Authors: M T Tetzlaff, J L Messina, J E Stein...

BACKGROUND

Clinical trials have recently evaluated safety and efficacy of neoadjuvant therapy among patients with surgically resectable regional melanoma metastases. To capture informative prognostic data connected to pathological response in such trials, it is critical to standardize pathologic assessment and reporting of tumor response after this treatment.

METHODS

The International Neoadjuvant Melanoma Consortium meetings in 2016 and 2017 assembled pathologists from academic centers to develop consensus guidelines for pathologic examination and reporting of surgical specimens from AJCC (8th edition) stage IIIB/C/D or oligometastatic stage IV melanoma patients treated with neoadjuvant-targeted or immune therapy. Patterns of pathologic response are provided context to inform these guidelines.

RESULTS

Based on our collective experience and guided by efforts in well-established neoadjuvant settings like breast cancer, procedures directing handling of pre- and post-neoadjuvant therapy-treated melanoma specimens are provided to facilitate comparison of findings across different trials and centers. Definitions of pathologic response are provided together with guidelines for reporting and quantifying the extent of pathologic response. Finally, the spectrum of histopathologic responses observed following neoadjuvant-targeted and immune-checkpoint therapy is described and illustrated.

CONCLUSIONS

Standardizing pathologic evaluation of resected melanoma metastases following neoadjuvant-targeted or immune-checkpoint therapy allows more robust stratification of patient outcomes. This includes recognizing the spectrum of histopathologic response patterns to neoadjuvant therapy and a standard approach to grading pathologic responses. Such an approach will facilitate comparison of results across clinical trials and inform ongoing correlative studies into the mechanisms of response and resistance to agents applied in the neoadjuvant setting.

Topics: Antineoplastic Agents, Immunological; Biopsy; Clinical Trials as Topic; Consensus; Dermatologic Surgical Procedures; Dermatology; Humans; Lymph Node Excision; Lymph Nodes; Medical Oncology; Melanoma; Neoadjuvant Therapy; Pathology; Practice Guidelines as Topic; Prognosis; Skin; Skin Neoplasms; Specimen Handling; Treatment Outcome

PubMed: 29945191
DOI: 10.1093/annonc/mdy226

Review

Authors: Xuemei Zeng, Yijun Chen, Anuradha Sehrawat...

Alzheimer's disease (AD), the most common form of dementia, remains challenging to understand and treat despite decades of research and clinical investigation. This might be partly due to a lack of widely available and cost-effective modalities for diagnosis and prognosis. Recently, the blood-based AD biomarker field has seen significant progress driven by technological advances, mainly improved analytical sensitivity and precision of the assays and measurement platforms. Several blood-based biomarkers have shown high potential for accurately detecting AD pathophysiology. As a result, there has been considerable interest in applying these biomarkers for diagnosis and prognosis, as surrogate metrics to investigate the impact of various covariates on AD pathophysiology and to accelerate AD therapeutic trials and monitor treatment effects. However, the lack of standardization of how blood samples and collected, processed, stored analyzed and reported can affect the reproducibility of these biomarker measurements, potentially hindering progress toward their widespread use in clinical and research settings. To help address these issues, we provide fundamental guidelines developed according to recent research findings on the impact of sample handling on blood biomarker measurements. These guidelines cover important considerations including study design, blood collection, blood processing, biobanking, biomarker measurement, and result reporting. Furthermore, the proposed guidelines include best practices for appropriate blood handling procedures for genetic and ribonucleic acid analyses. While we focus on the key blood-based AD biomarkers for the AT(N) criteria (e.g., amyloid-beta [Aβ]40, Aβ42, Aβ42/40 ratio, total-tau, phosphorylated-tau, neurofilament light chain, brain-derived tau and glial fibrillary acidic protein), we anticipate that these guidelines will generally be applicable to other types of blood biomarkers. We also anticipate that these guidelines will assist investigators in planning and executing biomarker research, enabling harmonization of sample handling to improve comparability across studies.

Topics: Humans; Alzheimer Disease; Biomarkers; Biological Specimen Banks; Research Design; Amyloid beta-Peptides; Specimen Handling; tau Proteins

PubMed: 38750570
DOI: 10.1186/s13024-024-00711-1

Randomized Controlled Trial

Authors: A Lalezari, M J Cohen, O Svinik...

OBJECTIVES

Blood culture contamination carries risks for patients, such as unnecessary antimicrobial therapy and other additional hazards and costs. One method shown to be effective in reducing contamination is initial blood specimen diversion during collection. We hypothesized that initial blood specimen diversion without a designated device or procedure would suffice for reduction in blood culture contamination rate.

METHODS

From 1 September 2017 through to 6 September 2018, we conducted a randomized controlled trial to assess the effect of an initial-specimen diversion technique (ISDT) on the rate of blood-culture contamination by changing the order of sampling using regular vacuum specimen tubes instead of commercially available sterile diversion devices. We included adults from whom the treating physician planned to take blood cultures and additional blood chemistry tests. Additionally, we evaluated the potential economic benefits of an ISDT. This was a researcher-initiated trial, Clinicaltrials.gov NCT03088865.

RESULTS

In all, 756 patients were enrolled. This method, compared with the standard procedure in use at our medical centre, reduced contamination by 66% (95% CI 17%-86%), from 20/400 (5%) with the standard method to 6/356 (1.6%) with the ISDT, without compromising detection of true bloodstream infection and at no additional cost. Hospital-wide implementation of ISDT was associated with a 1.1% saving in hospitalization days.

CONCLUSIONS

We offer this novel approach as a simple, cost-effective measure to reduce risks to patient safety from contaminated blood cultures, without the need for using costly devices.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Culture; Blood Specimen Collection; Costs and Cost Analysis; Female; Hospitals; Humans; Male; Middle Aged; Prospective Studies; Specimen Handling; Young Adult

PubMed: 31539635
DOI: 10.1016/j.cmi.2019.09.005

Authors: M Mathai

Topics: Amniocentesis; Clinical Protocols; Female; Humans; Pregnancy; Pregnancy Trimester, Second; Pregnancy Trimester, Third; Specimen Handling

PubMed: 1304245
DOI: No ID Found

Review

Authors: Yuxin Li, Yourong Ou, Kexin Fan...

Saliva contains a diverse array of biomarkers indicative of various diseases. Saliva testing has been a major advancement towards non-invasive point-of-care diagnosis with clinical significance. However, there are challenges associated with salivary diagnosis from sample treatment and standardization. This review highlights the biomarkers in saliva and their role in identifying relevant diseases. It provides an overview and discussion about the current practice of saliva collection and processing, and advancements in saliva detection systems from methods to wearable oral devices. The review also addresses challenges in saliva diagnostics and proposes solutions, aiming to offer a comprehensive understanding and practical guidance for improving saliva-based detection in clinical diagnosis. Saliva diagnosis provides a rapid, effective, and safe alternative to traditional blood and urine tests for screening large populations and enhancing infectious disease diagnosis and surveillance. It meets the needs of various fields such as disease management, drug screening, and personalized healthcare with advances in saliva detection systems offering high sensitivity, fast response times, portability, and automation. Standardization of saliva collection, treatment, biomarker discovery, and detection between different laboratories needs to be implemented to obtain reliable salivary diagnosis in clinical practice.

Topics: Saliva; Humans; Biomarkers; Specimen Handling; Point-of-Care Systems

PubMed: 39629130
DOI: 10.7150/thno.100600

Review

Authors: W Stuart A Smellie

Although severe hyperkalaemia is life threatening and a medical emergency, spurious hyperkalaemia (pseudohyperkalaemia) is common in blood samples taken in primary care, often because of sampling conditions and storage and transport problems

Topics: Aged; Diagnostic Errors; Female; Humans; Hyperkalemia; Male; Referral and Consultation; Specimen Handling

PubMed: 17395950
DOI: 10.1136/bmj.39119.607986.47

Review

Authors: Caitlyn R Martinez, Kelly S Santangelo

Synovial fluid analysis is a key component of the minimum database needed to diagnose and manage primary and secondary articular joint disorders. Unfortunately, preanalytical variables can drastically alter samples submitted for evaluation to veterinary laboratories and it is considered the stage at which most laboratory error occurs. This article addresses common sources of preanalytical variability and error that are seen in veterinary medicine. With consistent quality control and reporting of specimens, downstream clinical decision making and management of patients can be accelerated and improved.

Topics: Animals; Cytological Techniques; Specimen Handling; Synovial Fluid

PubMed: 27720280
DOI: 10.1016/j.cvsm.2016.07.007

Authors: E R Brown

Mandated, universal metabolic screening has been an effective tool for the early identification of infants with metabolic disorders, particularly those amenable to improved outcome with dietary management or medication. Although the availability of diagnosis long before symptoms occur may be useful to preclude expensive diagnostic evaluation when the subtle early symptoms begin and may allow for genetic counseling and testing in affected families, many concerns have been raised regarding the psychologic impact of presymptomatic diagnosis of diseases that are either fatal or for which no effective treatment is available. Before mass screening is initiated, careful pilot studies need to be done to evaluate sensitivity and specificity as well as the impact of early identification on infant outcome.

Topics: Humans; Infant, Newborn; Metabolism, Inborn Errors; Neonatal Screening; Specimen Handling

PubMed: 9646999
DOI: No ID Found

Review

Authors: Heather A Lankes, Hala Makhlouf

OBJECTIVES

Millions of biospecimens will be collected during the coronavirus disease 2019 (COVID-19) pandemic. As learned from severe acute respiratory syndrome (SARS), proper biospecimen handling is necessary to prevent laboratory-related infections.

METHODS

Centers for Disease Control and Prevention and World Health Organization severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) interim biosafety guidelines continue to be updated. Presented here are additional considerations intended to complement the interim guidance. These considerations draw on prior SARS recommendations and recent COVID-19 reports.

RESULTS

SARS-CoV-2 viral RNA has been detected in various biospecimen types; however, studies are needed to determine whether viral load indicates viable virus. Throughout the pandemic, biospecimens will be collected for various purposes from COVID-19 known and suspected cases, as well as presymptomatic and asymptomatic individuals. Current data suggest the pandemic start may be as early as October 2019; thus, all biospecimens collected since could be considered potentially infectious.

CONCLUSIONS

All entities handling these biospecimens should do risk assessments in accordance with institutional policies and adhere to any guidance provided. The scientific community has a responsibility to safely handle and maintain all biospecimens collected during the COVID-19 pandemic. Soon, it will be imperative to convene expert working groups to address the current and long-term storage and use of these biospecimens. Ideally, worldwide guidelines will be established to protect the personnel handling these biospecimens and communities at large.

Topics: Biological Specimen Banks; COVID-19; Clinical Laboratory Services; Global Health; Humans; Infection Control; Occupational Diseases; Pandemics; Practice Guidelines as Topic; Specimen Handling; Viral Load

PubMed: 32974640
DOI: 10.1093/ajcp/aqaa171

Review

Authors: Paolo A Ascierto, Carlo Bifulco, Giuseppe Palmieri...

An enduring goal of personalized medicine in cancer is the ability to identify patients who are likely to respond to specific therapies. Our growing understanding of the biology and molecular signatures of individual tumor types has facilitated the identification of predictive biomarkers and has led to an increasing number of diagnostic tests to be performed, often as serial and distinct assays on limited tumor specimens. The biomarker diagnostics field has been revolutionized by next-generation sequencing (NGS), which provides a comprehensive overview of the genomic profile of a tumor. Many preanalytic variables can influence the accuracy and reliability of NGS results. Standardization of preanalytic variables is, however, complicated by the plethora of specimen acquisition and processing methods. Variables across the tissue journey, including specimen acquisition, specimen fixation, and sectioning, as well as postfixation processing, such as nucleic acid extraction, library preparation, and choice of sequencing methods, are critical for the reliability of NGS analysis; thus, standardization would be beneficial. In this article, each step in the tissue journey is outlined, with specific focus on preanalytic variables that can influence NGS results. Practical considerations for standardization of these variables are provided to facilitate accurate, reliable, and reproducible NGS-based molecular characterization of tumors, ultimately informing diagnosis and guiding treatment.

Topics: Gene Library; High-Throughput Nucleotide Sequencing; Humans; Neoplasms; Precision Medicine; Sequence Analysis, DNA; Specimen Handling

PubMed: 31251989
DOI: 10.1016/j.jmoldx.2019.05.004