Purpose This prospective comparative study aims to evaluate the accuracy and validity of CoaguChek XS point-of-care system (Roche Diagnostics GmbH, Mannheim, Germany), compared with the standard central laboratory international normalized ratio (INR) results, in a vascular surgery ward. Methods Data based on 54 INR pairs, measured by the central laboratory analyzer and CoaguChek XS, were compared using the intraclass correlation coefficient. Other outcomes included the time and cost of the service from the patient's perspectives. Correlation was assessed using Pearson correlation test. Bland-Altman analysis was done to determine mean difference and 95% limits of agreement. Cohen κ test was done to assess agreement between the 2 methods. Results The mean INR values for CoaguChek XS and standard laboratory (Sysmex Ca-1500 system; Siemens Healthcare Diagnostics, Erlangen, Germany) were 1.21 ± 0.28 and 1.24 ± 0.43, respectively. The Pearson correlation coefficient in all 108 measurements was (r) = 0.591 (95% confidence interval, 0.38–0.74; P < 0.0001), indicating a moderately positive correlation. Overall intraclass correlation coefficient was 0.803 (95% confidence interval, 0.324–0.707) indicating good reliability. Bland-Altman analysis showed a bias of 0.035 and a 95% limits of agreement ranging from −0.63 to 0.70. There was substantial agreement between the 2 methods (κ = 0.694; SE, 0.108; 95% confidence interval, 0.481–0.907). CoaguChek XS results were obtained, on average, 213 minutes faster than the standard laboratory. Conclusions CoaguChek XS appears to have positive correlation, substantial agreement, and good reliability when compared with the standard laboratory. Thus, it is recommended to be used in hospital settings.
The ISO 22870:2016 standard requires validation of point-of-care testing (POCT) instruments before routine use. Although it is a relatively easy task for blood gas analyzers, it is much more involved in connected blood glucose monitoring (BGM) devices because they are used ubiquitously and in large numbers throughout hospital departments. Here we present the model used in order to validate efficiently and effectively compliance of 116 glucose/ketone BGM devices to ISO 22870. In a first step, a "reference" BGM was established and fully evaluated in comparison to our criterion-standard laboratory method. The 115 remaining connected and hospital-wide distributed BGM devices were then correlated against the "reference" BGM. We spiked donated blood samples with increasing amounts of glucose derived from a diluted oral glucose solution and tested it with the reference StatStrip BGM device and with a cobas 8000 glucose laboratory comparison method. Every connected BGM device was then compared with the BGM reference device using the same sample preparation methodology. The ISO 15197, POCT 12-A3, and Food and Drug Administration performance acceptance criteria were used for comparing the BGM reference results with the laboratory criterion-standard results and for comparing BGM reference results with the connected hospital BGM devices. Repeatability and interassay precision were assessed with aqueous controls. We show that it is possible to validate compliance of a large number of connected POCT BGM devices to ISO 22870 efficiently and effectively using only 1 operator. The StatStrip BGM device performances were excellent and met the ISO 15197, POCT 12-A3, and Food and Drug Administration criteria.
The main users of point-of-care testing devices placed outside the central laboratory are clinicians, predominantly nurses. Understanding the factors influencing sample accuracy is important to ensure appropriate clinical decision making. Previous studies focus on the analysis process; however, errors can also occur during the preanalytical phase, linked to user knowledge, skills, and other factors associated with the wider context of care. This study explored adult critical care nurses' views about point-of-care testing, the challenges they experience, and their suggestions on how the preanalytical phase might be improved. Using a qualitative design, 4 focus group discussions took place with 60 critical care nurses studying at 2 London-based universities between April and July 2019. Anonymized and verbatim-transcribed focus group data were uploaded into NVivo(11) and underwent a standard process of inductive thematic analysis. Findings suggest that nurses' concerns focus on 3 key areas: training and competence; sample frequency and volume; and impacts on patients, relatives, and staff. Critical care nurses view point-of-care testing as a necessary task, which aids timely patient management. However, the process can detract nurses from performing other care duties. Being able to draw less blood was identified as an important way to increase patient comfort and to reduce risks. Collaborative working is key to ensure that improvements made to the preanalytical process reflect users' needs. Ensuring best use of nurses' time by streamlining preanalytical processes and ensuring equipment is readily available for use are important to ensure other clinical priorities can be achieved.
From the Quidel Corporation, Athens, OH. Reprints: Molly Winters, BS, MHA, CCRP, Quidel Corporation, 2005 E State St, Suite 100, Athens, OH 45701. E-mail: [email protected]. The author declares no conflict of interest.
Major technical challenges often prevent developers from producing new point-of-care technologies that deliver the required clinical performance in the intended settings of use. However, even when devices meet clinical requirements, they can fail to be adopted and successfully implemented. Adoption barriers occur when decision makers do not understand the "value proposition" of new technologies. Current discussions of value in the context of point-of-care testing focus predominantly on the intended use and performance of the device from the manufacturer's point of view. However, the perspective of potential adopters in determining whether new devices provide value is also important, as is the opinion of all stakeholders who will be impacted. Incorporating value concepts into decisions made across the full development-to-adoption continuum can increase the likelihood that point-of-care testing will have the desired impact on health care delivery and patient outcomes. This article discusses how various approaches to technology development impact adoption and compares the characteristics of these approaches to emerging value concepts. It also provides an overview of value initiatives and tools that are being developed to support the evaluation of value propositions. These are presented for a range of technology adoption decision contexts, with particular applicability to point-of-care testing. Expanding the focus of research to address gaps in both the creation and evaluation of value propositions is imperative in order for value concepts to positively influence the adoption of point-of-care testing.
Microtechnology point-of-care tests (POCTs), which are accurate and easy to use, are needed for the diagnosis of infants with sickle cell disease (SCD) to facilitate linkage to early care and management in resource-constrained public health centers in sub-Saharan Africa. We systematically reviewed the evidence of 2 novel POCTs' characteristics, performance, and clinical utility compared with standard laboratory-based methods. Studies evaluating the use of POCTs for SCD screening were identified by a search of PubMed and CINAHL. Eighty-four abstracts were screened, and 68 full-text articles were assessed, of which 12 met the inclusion criteria. Twelve studies conducted in 10 countries evaluated performance and diagnostic accuracy of 2 qualitative immunoassay POCTs (Sickle SCAN and HemoTypeSC). Eight studies were field reviews that compared the performance of the POCTs to extant laboratory methods, and one study reported on clinical management of SCD. The studies of diagnostic accuracy showed excellent performance for immunoassay POCTs. The reported correlation between criterion standard comparator laboratory-based assays was high across the 2 POCTs. Specificity for both POCTs was excellent among newborns and infants even in the presence of high fetal hemoglobin levels. The POCTs were deemed easy to use and had rapid turnaround times. The performance of immunoassay SCD-POCTs is comparable to reference assays, and the SCD-POCTs have the potential to improve patient outcomes. Additional studies on clinical utility, implementation, and accessibility are needed. Future research should focus on understanding and mapping the barriers to implementation within the context of resource-constrained settings.
Background: Studies of current opinion of our community members for the characteristics, mode, and location of use, use cases, and overall enthusiasm for point-of-care testing (POCT) diagnosis and management tools are needed. Study Design and Methods: Qualitative research methods were used to develop, refine, and evaluate hardcopy and electronic versions of a 45-item English language survey. The accuracy of the instrument was measured by recorded structured interview, and its precision was measured by comparison to its administration to a group of uncompensated volunteers. Main Findings and Results: Comparison of survey and structured interview data demonstrated high levels of accuracy. Highly concordant with significant levels of correlation and of direct association indicated favorable precision. Ninety-three percent of respondents believed that POCT could improve their care, and 56% identified having a POCT in their home as a top priority. Accuracy, insurance coverage, immediacy of results, and ease of use were identified as the most important characteristics of a POCT. Conclusions: Community members strongly support the development of accurate, in-home devices that produce immediate results that can be used to diagnose, manage, and encourage their adherence to treatments for their medical conditions.
Purpose: The aim of this review was to summarize new data on the use of international normalized ratio (INR) point-of-care testing (POCT) devices in hypercoagulable disease states such as antiphospholipid syndrome (APS) and those with left ventricular assist devices (LVADs). Methods: PubMed and Google Scholar were searched for keywords relating to warfarin, point-of-care testing, and hypercoagulable conditions. Intensive care unit studies and articles not in English were excluded. Results: Four recent studies examining 3 different POCT devices in patients with APS and 2 for patients with LVADs were found. The studies compared devices against laboratory INRs as a standard or against another POCT device to determine device agreeability or bias. Results showed that CoaguChek XS does not correlate well with laboratory INRs in patients with APS but is acceptable in LVAD patients. Coagsense and ProTime InRhythm correlated well with laboratory INR values in APS patients. Conclusions: Coagsense and ProTime InRhythm may be acceptable POCT devices to use for APS patients, whereas CoaguChek XS is not acceptable. In LVAD patients, CoaguChek XS is acceptable because it correlates well with laboratory INR values.
Real-time point-of-care (POC) measurement of coagulation parameters, including activated clotting time (ACT), activated partial thromboplastin time, and prothrombin time with calculated international normalized ratio can improve patient outcomes in clinical settings, such as surgical and minimally invasive cardiac procedures, critical care units, and emergency departments. Point-of-care analyzers used in these settings must be small, portable, robust, and easy to use. The Hemochron Signature Elite system (Instrumentation Laboratory) offers 6 types of single-use disposable coagulation test cartridges, ACT+ (to measure high to moderate unfractionated heparin concentrations), ACT-LR (to measure moderate to low unfractionated heparin concentrations), activated partial thromboplastin time (citrate or whole-blood samples), and prothrombin time/international normalized ratio (citrate or whole-blood samples). Using a mechanical clot-detection technology, 1 to 2 drops of blood are mixed with an assay-specific reagent. Results are analyzed, displayed, and archived within minutes of testing. An integral barcode reader scans patient and operator IDs, and reagent lot details for documentation and traceability. The system supports remote connectivity (POCT01-A-compliant) and POC management of data, operators, and analyzers with GEMweb Plus 500 Custom Connectivity solution (Instrumentation Laboratory). The Hemochron Signature Elite system provides rapid and reliable testing with the broadest coagulation test menu of any POC instrument.
Background: The LumiraDx INR Test is a new point-of-care diagnostic test designed to analyze fingerstick blood samples. The test was assessed in patients receiving phenprocoumon (NCT04074980). Methods: Venous plasma international normalized ratio (INR) was measured using the LumiraDx INR Test. LumiraDx INR Test-ascertained capillary whole blood INR was compared with venous plasma INR measured using the IL ACL Elite Pro and Sysmex CS-5100 reference instruments. Results: A total of 102 patients receiving phenprocoumon were recruited. The INR results from venous plasma and capillary whole blood that were analyzed on the LumiraDx INR Test correlated well with those measured using the IL ACL Elite Pro (plasma: n = 25, r = 0.981; capillary blood: n = 74, r = 0.949) and the Sysmex CS-5100 (n = 73, r = 0.950). Conclusions: The LumiraDx INR Test showed high accuracy in analyzing venous plasma and capillary whole blood from patients receiving phenprocoumon.
Background: When postneurosurgery patients develop fever, there are no convenient methods to immediately indicate the site of infection. The choice of empirical antibiotic therapy is evidently different in nosocomial meningitis compared with ventilator-associated pneumonia or urinary tract infection. Conventional bacterial cultures run a risk of being false negative due to antibiotic prophylaxis, and direct microscopic analysis of cerebrospinal fluid (CSF) from such patients has limited diagnostic value. Because of the substantial mortality associated with nosocomial meningitis, broad spectrum antibiotics in high dosage are, therefore, commonly administered. Neutrophils as a part of the innate immunity system, trap and kill bacteria by neutrophil extracellular traps (NETs). Neutrophil extracellular traps are composed of extracellular DNA which is released to the CSF during bacterial meningitis. Using a combination of sulphated-glucosaminoglycan and aniline dyes, a measurement method was developed that reacts to extracellular host DNA and changes color within 1 minute in proportion to the amount of NETs in the body fluid tested. The present study aimed to evaluate the sensitivity and specificity of the "rapid NETs test" in identifying the site of infection. Methods: We performed analysis on the left-over CSF samples (n = 199) that were collected routinely at neurosurgical intensive care unit. No samples were included after patients were transferred to the ward. Besides CSF, bronchoalveolar fluid, and urine samples were collected in febrile patients. The "rapid NETs test" was used for simultaneous analysis of the fresh left-over samples. The final diagnosis was settled at discharge. Results: A total of 75 (64%) patients had received empirical antibiotic therapy against nosocomial meningitis, whereas only 19 patients of these cases (16%) had a verified diagnosis. The rapid NETs test could distinguish a verified meningitis (n = 19) with 89.5% sensitivity and 92.5% specificity. The test also identified ventilator-associated pneumonia (n = 32) with 93.8% sensitivity and 86.8% specificity. However, the test was not reliable in identifying nosocomial urinary tract infection (sensitivity and specificity, 78.6% and 55.2%, respectively). Conclusions: The rapid NETs test indicated the site of infection in febrile patients postneurosurgery with clinically relevant sensitivity and specificity, which might show its potential to minimize the unnecessary use of antibiotics.
From the Critical Care Solutions for Point of Care Diagnostics, Siemens Healthineers, Norwood, MA. Reprints: Martin Berner, BS, Siemens Healthcare Diagnostics Inc, Point of Care Diagnostics, 2 Edgewater Drive, Norwood, MA 02062-4637. E-mail: [email protected]. The author is an employee of Siemens Healthineers. epoc and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. The statements by Siemens' Healthineers customers described herein are based on results that were achieved in each customer's unique setting. Because there is no “typical” hospital, and many variables exist (eg, hospital size, case mix, level of Information Technology adoption), there can be no guarantee that other customers will achieve the same results.
The point-of-care testing (POCT) department at Cleveland Clinic Abu Dhabi sets out to transform the organization and management of its training and competency renewal program. Managing competencies in any large hospital is challenging for all POCT coordinators. Initially, a paper-based system was created, which was cumbersome and error prone, which led to many clerical and logistical challenges. As the scope of the program grew, this approach became more difficult to govern. In an effort to streamline the process, the department embarked on several continuous improvement projects to address this pressing issue. In collaboration with the laboratory information technology and hospital learning specialist teams, the POCT department has successfully streamlined and standardized its competency approach, migrating to learning management system platform Although limitations in devices and middleware systems kir POCT remain challenging, using the resources and expertise available has led to significant improvements and efficiencies. The transition has been educational and hugely beneficial to the laboratory and the hospital. Further enhancements have been identified and more improvements are planned in the future.
Background: Acute kidney injury is a common complication among hospitalized patients. The availability of creatinine and urea measurements as point-of-care testing provides an alternative strategy to monitor renal function and develop prevention strategies, especially in the emergency services, where reducing waiting times and rapid clinical decisions may be required. Objective: The aim of this study was to evaluate if cleatinine and urea measurements are interchangeable between ABL90 Flex Plus and three common central laboratory methods. Methods: With a multicenter design, creatinine and urea were first analyzed by ABL90 Flex Plus and then by laboratory method: Dimension Vista 1500, Cobas c702, and Architect c16000 according to Clinical and Laboratory Standards Institute EP09-A3 protocol. All measurements were performed in duplicate. Results were evaluated using Passing-Bablok regression and Bland-Altman comparison. Interchangeability of patient results was verified at different clinical decision levels. Results: Passing-Bablok regression between the 3 central laboratory methods and ABL90 Flex Plus showed correlation coefficients over 0.998 for creatinine and 0.994 for urea, and despite the presence of proportional and/or constant bias observed in the study, estimated difference was lower than the allowable difference (+/- 15.6% for urea and +/- 8.9% for creatinine) at clinical decision levels in all cases. Conclusion: Creatinine and urea measurements are interchangeable using ABL90 Flex Plus blood gas analyzer compared with 3 central laboratory methods, ensuring no impact on patient care using indistinctly any analyzer.
Objectives: The goals of this study were as follows: (a) to enhance point-of-care testing (POCT) and improve standards of care throughout Vietnam; (b) to educate point-of-care (POC) coordinators who provide leadership, oversight, and quality assurance; and (c) to promote international dialog and knowledge of POCT in limited-resource settings. Methods: Needs assessment of 16 provincial hospitals, 2 each randomly chosen from the 8 geographic regions of Vietnam, was performed. In Ho Chi Minh City, 10 referral, 5 provincial, and 7 district hospitals, and 8 community medical stations were surveyed. Emergency and intensive care unit nurses and doctors, and laboratorian were respondents. Results: Glucose meters and blood gas analyzers were the most frequent POC devices in the 16 provincial hospitals. Cardiac biomarker, coagulation, and human immunodeficiency tests were the highest needs. Biomedical engineers managed locations and quality. Point-of-care coordinators were deficient. Generally, hospitals with POCT had no laboratory oversight. Users performed POCT without internal or external quality control (QC). In Ho Chi Minh City, coagulation and cardiac biomarker tests were most desired. Conclusions: Clinicians were poorly informed about the availability of urgent, emergency department, and bedside POC tests. No provincial hospitals surveyed offered cardiac biomarker testing, despite the high prevalence of acute coronary syndromes. Challenges to the implementation of POCT comprise: (a) the quality assurance burden for non laboratory personnel; (b) limited human resources to support POCT programs, including virtually total absence of POC coordinators; and (c) no national POCT policy and guidelines. To rectify these deficiencies, we recommend fundamental education at all levels, promotion of POC coordinator user groups, heightened awareness of available POCT, and vigorous international exchanges to enhanced standards of care in Vietnam.
Purpose: The aim of this study was to determine if the Coagsense point-of-care (POC) instrument provides more reliable international normalized ratio (INR) measurements than Coagucheck XS POC in comparison to the Stago laboratory instrument in different disease states. Methods: This was a prospective study of outpatient warfarin patients comparing venous Stago INR to fingerstick INR on the Coagsense and Coagucheck XS POC meters. Patients were invited to study if they had an of INR 2.0 to 5.0 and had a medical history of antiphospholipid syndrome, hypercoagulable disorder, autoimmune condition, peripheral vascular disease, mechanical heart valve, atrial fibrillation, or deep vein thrombosis/pulmonary embolism/cerebrovascular accident history. Results: Seventy-seven patients were enrolled. Coagsense correlated well (92% of INRs within 20% of Stago, 64% of INRs within 0.2 of Stago, overall INR bias of 0.1 or 4%). Six patients had greater than 20% POC INR bias, which could have resulted in 4 warfarin dosing errors. Coagucheck XS INRs correlated poorly (49% within 20% of Stago, 10% of INRs were within 0.2 of Stago, overall INR bias of 0.66 or 25.7%). Forty-one patients had greater than 20% POC INR bias in all diseases, which could have resulted in 28 warfarin dosing errors. The average Coagucheck XS INR bias (0.46-1.3 INR) increased with each 0.5 increase in laboratory INR, whereas Coagsense bias remained stable (0.1-0.25) as INR increased up to 4.3. Two patients correlated well on Coagucheck XS but not Coagsense. Conclusion: Coagsense correlated better than Coagucheck XS and did not show increasing bias as INR increased. Both POC instruments had higher INR variability in 4 disease states (antiphospholipid syndrome, autoimmune, peripheral vascular disease, and hypercoagulable). Patient-specific laboratory correlations may be needed on each POC device.
With testing in health care becoming more decentralized to include the patient bedside, quality assurance in point-of-care testing (POCT) assumes immense significance in optimizing clinical outcomes. However, complex regulatory requirements, training of testing personnel, and implementation of a uniform quality policy in varied locations across the hospital pose the greatest challenges in achieving the desired result. Although 70 POCT instruments were being used across our hospital, there was no structured program in place. In accordance with the requirements of the Joint Commission (JCI) accreditation, efforts were made to bring the supervision of POCT under the supervision of the laboratory. Initial internal audits revealed absence of quality assurance policies, inadequate documentation, and lack of uniformity in POCT practices across the hospital. Standard operating procedures on uniform POCT practice, quality control, and critical values were formulated. Training of testing personnel was conducted. Internal quality control and proficiency testing programs were designed and implemented. Periodic evaluation revealed a paradigm shift in the attitude of the testing personnel and the treating physicians toward POCT. It helped in ensuring strict adherence to quality practices in POCT and increased confidence in the reported results. This impacted positive clinical outcomes. Although, on one hand, the implementation of a structured POCT program facilitated the accreditation by the Joint Commission, it also helped us achieve uniformity and a high level of quality in POCT across the hospital. A multidisciplinary organizational approach for POCT under the direct supervision of the laboratory improved the quality of patient care.
Point-of-care testing is widespread and requires a different form of quality control and quality assurance model to conventional laboratory testing because the types of error that occur are different. In many situations, the point-of-care instruments and operators are part of a broader organizational network. We have developed a different model for the provision of a quality framework for these situations. The quality of the instrument cartridges is checked centrally, and the quality assurance is wider in concept assessing the operator competence and instrument operation. Centralizing some of the quality control reduces errors and allows for greater confidence in the results.
A s the health care industry moves closer to the patient's side, point-of-care testing (POCT) is becoming more relevant than ever. With faster and easier access to results, health care providers can reduce lengths of stay and increase patient satisfaction by avoiding extended wait times for central laboratory results. With this new positive trend come new challenges, how do point-of-care (POC) coordinators keep hundreds of devices up and running while managing training and certification and enabling secure access for thousands of operators? How do health care systems enforce quality control (QC) so that compliance and accreditation requirements are being satisfied?
