multispot

Multispot
  • 文章类型: Journal Article
    背景:关于脑淀粉样血管病(CAA)的波士顿标准v2.0纳入了非出血性成像标志物。其在认知障碍患者中的患病率和意义仍不确定。
    方法:我们研究了622名记忆门诊患者,这些患者具有可用的磁共振成像(MRI)和脑脊液(CSF)生物标志物。两名评估者评估了非出血标志物,我们通过多变量分析探讨了它们与临床特征的关联.
    结果:大多数患者有轻度认知障碍;中位年龄为71岁,50%为女性。使用v2.0标准,可能或可能的CAA从75例增加到383例。68%的样本有非出血性CAA标记,与年龄独立相关(比值比[OR]=1.04,95%置信区间[CI]=1.01-1.07),女性(OR=1.68,95%CI=1.11-2.54),出血性CAA标志物(OR=2.11,95%CI=1.02-4.35)。
    结论:记忆诊所队列中三分之二的患者具有非出血性CAA标志物,增加符合v2.0CAA标准的患者数量。纵向方法应该探索这些标记的含义,尤其是这个人群的出血风险。
    结论:更新的波士顿脑淀粉样血管病(CAA)标准现在包括非出血性标志物。非出血性CAA标志物在记忆门诊患者中的患病率未知。我们的记忆诊所中有三分之二的患者表现出非出血性CAA标志物。这些标记的存在与年龄有关,女性性别,和出血性CAA标志物。出现这些类型标志物的患者的出血风险尚不清楚。
    The Boston criteria v2.0 for cerebral amyloid angiopathy (CAA) incorporated non-hemorrhagic imaging markers. Their prevalence and significance in patients with cognitive impairment remain uncertain.
    We studied 622 memory clinic patients with available magnetic resonance imaging (MRI) and cerebrospinal fluid (CSF) biomarkers. Two raters assessed non-hemorrhagic markers, and we explored their association with clinical characteristics through multivariate analyses.
    Most patients had mild cognitive impairment; median age was 71 years and 50% were female. Using the v2.0 criteria, possible or probable CAA increased from 75 to 383 patients. Sixty-eight percent of the sample had non-hemorrhagic CAA markers, which were independently associated with age (odds ratio [OR] = 1.04, 95% confidence interval [CI] = 1.01-1.07), female sex (OR = 1.68, 95% CI = 1.11-2.54), and hemorrhagic CAA markers (OR = 2.11, 95% CI = 1.02-4.35).
    Two-thirds of patients from a memory clinic cohort had non-hemorrhagic CAA markers, increasing the number of patients meeting the v2.0 CAA criteria. Longitudinal approaches should explore the implications of these markers, particularly the hemorrhagic risk in this population.
    The updated Boston criteria for cerebral amyloid angiopathy (CAA) now include non-hemorrhagic markers. The prevalence of non-hemorrhagic CAA markers in memory clinic patients is unknown. Two-thirds of patients in our memory clinic presented non-hemorrhagic CAA markers. The presence of these markers was associated with age, female sex, and hemorrhagic CAA markers. The hemorrhagic risk of patients presenting these type of markers remains unclear.
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  • 文章类型: Clinical Trial
    新的起搏技术提供了更多的左心室起搏部位选择和更个性化的心脏再同步治疗(CRT)。通常使用急性血液动力学测量的多搏动平均值来比较新型起搏配置对心脏功能的影响。在对iPot试验的分析中,我们探索这是否足够。
    iSpot试验是一项国际性的试验,prospective,评估七种CRT配置的急性血流动力学试验:标准CRT,MultiSpot(后外侧静脉),和MultiVein(前后静脉)起搏。有创和无创血压,记录左心室(LV)dP/dtmax。在从AAI交替到测试的起搏配置之前和之后记录了八次搏动,反之亦然。在五个房室延迟中的每一个,每个配置进行了八个交替。
    25名患者接受了8次交替的完整方案。仅有4例(16%)患者在统计学上比常规CRT配置改善>3mmHg(后外侧静脉,远端电极)。然而,如果只分析了一个交替(标准的多拍平均协议),15例(60%)患者错误地出现了优越的非常规构型。对起搏的反应在不同的血流动力学指标之间显着相关:有创收缩压(SBP)与非有创收缩压r=0.82(P<.001);有创SBP与LVdP/dtr=0.57,r2=0.32(P<.001)。
    不幸的是,当前的标准多拍采集协议无法防止个体患者出现的最佳错误印象。除了平均多个搏动之外,个性化过程还需要包括到测试的起搏配置的不同重复转变。需要不仅在研究阶段,而且在临床实施期间。
    New pacing technologies offer a greater choice of left ventricular pacing sites and greater personalization of cardiac resynchronization therapy (CRT). The effects on cardiac function of novel pacing configurations are often compared using multi-beat averages of acute hemodynamic measurements. In this analysis of the iSpot trial, we explore whether this is sufficient.
    The iSpot trial was an international, prospective, acute hemodynamic trial that assessed seven CRT configurations: standard CRT, MultiSpot (posterolateral vein), and MultiVein (anterior and posterior vein) pacing. Invasive and noninvasive blood pressure, and left ventricular (LV) dP/dtmax were recorded. Eight beats were recorded before and after an alternation from AAI to the tested pacing configuration and vice-versa. Eight alternations were performed for each configuration at each of the five atrioventricular delays.
    Twenty-five patients underwent the full protocol of eight alternations. Only four (16%) patients had a statistically significant >3 mm Hg improvement over conventional CRT configuration (posterolateral vein, distal electrode). However, if only one alternation was analyzed (standard multi-beat averaging protocol), 15 (60%) patients falsely appeared to have a superior nonconventional configuration. Responses to pacing were significantly correlated between the different hemodynamic measures: invasive systolic blood pressure (SBP) vs noninvasive SBP r = 0.82 (P < .001); invasive SBP vs LV dP/dt r = 0.57, r2  = 0.32 (P < .001).
    Current standard multibeat acquisition protocols are unfortunately unable to prevent false impressions of optimality arising in individual patients. Personalization processes need to include distinct repeated transitions to the tested pacing configuration in addition to averaging multiple beats. The need is not only during research stages but also during clinical implementation.
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  • 文章类型: Comparative Study
    In the US, the HIV diagnostic algorithm for laboratory settings recommends the use of an HIV-1/HIV-2 differentiation supplemental assay after an initial reactive antigen/antibody (Ag/Ab) assay result. Since the discontinuation of the Multispot HIV-1/HIV-2 Rapid Test (MS), the Geenius HIV-1/2 Supplemental assay (Geenius) is the only FDA-approved supplemental differentiation test.
    We compared the performance of Geenius to MS and Western Blot (WB).
    The relative seroconversion plasma reactivity of Geenius and MS was assessed using a 50% cumulative frequency analysis from 17 HIV-1 seroconverters. In addition, previously characterized plasma specimens, 186 HIV-1 positive, 100 HIV-2 positive, and 93 Ag/Ab-positive/HIV-1 RNA-negative, were tested with Geenius v1.1 software. McNemar\'s test was used for paired comparison analysis. A subset of 48 specimens were retested with the upgraded Geenius v1.3 software.
    In HIV-1 seroconverters, the relative seroconversion reactivity was 2.5 and 2 days before the first positive HIV-1 WB for Geenius and MS, respectively. In HIV-1 positive samples, Geenius performed similarly to HIV-1 WB (p=0.1687) and MS (p=0.8312). In HIV-2 positive samples, Geenius underperformed compared to HIV-2 WB (p=0.0005) and MS (p=0.0012). When using the upgraded software among the HIV-1 positive and Ag/Ab-reactive/HIV-1 RNA-negative samples, gp140 reactivity decreased without affecting characterization of HIV-2 samples.
    With HIV-1 samples, Geenius, WB and MS performance was similar as supplemental tests. The updated Geenius software reduced false gp140 reactivity, but had no impact on identifying true HIV-2 infections. Further evaluation will assess the impact of the Geenius software update on final diagnostic interpretations.
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  • 文章类型: Comparative Study
    BACKGROUND: The CLSI-M53-A, Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus (HIV) Infection; Approved Guideline includes an algorithm in which samples that are reactive on a 4th generation EIA screen proceed to a supplemental assay that is able to confirm and differentiate between antibodies to HIV-1 and HIV-2. The recently CE-marked Bio-Rad Geenius HIV-1/2 Confirmatory Assay was evaluated as an alternative to the FDA-approved Bio-Rad Multispot HIV-1/HIV-2 Rapid Test which has been previously validated for use in this new algorithm.
    METHODS: This study used reference samples submitted to the Canadian - NLHRS and samples from commercial sources. Data was tabulated in 2×2 tables for statistical analysis; sensitivity, specificity, predictive values, kappa and likelihood ratios.
    RESULTS: The overall performance of the Geenius and Multispot was very high; sensitivity (100%, 100%), specificity (96.3%, 99.1%), positive (45.3, 181) and negative (0, 0) likelihood ratios respectively, high kappa (0.96) and low bias index (0.0068). The ability to differentiate HIV-1 (99.2%, 100%) and HIV-2 (98.1%, 98.1%) Ab was also very high.
    CONCLUSIONS: The Bio-Rad Geenius HIV-1/2 Confirmatory Assay is a suitable alternative to the validated Multispot for use in the second stage of CLSI M53 algorithm-I. The Geenius has additional features including traceability and sample and cassette barcoding that improve the quality management/assurance of HIV testing. It is anticipated that the CLSI M53 guideline and assays such as the Geenius will reduce the number of indeterminate test results previously associated with the HIV-1 WB and improve the ability to differentiate HIV-2 infections.
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  • 文章类型: Comparative Study
    BACKGROUND: An accurate and rapid serologic method to differentiate HIV-2 from HIV-1 infection is required since the confirmatory HIV-1 Western Blot (WB) may demonstrate cross-reactivity with HIV-2 antibodies.
    OBJECTIVE: To evaluate the performance of the Bio-Rad Multispot HIV-1/HIV-2 rapid assay as a supplemental test to correctly identify HIV-2 infection and identify HIV-1 WB cross-reactivity with HIV-2 in clinical samples tested at an academic medical center.
    METHODS: Between August 2008 and July 2012, clinical samples were screened for HIV using either 3rd- or 4th-generation HIV-1/2 antibody or combination antibody and HIV-1 p24 antigen assays, respectively. All repeatedly reactive samples were reflexed for Multispot rapid testing. Multispot HIV-2 and HIV-1 and HIV-2-reactive samples were further tested using an HIV-2 immunoblot assay and HIV-1 or HIV-2 RNA assays when possible. The HIV-1 WB was performed routinely for additional confirmation and to assess for HIV-2 antibody cross-reactivity.
    RESULTS: Of 46,061 samples screened, 890 (89.6%) of 993 repeatedly reactive samples were also Multispot-reactive: 882 for HIV-1; three for only HIV-2; and five for both HIV-1 and HIV-2. All three HIV-2-only Multispot-positives along with a single dually reactive HIV-1/2 Multispot-positive were also HIV-2 immunoblot-positive; the latter was HIV-1 RNA negative and HIV-2 RNA positive.
    CONCLUSIONS: The Multispot rapid test performed well as a supplemental test for HIV-1/2 diagnostic testing. Four new HIV-2 infections (0.45%) were identified from among 890 Multispot-reactive tests. The use of HIV-1 WB alone to confirm HIV-1/2 screening assays may underestimate the true prevalence of HIV-2 infection in the United States.
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