{"title":"Reliability of Point-of-Care International Normalized Ratio Measurements in Various Patient Populations","authors":"Kim Arline, C. Rodriguez, K. Sanchez","doi":"10.1097/poc.0000000000000197","DOIUrl":"https://doi.org/10.1097/poc.0000000000000197","url":null,"abstract":"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.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"76 1","pages":"12 - 18"},"PeriodicalIF":0.0,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83869448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Status of Point-of-Care Testing and Coordinators in Vietnam","authors":"Thuy Nguyen, G. Kost","doi":"10.1097/poc.0000000000000196","DOIUrl":"https://doi.org/10.1097/poc.0000000000000196","url":null,"abstract":"Supplemental digital content is available in the text. 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.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"15 1","pages":"19 - 24"},"PeriodicalIF":0.0,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80731523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"AACC Presents: 27th International CPOCT Symposium The Role of Point-of-Care Testing in a Value-Based Healthcare Landscape","authors":"","doi":"10.1097/poc.0000000000000195","DOIUrl":"https://doi.org/10.1097/poc.0000000000000195","url":null,"abstract":"","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89186152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Usability of IBDoc, a Novel Fecal Calprotectin Home-Based Rapid Test in Clinical Practice","authors":"M. Røer, M. Småstuen, A. Røseth","doi":"10.1097/POC.0000000000000192","DOIUrl":"https://doi.org/10.1097/POC.0000000000000192","url":null,"abstract":"Abstract The aim of this study was to examine sustained usability and adherence to a fecal calprotectin (FC) home-based rapid test in an inflammatory bowel disease (IBD) monitoring program in clinical practice. Methods In total, 59 consecutive IBD outpatients were recruited. The participants were asked to measure FC with a home-based rapid test, IBDoc, every second month for a period of 14 months. At start and termination of this time period, they were invited to answer a questionnaire concerning the IBDoc device. The participants were also asked to deliver one stool sample for FC to be analyzed with enzyme-linked immunosorbent assay and analyze the same sample with the home-based FC test at start and termination. Results In total, one-third (34%) of the participants were adherent to the IBDoc program. No patient characteristics were significantly associated with being adherent. The home-based test correlated well with enzyme-linked immunosorbent assay method (Spearman rank correlation coefficient was 0.92, P < 0.001 and 0.74, P < 0.001, at study start and termination, respectively). After having used the IBDoc for over a year, all except for 1 of the 36 participants answering the follow-up questionnaire completely agreed with the statement “I would like to use IBDoc in the future.” Conclusions We found a low adherence to home-based FC measurements every second month for a period of 14 months. Nevertheless, all but 1 of the 36 participants who answered the follow-up questionnaire were interested in continuing using the IBDoc test.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"32 1","pages":"85 - 91"},"PeriodicalIF":0.0,"publicationDate":"2019-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88965109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Beyond Price and Functionality","authors":"Becky Clarke","doi":"10.1097/POC.0000000000000194","DOIUrl":"https://doi.org/10.1097/POC.0000000000000194","url":null,"abstract":"","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"124 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88808502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xiguang Liu, Xiangzhi Zhu, G. Kost, John Liu, Jing Huang, Xin Liu
{"title":"The Creation of Point-of-Careology","authors":"Xiguang Liu, Xiangzhi Zhu, G. Kost, John Liu, Jing Huang, Xin Liu","doi":"10.1097/POC.0000000000000191","DOIUrl":"https://doi.org/10.1097/POC.0000000000000191","url":null,"abstract":"Goals The objectives of this study were to improve awareness of point-of-care testing as a new medical field, to solidify relationships among point-of-care professionals and other medical disciplines, and to identify potential for advancing medical applications, economic benefits, and patient impact through timely decision-making for evidence-based medicine. Methods Literature review, comprehensive analysis, focused analysis, inductive logic, general summary of international outcomes, and comparative advances that improve point-of-care impact in China and other countries in need of rapid response were performed in this study. Results The creation of point-of-careology comprised the following: (a) introduction of its research and practical scope, (b) appropriate definition of this new field, (c) description of the range of applications, and (d) identification of relationships with other disciplines. Conclusions Point-of-care testing now is being written into a professional textbook in medical schools in China. Point-of-careology is the outcome of evolution in intelligent diagnostics. Notable achievements in critical care medicine, emergency response, and general practice have resulted from the implementation of point-of-care testing over the past 4 decades. As a new discipline, point-of-careology will contribute to key medical areas, such as disaster preparedness and public health, which we explore. The creation of this new specialty is justified by trends in modern medicine with improved service to the public and by parallel technological advances that empower health care providers at sites of need to deliver complete care cycles quickly and effectively.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"71 1","pages":"77 - 84"},"PeriodicalIF":0.0,"publicationDate":"2019-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85149786","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Extrapolation of the R-T Estimation in CoaguChek International Normalized Ratio Results Below 4","authors":"C. Richter","doi":"10.1097/POC.0000000000000189","DOIUrl":"https://doi.org/10.1097/POC.0000000000000189","url":null,"abstract":"Abstract While extensive literature has documented that the CoaguChek XS device results are not an accurate reflection of a patient's international normalized ratio (INR) when the values are elevated, only 1 equation has been able to consistently correct these results in the clinical setting. Data obtained from a previous study were used to apply the R-T Estimation to INR values below 4 to assess an extrapolation of this equation to an INR of 1. The results were consistent with previous studies using the R-T Estimation and demonstrate the correlation of this equation with venipuncture results with 95% confidence within 20% difference. This may be clinically relevant as a CoaguChek XS result of 3.8 is corrected using the R-T Estimation to an INR of 3.0.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"1 1","pages":"46 - 47"},"PeriodicalIF":0.0,"publicationDate":"2019-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91309186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S. Simpson, J. Storrar, J. Ritchie, Khalid Alshawy, L. Ebah, S. Sinha, P. Elton, D. Darby, D. Poulikakos
{"title":"Point-of-Care Creatinine to Assist Clinical Decision Making in Suspected Sepsis in the Community","authors":"S. Simpson, J. Storrar, J. Ritchie, Khalid Alshawy, L. Ebah, S. Sinha, P. Elton, D. Darby, D. Poulikakos","doi":"10.1097/POC.0000000000000184","DOIUrl":"https://doi.org/10.1097/POC.0000000000000184","url":null,"abstract":"Abstract Guidance published from the National Institute for Health and Care Excellence in the United Kingdom for recognition and management for sepsis in acute hospital settings dictates that patients who present with suspected sepsis who are found to have acute kidney injury are high risk and should receive urgent treatment. We aimed at evaluating point-of-care (POC) creatinine (Cr) testing for diagnosis of acute kidney injury in the context of suspected sepsis out of hospital. Correlation was calculated using Pearson correlation coefficient, and agreement using Bland-Altman plot analysis was performed between StatSensor (Nova) handheld analyzer measurement in capillary samples and concurrent serum Cr measurement measured by laboratory method using Siemens Advia 2400 Jaffe from patients presenting in the emergency department and nursing home residents. Altogether 59 paired samples from 57 patients were obtained. Mean age was 76.6 years, and 29% were females. Pearson correlation between POC and serum Cr was r = 0.812, P < 0.001. Fifty-five of 59 were within the 95% limits of agreement. Three values outside the limits of agreement were observed in mean Cr values greater than 200 μmol/L. The POC Cr was higher than serum Cr in 85% of cases with an average difference between POC Cr and serum Cr of 32.5 μmol/L. An algorithm was agreed defining high-risk patients with suspected sepsis based on doubling of baseline Cr for individuals with known or suspected baseline values of less than 200 μmol/L.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"10 2 1","pages":"41 - 45"},"PeriodicalIF":0.0,"publicationDate":"2019-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80517600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Invited Product Profile – GeneXpert Xpress System for Respiratory Testing","authors":"E. Baron, D. Persing","doi":"10.1097/POC.0000000000000187","DOIUrl":"https://doi.org/10.1097/POC.0000000000000187","url":null,"abstract":"Abstract Viral and bacterial respiratory infections represent a significant source of morbidity and mortality in the United States. Lateral flow immunoassays, frequently used to detect influenza, respiratory syncytial virus (RSV), and streptococcus group A infections, yield lower sensitivity (50%–70%) than testing other methods and often require culture confirmation for patients who test negative. The Clinical Laboratory Improvement Amendments–waived GeneXpert Xpress platform offers point-of-care influenza, RSV, and streptococcus group A nucleic acid amplification testing in a variety of health care settings. The system requires minimal training, and the user interface provides straightforward step-by-step video instructions that illustrate each phase of the testing procedure. The universal cartridge design allows simple sample loading that minimizes hands-on time and risk of contamination as well as the need for additional staff training. Test results generated by the Xpress System have high sensitivity and specificity and are available in 18 to 30 minutes. Together these features make the GeneXpert Xpress an attractive option to provide simple, rapid, and effective point-of-care testing to identify influenza, RSV, and streptococcus group A infections to better inform patient management and treatment decisions.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"42 1","pages":"66 - 71"},"PeriodicalIF":0.0,"publicationDate":"2019-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91391374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Evaluation of the i-STAT Alinity Point-of-Care Analyzer","authors":"Mee-Yin Lee, Sian-Foong Lim, L. Lam","doi":"10.1097/POC.0000000000000190","DOIUrl":"https://doi.org/10.1097/POC.0000000000000190","url":null,"abstract":"Objectives The objective of this study was to evaluate the analytical performance of CG4+ and CHEM8+ cartridges on the i-STAT Alinity analyzer prior to use in patient testing. We also evaluated the ease of use, design, and safety features to determine its suitability for use by the clinicians in our hospital. Methods The Abbott i-STAT System Performance Verification Protocol was observed for the imprecision study and was performed over the course of 2 days using 2 levels of control material (Abbott i-STAT TriControl Level 1 and Level 3). The CLSI-EP6-A guideline was used to verify the assay reportable range performance using 5 levels of linearity material (Abbott i-Stat TriControl Calibration Verification Set). The method comparison study was performed using up to 60 leftover anonymized heparinized whole-blood samples and serum samples against existing laboratory instruments (Siemens Rapidpoint 500, Abbott Architect C16000, and Sysmex XN9000). Results Precision was good (coefficient of variation <2%) for electrolytes, glucose, lactate, and pH, and satisfactory (coefficient of variation <5.2%) for blood gases, urea, creatinine, and hematocrit. Linearity concentrations spanning the analytical measuring ranges were demonstrated for all analytes. Method comparison studies revealed that agreement between the i-STAT Alinity analyzer and the central laboratory analyzers was good and clinically acceptable. Conclusions The i-STAT Alinity analyzer has good analytical performance, and we established the analyzer meets our safety and regulatory requirements and therefore suitable for use in our hospital as a point-of-care testing device.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":"12 1","pages":"48 - 55"},"PeriodicalIF":0.0,"publicationDate":"2019-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86999620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}