Examination of the analytical sensitivity of a novel rapid, point-of-care (POC) urinary antigen diagnostic test for Streptococcus pneumoniae utilizing a fluorescence detection methodology

2016 ◽  
Author(s):  
John Tamerius
Keyword(s):  
Streptococcus Pneumoniae ◽  
Diagnostic Test ◽  
Fluorescence Detection ◽  
Point Of Care ◽  
Analytical Sensitivity ◽  
Urinary Antigen

scholarly journals Streptococcus pneumoniae Antigen, Missing Opportunities of a Promising Point of Care Diagnostic Test

2017 ◽  
Vol 1 (4) ◽  
Author(s):  
Magdelina Stomka ◽  
Ruby Gupta ◽  
Baltej Singh ◽  
Venkatesh Gondhi ◽  
Siddartha Bhandary ◽  
...  
Keyword(s):  
Streptococcus Pneumoniae ◽  
Diagnostic Test ◽  
Point Of Care

scholarly journals PERFORMANCE CHARACTERISTICS OF A FRET-BASED IMMUNOASSAY FOR QUANTITATION OF INFLIXIMAB ON A POINT-OF-CARE INSTRUMENT SYSTEM

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S57-S57
Author(s):  
Edgar Ong ◽  
Ruo Huang ◽  
Richard Kirkland ◽  
Michael Hale ◽  
Larry Mimms
Keyword(s):  
Whole Blood ◽  
Limit Of Detection ◽  
Point Of Care ◽  
Quantitative Detection ◽  
Therapeutic Drug ◽  
Analytical Sensitivity ◽  
Sample Type ◽  
Hook Effect ◽  
Limit Of Quantitation ◽  
Assay Precision

Abstract Introduction A fast (<5 min), time-resolved fluorescence resonance energy transfer (FRET)-based immunoassay was developed for the quantitative detection of infliximab (IFX) and biosimilars for use in therapeutic drug monitoring using only 20 µL of fingerstick whole blood or serum at the point-of-care. The Procise IFX assay and ProciseDx analyzer are CE-marked. Studies were performed to characterize analytical performance of the Procise IFX assay on the ProciseDx analyzer. Methods Analytical testing was performed by spiking known amounts of IFX into negative serum and whole blood specimens. Analytical sensitivity was determined using limiting concentrations of IFX. Linearity was determined by testing IFX across the assay range. Hook effect was assessed at IFX concentrations beyond levels expected to be found within a patient. Testing of assay precision, cross-reactivity and potential interfering substances, and biosimilars was performed. The Procise IFX assay was also compared head-to-head with another CE-marked assay: LISA-TRACKER infliximab ELISA test (Theradiag, France). The accuracy of the Procise IFX assay is established through calibrators and controls traceable to the WHO 1st International Standard for Infliximab (NIBSC code: 16/170). Results The Procise IFX assay shows a Limit of Blank, Limit of Detection, and Lower Limit of Quantitation (LLoQ) of 0.1, 0.2, and 1.1 µg/mL in serum and 0.6, 1.1, and 1.7 µg/mL in whole blood, respectively. The linear assay range was determined to be 1.7 to 77.2 µg/mL in serum and whole blood. No hook effect was observed at an IFX concentration of 200 µg/mL as the value reported as “>ULoQ”. Assay precision testing across 20 days with multiple runs and reagent lots showed an intra-assay coefficient of variation (CV) of 2.7%, an inter-assay CV of <2%, and a total CV of 3.4%. The presence of potentially interfering/cross-reacting substances showed minimal impact on assay specificity with %bias within ±8% of control. Testing of biosimilars (infliximab-dyyb and infliximab-abda) showed good recovery. A good correlation to the Theradiag infliximab ELISA was obtained for both serum (slope=1.01; r=0.99) and whole blood (slope=1.01; r=0.98) samples (Figure 1). Conclusion Results indicate that the Procise IFX assay is sensitive, specific, and precise yielding results within 5 minutes from both whole blood and serum without the operator needing to specify sample type. Additionally, it shows very good correlation to a comparator assay that takes several hours and sample manipulation to yield results. This makes the Procise IFX assay ideal for obtaining fast and accurate IFX quantitation, thus allowing for immediate drug level dosing decisions to be made by the physician during patient treatment.

scholarly journals The diagnostic accuracy of isothermal nucleic acid point-of-care tests for human coronaviruses: A systematic review and meta-analysis

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Pakpoom Subsoontorn ◽  
Manupat Lohitnavy ◽  
Chuenjid Kongkaew
Keyword(s):  
Systematic Review ◽  
Diagnostic Accuracy ◽  
Diagnostic Test ◽  
Point Of Care ◽  
Meta Analysis ◽  
Isothermal Amplification ◽  
Diagnostic Test Accuracy ◽  
Test Accuracy ◽  
Index Test ◽  
Point Of Care Tests

AbstractMany recent studies reported coronavirus point-of-care tests (POCTs) based on isothermal amplification. However, the performances of these tests have not been systematically evaluated. Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy was used as a guideline for conducting this systematic review. We searched peer-reviewed and preprint articles in PubMed, BioRxiv and MedRxiv up to 28 September 2020 to identify studies that provide data to calculate sensitivity, specificity and diagnostic odds ratio (DOR). Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) was applied for assessing quality of included studies and Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) was followed for reporting. We included 81 studies from 65 research articles on POCTs of SARS, MERS and COVID-19. Most studies had high risk of patient selection and index test bias but low risk in other domains. Diagnostic specificities were high (> 0.95) for included studies while sensitivities varied depending on type of assays and sample used. Most studies (n = 51) used reverse transcription loop-mediated isothermal amplification (RT-LAMP) to diagnose coronaviruses. RT-LAMP of RNA purified from COVID-19 patient samples had pooled sensitivity at 0.94 (95% CI: 0.90–0.96). RT-LAMP of crude samples had substantially lower sensitivity at 0.78 (95% CI: 0.65–0.87). Abbott ID Now performance was similar to RT-LAMP of crude samples. Diagnostic performances by CRISPR and RT-LAMP on purified RNA were similar. Other diagnostic platforms including RT- recombinase assisted amplification (RT-RAA) and SAMBA-II also offered high sensitivity (> 0.95). Future studies should focus on the use of un-bias patient cohorts, double-blinded index test and detection assays that do not require RNA extraction.

A novel use of pneumococcal urinary antigen detection kits to identify Streptococcus pneumoniae cultures misidentified by the VITEK-2 system

2019 ◽  
Vol 50 (2) ◽  
pp. 146-149
Author(s):  
Sadia Khan ◽  
Sona P Hydrose ◽  
Sabthami Chandran ◽  
Kavitha Dinesh ◽  
Anil Kumar
Keyword(s):  
Streptococcus Pneumoniae ◽  
Latex Agglutination ◽  
Urinary Antigen ◽  
Urinary Antigen Test ◽  
Middle Income ◽  
Microbial Identification ◽  
Middle Income Countries ◽  
Vitek 2 ◽  
Urinary Antigen Detection ◽  
Viridans Group Streptococci

Streptococcus pneumoniae infections continue to be an important cause of morbidity and mortality in low-and middle-income countries. Differentiating S. pneumoniae from viridans group streptococci is essential to ensure appropriate antibiotic therapy. Conventional microbial identification tests can often misidentify the two groups. We used a common pneumococcal urinary antigen test to identify S. pneumoniae that were misidentified by the VITEK 2. The performance of the test was similar to the pneumococcal latex agglutination test.

scholarly journals Innovative point-of-care molecular diagnostic test for COVID-19 in India

2020 ◽  
Vol 1 (7) ◽  
pp. e277
Author(s):  
Nivedita Gupta ◽  
Salaj Rana ◽  
Harpreet Singh
Keyword(s):  
Diagnostic Test ◽  
Point Of Care ◽  
Molecular Diagnostic ◽  
Molecular Diagnostic Test

scholarly journals Closing the loop on test results to reduce communication failures: a rapid review of evidence, practice and patient perspectives

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Breanna Wright ◽  
Alyse Lennox ◽  
Mark L. Graber ◽  
Peter Bragge
Keyword(s):  
Diagnostic Test ◽  
Point Of Care ◽  
Patient Perspectives ◽  
Audit And Feedback ◽  
Rapid Review ◽  
Test Results ◽  
Multiple Perspectives ◽  
Communication Breakdown ◽  
Closing The Loop ◽  
Test Result

Abstract Background Communication failures involving test results contribute to issues of patient harm and sentinel events. This article aims to synthesise review evidence, practice insights and patient perspectives addressing problems encountered in the communication of diagnostic test results. Methods The rapid review identified ten systematic reviews and four narrative reviews. Five practitioner interviews identified insights into interventions and implementation, and a citizen panel with 15 participants explored the patient viewpoint. Results The rapid review provided support for the role of technology to ensure effective communication; behavioural interventions such as audit and feedback could be effective in changing clinician behaviour; and point-of-care tests (bedside testing) eliminate the communication breakdown problem altogether. The practice interviews highlighted transparency, and clarifying the lines of responsibility as central to improving test result communication. Enabling better information sharing, implementing adequate planning and utilising technology were also identified in the practice interviews as viable strategies to improve test result communication. The citizen panel highlighted technology as critical to improving communication of test results to both health professionals and patients. Patients also highlighted the importance of having different ways of accessing test results, which is particularly pertinent when ensuring suitability for vulnerable populations. Conclusions This paper draws together multiple perspectives on the problem of failures in diagnostic test results communication to inform appropriate interventions. Across the three studies, technology was identified as the most feasible option for closing the loop on test result communication. However, the importance of clear, consistent communication and more streamlined processes were also key elements that emerged. Review registration The protocol for the rapid review was registered with PROSPERO CRD42018093316.

My Patient is Short of Breath: Have They Got a Pneumothorax?

Ultrasound ◽  
2011 ◽  
Vol 19 (4) ◽  
pp. 230-235 ◽  
Author(s):  
David Lewis
Keyword(s):  
Emergency Department ◽  
Critical Care ◽  
Diagnostic Test ◽  
Chest Radiograph ◽  
Chest Radiography ◽  
Care Setting ◽  
Imaging Modality ◽  
Point Of Care ◽  
First Line ◽  
Resuscitation Room

Clinical diagnosis of pneumothorax in the emergency department (ED) resuscitation room can be difficult and in certain circumstances chest radiography is either impractical or the delay is unacceptable. The diagnosis must also be considered in other clinical areas such as critical care, theatres, respiratory units and acute medical units. Erect chest radiography is the standard first-line diagnostic test for pneumothorax in the ED, but the sensitivity is low (59–81%). For many patients in ED, critical care and theatre, an erect chest radiograph is not possible as the patient must remain supine. The sensitivity for a supine chest radiograph has been reported as being 45–75%. Ultrasound has been shown to be more sensitive than chest radiography in the diagnosis of pneumothorax in certain settings. This paper outlines the evidence for ultrasound in the diagnosis of pneumothorax in the point of care setting; it describes the technique and discusses the clinical application of this imaging modality.

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