Integrated Platform Addressing the Finger-Prick Blood Processing Challenges of Point-of-Care Electrical Biomarker Testing

2022 ◽  
Author(s):  
Edward Cheah ◽  
Duy P. Tran ◽  
Mohamed T. Amen ◽  
R. Dario Arrua ◽  
Emily F. Hilder ◽  
...  
Keyword(s):  
Point Of Care ◽  
Blood Processing ◽  
Integrated Platform ◽  
Finger Prick ◽  
Biomarker Testing

Patient’s insurance status impact on biomarker testing in the United States market.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18114-e18114
Author(s):  
Daniel F. Winkelman ◽  
Amir Forouzan ◽  
Mike Lavin ◽  
Tanuja Tangudu ◽  
Kristopher Custer ◽  
...  
Keyword(s):  
United States ◽  
Cancer Treatment ◽  
Targeted Therapies ◽  
Point Of Care ◽  
Metastatic Cancer ◽  
The United States ◽  
Baseline Measure ◽  
Data Set ◽  
Insurance Type ◽  
Biomarker Testing

e18114 Background: Precision medicine in cancer treatment is driven by biomarker testing. If a patient is not biomarker tested, he or she may not receive access to targeted therapies that often offer greater efficacy. The purpose of this research study is to examine the insurance type of patients that are untested for biomarkers in the United States. Methods: BrandImpact is a longitudinal panel of 450 Oncologists who continuously report cancer treatment decisions from the point-of-care. The BrandImpact data set includes 60,465 patient visits reported in 2018. This study followed market research best practices. This research included visits by patients diagnosed with metastatic: NSCLC, melanoma and ovarian cancer who were either tested or untested for the following biomarkers: EGFR, ALK, ROS1, PD-L1, BRAF and BRCA. Results: The baseline measure for this analysis is that 18% of the patient visits reported that were not biomarker tested. The table at the end of document outlines the untested patient visits by insurance type for comparison purposes. Conclusions: The rate of biomarker testing for metastatic cancer patients treated by Oncologists differs by insurance type. Patients with Medicare Only insurance (25%) are untested at a statistically significantly higher rate than the baseline All category. It should be noted that patients without insurance or who were cash-paying had the highest rates of being non-biomarker tested. It is recommended that further research be conducted into the reasons behind the significantly higher rate of non-testing for Medicare Only patients. It seems counter intuitive that this patient population is treated less than optimally due to limited access to targeted therapies. [Table: see text]

scholarly journals A pilot evaluation of whole blood finger-prick sampling for point-of-care HIV viral load measurement: the UNICORN study

2017 ◽  
Vol 7 (1) ◽  
Author(s):  
Sarah Fidler ◽  
Heather Lewis ◽  
Jodi Meyerowitz ◽  
Kristin Kuldanek ◽  
John Thornhill ◽  
...  
Keyword(s):  
Viral Load ◽  
Whole Blood ◽  
Point Of Care ◽  
Viral Load Measurement ◽  
Hiv Viral Load ◽  
Load Measurement ◽  
Finger Prick

scholarly journals P544 Point-of-care finger prick test for C-reactive protein, infliximab and adalimumab serum concentrations

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S514-S515
Author(s):  
A Volkers ◽  
M Löwenberg ◽  
K Bray ◽  
B Bahur ◽  
M Braad ◽  
...  
Keyword(s):  
Point Of Care ◽  
Serum Concentrations ◽  
C Reactive Protein ◽  
Prick Test ◽  
Reactive Protein ◽  
Drug Concentrations ◽  
Deming Regression ◽  
Finger Prick ◽  
Point Of Care Tests ◽  
Serum Crp

Abstract Background Point-of-Care tests (POCTs) allow instant measurement of inflammatory markers and/or drug concentrations. However, currently available POCTs for infliximab (IFX) and adalimumab (ADL) serum concentrations are time consuming. Recently, a new POCT device (ProciseDx, San Diego, CA, USA) was developed which conveniently measures C-reactive protein (CRP), IFX and ADL capillary concentrations within minutes. We aimed to validate this device by comparing POCT results with conventional laboratory tests for serum CRP, IFX and ADL in patients with inflammatory bowel disease (IBD). Methods IBD patients requiring routine measurement of serum CRP, IFX or ADL were invited to participate. Along with serum collection, 20μl of capillary blood was obtained via finger prick and dispensed in a cartridge with a buffer, and placed in the POCT device providing results within two to four minutes. Forty patients were needed to validate the CRP POCT, as this assay was already previously validated in a different population. For the IFX and ADL assays, 120 patients using IFX or ADL were required to validate the POCT. Agreement between the laboratory serum assay and POCT was visualized on a scatter diagram and a Bland-Altman plot. Deming regression was calculated to demonstrate agreement. In addition, Pearson’s correlation coefficient was calculated. Results Until now, 41 patients have been enrolled for the CRP assay, 120 patients for the IFX and 46 patients for the ADL assay. Two ADL patients were sampled twice (n=48). Significant correlations were found for CRP, IFX and ADL (r=0.98, r=0.88 and r=0.86 respectively, Fig. 1). Deming regression analysis of the CRP assay resulted in a slope of 0.71 (95% CI 0.49 to 0.93) and 1.5 (95% CI -0.44 to 3.50) for the intercept. For the IFX assay, the slope was 1.1 (95% CI 0.83 to 1.3) and the intercept was 1.4 (95% CI -0.47 to 3.4). For the ADL assay, the slope was 0.97 (95% CI 0.64 to 1.3) and the intercept was 2.3 (95% CI -0.64 to 5.2). Conclusion A novel POCT using a finger prick approach provides a rapid, user friendly and reliable measurement of CRP, IFX and ADL concentrations within minutes. The capillary CRP was slightly lower than the venous serum CRP, which was consistently observed and considered clinically irrelevant in this cohort.

scholarly journals P342 Correlation of the first lateral flow-based Point of Care test to quantify infliximab and anti-infliximab antibodies in a finger prick sample with the reference ELISA technique

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S366-S366
Author(s):  
M B Ruiz-Argüello ◽  
J Pascual ◽  
L Del Río ◽  
A Urigoitia ◽  
C Balo Farto ◽  
...  
Keyword(s):  
Correlation Coefficient ◽  
Point Of Care ◽  
Pearson Correlation ◽  
Capillary Blood ◽  
Lateral Flow ◽  
Real Point ◽  
Infliximab Treatment ◽  
Serum Samples ◽  
Finger Prick ◽  
Elisa Technique

Abstract Background The goal of this study was to validate the use of capillary blood in a real point-of-care (POC) setting for patients under infliximab treatment by using Promonitor Quick lateral flow (LF) tests. Results were compared to the Promonitor ELISA reference technique in serum samples used by centralised laboratories. Methods A prospective, observational study was designed to evaluate the performance of a rapid LF test (Promonitor Quick IFX, Progenika, Spain). 160 infliximab treated rheumatology consecutive patients (400 samples) were recruited in two hospitals in Galicia, Spain. Prior to the infusion, a finger prick sample was obtained and analysed. Anti-infliximab antibodies were also determined with Promonitor Quick ANTI-IFX1-4. Results were read with the automated portable PQreader instrument. Additionally, a serum sample was collected for subsequent comparative analysis with either LF or ELISA tests. Qualitative (positive (PPA) and negative (NPA) agreements) and quantitative (Pearson correlation and bias) performance of the LF test was compared to ELISA, as well as between different specimens following CLSI EP09-A3. Results Overall agreement between Promonitor Quick IFX finger prick and ELISA test was 91% (88% PPA; 100% NPA). The quantitative comparison showed a good correlation (Pearson correlation coefficient: 0.85 and observed bias: 25%) (Table 1). Similar results were also observed when serum was used with either the LF or the ELISA tests (98% overall agreement, 0.91 correlation coefficient; 6% bias) (Table 1). Overall agreements for visual and automated (PQreader) interpretations with Promonitor Quick ANTI-IFX were 99% and 100% for finger prick and serum specimens, respectively (Table 2). Conclusion Promonitor Quick can be used to reliably quantify infliximab in capillary blood samples and results are comparable to those obtained with the reference ELISA technique. The use of the rapid POC test with finger prick will allow clinicians to monitor their patients in a fully decentralized mode to aid in the decision making process. PQreader is a sensitive portable equipment to report drug as well as antibody levels in the patient samples. References

scholarly journals Patient acceptability of targeted risk-based detection of non-communicable diseases in a dental and pharmacy setting

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Zehra Yonel ◽  
Asma Yahyouche ◽  
Zahra Jalal ◽  
Alistair James ◽  
Thomas Dietrich ◽  
...  
Keyword(s):  
Vitamin D ◽  
Community Pharmacy ◽  
Healthcare Professionals ◽  
Point Of Care ◽  
Communicable Diseases ◽  
Blood Collection ◽  
Point Of Care Testing ◽  
Patient Acceptability ◽  
Non Communicable Diseases ◽  
Finger Prick

Abstract Background Non-communicable diseases [NCDs] are the major cause of mortality globally and are increasing in prevalence. Different healthcare professionals’ access different population groups; and engaging allied healthcare professionals in risk-driven early case detection of certain NCDs may be beneficial, especially those who have not been tested for NCDs within the previous 12 months. The objectives of this study were to determine: whether NCD case finding in dental/community pharmacy settings is feasible in terms of patient acceptability, barriers to recruitment, impact on the existing service. Determine time taken to test for: type 2 diabetes risk [T2DM], chronic obstructive pulmonary disease [COPD], hypertension, vitamin D deficiency and chronic kidney disease [CKD]. Determine whether there is added benefit of point of care testing [POCT] to identify diabetes risk compared to a validated screening questionnaire alone. Methods An exploratory study was undertaken to explore issues associated with NCD assessment in one dental practice and one community pharmacy within the West-Midlands, UK. Fifty patients > 40 years-of-age were recruited per site. Participants undertook: a questionnaire providing demographic data, any previous NCD diagnosis or positive family history. Validated questionnaires for determining NCD risk [T2DM/COPD]. Chair-side capillary blood [finger-prick] samples for HbA1C, creatinine/eGFR, Vitamin-D. Prior work had been undertaken to measure the agreement between point of care testing [POCT] devices and a central laboratory method, and to gauge the opinions of participants regarding discomfort experienced using venous (antecubital fossa) and capillary (finger-prick) blood collection, via a 10 cm Visual-Analogue-Scale. The POCT devices demonstrated good concordance with laboratory testing and were acceptable methods of blood collection for participants. Results Recruitment rates demonstrated that 8 days were needed to recruit 50 participants and 60% of those approached opted to participate. The principal barrier to participation was time, with average time taken to test being 19mins. Utilising dental and pharmacy settings identified potential cases of previously undiagnosed disease. Conclusions Risk-targeted testing for NCDs in high street dental and community pharmacies is both attractive and acceptable to patients.

scholarly journals Alternative approaches to managing respiratory tract infections: A survey of public perceptions

BJGP Open ◽  
2020 ◽  
pp. BJGPO.2020.0124
Author(s):  
Alex Moore ◽  
Rebecca Cannings-John ◽  
Christopher Butler ◽  
Cliodna McNulty ◽  
Nick Francis
Keyword(s):  
Point Of Care ◽  
Public Perceptions ◽  
Antibiotic Prescribing ◽  
Response Options ◽  
Prick Test ◽  
Explanatory Variables ◽  
Primary Care Health ◽  
Finger Prick ◽  
Different Response ◽  
Tract Infections

Aim: To describe public perceptions regarding finger-prick testing, back-up antibiotic prescriptions (BUP), and alternatives to traditional consultations for RTIs, and identify factors associated with favouring these approaches. Design and setting: Online national survey (HealthWise Wales) with linked primary care health record data. Methods: Survey item response distributions were described. Associations between responses about consultation alternatives, BUP and finger-prick point of care testing, and potential explanatory variables, were explored using logistic regression. Results: 8,752 participants completed the survey between 2016 and 2018. 76.7% (3,807/4,966) and 71.2% (3,529/4,953) of respondents with valid responses were in favour of being able to consult with a pharmacist or nurse in their GP surgery, or with a community pharmacist, respectively. 92.8% (8034/8659) of respondents indicated they would be happy to have a finger-prick test to guide antibiotic prescribing, and 31.8% (2746/8646) indicated they would like to be given a BUP if their clinician thought immediate antibiotics were not required. 47.4% (2342/4944) and 42.3% (2095/4949) were in favour of having video and email consultations respectively. Characteristics associated with different response options were identified. Conclusion: Consulting with pharmacists, using electronic communication tools, and finger-prick testing are widely acceptable approaches. BUP was described as acceptable less often and is likely to require greater information and support when used.

scholarly journals Study to evaluate the performance of a point-of-care whole blood HIV viral load test (SAMBA II HIV-1 Semi-Q Whole Blood).

2020 ◽  
Author(s):  
Gary Brook ◽  
Tetiana Stepchenkova ◽  
Innocent M. Ali ◽  
Sandra Chipuka ◽  
Neha Goel ◽  
...  
Keyword(s):  
Viral Load ◽  
Whole Blood ◽  
Point Of Care ◽  
Venous Blood ◽  
Load Test ◽  
Hiv Viral Load ◽  
Percent Agreement ◽  
Finger Prick ◽  
Hiv 1 ◽  
Point Of Care Assay

Remote areas of many low and middle income (LMI) countries have poor access to HIV viral load (HIV VL) testing. The SAMBA-II (Simple Amplification-based Assay) Semi-Q Whole Blood Test (Diagnostics for the Real World (DRW), Cambridge, UK) is a point of care assay which uses leucodepletion technology to allow whole blood testing in remote settings. 1540 consecutive HIV-positive clinic patients in Cameroon (250), UK (633), Ukraine (412) and Zimbabwe (245) donated venous blood (all countries) and finger-prick blood (all except UK) for testing on SAMBA-II. SAMBA II results were compared with simultaneous plasma results on the Abbott RealTime HIV-1 (Abbott Molecular, Des Plaines, IL) viral load assay and interpreted as either <1000 RNA copies/ml or ≥1000 RNA copies/ml. For 1528 venous whole-blood samples tested on SAMBA II, overall percent agreement with the reference test at a cut-off of HIV VL ≥1000 cps/ml was 96.9% (1480/1528 95% CI 95.9-97.7), negative percent agreement 97.7% (1259/1289 95% CI 96.7-98.4), positive percent agreement 92.5% (221/239 95% CI 88.4-95.5). For 854 finger-prick samples there was 95.0% (811/854 95% CI 93.3-96.3) overall percent agreement; negative percent agreement 98.0% (625/638, 95% CI 96.5-98.9); positive percent agreement 86.1% (186/216 95% CI 80.8-90.4). These rose to 93.5% (82.1, 98.6), 97.6% (95.6, 98.8) and 95.6% (93.3, 97.3) after exclusion of aberrant results from the Ukraine centre. These results show a high level of agreement between SAMBA-II and a laboratory-based assay. SAMBA-II has a performance that is suitable to use as a VL point of care assay in remote settings

scholarly journals Performance characteristics of an instrument-free point-of-care CD4 test (VISITECT®CD4) for use in resource-limited settings

2020 ◽  
Vol 48 (9) ◽  
pp. 030006052095502
Author(s):  
Vairamohan Vidhyavathi ◽  
Hussain Syed Iqbal ◽  
Kannaiyan Kanthamani ◽  
Sunil Suhas Solomon ◽  
Paneerselvam Nandagopal ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Predictive Value ◽  
Point Of Care ◽  
Low Cost ◽  
Venous Blood ◽  
Hiv Positive ◽  
Resource Limited ◽  
Immunodeficiency Virus ◽  
Finger Prick ◽  
Sensitivity Specificity

Objective CD4+ T lymphocyte count remains the most common biomarker of immune status and disease progression in human immunodeficiency virus (HIV)-positive individuals. VISITECT®CD4 is an instrument-free, low-cost point-of-care CD4 test with a cut-off of 350 CD4 cells/μL. This study aimed to evaluate VISITECT®CD4 test's diagnostic accuracy. Methods Two hundred HIV-positive patients attending a tertiary HIV centre in South India were recruited. Patients provided venous blood for reference and VISITECT®CD4 tests. An additional finger-prick blood sample was obtained for VISITECT®CD4. VISITECT®CD4's diagnostic performance in identifying individuals with CD4 counts ≤350 cells/μL was assessed by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) taking flow cytometry as the reference. Results The overall agreement between VISITECT®CD4 and flow cytometry was 89.5% using venous blood and 81.5% using finger-prick blood. VISITECT®CD4 showed better performance using venous blood [sensitivity: 96.6% (95% confidence interval: 92.1%–98.9%), specificity: 70.9% (57.1%–82.4%), PPV: 89.7% (83.9%–94.0%) and NPV: 88.6% (75.4%–96.2%)] than using finger-prick blood [sensitivity: 84.8% (77.9%–90.2%), specificity: 72.7% (59.0%–83.9%), PPV: 89.1% (82.7%–93.8%) and NPV: 64.5% (51.3%–76.3%)]. Conclusion VISITECT®CD4 performed well using venous blood, demonstrating its potential utility in decentralization of CD4 testing services in resource-constrained settings.

scholarly journals Field Performance and Diagnostic Accuracy of a Low-Cost Instrument-Free Point-of-Care CD4 Test (Visitect CD4) Performed by Different Health Worker Cadres among Pregnant Women

2018 ◽  
Vol 57 (2) ◽  
Author(s):  
Stanley Luchters ◽  
Karl Technau ◽  
Yasmin Mohamed ◽  
Matthew F. Chersich ◽  
Paul A. Agius ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Pregnant Women ◽  
Health Worker ◽  
Rural Areas ◽  
Point Of Care ◽  
Low Cost ◽  
Venous Blood ◽  
Field Performance ◽  
Hiv Care ◽  
Finger Prick

ABSTRACT Measuring CD4 counts remains an important component of HIV care. The Visitect CD4 is the first instrument-free low-cost point-of-care CD4 test with results interpreted visually after 40 min, providing a result of ≥350 CD4 cells/mm3. The field performance and diagnostic accuracy of the test was assessed among HIV-infected pregnant women in South Africa. A nurse performed testing at the point-of-care using both venous and finger-prick blood, and a counselor and laboratory staff tested venous blood in the clinic laboratory (four Visitect CD4 tests/participant). Performance was compared to the mean CD4 count from duplicate flow cytometry tests on venous blood (FACSCalibur Trucount). In 2017, 156 patients were enrolled, providing a total of 624 Visitect CD4 tests (468 venous and 156 finger-prick samples). Of 624 tests, 28 (4.5%) were inconclusive. Generalized linear mixed modeling showed better performance of the test on venous blood (sensitivity = 81.7%; 95% confidence interval [CI] = 72.3 to 91.1]; specificity = 82.6%, 95% CI = 77.1 to 88.1) than on finger-prick specimens (sensitivity = 60.7%; 95% CI = 45.0 to 76.3; specificity = 89.5%, 95% CI = 83.2 to 95.8; P = 0.001). No difference in performance was detected by cadre of health worker (P = 0.113) or between point-of-care versus laboratory-based testing (P = 0.108). Adequate performance of Visitect CD4 with different operators and at the point of care, with no need of electricity or instrument, shows the potential utility of this device, especially for facilitating decentralization of CD4 testing services in rural areas.

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