scholarly journals Considerations from the College of American Pathologists for implementation of an assay for SARS-CoV-2 testing after a change in regulatory status

2021 ◽  
Author(s):  
David R. Peaper ◽  
Daniel D. Rhoads ◽  
Kaede V. Sullivan ◽  
Marc R. Couturier ◽  
Romney M. Humphries ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Clinical Laboratory ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Regulatory Status ◽  
Pass Through ◽  
Clinical Laboratory Improvement Amendments ◽  
Regulatory Landscape ◽  
The U.S

The U.S. Food & Drug Administration FDA regulates the marketing of manufacturers’ in vitro diagnostic tests IVDs including assays for the detection of SARS-CoV-2. The U.S. government’s Clinical Laboratory Improvement Amendments CLIA of 1988 regulate the studies that a clinical diagnostic laboratory needs to perform for an IVD before placing it into use. Until recently, the FDA has authorized the marketing of SARS-CoV-2 IVDs exclusively through the Emergency Use Authorization EUA pathway. The regulatory landscape continues to evolve, and IVDs will eventually be required to pass through conventional non-EUA FDA review pathways once the emergency declaration is terminated in order to continue to be marketed as an IVD in the U.S. When FDA regulatory status of an IVD changes or is anticipated to change, the laboratory should review manufacturer information and previously performed internal verification studies to determine what, if any, additional studies are needed before implementing the non-EUA version of the IVD in accordance with CLIA regulations. Herein, the College of American Pathologists’ Microbiology Committee provides guidance for how to approach regulatory considerations when an IVD is converted from EUA to non-EUA status.

Organization of the work of the medical laboratory service in accordance with the requirements of the standard GOST ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence»

2020 ◽  
pp. 15-22
Author(s):  
Elena Vitalievna Perminova
Keyword(s):  
Clinical Laboratory ◽  
Medical Laboratory ◽  
Laboratory Research ◽  
Laboratory Diagnostics ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Iso 15189 ◽  
Laboratory Service ◽  
Medical Laboratories

Clinical laboratory diagnostics is a medical specialty, which is based on in vitro diagnostic studies of biomaterial obtained from an individual. At the present stage, there are three main types of organization of the laboratory research process — a laboratory service as part of a medical and preventive institution, a centralized laboratory where biomaterials are delivered for research from various healthcare institutions, as well as mobile laboratories that allow conducting the research directly at the patient’s bedside. This discipline involves the use of a wide variety of diagnostic research methods and the use of a huge number of specific techniques. Their list should include carrying out hematological, microbiological, virological, immunological, serological, parasitic, and biochemical studies. Also, when organizing laboratory diagnostic activities, a number of other studies (cytological, histological, toxicological, genetic, molecular biological, etc.) are provided. A laboratory report is formulated after obtaining clinical data and comparing them with the obtained test results. The quality of laboratory tests is ensured through the systematic implementation of internal laboratory control, as well as participation in a national program for external quality assessment. The activities of the clinical diagnostic laboratory should be organized in accordance with the requirements of the standard GOST R ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence», which is based on the provisions of two more fundamental standards — ISO 9001 and ISO 17025, and adds a number of special requirements related to medical laboratories.

scholarly journals Laboratory-Developed Tests: A Legislative and Regulatory Review

2017 ◽  
Vol 63 (10) ◽  
pp. 1575-1584 ◽  
Author(s):  
Jonathan R Genzen ◽  
Jeffrey S Mohlman ◽  
Jerry L Lynch ◽  
Michael W Squires ◽  
Ronald L Weiss
Keyword(s):  
Clinical Laboratory ◽  
Draft Guidance ◽  
In Vitro Diagnostics ◽  
Regulatory Oversight ◽  
Regulatory Review ◽  
Policy Documents ◽  
Congressional Hearings ◽  
Clinical Laboratory Improvement Amendments ◽  
Intense Debate

Abstract BACKGROUND Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that “home brew” tests—now commonly referred to as laboratory-developed tests (LDTs)—are subject to the same regulatory oversight as other in vitro diagnostics (IVDs)4. In 2010, the FDA began work on developing a proposed framework for future LDT oversight. Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation. While the proposed guidance has not been implemented, many questions regarding LDT oversight remain unresolved. CONTENT This review provides an overview of federal statutes and regulations related to IVDs and clinical laboratory operations, with a focus on those potentially applicable to LDTs and proposed regulatory efforts. Sources reviewed include the Code of Federal Regulations, the Federal Register, congressional hearings, guidance and policy documents, position statements, published literature, and websites. SUMMARY Federal statutes regarding IVDs were passed without substantive evidence of congressional consideration toward the concept of LDTs. The FDA has clear oversight authority over IVD reagents introduced into interstate commerce. A 16-year delay in publicly asserting FDA authority over LDTs, the pursuit of a draft guidance approach toward oversight, and establishment of regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) applicable to LDTs contributed to community uncertainty toward LDT oversight. Future regulatory and/or legislative efforts may be required to resolve this uncertainty.

Verification of Performance Specifications of a Molecular Test: Cystic Fibrosis Carrier Testing Using the Luminex Liquid Bead Array

2012 ◽  
Vol 136 (1) ◽  
pp. 14-19 ◽  
Author(s):  
Felicitas L Lacbawan ◽  
Karen E Weck ◽  
Jeffrey A Kant ◽  
Gerald L Feldman ◽  
Iris Schrijver ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Drug Administration ◽  
Clinical Laboratory ◽  
Food And Drug Administration ◽  
Carrier Testing ◽  
Clinical Diagnostic Laboratory ◽  
Cystic Fibrosis Carrier ◽  
Performance Specifications ◽  
In Vitro Diagnostic

Context.—The number of clinical laboratories introducing various molecular tests to their existing test menu is continuously increasing. Prior to offering a US Food and Drug Administration–approved test, it is necessary that performance characteristics of the test, as claimed by the company, are verified before the assay is implemented in a clinical laboratory. Objective.—To provide an example of the verification of a specific qualitative in vitro diagnostic test: cystic fibrosis carrier testing using the Luminex liquid bead array (Luminex Molecular Diagnostics, Inc, Toronto, Ontario). Design.—The approach used by an individual laboratory for verification of a US Food and Drug Administration–approved assay is described. Results.—Specific verification data are provided to highlight the stepwise verification approach undertaken by a clinical diagnostic laboratory. Conclusions.—Protocols for verification of in vitro diagnostic assays may vary between laboratories. However, all laboratories must verify several specific performance specifications prior to implementation of such assays for clinical use. We provide an example of an approach used for verifying performance of an assay for cystic fibrosis carrier screening.

scholarly journals Accurate PCR Detection of Influenza A/B and Respiratory Syncytial Viruses by Use of Cepheid Xpert Flu+RSV Xpress Assay in Point-of-Care Settings: Comparison to Prodesse ProFlu+

2017 ◽  
Vol 56 (2) ◽  
Author(s):  
Daniel M. Cohen ◽  
Jennifer Kline ◽  
Larissa S. May ◽  
Glenn Eric Harnett ◽  
Jane Gibson ◽  
...  
Keyword(s):  
Influenza A ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Reverse Transcription Pcr ◽  
Qualitative Detection ◽  
High Concordance ◽  
Respiratory Syncytial Viruses ◽  
Syncytial Virus ◽  
Clinical Laboratory Improvement Amendments

ABSTRACT The Xpert Flu+RSV Xpress Assay is a fast, automated in vitro diagnostic test for qualitative detection and differentiation of influenza A and B viruses and respiratory syncytial virus (RSV) performed on the Cepheid GeneXpert Xpress System. The objective of this study was to establish performance characteristics of the Xpert Flu+RSV Xpress Assay compared to those of the Prodesse ProFlu+ real-time reverse transcription-PCR (RT-PCR) assay (ProFlu+) for the detection of influenza A and B viruses as well as RSV in a Clinical Laboratory Improvement Amendments (CLIA)-waived (CW) setting. Overall, the assay, using fresh and frozen nasopharyngeal (NP) swabs, demonstrated high concordance with results of the ProFlu+ assay in the combined CW and non-CW settings with positive percent agreements (PPA) (100%, 100%, and 97.1%) and negative percent agreements (NPA) (95.2%, 99.5%, and 99.6%) for influenza A and B viruses and RSV, respectively. In conclusion, this multicenter study using the Cepheid Xpert Flu+RSV Xpress Assay demonstrated high sensitivities and specificities for influenza A and B viruses and RSV in ∼60 min for use at the point-of-care in the CW setting.

scholarly journals Stability Testing, Shelf Life and Product Expiration Dating

1998 ◽  
Vol 6 (10) ◽  
pp. 20-21
Author(s):  
Peter A. Takes
Keyword(s):  
Shelf Life ◽  
Laboratory Research ◽  
Stability Testing ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
In Vitro Diagnostic ◽  
Expiration Dating ◽  
Intended Use ◽  
Specific Reagent

Reagents available for laboratory, research, and clinical use are often acquired with a specified expiration date. Yet, many are not, depending on the manufacturer and reagent type. What a manufacturer does is frequency determined by how they label the product.The U.S. Ricd and Drug Administration [FDA] has defined categories by which reagents can he labeled based on their “intended use”. individual reagents (e.g., antibodies) intended for clinical diagnostic laboratory use will be labeled as an in Vitro Diagnostic [IVD] or Analyte Specific Reagent [ASR]. Under these categories, specified expiration dates must be supported by stability testing which establishes the product shelf life.

scholarly journals Laboratory and patient of kyiv city clinical emergency hospital

2021 ◽  
Vol 11 (5) ◽  
pp. 158-165
Author(s):  
O. B. Kryatchenko ◽  
V. P. Pechyborsch ◽  
V. M. Yakimets ◽  
S. I. Mazii ◽  
O. V. Pechyborsch ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Absolute Number ◽  
Laboratory Research ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Systematic Analysis ◽  
Emergency Hospital ◽  
Treatment And Prevention ◽  
Clinical Diagnostic ◽  
Clinical Emergency

The aim of the work is to analyze the activities of the clinical diagnostic laboratory of the Kyiv City Clinical Emergency Hospital (hereinafter – KCCEH) in comparison with the hospitals of Kyiv for 2017-2018 and determine the role of existing mechanisms to optimize the activities of this laboratory.The article uses the materials of statistical reports of KCCEH and treatment and prevention facilities of Kyiv for 2017-2018 using the method of systematic analysis of statistical materials, as well as systemic and structural-functional approaches.Analysis of the main performance indicators of the clinical diagnostic laboratory of the Kyiv City Clinical Emergency Hospital shows that in 2018 compared to 2017 there is an increase of 2.9% in the absolute number of laboratory tests due to increased highly informative research and introduction of innovative technologies in diagnosis.In the context of reforming the health care system under the conditions of social and economic crisis and our country's hybrid war, the only most appropriate way to optimize the laboratory department of the Kyiv City Clinical Emergency Hospital and similar hospitals in Ukraine is the centralization of clinical laboratory research and laboratory services.

scholarly journals Laboratory monitoring analysis and prospects for using its results in specialized clinical diagnostic laboratory

2020 ◽  
pp. 8-12
Author(s):  
V. V. Bibikova ◽  
V. L. Emanuel
Keyword(s):  
Retrospective Analysis ◽  
Clinical Laboratory ◽  
Diagnostic Methods ◽  
Diagnostic Process ◽  
Laboratory Monitoring ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Everyday Activity ◽  
Clinical Diagnostic ◽  
The Everyday

This article presents a retrospective analysis of the laboratory monitoring orders from the specialized clinical laboratory. It has been established that large amounts of information about rare, poorly understood diseases and special types of pathology are accumulated during the everyday activity of specialized clinical laboratory. This research indicated that the share of laboratory monitoring, with 17 % of all orders, has a tendency to increase, which may be associated with the improvement of laboratory diagnostic methods. The possibility of laboratory monitoring results using in order to facilitate diagnostic process by the means of an optimal examination algorithm compiling, as well as to study regional pathology, is discussed. Besides, the prospects of using information on laboratory monitoring in improving the organization of specialized clinical laboratory’s activity are assessed.

A Hexagonal (II) Phase Phospholipid Neutralization Assay for Lupus Anticoagulant Identification

1993 ◽  
Vol 70 (05) ◽  
pp. 787-793 ◽  
Author(s):  
Douglas A Triplett ◽  
Linda K Barna ◽  
Gail A Unger
Keyword(s):  
Hemophilia A ◽  
Clinical Laboratory ◽  
Neutralization Assay ◽  
Confirmatory Test ◽  
Specific Factor ◽  
Clinical Settings ◽  
Drug Induced ◽  
Variable Screening ◽  
Routine Clinical Laboratory

SummaryLupus anticoagulants (LAs) are immunoglobulins (IgG, IgM, or both) which interfere with in vitro phospholipid (PL) dependent tests of coagulation (e.g. APTT, dilute PT, dilute Russell Viper Venom Time). These antibodies may be identified in a wide variety of clinical settings. With the exception of heparinized patient samples, the presence of LAs is often the most common cause of an unexplained APTT in a routine clinical laboratory. The diagnosis of LAs is difficult due to variable screening reagent sensitivity and intrinsic heterogeneity of LAs. Recently, Rauch and colleagues have shown human monoclonal hybridoma LAs were inhibited by hexagonal (II) phase PLs. In contrast, lamellar phase PLs had no effect. We have evaluated a new assay system, Staclot LA®, which utilizes a hexagonal (II) phase PL (egg phosphatidylethanolamine [EPE]) as a confirmatory test for LAs. Plasma samples from the following patient populations were studied: LA positive, heparinized, oral anticoagulated, hemophilia A and B, and specific factor inhibitors (factors V, VIII, IX). Unlike previous studies, the LA positive patients were a mixed population including: autoimmune diseases, drug-induced, and post-infection. Our findings confirm the specificity of hexagonal (II) phase PL neutralization of LAs.

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