scholarly journals Implementation of the quality system according to ISO 15189:2015 in the Laboratory of Clinical Diagnostics of the Clinical Diagnostic Center at the National University of Pharmacy: applied aspects

2018 ◽  
Vol 22 (1) ◽  
pp. 28-33
Author(s):  
S. V. Misiurova ◽  
V. Ye. Dobrova ◽  
N. O. Svid ◽  
I. A. Otrishko
Keyword(s):  
Quality System ◽  
Clinical Diagnostics ◽  
Iso 15189 ◽  
Clinical Diagnostic ◽  
Diagnostic Center ◽  
National University

scholarly journals Colistin Heteroresistance Is Largely Undetected among Carbapenem-Resistant Enterobacterales in the United States

mBio ◽  
2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Victor I. Band ◽  
Sarah W. Satola ◽  
Richard D. Smith ◽  
David A. Hufnagel ◽  
Chris Bower ◽  
...  
Keyword(s):  
United States ◽  
Klebsiella Pneumoniae ◽  
Diagnostic Testing ◽  
Cladistic Analysis ◽  
The United States ◽  
Clinical Diagnostics ◽  
Infection Model ◽  
Content Type ◽  
Carbapenem Resistant ◽  
Clinical Diagnostic

ABSTRACT Heteroresistance is a form of antibiotic resistance where a bacterial strain is comprised of a minor resistant subpopulation and a majority susceptible subpopulation. We showed previously that colistin heteroresistance can mediate the failure of colistin therapy in an in vivo infection model, even for isolates designated susceptible by clinical diagnostics. We sought to characterize the extent of colistin heteroresistance among the highly drug-resistant carbapenem-resistant Enterobacterales (CRE). We screened 408 isolates for colistin heteroresistance. These isolates were collected between 2012 and 2015 in eight U.S. states as part of active surveillance for CRE. Colistin heteroresistance was detected in 10.1% (41/408) of isolates, and it was more common than conventional homogenous resistance (7.1%, 29/408). Most (93.2%, 38/41) of these heteroresistant isolates were classified as colistin susceptible by standard clinical diagnostic testing. The frequency of colistin heteroresistance was greatest in 2015, the last year of the study. This was especially true among Enterobacter isolates, of which specific species had the highest rates of heteroresistance. Among Klebsiella pneumoniae isolates, which were the majority of isolates tested, there was a closely related cluster of colistin-heteroresistant ST-258 isolates found mostly in Georgia. However, cladistic analysis revealed that, overall, there was significant diversity in the genetic backgrounds of heteroresistant K. pneumoniae isolates. These findings suggest that due to being largely undetected in the clinic, colistin heteroresistance among CRE is underappreciated in the United States. IMPORTANCE Heteroresistance is an underappreciated phenomenon that may be the cause of some unexplained antibiotic treatment failures. Misclassification of heteroresistant isolates as susceptible may lead to inappropriate therapy. Heteroresistance to colistin was more common than conventional resistance and was overwhelmingly misclassified as susceptibility by clinical diagnostic testing. Higher proportions of colistin heteroresistance observed in certain Enterobacter species and clustering among heteroresistant Klebsiella pneumoniae strains may inform colistin treatment recommendations. Overall, the rate of colistin nonsusceptibility was more than double the level detected by clinical diagnostics, suggesting that the prevalence of colistin nonsusceptibility among CRE may be higher than currently appreciated in the United States.

An effective method for determining the integrity of the sperm acrosome of canine-producers

2021 ◽  
Vol 1 (11) ◽  
pp. 59-63
Author(s):  
Seidfatima M. Borunova ◽  
◽  
Olga V. Karabanova ◽  
Ochir E. Badmaev ◽  
◽  
...  
Keyword(s):  
Research Method ◽  
The State ◽  
Sperm Production ◽  
Clinical Diagnostic ◽  
Diagnostic Center ◽  
Sperm Acrosome

In the presented work, a method was tested for determining the number of spermatozoa with intact acrosome in male producers using Diff-Quick dye. As a research method, we used a similar method for determining the integrity of the acrosome in breeding bulls developed in the FGBU «VGNKI» [5]. 25 samples of frozen sperm of canine producers were examined for the integrity of the sperm acrosome. Samples were provided by the clinical diagnostic center. The monitoring of the state of acrosomes in the sperm production of canine producers after staining with a specialized set of Diff-Quick dyes was carried out.

Comprehensive BRCA mutation analysis in the Greek population. Experience from a single clinical diagnostic center

2018 ◽  
Vol 220 ◽  
pp. 1-12 ◽  
Author(s):  
Angela Apessos ◽  
Konstantinos Agiannitopoulos ◽  
Georgia Pepe ◽  
Georgios N. Tsaousis ◽  
Eirini Papadopoulou ◽  
...  
Keyword(s):  
Mutation Analysis ◽  
Brca Mutation ◽  
Greek Population ◽  
Clinical Diagnostic ◽  
Diagnostic Center

scholarly journals Practical Guidance to Implementing Quality Management Systems in Public Health Laboratories Performing Next-Generation Sequencing: Personnel, Equipment, and Process Management (Phase 1)

2019 ◽  
Vol 57 (8) ◽  
Author(s):  
Rebecca J. Hutchins ◽  
Kristy L. Phan ◽  
Adeeba Saboor ◽  
Joseph D. Miller ◽  
Atis Muehlenbachs
Keyword(s):  
Public Health ◽  
Next Generation Sequencing ◽  
Quality Management ◽  
Process Management ◽  
Quality Management System ◽  
Phase 1 ◽  
Quality System ◽  
Clinical Diagnostics ◽  
Next Generation ◽  
Generation Sequencing

ABSTRACT Quality standards as part of an effective quality management system (QMS) are the cornerstone for generating high-quality test results. Next-generation sequencing (NGS) has the potential to improve both clinical diagnostics and public health surveillance efforts in multiple areas, including infectious diseases. However, the laboratories adopting NGS methods face significant challenges due to the complex and modular process design. This document summarizes the first phase of quality system guidance developed by the Centers for Disease Control and Prevention (CDC) NGS Quality Workgroup. The quality system essentials of personnel, equipment, and process management (quality control and validation) were prioritized based on a risk assessment using information gathered from participating CDC laboratories. Here, we present a prioritized QMS framework, including procedures and documentation tools, to assist laboratory implementation and maintenance of quality practices for NGS workflows.

scholarly journals Real-time reverse transcription PCR (qRT-PCR) and its potential use in clinical diagnosis

2005 ◽  
Vol 109 (4) ◽  
pp. 365-379 ◽  
Author(s):  
Stephen A. Bustin ◽  
Reinhold Mueller
Keyword(s):  
Real Time ◽  
Reverse Transcription ◽  
Therapy Monitoring ◽  
Clinical Diagnostics ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Qrt Pcr ◽  
Reverse Transcription Pcr ◽  
Clinical Diagnostic ◽  
Pcr Assays

qRT-PCR (real-time reverse transcription-PCR) has become the benchmark for the detection and quantification of RNA targets and is being utilized increasingly in novel clinical diagnostic assays. Quantitative results obtained by this technology are not only more informative than qualitative data, but simplify assay standardization and quality management. qRT-PCR assays are most established for the detection of viral load and therapy monitoring, and the development of SARS (severe acute respiratory syndrome)-associated coronavirus qRT-PCR assays provide a textbook example of the value of this technology for clinical diagnostics. The widespread use of qRT-PCR assays for diagnosis and the detection of disease-specific prognostic markers in leukaemia patients provide further examples of their usefulness. Their value for the detection of disease-associated mRNA expressed by circulating tumour cells in patients with solid malignancies is far less apparent, and the clinical significance of results obtained from such tests remains unclear. This is because of conceptual reservations as well as technical limitations that can interfere with the diagnostic specificity of qRT-PCR assays. Therefore, although it is evident that qRT-PCR assay has become a useful and important technology in the clinical diagnostic laboratory, it must be used appropriately and it is essential to be aware of its limitations if it is to fulfil its potential.

scholarly journals Novel Diagnosis of Lyme Disease: Potential for CAM Intervention

2009 ◽  
Vol 6 (3) ◽  
pp. 283-295 ◽  
Author(s):  
Aristo Vojdani ◽  
Frank Hebroni ◽  
Yaniv Raphael ◽  
Jonathan Erde ◽  
Bernard Raxlen
Keyword(s):  
Lyme Disease ◽  
Herbal Medicines ◽  
Clinical Diagnostics ◽  
Diagnostic Methods ◽  
Diagnostic Tools ◽  
Diagnostic Process ◽  
Clinical Diagnostic ◽  
Wide Range ◽  
Tick Borne Disease

Lyme disease (LD) is the most common tick-borne disease in the northern hemisphere, producing a wide range of disabling effects on multiple human targets, including the skin, the nervous system, the joints and the heart. Insufficient clinical diagnostic methods, the necessity for prompt antibiotic treatment along with the pervasive nature of infection impel the development and establishment of new clinical diagnostic tools with increased accuracy, sensitivity and specificity. The goal of this article is 4-fold: (i) to detail LD infection and pathology, (ii) to review prevalent diagnostic methods, emphasizing inherent problems, (iii) to introduce the usage ofin vivoinduced antigen technology (IVIAT) in clinical diagnostics and (iv) to underscore the relevance of a novel comprehensive LD diagnostic approach to practitioners of Complementary and Alternative Medicine (CAM). Utilization of this analytical method will increase the accuracy of the diagnostic process and abridge the time to treatment, with antibiotics, herbal medicines and nutritional supplements, resulting in improved quality of care and disease prognosis.

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