Assessing the Risk of Contrast-Induced Nephropathy Using a Finger Stick Analysis in Recalls from Breast Screening: The CINFIBS Explorative Study

Purpose. To evaluate whether a handheld point-of-care (POC) device is able to predict and discriminate patients at potential risk of contrast-induced nephropathy (CIN) prior to iodine-based contrast media delivery. Methods and Materials. Between December 2014 and June 2016, women undergoing contrast-enhanced spectral mammography (CESM) with an iodine-based contrast agent were asked to have their risk of CIN assessed by a dedicated POC device (StatSensor CREAT) and a risk factor questionnaire based on national guidelines. Prior to contrast injection, a venous blood sample was drawn to compare the results of POC with regular laboratory testing. Results. A total of 351 patients were included; 344 were finally categorized as low risk patients by blood creatinine evaluation. Seven patients had a eGFR below 60 ml/min/1.73 m2, necessitating additional preparation prior to contrast delivery. The POC device failed to categorize six out of seven patients (86%), leading to (at that stage) unwanted contrast administration. Two patients subsequently developed CIN after 2–5 days, which was self-limiting after 30 days. Conclusion. The POC device tested was not able to reliably assess impairment of renal function in our patient cohort undergoing CESM. Consequently, we still consider classic clinical laboratory testing preferable in patients at potential risk for developing CIN.

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Hemoglobin A1c Point-of-Care Assays; A New World with a Lot of Consequences!

Journal of Diabetes Science and Technology ◽

10.1177/193229680900300303 ◽

2009 ◽

Vol 3 (3) ◽

pp. 418-423 ◽

Cited By ~ 20

Author(s):

Erna Lenters-Westra ◽

Robbert J. Slingerland

Keyword(s):

Nurse Practitioners ◽

Hemoglobin A1c ◽

Clinical Laboratory ◽

Point Of Care ◽

Care Center ◽

Venous Blood ◽

Coefficients Of Variation ◽

Rapid Result ◽

Performance Results ◽

Clinical Laboratory Improvement Amendments

Background: Point-of-care instruments for the measurement of hemoglobin A1c (HbA1c) may improve the glycemic control of people with diabetes by providing a rapid result if the performance of the instruments used is acceptable. A 0.5% HbA1c difference between successive results is considered a clinically relevant change. With this in mind, the In2it from Bio-Rad and the DCA Vantage from Siemens were evaluated according to Clinical and Laboratory Standards Institute (CLSI) protocols. Methods: The CLSI protocols EP-5 and EP-9 were applied to investigate precision, accuracy, and bias. The bias was compared with three certified secondary reference measurement procedures. Differences between capillary and venous blood were investigated by an end-user group consisting of nurse practitioners at a diabetes care center. Results: At HbA1c levels of 5.1 and 11.2%, total coefficients of variation (CV) for the In2it were 4.9 and 3.3%, respectively, and for the DCA Vantage were 1.7 to 1.8% and 3.7 to 5.5% depending on the lot number of the cartridges. Method comparisons showed significant lot number-dependent results for the In2it and the DCA Vantage compared with the three reference methods. No overall difference was observed between capillary and venous blood for both methods. Conclusion: Performance results of the In2it and the DCA Vantage showed variable and lot number-dependent results. To maintain the interlaboratory CV of 5% for HbA1c, the Clinical Laboratory Improvement Amendments rules for waived point-of-care instruments should be revised. An obligation for participating in external quality schemes and taking adequate action should be considered for POC instruments that perform poorly.

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Types of Assays for SARS-CoV-2 Testing: A Review

Laboratory Medicine ◽

10.1093/labmed/lmaa039 ◽

2020 ◽

Vol 51 (5) ◽

pp. e59-e65 ◽

Cited By ~ 6

Author(s):

Marie C Smithgall ◽

Mitra Dowlatshahi ◽

Steven L Spitalnik ◽

Eldad A Hod ◽

Alex J Rai

Keyword(s):

Patient Care ◽

Laboratory Testing ◽

Clinical Laboratory ◽

Point Of Care ◽

Direct Patient Care ◽

Point Of Care Testing ◽

Clinical Laboratories ◽

Novel Coronavirus ◽

Outpatient Settings ◽

Clinical Laboratory Testing

Abstract Clinical laboratory testing routinely provides actionable results, which help direct patient care in the inpatient and outpatient settings. Since December 2019, a novel coronavirus (SARS-CoV-2) has been causing disease (COVID-19 [coronavirus disease 2019]) in patients, beginning in China and now extending worldwide. In this context of a novel viral pandemic, clinical laboratories have developed multiple novel assays for SARS-CoV-2 diagnosis and for managing patients afflicted with this illness. These include molecular and serologic-based tests, some with point-of-care testing capabilities. Herein, we present an overview of the types of testing available for managing patients with COVID-19, as well as for screening of potential plasma donors who have recovered from COVID-19.

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Point-of-care measurement of clozapine concentration using a finger-stick blood sample

Journal of Psychopharmacology ◽

10.1177/0269881121991567 ◽

2021 ◽

pp. 026988112199156

Author(s):

David Taylor ◽

Matthew Atkins ◽

Robert Harland ◽

Irina Baburina ◽

James H MacCabe ◽

...

Keyword(s):

Blood Sample ◽

Point Of Care ◽

Venous Blood ◽

Laboratory Method ◽

Capillary Blood ◽

Strong Positive Correlation ◽

Blood Samples ◽

Clozapine Concentration ◽

Capillary Sample ◽

Finger Stick

Background: The use of clozapine demands regular monitoring of clozapine plasma concentrations and of white blood cell parameters. The delay between sending blood samples for analysis and receiving the results hinders clinical care. Point-of-care testing (POCT) can provide drug assay results within a few minutes. Aim: This study aimed to investigate the utility of a novel point-of-care device that can measure clozapine concentrations using capillary blood samples collected via a finger stick. Method: During a five-week period starting in June 2019 eligible patients were asked to provide a finger-stick capillary sample in addition to their usual venous blood sample. Samples were analysed by the novel point-of-care device and by the standard laboratory method. Capillary blood samples were tested by the MyCare™ Insite POCT analyser, and a quantitative measurement of clozapine concentration was provided within six minutes. Results: A total of 309 patients agreed to measurements by the two methods. Analysis revealed clozapine concentrations in venous blood as determined by the laboratory method ranged from 20 to 1310 ng/mL and by POCT from 7 to 1425 ng/mL. There was a strong positive correlation ( R = 0.89) between the results from the venous and the capillary sample methods. The slope of the association between standard assay and MyCare™ Insite was 1.0 with an intercept of –21 ng/mL, indicating minimal bias. Conclusion: Clozapine concentrations can be accurately measured at the point of care using capillary blood samples collected via a finger stick. This approach may be more acceptable than venous sampling to patients and, with almost instant results available, more useful to clinicians.

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The Reliability of Point-of-Care (POC) Prothrombin Time Testing - A Comparison of CoaguChek XS® INR Measurements with Hospital Laboratory Monitoring.

Blood ◽

10.1182/blood.v110.11.973.973 ◽

2007 ◽

Vol 110 (11) ◽

pp. 973-973 ◽

Cited By ~ 1

Author(s):

Fiona Ryan ◽

Susan O’Shea ◽

Thomas L. Ortel ◽

Stephen Byrne

Keyword(s):

Clinical Laboratory ◽

Point Of Care ◽

Venous Blood ◽

Anticoagulation Therapy ◽

University Hospital ◽

External Quality ◽

Hospital Laboratory ◽

Laboratory Values ◽

Venous Sample ◽

Coaguchek Xs

Abstract Background The development of Point of Care (POC) testing devices enables patients to test their own International Normalised Ratio (INR) at home, and has lead to the development of patient self- testing (PST) programmes. This facilitates more frequent testing of anticoagulation levels which in turn improves time in therapeutic range (TTR) and reduces bleeding and thrombotic complications in patients on oral anticoagulation therapy (OAT).1 External quality control of POC devices is essential to ensure that results are robust. One approach is to collect a venous sample at the same time as POC testing, which is analysed using an appropriate hospital laboratory analyzer. It has been recommended that INR results should be within 0.5 of each other when measured by each method2. However, previous studies have shown that when compared with clinical laboratory values, POC devices may show statistically significant differences between the INR values.3 Aim The aim of this study is primarily to compare TTR and adverse events between two different approaches to OAT management and more specifically in this presentation to examine the intra patient variability of INR measurements performed by two different techniques. Methods 160 patients routinely attending the anticoagulant clinic of Cork University Hospital (CUH) were enrolled to take part in a prospective randomized controlled, cross-over design trial of supervised PST of warfarin therapy using an internet based expert system (Coagcare®, ZyCare, Inc) and POC testing device (CoaguChek XS®, Roche, UK) vs. rountine medical care in CUH. During the 6 months PST arm of the study a venous blood sample was taken from each patient for laboratory determination of the INR on 3 occasions; at enrolment, 2 months and 4 months. This measurement was then compared with the INR measured on the Coaguchek XS® machine using capillary blood from the patient’s fingertip. Results 88 patients have being enrolled in the PST arm of the study to date and 454 POC measurements have been compared with laboratory values. Good correlation has been shown between the two methods of INR determination (r2 = 0.8314), however, statistically significant differences did occur (p < 0.005). A Bland and Altman plot showed good agreement between the dual measurements at values between 2.0–3.5 INR units. However there seemed to be increasing disagreement between the two methods as the INR rose above 3.5. Four patients were excluded from the study because the differences in the INR measurements were greater than 0.5 INR units. Conclusion POC testing devices for OAT are reliable and safe. External quality assessment should be inherent to any programme involving these devices. Clinicians involved in the use of POC anticoagulation monitoring should be aware that POC and laboratory values may differ and intervene if there is not adequate correlation between the two INR measurements.

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Analysis of a Point-of-Care HbA1c Assay: Is It Time for an HbA1c Error Grid?

Journal of Diabetes Science and Technology ◽

10.1177/1932296819861983 ◽

2019 ◽

Vol 14 (5) ◽

pp. 896-897

Author(s):

Jan S. Krouwer

Keyword(s):

Adverse Event ◽

Error Estimate ◽

Hemoglobin A1c ◽

Clinical Laboratory ◽

Point Of Care ◽

Total Error ◽

User Facility ◽

Finger Stick ◽

Error Grid ◽

Clinical Laboratory Improvement Amendments

In an article in Journal of Diabetes Science and Technology, Arnold et al have presented a thorough study of imprecision components for a point-of-care hemoglobin A1c (HbA1c) assay. An interesting and innovative approach is the combination of data from different studies to arrive at a total error estimate. But total error has the oxymoron feature of estimating performance for most (95%) but not all of the results. An HbA1c error grid would provide the severity for results that exceed the 6% requirement. Since this device is intended for Clinical Laboratory Improvement Amendments waived labs and allows for finger-stick samples, monitoring the Food and Drug Administration adverse event database (MAUDE, Manufacturer and User Facility Device Experience) is recommended.

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“On Vivo” and Wearable Clinical Laboratory Testing Devices for Emergency and Critical Care Laboratory Testing

The Journal of Applied Laboratory Medicine ◽

10.1373/jalm.2018.028654 ◽

2019 ◽

Vol 4 (2) ◽

pp. 254-263 ◽

Cited By ~ 2

Author(s):

Alan H B Wu

Keyword(s):

Laboratory Testing ◽

Clinical Laboratory ◽

Point Of Care ◽

Surgical Excision ◽

Turnaround Time ◽

Test Results ◽

Next Generation ◽

Laboratory Test Results ◽

Blood Gas Analyses ◽

Clinical Laboratory Testing

Abstract Background Point-of-care testing (POCT) devices are designed for clinical laboratory testing at the bedside or near the patient and can significantly reduce the turnaround time for laboratory test results. The next generation for clinical laboratory testing may be devices that are worn or attached to the patient. Content POCT devices that are designed where samples are tested directly on the patient include bilirubinometers, pulse oximeters, breathalyzers (for alcohol and, more recently, cannabinoid detection), transcutaneous blood gas analyses, and novel testing applications such as glucose and tumor signatures following surgical excision. The utility of these devices with special reference for use within the intensive care unit and the emergency department is reviewed. Summary It is likely that wearable POCT devices will be developed in the future that can meet current and emerging clinical needs. Advancements in biomedical engineering and information technology will be needed in the creation of next-generation devices.

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Finger stick blood test to assess post vaccination SARS-CoV-2 neutralizing antibody response against variants

10.1101/2021.11.11.21266241 ◽

2021 ◽

Author(s):

Rachel Lim ◽

Hoi Lok Cheng ◽

Jia Huan ◽

Patthara Kongsuphol ◽

Bhuvaneshwari D/O Shunmuganath ◽

...

Keyword(s):

Point Of Care ◽

Venous Blood ◽

Substantial Reduction ◽

Neutralizing Antibody ◽

Post Vaccination ◽

Binding Domains ◽

Alpha Beta ◽

Finger Stick ◽

Relevant Range ◽

Group Post

There is clinical need for a quantifiable point-of-care (PoC) SARS-CoV-2 neutralizing antibody (nAb) test that is adaptable with the pandemics changing landscape. Here, we present a rapid and semi-quantitative nAb test that uses finger stick or venous blood to assess the nAb response of vaccinated population against wild-type, alpha, beta, gamma, and delta variant receptor binding domains. It captures a clinically relevant range of nAb levels, and effectively differentiates pre-vaccination, post 1st dose and post 2nd dose vaccination samples within 10 minutes. The data observed against alpha, beta, gamma, and delta variants agrees with published results evaluated in established serology tests. Finally, our test revealed a substantial reduction in nAb level for beta, gamma, and delta variants between early BNT162b2 vaccination group (within 3 months) and later vaccination group (post 3 months). This test is highly suited for PoC settings and provides an insightful nAb response in a post-vaccinated population.

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Comparing the Accuracy of 2 Point-of-Care Lipid Testing Devices

Journal of Pharmacy Practice ◽

10.1177/0897190016651546 ◽

2016 ◽

Vol 30 (5) ◽

pp. 490-497 ◽

Cited By ~ 10

Author(s):

Karen Bastianelli ◽

Stacey Ledin ◽

Jennifer Chen

Keyword(s):

Point Of Care ◽

Venous Blood ◽

Intraclass Correlation ◽

Density Lipoprotein ◽

Correlation Coefficients ◽

Hdl Cholesterol ◽

Reference Laboratory ◽

Average Difference ◽

Industry Standards ◽

Finger Stick

Background: Device manufacturers have improved technology since studies were last published, thus warranting an updated analysis. Objective: Two point-of-care (POC) cholesterol testing devices were directly compared to a venous sample to determine device accuracy. Methods: Institutional review board (IRB)–approved study collected finger-stick blood samples analyzed by Cholestech LDX (Cholestech Corporation, Hayward, California) and CardioChek Plus (Polymer Technology Systems Inc, Indianapolis, Indiana) devices and compared to venous blood for 30 study participants. Statistical analyses were completed using StatisPro. Intraclass correlation coefficients were generated, and the average difference expected to be within the industry standards of total cholesterol (TC; ±10%), high-density lipoprotein (HDL) cholesterol (±12%), and triglycerides (TG; ±15%). Results: The POC devices produced clinically equivalent values when compared to the same patients’ samples analyzed in a reference laboratory. The average difference calculated from the actual individual paired percentage bias with the Integra analyzer: venous—TC −3.8%, HDL −6.9%, TG −1.8%; CardioChek—TC −7.8%, HDL −6.2%, TG 5.1%; and Cholestech—TC 0.5%, HDL −4.5%, TG −3.3%. The average of the actual paired percentage bias with the Roche Cobas analyzer: CardioChek—TC −4.2%, HDL 0.8%, TG 7.0% and Cholestech—TC 4.6%, HDL 2.6%, TG −1.6%. Conclusion: Both screening devices operated within industry accuracy standards.

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Pulmonary emboli due to venous aneurysm of extremities

VASA ◽

10.1024/0301-1526/a000124 ◽

2011 ◽

Vol 40 (4) ◽

pp. 327-332 ◽

Cited By ~ 6

Author(s):

Gabrielli ◽

Rosati ◽

Vitale ◽

Millarelli ◽

Siani ◽

...

Keyword(s):

Pulmonary Embolism ◽

Surgical Resection ◽

Potential Risk ◽

Acute Pulmonary Embolism ◽

Prophylactic Surgery ◽

Venous Aneurysm ◽

Pulmonary Emboli ◽

Thromboembolic Events ◽

Thromboembolic Complications ◽

Risk Patients

Venous aneurysms are uncommon but they can have devastating consequences, including pulmonary embolism, other thromboembolic events and death. We report six cases of venous aneurysm of the extremities, in which the first sign of presence was acute pulmonary embolism. Surgical resection is recommended whenever possible. Our experience suggests that prophylactic surgery is cautiously recommended for low-risk patients with venous aneurysms of the abdomen and strongly recommended for extremity deep and superficial venous aneurysms for their potential risk of developing thromboembolic complications despite adequate anticoagulation. Other venous aneurysms should be excised only if they are symptomatic or enlarging.

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