapid testing.

(1→3)-β-D-glucan testing for the detection of invasive fungal infections in immunocompromised or critically ill people.

Background: Invasive fungal infections (IFIs) are life-threatening opportunistic infections that occur in immunocompromised or critically ill people. Early detection and treatment of IFIs is essential to reduce morbidity and mortality in these populations. (1→3)-β-D-glucan (BDG) is a component of the fungal cell wall that can be detected in the serum of infected individuals.

The comparative safety of bacterial risk control strategies for platelet components: a simulation study.

Background: Bacterial contamination of platelets is a problem that can lead to harmful septic transfusion reactions. The US Food and Drug Administration published a guidance in September 2019 detailing several permissible risk control strategies. Our objective was to compare the safety of each bacterial testing strategy for apheresis platelets.

Bacterial contamination rate of platelet components by primary culture: a systematic review and meta-analysis.

Background: Platelets have the highest bacterial contamination risk of all blood components, and septic transfusion reactions remain a problem. A good estimate of contamination rates could provide information about residual risk and inform optimal testing strategies. We performed a systematic review and meta-analysis of platelet contamination rates by primary culture.

Cost effectiveness of therapeutic drug monitoring for imatinib administration in chronic myeloid leukemia.

Background: Imatinib mesylate (IM) is a first-line treatment option for patients with chronic myeloid leukemia (CML). Patients who fail or are intolerant to IM therapy are treated with more expensive second and third-generation tyrosine kinase inhibitors. Patients show wide variation in trough concentrations in response to standard dosing.

Cost-effectiveness of antifungal prophylaxis, preemptive therapy, or empiric treatment following allogeneic hematopoietic stem cell transplant.

Background: Invasive fungal infection (IFI) is a life-threatening complication of allogeneic hematopoietic stem cell transplantation (HSCT) that is also associated with excess healthcare costs. Current approaches include universal antifungal prophylaxis, preemptive therapy based on biomarker surveillance, and empiric treatment initiated in response to clinical signs/symptoms. However, no study has directly compared the cost-effectiveness of these treatment strategies for an allogeneic HSCT patient population.

An Analysis of Multirules for Monitoring Assay Quality Control.

Background: Multirules are often employed to monitor quality control (QC). The performance of multirules is usually determined by simulation and is difficult to predict. Previous studies have not provided computer code that would enable one to experiment with multirules.

Diagnostic Accuracy of Fine-Needle Aspiration Cytology for Discrimination of Squamous Cell Carcinoma from Adenocarcinoma in Non-Small Cell Lung Cancer: A Systematic Review and Meta-Analysis.

Objective: To determine the accuracy with which morphology alone can distinguish adenocarcinoma and squamous cell carcinoma in non-small cell lung cancer.

Methods: We performed a systematic review and meta-analysis. Three data bases (MEDLINE, EMBASE, Scopus) were searched for studies on the diagnostic accuracy of subtyping non-small cell lung cancer.

Diagnostic Accuracy of β-d-Glucan (Fungitell) Testing Among Patients With Hematologic Malignancies or Solid Organ Tumors: A Systematic Review and Meta-Analysis.

Objectives: To determine the accuracy of Fungitell, a β-d-glucan (BDG) test, for the diagnosis of invasive fungal infection (IFI) among cancer patients.

Methods: For this meta-analysis, MEDLINE and EMBASE were searched for references related to BDG testing. Study quality was evaluated using QUADAS-2.

Quality control limits: Are we setting them too wide?

Background: Quality control charts (Levey Jennings Charts) are based on estimates of variation. There are two general approaches for estimating variation: those based on short-term variation and those based on long-term variation. We have observed that clinical laboratory science (CLS) tends to estimate variation using long-term variation but that most other fields use short-term variation.

Rapid On-Site Evaluation of Fine-Needle Aspiration by Non-Cytopathologists: A Systematic Review and Meta-Analysis of Diagnostic Accuracy Studies for Adequacy Assessment.

Objective: Rapid on-site evaluation (ROSE) has been shown to improve adequacy rates and reduce needle passes. ROSE is often performed by cytopathologists who have limited availability and may be costlier than alternatives. Several recent studies examined the use of alternative evaluators (AEs) for ROSE.