Evaluation of a new smartphone optical blood pressure application (OptiBP™) in the post-anesthesia care unit: a method comparison study against the non-invasive automatic oscillometric brachial cuff as the reference method

Introduction: Elevated arterial blood pressure (BP) increases the risk of intracerebral hemorrhage after intravenous (IV) thrombolysis with tPA in acute ischemic stroke (AIS). While arterial BP is usually monitored using intermittent oscillometric measurements with an upper arm cuff, the vascular unloading technique (VUT) provides non-invasive continuous BP monitoring with a finger cuff. Hypothesis: We hypothesized that VUT monitoring is feasible in AIS patients receiving IV tPA, is comparable to the standard technique, and allows detection of BP peaks that might be missed in oscillometric BP monitoring. Methods: We performed an interim analysis of an ongoing prospective method comparison study. AIS patients were simultaneously monitored over 24 h following IV tPA bolus using VUT and contralateral oscillometric BP assessment every 30 min. Results: We present interim data from 15 out of 24 AIS (4 m, 11 f; aged 72.5±14.9 y, mean±SD) receiving IV tPA. Nominal significance level was set to 0.029 in accordance with Pocock’s rule. Missing data were less than 5% for both techniques. There was a positive correlation between VUT and oscillometric BP assessment (Pearson’s correlation coefficient r=0.91, p<0.001 for systolic BP; and r=0.88, p<0.001 for diastolic BP). Bland-Altman analysis confirmed this agreement (figure 1). The mean difference between VUT and oscillometric BP measurements was 9.4±6.1 mmHg for systolic, and 4.5±3.0 mmHg for diastolic BP (p=n.s.). Peaks (systolic BP>180 or diastolic BP>110 mmHg) were detected by VUT monitoring (at least one episode≥5 min) in 12 patients, and by oscillometric BP assessment (≥one time point of measurement) in 7 patients (p<0.01). Conclusions: Our interim data suggest that VUT-based BP monitoring is feasible in AIS patients receiving IV tPA, and might be more sensitive than intermittent oscillometric BP assessment in detecting potentially harmful blood pressure peaks. Figure 1: Bland Altman plot

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Non-invasive continuous arterial pressure measurement based on radial artery tonometry in the intensive care unit: a method comparison study using the T-Line TL-200pro device

British Journal of Anaesthesia ◽

10.1093/bja/aet025 ◽

2013 ◽

Vol 111 (2) ◽

pp. 185-190 ◽

Cited By ~ 30

Author(s):

B Saugel ◽

A.S. Meidert ◽

A Hapfelmeier ◽

F Eyer ◽

R.M. Schmid ◽

...

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Arterial Pressure ◽

Radial Artery ◽

Pressure Measurement ◽

Method Comparison ◽

Comparison Study ◽

Non Invasive ◽

Arterial Pressure Measurement ◽

Method Comparison Study

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12 / Low Perfusion Index may negatively affect the accuracy of the non-invasive continuous arterial pressure measured with ClearSight®: a method comparison study

10.26226/morressier.5aeb0ac507b0d6001a79a071 ◽

2018 ◽

Author(s):

Masahiro Takaya

Keyword(s):

Arterial Pressure ◽

Method Comparison ◽

Perfusion Index ◽

Comparison Study ◽

Non Invasive ◽

Method Comparison Study

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Validity of non-invasive point-of-care hemoglobin estimation in healthy and sick children—a method comparison study

European Journal of Pediatrics ◽

10.1007/s00431-015-2602-9 ◽

2015 ◽

Vol 175 (2) ◽

pp. 171-179 ◽

Cited By ~ 8

Author(s):

Aditya Bhat ◽

Amit Upadhyay ◽

Vijay Jaiswal ◽

Deepak Chawla ◽

Dharamveer Singh ◽

...

Keyword(s):

Point Of Care ◽

Method Comparison ◽

Comparison Study ◽

Non Invasive ◽

Sick Children ◽

Method Comparison Study

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Evaluation of NG-Test Carba 5 for Rapid Phenotypic Detection and Differentiation of Five Common Carbapenemase Families: Results of a Multicenter Clinical Evaluation

Journal of Clinical Microbiology ◽

10.1128/jcm.00344-20 ◽

2020 ◽

Vol 58 (7) ◽

Cited By ~ 1

Author(s):

Stephen Jenkins ◽

Nathan A. Ledeboer ◽

Lars F. Westblade ◽

Carey-Ann D. Burnham ◽

Matthew L. Faron ◽

...

Keyword(s):

Medical Center ◽

Method Comparison ◽

Reference Method ◽

The United States ◽

Comparison Study ◽

Content Type ◽

Percent Agreement ◽

Mueller Hinton ◽

Method Comparison Study

ABSTRACT NG-Test Carba 5 is a rapid in vitro multiplex immunoassay for the phenotypic detection and differentiation of five common carbapenemase families (KPC, OXA-48-like, VIM, IMP, and NDM) directly from bacterial colonies. The assay is simple to perform and has recently received U.S. Food and Drug Administration clearance. A method comparison study was performed at geographically diverse medical centers (n = 3) in the United States, where 309 Enterobacterales and Pseudomonas aeruginosa isolates were evaluated by NG-Test Carba 5 (NG Biotech, Guipry, France), the Xpert Carba-R assay (Cepheid, Inc., Sunnyvale, CA), the modified carbapenem inactivation method (mCIM), the EDTA-modified carbapenem inactivation method, and disk diffusion with carbapenems. Colonies from tryptic soy agar with 5% sheep blood (blood agar) and MacConkey agar were tested, and the results were compared to those obtained by a composite reference method. Additionally, a fourth medical center performed a medium comparison study by evaluating the performance characteristics of NG-Test Carba 5 from blood, MacConkey, and Mueller-Hinton agars with 110 isolates of Enterobacterales and P. aeruginosa. These results were compared to the expected genotypic and mCIM results. For the multicenter method comparison study, the overall positive percent agreement (PPA) and the overall negative percent agreement (NPA) of NG-Test Carba 5 with the composite reference method were 100% for both blood and MacConkey agars. The medium comparison study at the fourth site showed that the PPA ranged from 98.9% to 100% and that the NPA ranged from 95.2% to 100% for blood, MacConkey, and Mueller-Hinton agars. NG-Test Carba 5 accurately detected and differentiated five common carbapenemase families from Enterobacterales and P. aeruginosa colonies on commonly used agar media. The results of this test will support a streamlined laboratory work flow and will expedite therapeutic and infection control decisions.

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Evaluation of the Solus One Listeria Method for the Detection of Listeria Species on Environmental Surfaces

Journal of AOAC International ◽

10.5740/jaoacint.18-0199 ◽

2019 ◽

Vol 102 (2) ◽

pp. 570-579

Author(s):

Elizabeth Tonner ◽

Siobhan Kelly ◽

Simon Illingworth ◽

Nevin Perera ◽

Benjamin Bastin ◽

...

Keyword(s):

Stainless Steel ◽

Preparation Method ◽

Method Comparison ◽

Reference Method ◽

Test System ◽

Probability Of Detection ◽

Comparison Study ◽

Listeria Species ◽

Environmental Surfaces ◽

Method Comparison Study

Abstract Background: Solus One Listeria is designed to accurately detect Listeria species (Listeria grayi, L. innocua, L. ivanovii, L. marthii, L. monocytogenes, L. seeligeri, and L. welshimeri) from stainless steel and plastic environmental surface matrixes using an antibody-based technology test system paired with proprietary SOLO+ media and combined with manual or automated sample preparation method. Objective: Solus One Listeria was evaluated for inclusivity and exclusivity and a matrix comparison study fortwo environmental surfaces. Methods: Solus One Listeria was comparedwith the following reference method for the method comparison study: the U.S. Food and Drug Administration Bacteriological Analytical Manual Chapter 10 from stainless steel and plastic environmental surfaces. Both the manual and automatedpreparation methods were performed for stainless steel and plastic environmental surfaces. Results: For the inclusivity and exclusivityevaluation, Solus One Listeria correctly identified all 50 target organism isolates and correctly excluded all 30 nontarget strains that were analyzed. In the method comparison study, bothSolus One Listeria manual and automated preparation methods demonstrated no significant differences based on probability of detection statistical analysis between presumptive and confirmed results or between candidate and reference methodresults for two environmental surfaces after 22–30 h of enrichment time. Probability of detection analysis of Solus One Listeria method robustness, product consistency (lot-to-lot), and stability studies using the automated preparation method demonstrated no statistically significant differences. Conclusions: The data from the study support the product claims of Solus One Listeria for the accurate detection of Listeria species, using both the manual and automated methods (using theDynex DS2 instrument), on both environmental surfaces analyzed.

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