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Point of Care: The Journal of Near-Patient Testing & Technology最新文献

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Challenges in Primary Care Delivery and the Opportunities for Point-of-Care Testing: A UK Perspective 初级保健服务的挑战和护理点测试的机会:英国的观点
Pub Date : 2017-09-01 DOI: 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.
世界各地的卫生保健系统正在改变,以改善获取和质量,以及寻求控制成本。这些变化是在诊断和治疗都有所改善以及患者预期寿命增加的背景下寻求的。在过去的几十年里,卫生保健服务已经变得非常以医院为中心,并且随着设施的整合,以管理日益专业化的护理,并提高效率——包括在诊断领域。然而,后一种发展对患者获得护理产生了不利影响,对初级保健的压力越来越大。即时检测技术为临床医生、护理人员和患者提供了一种改善诊断和监测决策的手段。从联合王国的角度,在卫生保健服务变化的背景下,讨论了在初级保健中使用护理点检测的机会。
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引用次数: 1
Point-of-Care Testing in an Acute Tertiary Care Hospital in Singapore: Planning for the Future After 10 Years of Implementation 新加坡一家急性三级医院的即时护理测试:实施10年后的未来规划
Pub Date : 2017-09-01 DOI: 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.
摘要:在我国三级医院,即时检测(POCT)已融入到日常临床流程中。2005年,中央实验室受命监督POCT,使其符合医院认证标准。在随后的10年里,医院发出了重新审视议程的信号,以确保满足医院下一阶段重组的需求。成立了一个多学科POCT委员会,并为当前和新的pocc测试/设备实施了执行框架和更新流程。建立了标准化作业程序和质量控制及培训文件的中央储存库,并计划由医院中心实验室组织的POC血糖和血气的内部质量保证测试替换为订阅外部质量保证方案。修订后的POCT政策与所有利益相关者(医生和护士)共享,以促进顺利过渡。进一步加强治理和使POC活动制度化的共同愿景仍然是一个关键的优先事项。
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引用次数: 0
Evaluation of the HemoCue HbA1c 501 System in Primary Care Settings HemoCue HbA1c 501系统在初级保健机构中的评价
Pub Date : 2017-09-01 DOI: 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.
摘要:糖化血红蛋白(HbA1c)是临床主要糖尿病组织推荐的常规检测方法。通过即时护理设备快速提供结果,可以更及时地做出最佳治疗决策,研究证实,即时反馈HbA1c结果可改善1型和胰岛素治疗的2型糖尿病患者的血糖控制。本研究的目的是评估HemoCue HbA1c 501在初级保健机构常规使用期间的表现。结果验证了HemoCue HbA1c 501系统在初级保健环境中是准确且易于使用的。这是基于96%以上的结果偏差在6%以内,总变异系数小于2%,从而满足最新的国家糖蛋白标准化计划的要求。
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引用次数: 6
Point-of-Care Lactate for Sepsis Detection: Reconsidering Accuracy, Precision, and Concordance Criteria 护理点乳酸检测败血症:重新考虑准确性,精密度和一致性标准
Pub Date : 2017-09-01 DOI: 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.
点护理乳酸盐(POC)被广泛应用于医院脓毒症的早期检测。有证据表明,在这种情况下快速测量乳酸可以改善患者的预后。许多乳酸POC方法在脓毒症筛查中具有可接受的准确性、精密度和临床一致性。与血浆乳酸相比,护理点全血乳酸显示出系统性负偏倚,因此POC全血和血浆乳酸不应在乳酸水平升高的患者中互换使用。
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引用次数: 3
Evaluation of 3 Point-of-Care Testing Hematology Analyzers for White Blood Count 3种即时检测血液分析仪对白细胞计数的评价
Pub Date : 2017-09-01 DOI: 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.
在过去的几年里,一些小型血液分析仪被引入到护理点检测(POCT)的目的。POCT血液学分析仪可用于与集中式系统相同的目的,但在几种情况下,使用手指刺破的毛细血管血液的可能性是一个主要优势。测试的3种POCT系统分别是瑞典Hemocue公司的WBC DIFF系统、日本Horiba公司的Microsemi c反应蛋白系统和奥地利Norma Icon血液学分析仪。同时测定Microsemi和WBC DIFF。为了与实验室方法一致,125例患者样本(EDTA血液,来自全科医生的患者)与Sysmex XE-2100进行了比较。为了与实验室方法的一致性,188例患者样本(EDTA血液,90例临床患者和98例综合诊所患者)与Sysmex XN-9000进行了比较。各种样品的测定内变异系数(低、中、高)在所有系统中都优于制造商所声明的[白细胞(WBC), 3%;或分数,5%],除了单核细胞,约占25%。普通线性回归分析和Bland-Altman差异分析显示白细胞与粒细胞或中性粒细胞比较结果良好。淋巴细胞比较在Bland-Altman分析中显示不太有利的结果。在单核细胞的情况下,相关系数不足以进行线性回归。所有3种POCT血液学分析仪似乎都适用于白细胞的测量和静脉血中淋巴细胞、粒细胞或中性粒细胞的差异分析,但用毛细血管刺血进行评估是必要的。
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引用次数: 2
Evaluation of the Roche Cobas b 101 Glycosylated Hemoglobin Point-of-Care Analyzer 罗氏Cobas b 101糖化血红蛋白即时分析仪的评价
Pub Date : 2017-09-01 DOI: 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.
糖化血红蛋白(HbA1c)是评估糖尿病患者长期血糖控制的生物标志物,最近被推荐用于糖尿病的诊断。对罗氏Cobas b101即时护理(POC) HbA1c分析仪进行了评估,以评估其分析性能。方法对2个对照样品进行精密度和准确度评价,运行内分析11次,批间精密度评价11 d。一致性与实验室方法相关,Tosoh Biosciences G8 HbA1c分析仪(n = 51;结果范围,4.7%-15.1%),以及POC方法,即西门子DCA Vantage血红蛋白A1c系统,使用实验室分析剩余的EDTA样品(n = 16;结果范围:5.5%-14.2%)。使用2个不同的试剂批次分析11个患者样本,对批次间的重复性进行了调查。还研究了血红蛋白变异存在的干扰。结果Cobas b101分析仪具有良好的精密度。一级对照的组内和批间变异系数分别为1.6%和3.5%(平均值为5.2%),二级对照的组内变异系数为0.3%,批间变异系数为3%。该分析仪与Tosoh G8 (r = 1, P < 0.001)和DCA Vantage (r = 0.99, P < 0.001)具有良好的一致性。两个不同试剂批次的比较结果显示出良好的一致性,线性实验证实该系统在4%到14%的范围内呈线性。与Tosoh G8值相比,Cobas b 101分析仪未发现常见血红蛋白变异的干扰。结论Cobas b101是一种可靠的POC分析仪,与实验室方法相关性好,精密度可接受。该设备易于使用,适用于儿科和重症监护病房的糖化血红蛋白检测以及我们卫生系统的移动筛查项目。
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引用次数: 4
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 评估一种新的离体即时检测装置或血气和电解质测量,以供即时检测委员会接受
Pub Date : 2017-09-01 DOI: 10.1097/POC.0000000000000143
P. Holloway
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引用次数: 0
Direct-to-Consumer Testing: The Business With Lifestyle Tests 直接面向消费者的测试:生活方式测试的业务
Pub Date : 2017-09-01 DOI: 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.
医生的医疗包括诊断病人的疾病和选择正确的治疗方法。在大多数情况下,医学诊断使用实验室检测,在大多数国家,实验室检测被视为卫生保健的一个组成部分。某些国家的特定法规甚至限制仅向医生提供检测试剂盒,或禁止在实验室报告中直接向患者发表意见。这些条例背后的想法源于医疗保健领域特殊情况下的患者安全问题,例如,训练有素的医疗保健专业人员与医学文盲患者之间的不对称情况,他们需要通过复杂的法律限制等特殊保护。直接面向消费者的测试(DTCT)挑战了这些限制。DTCT背后的理念是“消费者”(以前的“病人”)直接获得医学测试结果和“消费者”自我授权的概念(“4p医学”的概念)。在许多情况下,互联网技术既被用来为"消费者"提供便利,又被用来规避卫生保健方面的国家法律限制。毫无疑问,一些DTCT如葡萄糖自测在医学上是必要的,对患者是有益的。然而,在许多其他情况下,dtc甚至对患者的安全构成严重威胁,其目的只是为了使供应商的利润最大化。一个特别的挑战是,可用的检测几乎是无限的,而且对DCTC实验室进行的检测的非医学解释模糊不清。
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引用次数: 2
A Comparison Between the HORIBA Yumizen H500 Point-of-Care Hematology Analyzer With a 5-Part White Cell Differential and the HORIBA Pentra 120 HORIBA Yumizen H500 5组分白细胞鉴别检测仪与HORIBA Pentra 120的比较
Pub Date : 2017-06-01 DOI: 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.
新的创新平台的发布帮助了即时检测市场的增长,并巩固了其在各种临床环境中的广泛应用。由于引入了通常以远离实验室的诊所为中心的新型患者途径,对实验室级参数和护理点分析仪结果的需求现在至关重要。在本文中,我们比较了HORIBA医疗公司的主流血液分析仪Pentra 120和最近发布的Yumizen H500点护理分析仪提供的5组分白细胞(WBC)差异。Yumizen H500基于HORIBA的Micros平台,目标是护理点/初级保健市场。Yumizen H500能够在大约2分钟内测量全血计数(27个参数),包括5部分白细胞差异,仅使用20 μ L全血。该分析仪还具有开放和封闭静脉管选项,使其适用于儿科和毛细管样品,以及更容易和更安全的使用在护理点设置。我们发现所有全血细胞计数参数都是可重复的,并且与之前的精确研究相比很好;同样,中性粒细胞、淋巴细胞、单核细胞和嗜酸性粒细胞的患者R2值也比较好,白细胞为0.994,中性粒细胞为0.952,淋巴细胞为0.942,单核细胞为0.84,嗜酸性粒细胞为0.81。总之,与我们研究所的主流实验室分析仪相比,Yumizen H500提供了可重复、精确和准确的结果。
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引用次数: 0
Effect of Point-of-Care Diagnostics on Maternal Outcomes in Human Immunodeficiency Virus–Infected Women: Systematic Review and Meta-analysis 即时诊断对人类免疫缺陷病毒感染妇女产妇结局的影响:系统回顾和荟萃分析
Pub Date : 2017-06-01 DOI: 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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引用次数: 10
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Point of Care: The Journal of Near-Patient Testing & Technology
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