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.

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.

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 Food and Drug Administration (FDA)'s impact on laboratory performance: FDA's perspective

1996 ◽  
Vol 42 (5) ◽  
pp. 786-789
Author(s):  
S Gutman
Keyword(s):  
Drug Administration ◽  
De Novo ◽  
Clinical Laboratory ◽  
Food And Drug Administration ◽  
Scientific Review ◽  
Regulatory Issue ◽  
In Vitro Diagnostic ◽  
Intended Use

Abstract The Division of Clinical Laboratory Devices is responsible for the premarket review of in vitro diagnostic devices (laboratory tests). We currently process >1000 diverse applications per year. New versions of old devices are handled as premarket notifications, so-called 510(k) submissions. The review objective is to establish that the new product is "substantially equivalent" to its predicate. Fundamentally new devices are handled as premarket applications. The review objective is to establish de novo that the product is ¿safe and effective.¿ A central regulatory issue over the past several years has been the development of a standardized model for scientific review. The Food and Drug Administration contributes to the quality of in vitro diagnostic devices by providing oversight and objective review, by setting thresholds for product safety and effectiveness, and by ensuring that organized data and appropriate labeling is present in support of a device's intended use.

scholarly journals Clinical Laboratory Reagents: The Regulatory Hurdle

1999 ◽  
Vol 7 (7) ◽  
pp. 8-9
Author(s):  
Peter A. Takes
Keyword(s):  
Urine Analysis ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Molecular Probes ◽  
Research Use ◽  
Diagnostic Use ◽  
In Vitro Diagnostic ◽  
Regulatory Hurdle ◽  
Specific Reagent

Today's clinical laboratory has a diversity of reagents and protocols from which to choose: a variety of clinical chemistry reagents, antibodies, and molecular probes, among others. These materials facilitate serum and urine analysis, histology, hematology, cytology, and a host of additional sensitive and specific assaysRegardless of the application, labs may see an array of labeling statements indicating a reagent's general use: "For Laboratory Use Only" [LUO]; "For Research Use Only" [RUO]; "For Investigational Use Only" [IUO]; "For In Vitro Diagnostic Use" [IVD]; and "Analyte Specific Reagent" [ASR]. These preparations are often employed without realizing the course manufacturer's must follow in order to provide reagents, and the reasons for these designations.

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 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.

Sign in / Sign up

Export Citation Format

Share Document