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.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.5858/arpa.2010-0536-OA | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Drug Treatment of Cystic Fibrosis and Breastfeeding.
Breastfeed Med
December 2024
Division of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, California, USA.
Time-dependent prognostic accuracy measures for recurrent event data.
Biometrics
October 2024
Evidence Generation and Advanced Analytics Biogen Digital Health, Biogen, Cambridge, MA 02142, United States.
In many clinical contexts, the event of interest could occur multiple times for the same patient. Considerable advancement has been made on developing recurrent event models based on or that use biomarker information. However, less attention has been given to evaluating the prognostic accuracy of a biomarker or a composite score obtained from a fitted recurrent event-rate model.
View Article and Find Full Text PDFWidening the infantile hypotonia with psychomotor retardation and characteristic Facies-1 Syndrome's clinical and molecular spectrum through NALCN structural analysis.
Front Genet
December 2024
Bioinformatics Unit, Fondazione IRCCS Casa Sollievo Della Sofferenza, San Giovanni Rotondo, Italy.
Introduction: Infantile hypotonia with psychomotor retardation and characteristic facies-1 (IHPRF1, MIM#615419) is a rare, birth onset, autosomal recessive disorder caused by homozygous or compound heterozygous truncating variants in gene (MIM#611549) resulting in a loss-of-function effect.
Methods: We enrolled a new IHPRF1 patients' cohort in the framework of an international multicentric collaboration study. Using specialized pathogenicity predictors and structural analyses, we assessed the mechanistic consequences of the deleterious variants retrieved on NALCN structure and function.
Cholangiocyte organoids for disease, cancer, and regenerative medicine.
Eur J Cell Biol
December 2024
Department of Gastroenterology and Hepatology, Kyoto University Graduate School of Medicine, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan.
The biliary tract is a ductal network comprising the intrahepatic (IHBDs) and extrahepatic bile duct (EHBDs). Biliary duct disorders include cholangitis, neoplasms, and injury. However, the underlying mechanisms are not fully understood.
View Article and Find Full Text PDF[Diagnostic capabilities of sound-breathing test in assessment of pulmonary ventilation function in children and adults (retrospective review and prospect)].
Vopr Kurortol Fizioter Lech Fiz Kult
December 2024
Patrice Lumumba Peoples' Friendship University of Russia, Moscow, Russia.
Objective: To develop and try out a convenient and accessible for use technology for testing the pulmonary function in children and adults, including in patients with chronic bronchopulmonary pathology.
Material And Methods: The article presents the results of Lazarev sound-breathing test (LST) in different cohorts of children and adults, including pregnant women and children suffering from chronic bronchopulmonary diseases, in particular cystic fibrosis.
Results: A direct dependence of the LST indicators' level from the age of children and adolescents has been obtained.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!