Pub Date : 2017-09-01DOI: 10.1097/POC.0000000000000138
C. Price, A. Van den Bruel
Abstract Health care systems around the world are changing to improve access and quality, as well as seeking to contain costs. These changes are being sought against a backcloth of improvements in both diagnosis and treatment, and increased patient life expectancy. Health care delivery for the past few decades has become very hospital centric and with consolidation of facilities to manage increasing specialization of care, as well as promoting efficiency—including in the field of diagnostics. However, these latter developments have had an adverse impact on patient access to care, with increasing pressure on primary care. Point-of-care testing technologies offer a means of improving access to diagnostic and monitoring decision-making—for clinician, carer, and patient. The opportunities for the use of point-of-care testing in primary care are discussed in the context of changes in health care delivery, from a UK perspective.
{"title":"Challenges in Primary Care Delivery and the Opportunities for Point-of-Care Testing: A UK Perspective","authors":"C. Price, A. Van den Bruel","doi":"10.1097/POC.0000000000000138","DOIUrl":"https://doi.org/10.1097/POC.0000000000000138","url":null,"abstract":"Abstract Health care systems around the world are changing to improve access and quality, as well as seeking to contain costs. These changes are being sought against a backcloth of improvements in both diagnosis and treatment, and increased patient life expectancy. Health care delivery for the past few decades has become very hospital centric and with consolidation of facilities to manage increasing specialization of care, as well as promoting efficiency—including in the field of diagnostics. However, these latter developments have had an adverse impact on patient access to care, with increasing pressure on primary care. Point-of-care testing technologies offer a means of improving access to diagnostic and monitoring decision-making—for clinician, carer, and patient. The opportunities for the use of point-of-care testing in primary care are discussed in the context of changes in health care delivery, from a UK perspective.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78470104","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}
Pub Date : 2017-09-01DOI: 10.1097/POC.0000000000000145
C. Yeo, W. Ng
Abstract Point-of-care testing (POCT) in our tertiary care hospital is embedded in the daily clinical processes. In 2005, the central laboratory was tasked with POCT oversight to align compliance to hospital accreditation standards. With 10 years that has since ensued, the hospital signalled a fresh relook at the agenda to ensure needs in the next lap of the hospital's reorganization are met. A multidisciplinary POCT committee was formed, and it implemented an executive framework and updated processes for current and new point-of-care (POC) tests/devices. A central repository of standardized operating procedures and quality control and training documents was put in place, and in-house quality assurance tests for POC glucose and blood gases organized by the hospital's central laboratory were scheduled to be replaced with subscription to external quality assurance programs. The revised POCT policy was shared with all stakeholders, the physicians and nurses, to facilitate a smooth transition. A shared vision to further enhance governance and institutionalize POC activities remains a key priority.
{"title":"Point-of-Care Testing in an Acute Tertiary Care Hospital in Singapore: Planning for the Future After 10 Years of Implementation","authors":"C. Yeo, W. Ng","doi":"10.1097/POC.0000000000000145","DOIUrl":"https://doi.org/10.1097/POC.0000000000000145","url":null,"abstract":"Abstract Point-of-care testing (POCT) in our tertiary care hospital is embedded in the daily clinical processes. In 2005, the central laboratory was tasked with POCT oversight to align compliance to hospital accreditation standards. With 10 years that has since ensued, the hospital signalled a fresh relook at the agenda to ensure needs in the next lap of the hospital's reorganization are met. A multidisciplinary POCT committee was formed, and it implemented an executive framework and updated processes for current and new point-of-care (POC) tests/devices. A central repository of standardized operating procedures and quality control and training documents was put in place, and in-house quality assurance tests for POC glucose and blood gases organized by the hospital's central laboratory were scheduled to be replaced with subscription to external quality assurance programs. The revised POCT policy was shared with all stakeholders, the physicians and nurses, to facilitate a smooth transition. A shared vision to further enhance governance and institutionalize POC activities remains a key priority.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74261624","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}
Pub Date : 2017-09-01DOI: 10.1097/POC.0000000000000140
Anita Andersson, J. Lindh, Annika Eriksson
Abstract The routine measurement of hemoglobin A1c (HbA1c) is recommended by major clinical diabetes organizations. By providing results rapidly with point-of-care devices, more timely decisions regarding optimal treatment can be made, and studies have confirmed that immediate feedback of HbA1c results improves glycemic control in patients with type 1 and insulin-treated type 2 diabetes mellitus. The aim of this study was to evaluate the performance of the HemoCue HbA1c 501 during regular use in primary care settings. The results verify that the HemoCue HbA1c 501 system is accurate and easy to use in the hands of the intended user in a primary care setting. This is based on the fact that more than 96% of results fall within 6% bias and a total coefficient of variation of less than 2%, thereby fulfilling the latest National Glycohemoglobin Standardization Program requirements.
{"title":"Evaluation of the HemoCue HbA1c 501 System in Primary Care Settings","authors":"Anita Andersson, J. Lindh, Annika Eriksson","doi":"10.1097/POC.0000000000000140","DOIUrl":"https://doi.org/10.1097/POC.0000000000000140","url":null,"abstract":"Abstract The routine measurement of hemoglobin A1c (HbA1c) is recommended by major clinical diabetes organizations. By providing results rapidly with point-of-care devices, more timely decisions regarding optimal treatment can be made, and studies have confirmed that immediate feedback of HbA1c results improves glycemic control in patients with type 1 and insulin-treated type 2 diabetes mellitus. The aim of this study was to evaluate the performance of the HemoCue HbA1c 501 during regular use in primary care settings. The results verify that the HemoCue HbA1c 501 system is accurate and easy to use in the hands of the intended user in a primary care setting. This is based on the fact that more than 96% of results fall within 6% bias and a total coefficient of variation of less than 2%, thereby fulfilling the latest National Glycohemoglobin Standardization Program requirements.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79520833","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}
Pub Date : 2017-09-01DOI: 10.1097/POC.0000000000000141
B. Karon
Abstract Point-of-care (POC) lactate is widely used in hospital “bundles” for the early detection of sepsis. There is evidence that rapid measurement of lactate in this context improves patient outcome. Many POC lactate methods have acceptable accuracy, precision, and clinical concordance for use in sepsis screening. Point-of-care whole-blood lactate demonstrates systematic negative bias compared with plasma lactate, and therefore POC whole-blood and plasma lactate should not be used interchangeably in patients with elevated lactate levels.
{"title":"Point-of-Care Lactate for Sepsis Detection: Reconsidering Accuracy, Precision, and Concordance Criteria","authors":"B. Karon","doi":"10.1097/POC.0000000000000141","DOIUrl":"https://doi.org/10.1097/POC.0000000000000141","url":null,"abstract":"Abstract Point-of-care (POC) lactate is widely used in hospital “bundles” for the early detection of sepsis. There is evidence that rapid measurement of lactate in this context improves patient outcome. Many POC lactate methods have acceptable accuracy, precision, and clinical concordance for use in sepsis screening. Point-of-care whole-blood lactate demonstrates systematic negative bias compared with plasma lactate, and therefore POC whole-blood and plasma lactate should not be used interchangeably in patients with elevated lactate levels.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81977874","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}
Pub Date : 2017-09-01DOI: 10.1097/POC.0000000000000139
N. Brouwer, M. Chevallier, Willem Wilbie, M. Schoorl, J. van Pelt
Abstract In the past few years, several small hematology analyzers were introduced for point-of-care testing (POCT) purposes. The POCT hematology analyzers can be used for the same purposes as centralized systems, but the possibility to use capillary blood from a fingerprick is a major advantage in several situations. The 3 tested POCT systems were the WBC DIFF system of Hemocue (Sweden), the Microsemi C-reactive protein of Horiba (Japan), and the Norma Icon hematology analyzer (Austria). The Microsemi and WBC DIFF were evaluated simultaneously. For the agreement with the laboratory method, 125 patient samples (EDTA blood, patients from general practitioners) were compared with the Sysmex XE-2100. For the agreement of the Norma Icon with the laboratory method, 188 patient samples (EDTA blood, 90 clinical and 98 polyclinic patients) were compared with the Sysmex XN-9000. The intra-assay coefficients of variation of the various samples (low, medium, high) are in all systems better than stated by the manufacturer [white blood cell (WBC), 3%; or fractions, 5%] except for monocytes, which were approximately 25%. Ordinary linear regression analysis and Bland-Altman difference analysis showed good results for the WBC and granulocyte or neutrophil comparisons. Lymphocyte comparisons showed less favorable results in the Bland-Altman analyses. In the case of the monocytes, the correlation coefficients were inadequate for linear regression. All 3 POCT hematology analyzers seemed to be suitable for WBC measurements and differential analyses of lymphocytes and granulocytes or neutrophils in venous blood, but evaluations with capillary fingerprick blood will be necessary.
{"title":"Evaluation of 3 Point-of-Care Testing Hematology Analyzers for White Blood Count","authors":"N. Brouwer, M. Chevallier, Willem Wilbie, M. Schoorl, J. van Pelt","doi":"10.1097/POC.0000000000000139","DOIUrl":"https://doi.org/10.1097/POC.0000000000000139","url":null,"abstract":"Abstract In the past few years, several small hematology analyzers were introduced for point-of-care testing (POCT) purposes. The POCT hematology analyzers can be used for the same purposes as centralized systems, but the possibility to use capillary blood from a fingerprick is a major advantage in several situations. The 3 tested POCT systems were the WBC DIFF system of Hemocue (Sweden), the Microsemi C-reactive protein of Horiba (Japan), and the Norma Icon hematology analyzer (Austria). The Microsemi and WBC DIFF were evaluated simultaneously. For the agreement with the laboratory method, 125 patient samples (EDTA blood, patients from general practitioners) were compared with the Sysmex XE-2100. For the agreement of the Norma Icon with the laboratory method, 188 patient samples (EDTA blood, 90 clinical and 98 polyclinic patients) were compared with the Sysmex XN-9000. The intra-assay coefficients of variation of the various samples (low, medium, high) are in all systems better than stated by the manufacturer [white blood cell (WBC), 3%; or fractions, 5%] except for monocytes, which were approximately 25%. Ordinary linear regression analysis and Bland-Altman difference analysis showed good results for the WBC and granulocyte or neutrophil comparisons. Lymphocyte comparisons showed less favorable results in the Bland-Altman analyses. In the case of the monocytes, the correlation coefficients were inadequate for linear regression. All 3 POCT hematology analyzers seemed to be suitable for WBC measurements and differential analyses of lymphocytes and granulocytes or neutrophils in venous blood, but evaluations with capillary fingerprick blood will be necessary.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82566529","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}
Pub Date : 2017-09-01DOI: 10.1097/POC.0000000000000142
Chetanand Imrit, V. Neergheen-Bhujun, N. Joonas
Background Glycosylated hemoglobin (HbA1c) is a biomarker to assess long-term glycemic control in diabetic patients and has recently been recommended for diagnosis of diabetes. An evaluation of the Roche Cobas b 101 point-of-care (POC) HbA1c analyzer was conducted to assess its analytical performance. Methods Precision and accuracy were estimated by analyzing 2 control samples 11 times for the within-run experiment and over 11 days for the between-batch precision. Agreement was correlated to the laboratory method, Tosoh Biosciences G8 HbA1c analyzer (n = 51; range of results, 4.7%–15.1%), and a POC method, the Siemens DCA Vantage Hemoglobin A1c System, using leftover EDTA samples from laboratory analysis (n = 16; range of results, 5.5%–14.2%). Lot-to-lot reproducibility was investigated using 11 patient samples analyzed with 2 different reagent lots. Interference from the presence of hemoglobin variants was also investigated. Results The Cobas b 101 analyzer showed good precision. Within-run and between-batch coefficient of variations were 1.6% and 3.5% for level 1 control (mean value, 5.2%), and for level 2 control (mean, 10.2%), coefficient of variations were 0.3% for within run and 3% for between batch. The analyzer had a good agreement with both Tosoh G8 (r = 1, P < 0.001) and DCA Vantage (r = 0.99, P < 0.001). Comparison of 2 different reagent lots showed good agreement, and a linearity experiment confirmed the system to be linear for values from 4% to 14%. Compared with the Tosoh G8 values, no interference from common hemoglobin variants was found on the Cobas b 101 analyzer. Conclusions The Cobas b 101 is a reliable POC analyzer showing good correlation with the laboratory method and acceptable precision. The equipment is easy to use and will be suitable for HbA1c testing at pediatric and intensive care units and for mobile screening programs of our health system.
{"title":"Evaluation of the Roche Cobas b 101 Glycosylated Hemoglobin Point-of-Care Analyzer","authors":"Chetanand Imrit, V. Neergheen-Bhujun, N. Joonas","doi":"10.1097/POC.0000000000000142","DOIUrl":"https://doi.org/10.1097/POC.0000000000000142","url":null,"abstract":"Background Glycosylated hemoglobin (HbA1c) is a biomarker to assess long-term glycemic control in diabetic patients and has recently been recommended for diagnosis of diabetes. An evaluation of the Roche Cobas b 101 point-of-care (POC) HbA1c analyzer was conducted to assess its analytical performance. Methods Precision and accuracy were estimated by analyzing 2 control samples 11 times for the within-run experiment and over 11 days for the between-batch precision. Agreement was correlated to the laboratory method, Tosoh Biosciences G8 HbA1c analyzer (n = 51; range of results, 4.7%–15.1%), and a POC method, the Siemens DCA Vantage Hemoglobin A1c System, using leftover EDTA samples from laboratory analysis (n = 16; range of results, 5.5%–14.2%). Lot-to-lot reproducibility was investigated using 11 patient samples analyzed with 2 different reagent lots. Interference from the presence of hemoglobin variants was also investigated. Results The Cobas b 101 analyzer showed good precision. Within-run and between-batch coefficient of variations were 1.6% and 3.5% for level 1 control (mean value, 5.2%), and for level 2 control (mean, 10.2%), coefficient of variations were 0.3% for within run and 3% for between batch. The analyzer had a good agreement with both Tosoh G8 (r = 1, P < 0.001) and DCA Vantage (r = 0.99, P < 0.001). Comparison of 2 different reagent lots showed good agreement, and a linearity experiment confirmed the system to be linear for values from 4% to 14%. Compared with the Tosoh G8 values, no interference from common hemoglobin variants was found on the Cobas b 101 analyzer. Conclusions The Cobas b 101 is a reliable POC analyzer showing good correlation with the laboratory method and acceptable precision. The equipment is easy to use and will be suitable for HbA1c testing at pediatric and intensive care units and for mobile screening programs of our health system.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73865245","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}
Pub Date : 2017-09-01DOI: 10.1097/POC.0000000000000143
P. Holloway
{"title":"Evaluating a Novel Ex Vivo Point-of-Care Testing Device or Blood Gas and Electrolyte Measurement for Acceptance by the Point-of-Care Testing Committee","authors":"P. Holloway","doi":"10.1097/POC.0000000000000143","DOIUrl":"https://doi.org/10.1097/POC.0000000000000143","url":null,"abstract":"","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72568843","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}
Pub Date : 2017-09-01DOI: 10.1097/POC.0000000000000144
M. Orth
Abstract Medical treatment by a physician consists of diagnosing the disease of a patient and choosing the right treatment for the disease. In most cases, medical diagnosing uses laboratory testing, and in most countries, laboratory testing is regarded as an integral part of health care. Certain country-specific regulations even restrict the access only to physicians such as for the test kits or prohibit to addressing the patient directly with the laboratory report. The idea behind these regulations originates from patient safety issues with the special situation in health care with, for example, the asymmetric situation between highly trained health care professionals and the medically illiterate patient who needs a particular protection such as by sophisticated legal restrictions. Direct-to-consumer testing (DTCT) challenges these restrictions. The idea behind DTCT is the direct access of the “consumer” (the former “patient”) to medical test results and the concept to self-empower the “consumer” (with the concept of “4P-medicine”). In many cases, Internet technologies are used both to offer convenience to the “consumer” and to circumvent national legal restrictions in health care. Without doubt, some DTCT such as glucose self-testing are medically necessary and beneficial for the patients. However, in many other cases, DTCTs are even a severe threat to patients’ safety and aimed to maximize the profits of the vendors only. A particular challenge is the nearly unlimited number of tests available and the blurred nonmedical interpretation of the DCTC laboratory tests performed.
{"title":"Direct-to-Consumer Testing: The Business With Lifestyle Tests","authors":"M. Orth","doi":"10.1097/POC.0000000000000144","DOIUrl":"https://doi.org/10.1097/POC.0000000000000144","url":null,"abstract":"Abstract Medical treatment by a physician consists of diagnosing the disease of a patient and choosing the right treatment for the disease. In most cases, medical diagnosing uses laboratory testing, and in most countries, laboratory testing is regarded as an integral part of health care. Certain country-specific regulations even restrict the access only to physicians such as for the test kits or prohibit to addressing the patient directly with the laboratory report. The idea behind these regulations originates from patient safety issues with the special situation in health care with, for example, the asymmetric situation between highly trained health care professionals and the medically illiterate patient who needs a particular protection such as by sophisticated legal restrictions. Direct-to-consumer testing (DTCT) challenges these restrictions. The idea behind DTCT is the direct access of the “consumer” (the former “patient”) to medical test results and the concept to self-empower the “consumer” (with the concept of “4P-medicine”). In many cases, Internet technologies are used both to offer convenience to the “consumer” and to circumvent national legal restrictions in health care. Without doubt, some DTCT such as glucose self-testing are medically necessary and beneficial for the patients. However, in many other cases, DTCTs are even a severe threat to patients’ safety and aimed to maximize the profits of the vendors only. A particular challenge is the nearly unlimited number of tests available and the blurred nonmedical interpretation of the DCTC laboratory tests performed.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85018145","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}
Pub Date : 2017-06-01DOI: 10.1097/POC.0000000000000133
T. Woolley, Bethan J. V. Davies, E. Rutter, C. Probert, L. Fitzgerald, William Relf
Abstract The release of new and innovative platforms has helped the point-of-care testing market to grow and cement its wider uptake in various clinical settings. Driven by the introduction of novel patient pathways often centered on clinics remote from a laboratory, the need for laboratory grade parameters and results from point-of-care analyzers is now critical. In this paper, we compare the 5-part white blood cell (WBC) differential from HORIBA Medicals mainline hematology analyzer, the Pentra 120, and those provided from the recently released Yumizen H500 point-of-care analyzer. The Yumizen H500 is based on HORIBA's Micros platform and is aimed at the point-of-care/primary care market. The Yumizen H500 is capable of measuring a full blood count (27 parameters) including a 5-part WBC differential using only 20 &mgr;L of whole blood in approximately 2 minutes. The analyzer also has both open and closed venous tube options, making it suitable for pediatric and capillary samples as well as easier and safer to use in the point-of-care setting. We found that all full blood count parameters were intra-assay reproducible and compared well with previous precision studies; likewise, the patient R2 values for neutrophils, lymphocytes, monocytes, and eosinophils also compared well at 0.994 for WBC, 0.952 for neutrophils, 0.942 for lymphocytes, 0.84 for monocytes, and 0.81 for eosinophils. In conclusion, the Yumizen H500 provides reproducible, precise, and accurate results compared with our institute's mainline laboratory analyzers.
{"title":"A Comparison Between the HORIBA Yumizen H500 Point-of-Care Hematology Analyzer With a 5-Part White Cell Differential and the HORIBA Pentra 120","authors":"T. Woolley, Bethan J. V. Davies, E. Rutter, C. Probert, L. Fitzgerald, William Relf","doi":"10.1097/POC.0000000000000133","DOIUrl":"https://doi.org/10.1097/POC.0000000000000133","url":null,"abstract":"Abstract The release of new and innovative platforms has helped the point-of-care testing market to grow and cement its wider uptake in various clinical settings. Driven by the introduction of novel patient pathways often centered on clinics remote from a laboratory, the need for laboratory grade parameters and results from point-of-care analyzers is now critical. In this paper, we compare the 5-part white blood cell (WBC) differential from HORIBA Medicals mainline hematology analyzer, the Pentra 120, and those provided from the recently released Yumizen H500 point-of-care analyzer. The Yumizen H500 is based on HORIBA's Micros platform and is aimed at the point-of-care/primary care market. The Yumizen H500 is capable of measuring a full blood count (27 parameters) including a 5-part WBC differential using only 20 &mgr;L of whole blood in approximately 2 minutes. The analyzer also has both open and closed venous tube options, making it suitable for pediatric and capillary samples as well as easier and safer to use in the point-of-care setting. We found that all full blood count parameters were intra-assay reproducible and compared well with previous precision studies; likewise, the patient R2 values for neutrophils, lymphocytes, monocytes, and eosinophils also compared well at 0.994 for WBC, 0.952 for neutrophils, 0.942 for lymphocytes, 0.84 for monocytes, and 0.81 for eosinophils. In conclusion, the Yumizen H500 provides reproducible, precise, and accurate results compared with our institute's mainline laboratory analyzers.","PeriodicalId":20262,"journal":{"name":"Point of Care: The Journal of Near-Patient Testing & Technology","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91413371","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}
Pub Date : 2017-06-01DOI: 10.1097/POC.0000000000000135
T. Mashamba-Thompson, R. Morgan, B. Sartorius, B. Dennis, P. Drain, L. Thabane
Introduction The World Health Organization advocates for increased accessibility of human immunodeficiency virus (HIV)–related point-of-care (POC) diagnostics in settings that lack laboratory infrastructure. The aim of this study was to assess the effect of POC diagnostics on maternal health outcomes in HIV-infected women. Methods A systematic literature review used the following multiple data sources: Cochrane Infectious Disease Group Specialized Register, Cochrane Central Register of Control Trials, published in The Cochrane Library, PubMed, Elton B. Stephens Co Host, and Latin American and Caribbean Health Sciences Literature from January 2000 to October 2015. References of included studies were hand-searched. Randomized controlled trials and observational studies examining health outcomes of HIV-infected women were eligible for inclusion in this review. The Cochrane Risk of Bias tool was used for bias assessment of the included studies. Preferred reporting items for systematic reviews and meta-analyses guidelines were used for reporting. Results Of 695 studies identified, 6 retrievable studies (5 cross-sectional studies and 1 case-control study) met the inclusion criteria and were included in this study. These studies examined a total of 167 HIV-infected women in different study settings. No studies reported evidence of CD4 count, viral load, and tuberculosis, and the syphilis POC test effect on HIV-infected women was not found by this study. Included studies reported the effect of various HIV rapid tests across the following 5 maternal outcomes: timely receipt of results with a pooled effect size (ES) of 1.00 (95% confidence interval [CI], 0.98–1.02); enabling partner testing with an ES of 0.95 (95% CI, 0.85–1.04); prevention of mother-to-child transmission of HIV with an ES of 0.86 (95% CI, 0.79–0.93); linkage to antiretroviral treatment with an ES of 0.76 (95 CI, 0.69–0.84); and linkage to HIV care with an ES of 0.50 (95% CI, 0.18–0.82). No studies reported evidence of the effect of POC testing on maternal mortality or maternal and child morbidity of HIV-infected women. Conclusions The review provides an international overview of the effect of HIV POC diagnostics on maternal outcomes in HIV-infected women, showing the evidence that the HIV POC test is significantly associated with decreased mother-to-child transmission of HIV and increased linkage to antiretroviral treatment and HIV care for HIV-infected women. It also revealed a gap in the literature aimed at assessing the effect of POC diagnostics on maternal morbidity and mortality in HIV-infected women. PROSPERO registration number: CRD42014015439
世界卫生组织倡导在缺乏实验室基础设施的环境中增加获得与人类免疫缺陷病毒(HIV)相关的即时护理(POC)诊断的机会。本研究的目的是评估POC诊断对艾滋病毒感染妇女孕产妇健康结果的影响。方法采用以下多个数据来源进行系统文献综述:2000年1月至2015年10月在Cochrane图书馆、PubMed、Elton B. Stephens Co Host和拉丁美洲和加勒比健康科学文献中发表的Cochrane传染病组专业登记册、Cochrane中央对照试验登记册。手工检索纳入研究的参考文献。检查艾滋病毒感染妇女健康结果的随机对照试验和观察性研究符合纳入本综述的条件。采用Cochrane偏倚风险工具对纳入的研究进行偏倚评估。采用系统评价和荟萃分析指南的首选报告项目进行报告。结果在695项研究中，6项可检索研究(5项横断面研究和1项病例对照研究)符合纳入标准，被纳入本研究。这些研究在不同的研究环境中调查了167名感染艾滋病毒的妇女。本研究未发现CD4计数、病毒载量、结核病和梅毒POC检测对hiv感染妇女的影响。纳入的研究报告了各种艾滋病毒快速检测对以下5种孕产妇结局的影响:及时收到汇总效应大小(ES)为1.00(95%可信区间[CI]， 0.98-1.02)的结果;允许伴侣测试，ES为0.95 (95% CI, 0.85-1.04);预防艾滋病毒母婴传播，ES为0.86 (95% CI, 0.79-0.93);与抗逆转录病毒治疗相关，ES为0.76 (95 CI, 0.69-0.84);与艾滋病毒护理相关，ES为0.50 (95% CI, 0.18-0.82)。没有研究报告有证据表明POC检测对感染艾滋病毒的妇女的产妇死亡率或母婴发病率有影响。该综述提供了艾滋病毒POC诊断对艾滋病毒感染妇女产妇结局影响的国际概况，显示了艾滋病毒POC检测与艾滋病毒母婴传播减少显著相关的证据，并增加了艾滋病毒感染妇女抗逆转录病毒治疗和艾滋病毒护理的联系。它还揭示了旨在评估POC诊断对艾滋病毒感染妇女产妇发病率和死亡率影响的文献中的空白。普洛斯彼罗注册号:CRD42014015439
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