Real evidence to assess clinical testing interference risk (REACTIR): A strategy using real world data to assess the prevalence of interfering substances in patients undergoing clinical laboratory testing.

Introduction: Laboratory test interferences can cause spurious test results and patient harm. Knowing the frequency of various interfering substances in patient populations likely to be tested with a particular laboratory assay may inform test development, test utilization and strategies to mitigate interference risk.

Methods: We developed REACTIR (Real Evidence to Assess Clinical Testing Interference Risk), an approach using real world data to assess the prevalence of various interfering substances in patients tested with a particular type of assay.

A Multicenter Evaluation of a Point-of-Care Blood Glucose Meter System in Critically Ill Patients.

Background: Our purpose was to evaluate the performance of the ACCU-CHEK® Inform II blood glucose monitoring system (Roche Diagnostics GmbH) compared with the perchloric acid hexokinase (PCA-HK) comparator method on the cobas® 6000 analyzer (Roche Diagnostics International Ltd) in critically ill patients.

Methods: Overall, 476 arterial (376 pediatric/adult, 100 neonate), 375 venous, and 100 neonatal heel-stick whole-blood samples were collected and evaluated from critical care settings at 10 US hospitals, including the emergency department, medical and surgical intensive care units (ICUs), and neonatal and pediatric ICUs. The ACCU-CHEK Inform II system was evaluated at 2 cutoff boundaries: boundary 1 was ≥95% of results within ±12 mg/dL of the reference (samples with blood glucose <75 mg/dL) or ±12% of the reference (glucose ≥75 mg/dL), and boundary 2 was ≥98% of results within ±15 mg/dL or ±15% of the reference.

Implementation of High-Sensitivity and Point-of-Care Cardiac Troponin Assays into Practice: Some Different Thoughts.

Background: The primary role of the International Federation of Clinical Chemistry (IFCC) Committee on Clinical Application of Cardiac Bio-Markers (C-CB) is to provide educational materials about cardiac biomarker use, emphasizing high-sensitivity cardiac troponin assays.

Content: This mini-review, regarding high-sensitivity cardiac and point-of-care troponin assays, addresses 1) new IFCC C-CB/AACC Academy laboratory practice recommendations; 2) new and updated concepts from the Fourth Universal Definition of Myocardial Infarction; 3) the role of point-of-care assays in practice and research; 4) regulatory challenges concerning point-of-care assays; e) testing in the COVID-19 world.

Summary: Implementation of high-sensitivity cardiac troponin assays makes a difference now and into the future in clinical practice and research.

Assay Integrity of a PCR Influenza Point-of-Care Test Remains Following Artificial System Contamination.

Background: Healthcare providers who have access to tests at the point of care (POC) are increasingly requesting the same performance from the POC test as they expect from the laboratory. With the introduction of the cobas Liat instrument, highly sensitive molecular diagnostic testing can be performed closer to the patient in CLIA-waived, POC settings. As more sensitive tests become available, there is concern regarding contamination of instrumentation owing to improper handling, mistakes made when processing, or environmental contamination.

Current evidence and future perspectives on the effective practice of patient-centered laboratory medicine.

Background: Systematic evidence of the contribution made by laboratory medicine to patient outcomes and the overall process of healthcare is difficult to find. An understanding of the value of laboratory medicine, how it can be determined, and the various factors that influence it is vital to ensuring that the service is provided and used optimally.

Content: This review summarizes existing evidence supporting the impact of laboratory medicine in healthcare and indicates the gaps in our understanding.

Pathology consultation on prostate-specific antigen testing.

Objectives: To provide clarity on the pros and cons of using prostate-specific antigen (PSA) as a screening tool for prostate cancer.

Methods: Case scenarios and a literature review of recently published clinical trial data are presented to provide evidence of the controversy.

Results: PSA is a sensitive biomarker for detecting diseases of the prostate, but it is limited in its ability to distinguish cancerous from noncancerous conditions or aggressive from indolent cancers and has resulted in a considerable amount of overdiagnosis and overtreatment.

A prospective tool for risk assessment of sendout testing.

Objective: Errors associated with laboratory testing can cause significant patient harm. Sendout testing refers to tests sent by a primary lab to a reference lab when testing is unavailable at the primary lab. Sendout testing is particularly high risk for patient harm, due to many factors including increased hand-offs, manual processes, and complexity associated with rare, low-volume tests.

Barriers to quality health care for the transgender population.

The transgender community is arguably the most marginalized and underserved population in medicine. A special issue focusing on men's health would be incomplete without mention of this vulnerable population, which includes those transitioning to and from the male gender. Transgender patients face many barriers in their access to healthcare including historical stigmatization, both structural and financial barriers, and even a lack of healthcare provider experience in treating this unique population.

Interpreting laboratory results in transgender patients on hormone therapy.

Background: Clinical guidelines recommend laboratory monitoring of transgender persons on cross-sex hormone therapy, but gender-specific reference intervals leave clinicians with the dilemma of deciding what is "normal" for each patient. The goal of this study was to identify consistent changes in measurands with hormone therapy and determine which reference interval is appropriate.

Methods: Laboratory data were abstracted from the medical records of 55 male-to-female patients on hormone therapy and compared with 20 male and 20 female nontransgender subjects.

Dermal exposure to a compounded pain cream resulting in severely elevated clonidine concentration.

Introduction: Clonidine is an imidazoline derivative antihypertensive medication that is also used as adjunctive therapy for neuropathic pain disorders via topical administration. Clonidine overdose can manifest both central and peripheral alpha-adrenergic agonist effects.

Case Report: A 23-year-old man presented to an emergency department with altered mental status, bradycardia, and hypertension after suspected overdose.

Using an algorithmic approach to secondary amenorrhea: Avoiding diagnostic error.

Secondary amenorrhea in women of reproductive age may be an indication of an undiagnosed, chronic condition and appropriate treatment is dependent upon accurate diagnosis of the underlying etiology. A thorough clinical assessment and a few common laboratory tests can easily identify the most frequent causes of secondary amenorrhea. However, once these have been ruled out, the more uncommon pathophysiologies can be difficult to diagnose due to similarities in presentation and appropriate laboratory testing and interpretation become critical.

Teaching laboratory medicine to medical students: implementation and evaluation.

Context: Laboratory medicine is an integral component of patient care. Approximately 60% to 70% of medical decisions are based on laboratory results. Physicians in specialties that order the tests are teaching medical students laboratory medicine and test use with minimal input from laboratory scientists who implement and maintain the quality control for those tests.

Effectiveness of barcoding for reducing patient specimen and laboratory testing identification errors: a Laboratory Medicine Best Practices systematic review and meta-analysis.

Objectives: This is the first systematic review of the effectiveness of barcoding practices for reducing patient specimen and laboratory testing identification errors.

Design And Methods: The CDC-funded Laboratory Medicine Best Practices Initiative systematic review methods for quality improvement practices were used.

Results: A total of 17 observational studies reporting on barcoding systems are included in the body of evidence; 10 for patient specimens and 7 for point-of-care testing.

Development of a fast and simple liquid chromatography-tandem mass spectrometry method for the quantitation of argatroban in patient plasma samples.

An ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for the direct measurement of argatroban in human plasma was developed and compared with the activity-based Hemoclot Thrombin Inhibitors assay. UPLC-MS/MS was performed using diclofenac as an internal standard. In summary, argatroban and diclofenac were extracted from 100 μL of plasma using a methanol precipitation protocol, and chromatographic separation was performed on an ACQUITY TQD mass spectrometer using a UPLC C18 BEH 1.

Falsely decreased human chorionic gonadotropin (hCG) results due to increased concentrations of the free beta subunit and the beta core fragment in quantitative hCG assays.

Background: Earlier studies have shown that increased concentrations of certain human chorionic gonadotropin (hCG) variants can cause false-negative results in some qualitative hCG devices. The objective of this study was to determine if increased concentrations of hCGβ and hCGβ core fragment (hCGβcf) cause falsely decreased results on 9 commercially available quantitative hCG assays.

Methods: Several concentrations of purified hCGβ and hCGβcf were added to 2 sets of 6 serum samples with and without a fixed concentration of intact hCG.

Patient misidentifications caused by errors in standard bar code technology.

Background: Bar code technology has decreased transcription errors in many healthcare applications. However, we have found that linear bar code identification methods are not failsafe. In this study, we sought to identify the sources of bar code decoding errors that generated incorrect patient identifiers when bar codes were scanned for point-of-care glucose testing and to develop solutions to prevent their occurrence.