scholarly journals Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)

2020 ◽  
Vol 3 (1) ◽  
Author(s):  
Jennifer C. Goldsack ◽  
Andrea Coravos ◽  
Jessie P. Bakker ◽  
Brinnae Bent ◽  
Ariel V. Dowling ◽  
...  
Keyword(s):  
Clinical Validation ◽  
Analytical Validation ◽  
Fit For Purpose ◽  
Monitoring Technologies

scholarly journals Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs) (Preprint)

2019 ◽  
Author(s):  
Jennifer Goldsack ◽  
Andrea Coravos ◽  
Jessie Bakker ◽  
Brinnae Bent ◽  
Ariel V. Dowling ◽  
...  
Keyword(s):  
Best Practices ◽  
Data Science ◽  
Evidence Base ◽  
Evaluation Framework ◽  
Clinical Validation ◽  
Analytical Validation ◽  
Science Data ◽  
Interdisciplinary Field ◽  
Digital Medicine ◽  
Monitoring Technologies

UNSTRUCTURED Digital medicine is an interdisciplinary field, drawing together stakeholders with expertise in engineering, manufacturing, clinical science, data science, biostatistics, regulatory considerations, ethics, patient advocacy, and healthcare policy, to name a few. While this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes 1) verification, 2) analytical validation, and 3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field.

BioMeT and algorithm measures: A proposed standardized evaluation framework (Preprint)

2019 ◽  
Author(s):  
Alan Godfrey ◽  
Jennifer Goldsack ◽  
Pamela Tenaerts ◽  
Clara Aranda ◽  
Azad Hussain ◽  
...  
Keyword(s):  
Healthcare Professionals ◽  
Evaluation Framework ◽  
Audit Trail ◽  
Digital Medicine ◽  
Fit For Purpose ◽  
Monitoring Technologies

UNSTRUCTURED Technology is advancing at extraordinary rates with novel data being generated which could potentially revolutionary different therapeutic areas of medicine. However, adoption is medicine is hampered by a lack of trust, particularly for biometric monitoring technologies (BioMeTs) where a key question facing frontline healthcare professionals is are BioMeTs fit for purpose? Here, we discuss pragmatic barriers and guidance regarding BioMeTs, cumulating in a proposed guidance framework to better inform their development and deployment in digital medicine. Furthermore, the framework proposes a process to establish an audit trail of BioMeTs (hardware and algorithms), to instil trust amongst multidisciplinary users.

scholarly journals Analytical and physiological validation of an enzyme immunoassay to measure oxytocin in dog, wolf, and human urine samples

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
G. Wirobski ◽  
F. S. Schaebs ◽  
F. Range ◽  
S. Marshall-Pescini ◽  
T. Deschner
Keyword(s):  
Enzyme Immunoassay ◽  
Human Urine ◽  
Extraction Efficiency ◽  
Urine Samples ◽  
Antibody Specificity ◽  
Analytical Validation ◽  
Human Urine Samples ◽  
Assay Performance ◽  
Fit For Purpose ◽  
Commercial Enzyme Immunoassay

AbstractOxytocin (OT) promotes pro-sociality, bonding, and cooperation in a variety of species. Measuring oxytocin metabolite (OTM) concentrations in urine or saliva provides intriguing opportunities to study human and animal behaviour with minimal disturbance. However, a thorough validation of analytical methods and an assessment of the physiological significance of these measures are essential. We conducted an analytical validation of a commercial Enzyme Immunoassay (EIA; Arbor OT assay kit) to measure OTM concentrations in dog, wolf, and human urine samples. To test the assay’s ability to detect changes in OTM concentrations, we administered oxytocin intranasally to 14 dogs. Assay performance with regard to parallelism was acceptable. Assay accuracy and extraction efficiency for dog and wolf samples were comparable to a previously validated assay (Enzo OT assay kit) but variation was smaller for human samples. Binding sensitivity and antibody specificity were better in the Arbor assay. Average OTM concentrations were more than twice as high as in comparable samples measured with the Enzo assay, highlighting a lack of comparability of absolute values between different assays. Changes in OTM concentrations after intranasal treatment were detected reliably. The Arbor assay met requirements of a “fit-for-purpose” validation with improvement of several parameters compared to the Enzo assay.

Impact of Fit-for-Purpose Monitoring on EOR Planning

2021 ◽  
Author(s):  
Jaime Eduardo Moreno ◽  
Yunlong Liu ◽  
Oluwale Talabi ◽  
Omer Gurpinar ◽  
Morten Kristensen ◽  
...  
Keyword(s):  
Control Strategies ◽  
Time Lapse ◽  
Monitoring Strategy ◽  
Reservoir Performance ◽  
Fit For Purpose ◽  
Reduce Risk ◽  
Pilot Design ◽  
Monitoring Technologies ◽  
Performance Heterogeneity ◽  
Structured Approach

Abstract Challenges in the design of efficient EOR field pilots have been discussed and documented in the industry, particularly when it comes to optimization of monitoring plans for technical and economical perspectives. This paper explores the benefits of pilot planning where the monitoring/control strategies are included in the early stages of the design to reduce risk of measurements ambiguity and ensure good quality pilot results evaluation. It addresses the use of new and existing technology in monitoring by highlighting the advantages and challenges of each alternative including potential pairing of complementary options to achieve the pilot objectives including illustration of the use of continuous and sporadic measurements on the evaluation. The proposed approach starts with a review of reservoir performance, heterogeneity and pilot objectives to ascertain the plausible monitoring technologies/strategies to aid during the pilot de-risking, followed by the identification of adequate novel and mature monitoring options, which are specific to EOR type and measurement nature (permanent, time lapse, etc.). Advantages of incorporating the monitoring strategy as integral part of the pilot design, as well as evaluation of the effectiveness/viability in the presence of uncertainty of the selected monitoring alternatives are discussed providing a reference of suitable/plausible EOR specific technologies. The paper illustrates the importance of selecting monitoring alternatives that feed off each other and the importance of using fit-for-purpose evaluation algorithms and a digitally enabled, structured approach to analyze and democratize pilot results and enable actionable decisions in operations.

P2-217: Fit for purpose Clinical validation of a multiplex immunoassay for the measurement of Tau, p-Tau and Abeta 42

2011 ◽  
Vol 7 ◽  
pp. S382-S382
Author(s):  
Flora Berisha ◽  
Oitak Allen Wong ◽  
Robert Neely ◽  
Carol Gleason ◽  
Yan Zhang ◽  
...  
Keyword(s):  
Clinical Validation ◽  
Multiplex Immunoassay ◽  
Fit For Purpose

scholarly journals Detecting Spurious Correlations With Sanity Tests for Artificial Intelligence Guided Radiology Systems

2021 ◽  
Vol 3 ◽  
Author(s):  
Usman Mahmood ◽  
Robik Shrestha ◽  
David D. B. Bates ◽  
Lorenzo Mannelli ◽  
Giuseppe Corrias ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Best Practices ◽  
Learning System ◽  
Clinical Validation ◽  
Efficacy And Safety ◽  
Analytical Validation ◽  
Validation Data ◽  
Machine Perception ◽  
Computed Tomography Scans ◽  
Development Data

Artificial intelligence (AI) has been successful at solving numerous problems in machine perception. In radiology, AI systems are rapidly evolving and show progress in guiding treatment decisions, diagnosing, localizing disease on medical images, and improving radiologists' efficiency. A critical component to deploying AI in radiology is to gain confidence in a developed system's efficacy and safety. The current gold standard approach is to conduct an analytical validation of performance on a generalization dataset from one or more institutions, followed by a clinical validation study of the system's efficacy during deployment. Clinical validation studies are time-consuming, and best practices dictate limited re-use of analytical validation data, so it is ideal to know ahead of time if a system is likely to fail analytical or clinical validation. In this paper, we describe a series of sanity tests to identify when a system performs well on development data for the wrong reasons. We illustrate the sanity tests' value by designing a deep learning system to classify pancreatic cancer seen in computed tomography scans.

Analytical and clinical validation of the TruCheck platform for diagnostic triaging of symptomatic cases suspected of colorectal cancer.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 24-24
Author(s):  
Dadasaheb B Akolkar ◽  
Darshana Patil ◽  
Pradip Fulmali ◽  
Pooja Fulmali ◽  
Revati Patil ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Limit Of Detection ◽  
Significant Proportion ◽  
Clinical Validation ◽  
Analytical Validation ◽  
Invasive Approach ◽  
Blood Samples ◽  
Non Invasive ◽  
Asymptomatic Individuals ◽  
Sensitivity Specificity

24 Background: Trucheck is a non-invasive approach for diagnostic triaging of symptomatic individuals who are suspected of Colorectal Cancer (CRC) and have been advised an invasive biopsy. Trucheck evaluates blood samples for presence of Circulating Ensembles of Tumor Associated Cells (C-ETACs: EpCAM+, Pan-CK+, CD45±) originating from a primary Colorectal Adenocarcinoma (CR-AD: CDX-2, CK-20, Muc2); such C-ETACs are unexpected in asymptomatic individuals as well as in individuals with benign Colorectal conditions. Methods: For Analytical Validation, spike-recovery analysis was performed using control cells / cell lines for EpCAM (SKBR-3), Pan-CK (SKBR-3), CD45 (PBMCs), CDX2 (CaCO2), CK20 (HCT15) and MUC2 (SW620) to determine the Sensitivity, Specificity, Accuracy, Limit of Detection, Linearity and Precision. Clinical Validations were performed using 15 mL blood samples from 587 participants. An initial Retrospective Clinical Pre-validation was based on blood samples from 350 known cases of CR-AD and 20 cases of non-CRC. The Prospective Clinical Validation was performed on blood samples collected prior to any invasive procedures from 217 symptomatic cases suspected of CRC. Results: Analytical Validation indicated 100% Sensitivity, 100% Specificity, 100% Accuracy, 90% Precision and significant linearity (R2≥0.98) for all ICC markers. Clinical Pre-validation indicated 84.9 % Sensitivity and 100% Specificity for CR-AD v/s non-CRC. In the Prospective Clinical Validation cohort, histopathological evaluation (HPE) of biopsied tumor tissue indicated benign Colorectal conditions in 10 cases and CR-AD 207 of the 217 suspected cases. Based on HPE as the standard, the Trucheck approach had 90.3% Sensitivity, 100% Specificity and 95.2% Accuracy. Conclusions: Symptomatic individuals suspected of CRC may benefit from the sensitive and specific non-invasive Trucheck approach. Individuals positive for CR-AD-specific C-ETACs can be prioritized for further clinical procedures while C-ETAC negative individuals can be considered for alternate diagnoses. The Trucheck approach can eliminate the need for (and risks associated with) invasive colon biopsies in a significant proportion of suspected cases and is especially useful where

scholarly journals State of the art and trends of circulating cancer biomarkers

2020 ◽  
Vol 35 (1_suppl) ◽  
pp. 12-15
Author(s):  
Massimo Gion ◽  
Chiara Trevisiol ◽  
Aline S.C. Fabricio
Keyword(s):  
Anticancer Agents ◽  
Clinical Utility ◽  
State Of The Art ◽  
Clinical Validation ◽  
Circulating Biomarkers ◽  
Analytical Validation ◽  
Cancer Treatments ◽  
Clinical Role ◽  
Tissue Biomarkers

The role of biomarkers is crucial in oncology for both early diagnosis and the personalization of cancer treatments. Tissue biomarkers have gained a central role as predictors of the response to an increasing number of anticancer agents; conversely, the clinical role of circulating biomarkers (c-TMs) is limited and has remained almost unchanged over the years. The position of guidelines is summarized and discussed with reference to the potential usefulness of c-TMs in those areas of application that cannot be covered by tissue biomarkers. The pipeline of translational research on biomarkers is briefly described; the differences among analytical validation, clinical validation, and clinical utility are discussed, emphasizing that the assessment of clinical utility is the ultimate step toward clinical use. The role of monitoring of appropriateness as a proxy indicator of how the research pipeline has actually worked is discussed, and data and c-TMs overordering rates are reported. The role and limits of guidelines to influence appropriate c-TMs ordering are discussed. The design of primary studies on c-TMs is examined, underlining that they mainly focus on clinical validation rather than on clinical utility. The role of regulatory boards is also briefly presented and discussed.

scholarly journals Validation and Implementation of a Highly Sensitive and Efficient Newborn Screening Assay for Mucopolysaccharidosis Type II

2020 ◽  
Vol 6 (4) ◽  
pp. 79
Author(s):  
Heather Bilyeu ◽  
Jon Washburn ◽  
Lacey Vermette ◽  
Tracy Klug
Keyword(s):  
Newborn Screening ◽  
Hunter Syndrome ◽  
Clinical Validation ◽  
Analytical Sensitivity ◽  
Mucopolysaccharidosis Type ◽  
Type Ii ◽  
Mucopolysaccharidosis Type Ii ◽  
Analytical Validation ◽  
Screening Assay ◽  
Mps Ii

Mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome, is a lysosomal storage disorder (LSD) caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (IDS). MPS II satisfies all criteria defined by the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) for inclusion in the Recommended Uniform Screening Panel (RUSP) for newborn screening, apart from the fact that only minimal prospective population screening data are available. This report details the analytical validation, clinical validation, and implementation of a fluorometric assay for measurement of IDS activity in newborn dried blood spot (DBS) specimens at the Missouri State Public Health Laboratory (MSPHL). The assay is performed in a microwell plate format requiring approximately 15 min of hands-on time per plate and an incubation time of two hours. The analytical validation of this assay included linearity, analytical sensitivity, precision, and carry-over testing. Clinical validation was completed using more than 5000 deidentified presumptive normal newborn DBS specimens as well as seven specimens from patients known to be affected with MPS II. Following validation, MSPHL began prospective screening using the IDS assay on 1 November 2018. In the first 18 months of screening (to 30 June 2020), 146,954 specimens were prospectively screened using the method. Two newborns were identified with severe Hunter syndrome and the assay had a presumptive positive rate of 0.022%.

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