The Case for Laboratory Developed Procedures

Kaul, Karen L.; Sabatini, Linda M.; Tsongalis, Gregory J.; Caliendo, Angela M.; Olsen, Randall J.; Ashwood, Edward R.; Bale, Sherri J.; Benirschke, Robert C.; Carlow, Dean; Funke, Birgit; Grody, Wayne W.; Hayden, Randall T.; Hegde, Madhuri; Lyon, Elaine; Murata, Kazunori; Pessin, Melissa S.; Press, Richard D.; Thomson, Richard B.

doi:10.1177/2374289517708309

Cited by 25 publications

(8 citation statements)

References 158 publications

(189 reference statements)

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“…Results from (inter)national EQA show that the success rate depends on the combination of the Ab clone (or polyclonal reference), the detection system, the staining protocol, and the equipment (total process). Hence, both CE-IVD tests according to IFU and LDTs can be used provided that these tests are respectively verified and validated 33 . In addition to verification/validation, in the application of the IVDR, the laboratory will have to provide a justification for the use of an LDT compared with a CE-IVD test according to the IFU.…”

Section: Discussionmentioning

confidence: 99%

Belgian Recommendations for Analytical Verification and Validation of Immunohistochemical Tests in Laboratories of Anatomic Pathology

Verbeke,

Van Hecke,

Bauraing

et al. 2023

Applied Immunohistochemistry &Amp; Molecular Morphology

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Analytical verification and validation of immunohistochemical (IHC) tests and their equipment are common practices for today’s anatomic pathology laboratories. Few references or guidelines are available on how this should be performed. The study of Sciensano (the Belgian national competent authority regarding licensing of medical laboratories) performed in 2016, demonstrated a significant interlaboratory variation in validation procedures of IHC tests among Belgian laboratories. These results suggest the unavailability of practical information on the approach to the verification and validation of these tests. The existing Belgian Practice Guideline for the implementation of a quality management system in anatomic pathology laboratories has been reviewed to meet this demand and, in addition, to prepare the laboratories for the EU—IVD revised regulations (IVDR). This paper describes Belgian recommendations for the verification and validation of IHC tests before implementation, for ongoing validation, and for revalidation. For each type of test (according to the IVDR classification and the origin) and its intended use (purpose), it addresses how to perform analytical verification/validation by recommending: (1) the number of cases in the validation set, (2) the performance characteristics to be evaluated, (3) the objective acceptance criteria, (4) the evaluation method for the obtained results, and (5) how and when to revalidate. A literature study and a risk analysis taking into account the majority of variables regarding verification/validation of methods have been performed, resulting in an expert consensus recommendation that is a compromise among achievability, affordability, and patient safety. This new consensus recommendation has been incorporated in the aforementioned ISO 15189:2012–based Practice Guideline.

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Section: Discussionmentioning

confidence: 99%

Belgian Recommendations for Analytical Verification and Validation of Immunohistochemical Tests in Laboratories of Anatomic Pathology

Verbeke,

Van Hecke,

Bauraing

et al. 2023

Applied Immunohistochemistry &Amp; Molecular Morphology

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“…The proven CLIA model provides a successful approach to the oversight of mHealth apps and ensures that they are both safe and clinically effective. The science of laboratory medicine has evolved rapidly in the three decades since CLIA was enacted, and the model also has been nimble in responding to new technology and approaches [ 11 ].…”

Section: Potential Solutionmentioning

confidence: 99%

A Path to Better-Quality mHealth Apps

Larson¹

2018

JMIR Mhealth Uhealth

108

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The rapid growth of mobile health (mHealth) apps has resulted in confusion among health care providers and the public about which products rely on evidence-based medicine. Only a small subset of mHealth apps are regulated by the US Food and Drug Administration. The system similar to that used to accredit and certify laboratory testing under the Clinical Laboratory Improvement Amendment offers a potential model for ensuring basic standards of quality and safety for mHealth apps. With these products expanding into the realm of diagnosis and treatment, physicians and consumers are in a strong position to demand oversight that delivers safe and high-quality mHealth apps.

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“…Conversely, in our search, we did not find any kit based on the detection of circulating miRNAs approved by the FDA. However, there exists few assays under the oversight provided by the Clinical Laboratory Improvement Amendments (CLIA) which ensures accurate, reliable, and reproducible testing in clinical laboratories [99]. Some examples are ThyGenX® Oncogene Panel and ThyraMIR™ developed by Interpace® Diagnostic Inc. (Parsippany, NJ) and the wide array of miRView tests developed by Rosetta® Genomics (Rehovot, Israel).…”

Section: Epigenetic Biomarkers (Currently Used In Clinical Protocols mentioning

confidence: 99%

Epigenetic biomarkers: Current strategies and future challenges for their use in the clinical laboratory

García-Giménez

Seco-Cervera

Tollefsbol

et al. 2017

Critical Reviews in Clinical Laboratory Sciences

116

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Epigenetic modifications and regulators represent potential molecular elements which control relevant physiological and pathological features, thereby contributing to the natural history of human disease. These epigenetic modulators can be employed as disease biomarkers, since they show several advantages and provide information about gene function, thus explaining differences among patient endophenotypes. In addition, epigenetic biomarkers can incorporate information regarding the effects of the environment and lifestyle on health and disease, and monitor the effect of applied therapies. Technologies used to analyze these epigenetic biomarkers are constantly improving, becoming much easier to use. Laboratory professionals can easily acquire experience and techniques are becoming more affordable. A high number of epigenetic biomarker candidates are being continuously proposed, making now the moment to adopt epigenetics in the clinical laboratory and convert epigenetic marks into reliable biomarkers. In this review, we describe some current promising epigenetic biomarkers and technologies being applied in clinical practice. Furthermore, we will discuss some laboratory strategies and kits to accelerate the adoption of epigenetic biomarkers into clinical routine. The likelihood is that over time, better markers will be identified and will likely be incorporated into future multi-target assays that might help to optimize its application in a clinical laboratory. This will improve cost-effectiveness, and consequently encourage the development of theragnosis and the application of precision medicine.

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The Case for Laboratory Developed Procedures

Cited by 25 publications

References 158 publications

Belgian Recommendations for Analytical Verification and Validation of Immunohistochemical Tests in Laboratories of Anatomic Pathology

Belgian Recommendations for Analytical Verification and Validation of Immunohistochemical Tests in Laboratories of Anatomic Pathology

A Path to Better-Quality mHealth Apps

Epigenetic biomarkers: Current strategies and future challenges for their use in the clinical laboratory

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