scholarly journals A novel method for sample delivery and testing of whole blood: gel strip PCR for point of care (POC) molecular diagnostics

Lab on a Chip ◽  
2013 ◽  
Vol 13 (20) ◽  
pp. 4011 ◽  
Author(s):  
Dammika P. Manage ◽  
Jana Lauzon ◽  
Alexey Atrazhev ◽  
Xiaoli Pang ◽  
Linda M. Pilarski
Keyword(s):  
Molecular Diagnostics ◽  
Whole Blood ◽  
Point Of Care ◽  
Novel Method

Comparison of 2 glucose analytical methodologies in immature Kemp’s ridley sea turtles: dry chemistry of plasma versus point-of-care glucometer analysis of whole blood

2021 ◽  
pp. 104063872110018
Author(s):  
Justin R. Perrault ◽  
Michael D. Arendt ◽  
Jeffrey A. Schwenter ◽  
Julia L. Byrd ◽  
Kathryn A. Tuxbury ◽  
...  
Keyword(s):  
Whole Blood ◽  
Point Of Care ◽  
Sea Turtles ◽  
Sample Volume ◽  
Specific Reference ◽  
Volume Data ◽  
Analytical Methodology ◽  
Glucose Determination ◽  
Kemp's Ridley Sea Turtles ◽  
Kemp's Ridley

Blood glucose measurements provide important diagnostic information regarding stress, disease, and nutritional status. Glucose analytical methodologies include dry chemistry analysis (DCA) of plasma and point-of-care (POC) glucometer analysis of whole blood; however, these 2 methods differ in cost, required sample volume, and processing time. Because POC glucometers use built-in equations based on features of mammalian blood to convert whole blood measurements to plasma equivalent units, obtained glucose data must be compared and validated using gold-standard chemistry analytical methodology in reptiles. For in-water, trawl-captured, immature Kemp’s ridley sea turtles ( Lepidochelys kempii) from Georgia, USA, we observed significant, positive agreement between the 2 glucose determination methods; however, the glucometer overestimated glucose concentrations by 1.4 mmol/L on average in comparison to DCA and produced a wider range of results. The discordance of these results suggests that POC glucometer glucose data should be interpreted in the context of methodology- and brand-specific reference intervals along with concurrent packed cell volume data.

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 A glucose meter interface for point-of-care gene circuit-based diagnostics

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Evan Amalfitano ◽  
Margot Karlikow ◽  
Masoud Norouzi ◽  
Katariina Jaenes ◽  
Seray Cicek ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Synthetic Biology ◽  
Molecular Diagnostics ◽  
Point Of Care ◽  
Low Cost ◽  
Gene Circuit ◽  
Reporter Systems ◽  
Glucose Meter ◽  
Pandemic Response ◽  
Glucose Output

AbstractRecent advances in cell-free synthetic biology have given rise to gene circuit-based sensors with the potential to provide decentralized and low-cost molecular diagnostics. However, it remains a challenge to deliver this sensing capacity into the hands of users in a practical manner. Here, we leverage the glucose meter, one of the most widely available point-of-care sensing devices, to serve as a universal reader for these decentralized diagnostics. We describe a molecular translator that can convert the activation of conventional gene circuit-based sensors into a glucose output that can be read by off-the-shelf glucose meters. We show the development of new glucogenic reporter systems, multiplexed reporter outputs and detection of nucleic acid targets down to the low attomolar range. Using this glucose-meter interface, we demonstrate the detection of a small-molecule analyte; sample-to-result diagnostics for typhoid, paratyphoid A/B; and show the potential for pandemic response with nucleic acid sensors for SARS-CoV-2.

Fibrinogen measurement by a novel point-of-care device with whole blood: comparison of values against Clauss method

2021 ◽  
Author(s):  
Shoko Okahara ◽  
Tetsuya Handoh ◽  
Mitsuru Wakita ◽  
Takamasa Yamamoto ◽  
Shigeki Misawa ◽  
...  
Keyword(s):  
Whole Blood ◽  
Point Of Care

Development of a point-of-care assay system for high-sensitivity C-reactive protein in whole blood

2003 ◽  
Vol 332 (1-2) ◽  
pp. 51-59 ◽  
Author(s):  
Jae Soon Ahn ◽  
Sunga Choi ◽  
Sang Ho Jang ◽  
Hyuk Jae Chang ◽  
Jae Hoon Kim ◽  
...  
Keyword(s):  
Whole Blood ◽  
Point Of Care ◽  
High Sensitivity ◽  
Assay System ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Point Of Care Assay
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