Task Targeted Automation, (TTA) from Roche Diagnostics Provides a Cost Effective and Easily Justified Approach to Automation for Improving the Efficiency of the Clinical Laboratory

1998 ◽  
Vol 3 (5) ◽  
pp. 64-66
Author(s):  
Chris H. Demiris ◽  
Peter R. Ciment
Pathogens ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. 137
Author(s):  
Olympia E. Anastasiou ◽  
Viktoria Thodou ◽  
Annemarie Berger ◽  
Heiner Wedemeyer ◽  
Sandra Ciesek

Introduction: Reliable and cost-effective diagnostics for hepatitis E virus (HEV) infection are necessary. The aim of our study was to investigate which diagnostic test is most accurate to detect HEV infection in immunocompetent and immunosuppressed patients in a real world setting. Patients and Methods: We performed a retrospective analysis of 1165 patients tested for HEV antibodies and HEV PCR at the same time point. Clinical, laboratory and virological data were taken from patient charts. HEV IgA was measured in a subgroup of 185 patients. Results: HEV RNA was detectable in 61 patients (5.2%); most of them (n = 49, 80.3%/n = 43, 70.5%) were HEV IgM+ and IgG+; however, 12 patients (19.6%) were HEV RNA positive/HEV IgM negative and 17 patients (27.8%) were HEV RNA positive/HEV IgG negative. Ten HEV RNA positive patients (16.4%) had neither HEV IgG nor IgM antibodies. Importantly, all of them were immunosuppressed. HEV IgA testing was less sensitive than HEV IgM for HEV diagnosis. Conclusions: HEV infection can be overlooked in patients without HEV specific antibodies. Performing PCR is necessary to diagnose or exclude HEV infection in immunocompromised hosts. In immunocompetent patients, a screening based on HEV antibodies (IgG/IgM) is sufficient.


2005 ◽  
Vol 2005 (1) ◽  
pp. 8-25 ◽  
Author(s):  
Gary L. Horowitz ◽  
Zahur Zaman ◽  
Norbert J. C. Blanckaert ◽  
Daniel W. Chan ◽  
Jeffrey A. Dubois ◽  
...  

MODULARANALYTICS(Roche Diagnostics) (MODULARANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack rack transportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULARANALYTICSallows customised configurations for various laboratory workloads. The performance and practicability of MODULARANALYTICSwere evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically less than 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULARANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULARANALYTICSwas less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULARANALYTICSmet diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality.


2017 ◽  
Vol 4 ◽  
pp. 237428951770830 ◽  
Author(s):  
Karen L. Kaul ◽  
Linda M. Sabatini ◽  
Gregory J. Tsongalis ◽  
Angela M. Caliendo ◽  
Randall J. Olsen ◽  
...  

An explosion of knowledge and technology is revolutionizing medicine and patient care. Novel testing must be brought to the clinic with safety and accuracy, but also in a timely and cost-effective manner, so that patients can benefit and laboratories can offer testing consistent with current guidelines. Under the oversight provided by the Clinical Laboratory Improvement Amendments, laboratories have been able to develop and optimize laboratory procedures for use in-house. Quality improvement programs, interlaboratory comparisons, and the ability of laboratories to adjust assays as needed to improve results, utilize new sample types, or incorporate new mutations, information, or technologies are positive aspects of Clinical Laboratory Improvement Amendments oversight of laboratory-developed procedures. Laboratories have a long history of successful service to patients operating under Clinical Laboratory Improvement Amendments. A series of detailed clinical examples illustrating the quality and positive impact of laboratory-developed procedures on patient care is provided. These examples also demonstrate how Clinical Laboratory Improvement Amendments oversight ensures accurate, reliable, and reproducible testing in clinical laboratories.


1993 ◽  
Vol 6 (3) ◽  
pp. 35-42
Author(s):  
M.J. McQueen ◽  
A.J. Bailey

Clinical Laboratory Sciences are under pressure to reduce the number of tests and cut staff and supply costs. The ability of academic centres to continue to deliver high quality service, teaching and research is threatened. In difficult economic times imaginative strategies are needed to look for solutions which will permit continued advancement in academic and clinical standards. Rationalization of service and cost-effective use of resources are not new concepts; however, there is a scarcity of models which have been developed and promoted by the providers of laboratory services, rather than those imposed by governments and other paying agencies. A model developed and evolved over the last two decades by The Hamilton Health Sciences Laboratory Program (HHSLP) is outlined.


2019 ◽  
Vol 01 (04) ◽  
pp. 29-38
Author(s):  
Asma Akhter ◽  
Mahwish Javed ◽  
Muhammad Imran

Background: Hepatitis C virus (HCV) is a major health problem worldwide. About 6% of the population of Pakistan is suffering from HCV infection. HCV has a high mutation rate and consists of seven genotypes and sixty-seven subtypes. Genotype information of patients infected with HCV is significant for its treatment. Methods: In this study, 416 HCV serum samples were collected and HCV prevalence rate was studied in different districts of Punjab, Pakistan. Nested PCR and INNO LIPA HCV-II were used for HCV genotyping and their respective performance was evaluated. This study was conducted by the approval of Lahore Clinical Laboratory and Research Centre situated at Shadman, Lahore. Results: The highest prevalence of HCV was found in Shekhupura district followed by Bhakkar, Narowal and Okara districts, respectively. In Punjab, the most prevalent genotype was 3a (70.29%), followed by genotype 1 (5.47%), untypable genotypes (5.44%) and genotype 3a/3b (4.64%). Nested PCR was found to be more reliable than INNO LIPA-II. Nested PCR results were more accurate and only 5 samples remained untypable whereas 33 samples could not be typed by LIPA method. Conclusion: This study was focused on the comparative analysis of Nested PCR and LIPA method for screening HCV genotypes and their prevalence in different districts of Punjab, Pakistan. HCV genotyping is important since different genotypes require different therapeutic treatments. In Punjab, 3a is the most prevalent genotype followed by non-typable genotypes. LIPA is the most commonly used HCV genotype assay but this study found Nested PCR to be a highly sensitive and cost-effective method in this regard. This study can lead to the better selection of genotyping methods and treatment.


2021 ◽  
Author(s):  
Nick P.G. Gauthier ◽  
Cassidy Nelson ◽  
Michael B. Bonsall ◽  
Kerstin Locher ◽  
Marthe Charles ◽  
...  

AbstractThe COVID-19 pandemic has underscored the need for rapid novel diagnostic strategies to detect and characterize pathogens from clinical specimens. The MinION sequencing device allows for rapid, cost-effective, high-throughput sequencing; useful features for translation to clinical laboratory settings. Metagenomic Next-Generation Sequencing (mNGS) approaches provide the opportunity to examine the entire genomic material of a sample; allowing for detection of emerging and clinically relevant pathogens that may be missed in targeted assays. Here we present a pilot study on the performance of Sequence-Independent Single Primer Amplification (SISPA) to amplify RNA randomly for the detection and characterization of SARS-CoV-2. We designed a classifier that corrects for barcode crosstalk between specimens. Our assay yielded 100% specificity overall and 95.2% sensitivity for specimens with a RT-qPCR cycle threshold value less than 30. We assembled 10 complete (>95% coverage at 20x depth), and one near-complete (>80% coverage at 20x depth) genomes from 20 specimens that were classified as positive by mNGS. We characterized these genomes through phylogenetic analysis and found that 10/11 specimens from British Columbia had a closest relative to another British Columbian specimen. Of five samples that we had both assembled genomes, as well as Variant of Concern (VOC) PCR results, we found 100% concordance between these results. Additionally, our assay was able to distinguish between the Alpha and Gamma variants, which was not possible with our VOC PCR technique. This study supports future work examining the broader feasibility of SISPA as a diagnostic strategy for the detection and characterization of viral pathogens.


2000 ◽  
Vol 38 (2) ◽  
pp. 537-541 ◽  
Author(s):  
Harriet Provine ◽  
Susan Hadley

This report presents a semisolid agar antifungal susceptibility (SAAS) method for the rapid susceptibility screening of yeasts and molds. The reproducibility and accuracy of the SAAS method were assessed by comparing the MICs of amphotericin B and fluconazole obtained for 10 candidate quality control (QC) American Type Culture Collection yeast strains in ≥15 replicates with those found by six independent laboratories using the National Committee for Clinical Laboratory Standards (NCCLS) M27-P broth macrodilution method (M. A. Pfaller et al., J. Clin. Microbiol. 33:1104–1107, 1995). Overall, 96% of MICs for both drugs fell within 1 log2dilution of the modal MIC for each strain. The MICs for amphotericin B showed 99% agreement with the NCCLS proposed QC ranges within 1 log2 dilution. Likewise, the MICs for fluconazole at ≥75% growth reduction showed 99% agreement for seven strains. Three strains, Candida albicans ATCC 24333 and ATCC 76615 and Candida tropicalis ATCC 750, showed a less sharp fluconazole endpoint at ≥75% growth reduction, but at >50% growth reduction, the agreement was 98% within 1 log2 dilution of the proposed range. The MIC agreement within the proposed range for the suggested QC strains Candida parapsilosisATCC 22019 and Candida krusei ATCC 6258 was 100% for fluconazole and 100% within 1 log2 dilution of the proposed range for amphotericin B. The SAAS method demonstrated the susceptibility or resistance of 25 clinical isolates of filamentous fungi such as Aspergillus fumigatus to amphotericin B, itraconazole, and fluconazole, usually within 48 h. Although the results are preliminary, this SAAS method is promising as a rapid and cost-effective screen and is worthy of concerted investigation.


1999 ◽  
Vol 37 (10) ◽  
pp. 3369-3369 ◽  
Author(s):  
Sinead Kelly ◽  
Martin Cormican ◽  
Leanne Parke ◽  
Geraldine Corbett-Feeney ◽  
John Flynn

Data from 8,717 fecal specimens indicate that primary inoculation of xylose lysine deoxycholate (XLD) agar may enhance the speed, but not the sensitivity, of isolation of Salmonella enterica over that achieved with Selenite enrichment only. Plating of Selenite broth onto both brilliant green and XLD agar offers no advantage over plating onto XLD alone.


2000 ◽  
Vol 38 (9) ◽  
pp. 3407-3412 ◽  
Author(s):  
Richard I. Jaffe ◽  
Janae D. Lane ◽  
Stephen V. Albury ◽  
Debra M. Niemeyer

Methicillin-resistant staphylococci (MRS) are one of the most common causes of nosocomial infections and bacteremia. Standard bacterial identification and susceptibility testing frequently require as long as 72 h to report results, and there may be difficulty in rapidly and accurately identifying methicillin resistance. The use of the PCR is a rapid and simple process for the amplification of target DNA sequences, which can be used to identify and test bacteria for antimicrobial resistance. However, many sample preparation methods are unsuitable for PCR utilization in the clinical laboratory because they either are not cost-effective, take too long to perform, or do not provide a satisfactory DNA template for PCR. Our goal was to provide same-day results to facilitate rapid diagnosis and therapy. In this report, we describe a rapid method for extraction of bacterial DNA directly from blood culture bottles that gave quality DNA for PCR in as little as 20 min. We compared this extraction method to the standard QIAGEN method for turnaround time (TAT), cost, purity, and use of template in PCR. Specific identification of MRS was determined using intragenic primer sets for bacterial and Staphylococcus 16S rRNA and mecAgene sequences. The PCR primer sets were validated with 416 isolates of staphylococci, including methicillin-resistant Staphylococcus aureus (n = 106), methicillin-sensitive S. aureus (n = 134), and coagulase-negativeStaphylococcus (n = 176). The total supply cost of our extraction method and PCR was $2.15 per sample with a result TAT of less than 4 h. The methods described herein represent a rapid and accurate DNA extraction and PCR-based identification system, which makes the system an ideal candidate for use under austere field conditions and one that may have utility in the clinical laboratory.


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