scholarly journals Trends in Multiplex Immunoassays for In Vitro Diagnostics and Point-of-Care Testing

Diagnostics ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. 1630
Author(s):  
Sandeep Kumar Vashist
Keyword(s):  
Clinical Utility ◽  
Point Of Care ◽  
Complex Diseases ◽  
Clinical Score ◽  
Single Sample ◽  
In Vitro Diagnostics ◽  
Point Of Care Testing ◽  
Future Directions ◽  
Wide Range

The tremendous advances in multiplex immunoassays (MIAs) are leading to novel in vitro diagnostics (IVD) and point-of-care testing (POCT). MIAs can simultaneously detect numerous analytes in a single sample, which facilitates the diagnosis of many complex diseases. Various clinical score-based diagnostic algorithms have already been developed for several complex diseases, where the clinical score is determined by assigning appropriate weightage to various biomarkers based on their contribution to the disease. Despite a wide range of MIA formats being developed, only a few have been commercialized. There is a need for considerable improvements in MIAs so that they are analytically superior and can compete with the most extensively used automated IAs. The readout of most MIAs is still completed by bulky and expensive reader devices, which emphasizes the need for compact, handheld multiplex readers. Further, the clinical utility, reimbursement models, pathophysiological range of analytes, nature and dilution of samples, and the reagents used to develop an MIA need to be analyzed stringently. This manuscript provides guided insights into MIA formats and discusses the challenges and future directions.

scholarly journals Proceedings of the First Workshop on Standards for Microfluidics

2019 ◽  
Vol 124 ◽  
Author(s):  
Darwin R. Reyes ◽  
Henne van Heeren
Keyword(s):  
Point Of Care ◽  
Lab On A Chip ◽  
In Vitro Diagnostics ◽  
Point Of Care Testing ◽  
Future Developments ◽  
Exciting Opportunity ◽  
Micro Total Analysis Systems ◽  
Advance Research ◽  
Total Analysis

In the last two decades, the microfluidics/lab-on-a-chip field has evolved from the concept of micro total analysis systems, where systems with integrated pretreatment and analysis of chemicals were envisioned, to what is known today as lab-on-a-chip, which is expected to be modular. This field has shown great potential for the development of technologies that can make, and to some extent are making, a big difference in areas such as in vitro diagnostics, point of care testing, organ on a chip, and many more. Microfluidics plays an essential role in these systems, and determining the standards needed in this area is critical for enabling new markets and products, and to advance research and development. Our goal was to bring together stakeholders from industry, academia, and government to discuss and define the needs within the field for the development of standards. This publication contains a summary of the workshop, abstracts from each presentation, and a summary of the breakout sessions from the National Institute of Standards and Technology Workshop on Standards for Microfluidics, held on June 1–2, 2017. The workshop was attended by 46 persons from 26 organizations and 11 countries. This was a unique and exciting opportunity for stakeholders from all over the world to join in the discussion of future developments towards standardization in the microfluidics arena.

Current nursing practice of point-of-care laboratory diagnostic testing in critical care units

1995 ◽  
Vol 4 (6) ◽  
pp. 429-434 ◽  
Author(s):  
Lamb LSJr ◽  
RS Parrish ◽  
SF Goran ◽  
MH Biel
Keyword(s):  
Critical Care ◽  
Patient Care ◽  
Laboratory Testing ◽  
Point Of Care ◽  
Diagnostic Testing ◽  
Critical Care Nurses ◽  
Point Of Care Testing ◽  
Critical Care Units ◽  
In Vitro Diagnostic

BACKGROUND: The development of user-friendly laboratory analyzers, combined with the need for rapid assessment of critically ill patients, has led to the performance of in vitro diagnostic testing at the point of care by personnel without formal laboratory training. OBJECTIVES: To determine the range of laboratory testing performed by critical care nurses and their attitudes toward this role. METHODS: A survey of critical care nursing consultants was conducted, using a modified Likert scale, to assess objective measures of point-of-care testing practice in critical care units and to determine nurses' attitudes toward the practice of point-of-care testing. Statistical analysis was performed to determine significant trends in responses. RESULTS: Of the units responding to the survey, 35% used critical care nurses exclusively to perform point-of-care testing, 32.5% used laboratory technicians and critical care nurses, and 25% used other personnel. Of critical care nurses performing laboratory testing, 95.5% performed blood glucose analysis; 18.7%, arterial blood gas analysis; 4.5%, electrolyte analysis; 4.5%, hematology profiles; and 22.7%, other testing. Most agreed that stat tests were not reported promptly, thereby necessitating bedside testing. Respondents indicated that they would prefer that laboratory personnel operate in vitro diagnostic equipment and that requirements for critical care nurses to perform laboratory testing detracted from other patient care duties. CONCLUSIONS: Most nurses who perform point-of-care testing responded that it was necessary and helpful in patient management. However, they would prefer, because of their other patient care responsibilities, that laboratory personnel take this responsibility.

Clinical governance: implications for point-of-care testing

2002 ◽  
Vol 39 (5) ◽  
pp. 421-423 ◽  
Author(s):  
Danielle B Freedman
Keyword(s):  
Point Of Care ◽  
Clinical Governance ◽  
Management Support ◽  
Point Of Care Testing ◽  
Financial Perspective ◽  
National Guidance ◽  
In Vitro Diagnostic ◽  
The Uk ◽  
Based Medicine

With the introduction of clinical governance in the UK during 1997 and the shift in focus from a purely financial perspective to one of quality, it has become even more important that laboratories become involved with in vitro diagnostic devices (IVDs) used outside the laboratories by non-laboratory personnel, namely, point-of-care testing (POCT). The demand for POCT is increasing and its growth will continue with advances in technology, increasing pressure to shorten patient length of stay and requirements to decrease turnaround times, alongside the national initiatives to consolidate laboratories. However, clinical governance is about practising evidence-based medicine, and both the clinical and cost-effectiveness of POCT continue to be debated. Accountability and leadership are pivotal in the implementation of clinical governance. Thus, the onus is on laboratories to take the lead for POCT and ensure that there is a robust risk management strategy to protect not only the staff, but, importantly, the patient. A rigorous POCT policy and national guidance must be adhered to. For a high quality POCT service to be delivered, fulfilling the requirements of clinical governance, a multidisciplinary local group must be established with recognized accountability, appropriate resources and, importantly, management support.

Smartphone and tablet based point-of-care in vitro diagnostics and devices for mobile healthcare

2014 ◽  
Vol 20 (1) ◽  
pp. 25-26
Author(s):  
S.K. Vashist ◽  
Th. van Oordt ◽  
E.M. Schneider ◽  
F. von Stetten ◽  
R. Zengerle
Keyword(s):  
Point Of Care ◽  
In Vitro Diagnostics ◽  
Mobile Healthcare

scholarly journals In vivo activity of human-simulated regimens of imipenem alone and in combination with relebactam against Pseudomonas aeruginosa in the murine thigh infection model

2020 ◽  
Author(s):  
Sergio Reyes ◽  
Kamilia Abdelraouf ◽  
David P Nicolau
Keyword(s):  
Pseudomonas Aeruginosa ◽  
Clinical Utility ◽  
Infection Model ◽  
Treatment Groups ◽  
Log Reduction ◽  
Wide Range ◽  
To Receive ◽  
Inhibitor Combination

Abstract Background Imipenem/relebactam is a carbapenem/β-lactamase inhibitor combination with in vitro activity against Pseudomonas aeruginosa and Enterobacterales, including KPC producers. Objectives To provide translational data to support the clinical utility of the imipenem/relebactam 500/250 mg q6h regimen using a human-simulated regimen (HSR) of imipenem/relebactam, compared with imipenem alone, against a phenotypically and genotypically diverse population of P. aeruginosa. Methods Twenty-nine P. aeruginosa isolates, including KPC (n = 6), PDC (n = 9), PAO (n = 4), GES (n = 5) and VIM (n = 1) producers, were used for the in vivo efficacy studies. Neutropenic mice were thigh-inoculated and randomized to receive HSRs of either imipenem 500 mg q6h, imipenem 1 g q8h, imipenem/relebactam 500/250 mg q6h or saline. Results Twenty-seven of the 29 isolates examined were imipenem resistant, with 24/29 isolates showing imipenem MICs of ≥32 mg/L. The addition of relebactam decreased the MICs up to 64-fold; imipenem/relebactam MICs ranged from 0.25 to >32 mg/L. Efficacies of the imipenem monotherapies and the imipenem/relebactam therapy were comparable for the two imipenem-susceptible organisms. Among the imipenem-resistant isolates, an increased mean growth was observed in the imipenem 500 mg q6h HSR and 1 g q8h HSR treatment groups of 1.31 ± 1.01 and 0.18 ± 1.67 log10 cfu/thigh, respectively. In contrast, a ≥2 log reduction in bacterial density was observed in 27/29 (93%) of the imipenem-resistant isolates subjected to imipenem/relebactam 500/250 mg q6h HSR. Conclusions The imipenem/relebactam 500/250 mg q6h HSR demonstrated superior in vivo activity compared with the conventionally employed imipenem regimens against MDR P. aeruginosa over a wide range of imipenem/relebactam MICs.

scholarly journals Analysis: Investigating the quality of POCT devices for HbA1c, what are our next steps?

2019 ◽  
Vol 13 (6) ◽  
pp. 1154-1157 ◽  
Author(s):  
Erna Lenters-Westra ◽  
Emma English
Keyword(s):  
Point Of Care ◽  
Performance Evaluations ◽  
Clinical Settings ◽  
Point Of Care Testing ◽  
Performance History ◽  
Future Studies ◽  
Wide Range ◽  
Need To Evaluate ◽  
Number Of Publications

There are a growing number of publications evaluating the performance of HbA1c point-of-care testing (POCT) devices when compared to routine laboratory instruments, but is this what we need from future studies? Here we describe the current understanding of the performance of POCT for HbA1c, which areas need further studies, and the key requirements for future publications based on performance evaluations of these devices. These include studies in clinical settings, performance measured against internationally standardized reference methods, and the need to evaluate new to the market devices that do not currently have a detailed performance history. In addition we highlight the need for external quality assessment schemes that are designed to support POCT in a wide range of clinical settings.

scholarly journals Evolvable Smartphone-Based Platforms for Point-of-Care In-Vitro Diagnostics Applications

Diagnostics ◽  
2016 ◽  
Vol 6 (3) ◽  
pp. 33 ◽  
Author(s):  
François Patou ◽  
Fatima AlZahra’a Alatraktchi ◽  
Claus Kjægaard ◽  
Maria Dimaki ◽  
Jan Madsen ◽  
...  
Keyword(s):  
Point Of Care ◽  
In Vitro Diagnostics
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