News from the Biological Stain Commission No. 12

Abstract

In this 12^th issue of News from the Biological Stain Commission (BSC) under the heading of Regulatory affairs, the Biological Stain Commission’s International Affairs Committee presents information from the meetings of ISO/TC 212/WG 1 Quality and competence in the medical laboratory and ISO/TC 212/WG 3 In vitro diagnostic products both held on 2 – 3 June 2010, plus information on the second plenary meeting of ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems held on 4 June 2010. All meetings took place in Seoul, Republic of Korea. Finally, information is provided concerning the 25^th meeting of CEN/TC 140 In vitro diagnostic medical devices held on 23 June 2010 in Berlin, Germany.     

Drugs derived from phage display: From candidate identification to clinical practice

Phage display, one of today’s fundamental drug discovery technologies, allows identification of a broad range of biological drugs, including peptides, antibodies and other proteins, with the ability to tailor critical characteristics such as potency, specificity and cross-species binding. Further, unlike in vivo technologies, generating phage display-derived antibodies is not restricted by immunological tolerance. Although more than 20 phage display-derived antibody and peptides are currently in late-stage clinical trials or approved, there is little literature addressing the specific challenges and successes in the clinical development of phage-derived drugs. This review uses case studies, from candidate identification through clinical development, to illustrate the utility of phage display as a drug discovery tool, and offers a perspective for future developments of phage display technology.     

REEXAMINATION OF THE ETHICS OF PLACEBO USE IN CLINICAL PRACTICE

A placebo is a substance or intervention believed to be inactive, but is administered by the healthcare professional as if it was an active medication. Unlike standard treatments, clinical use of placebo usually involves deception and is therefore ethically problematic. Our attitudes toward the clinical use of placebo, which inevitably includes deception or withholding information, have a tremendous effect on our practice regarding truth‐telling and informed consent. A casual attitude towards it weakens the current practice based on shared decision‐making and mutual trust between patients and healthcare professionals. Issues concerning the clinical use of placebo are thus intimately related to patient‐provider relationships, the public's trust in medicine, and medical education. A review of recent survey studies suggests that the clinical use of placebo appears to be fairly well accepted among healthcare professionals and is common in clinical settings in various countries. However, we think that an ethical discussion is urgently needed because of its controversial nature. If judged to be ethically wrong, the practice should end. In the present paper, we discuss the ethicality of the clinical use of placebo with deception and argue against it, concluding that it is unethical and should be banned. We will show that most arguments in favor of the clinical use of placebo can be refuted and are therefore incorrect or weak. These arguments will be presented and examined individually. Finally, we will briefly consider issues relevant to the clinical use of placebo without deception.     

Evolutionary transitions in symbioses: dramatic reductions in bathymetric and geographic ranges of Zoanthidea coincide with loss of symbioses with invertebrates

Two fundamental symbiosis‐based trophic types are recognized among Zoanthidea (Cnidaria, Anthozoa): fixed carbon is either obtained directly from zooxanthellae photosymbionts or from environmental sources through feeding with the assistance of host‐invertebrate behaviour and structure. Each trophic type is characteristic of the suborders of Zoanthidea and is associated with substantial distributional asymmetries: suborder Macrocnemina are symbionts of invertebrates and have global geographic and bathymetric distributions and suborder Brachycnemina are hosts of endosymbiotic zooxanthellae and are restricted to tropical photic zones. While exposure to solar radiation could explain the bathymetric asymmetry it does not explain the geographic asymmetry, nor is it clear why evolutionary transitions to the zooxanthellae‐free state have apparently occurred within Macrocnemina but not within Brachycnemina. To better understand the transitions between symbiosis‐based trophic types of Zoanthidea, a concatenated data set of nuclear and mitochondrial nucleotide sequences were used to test hypotheses of monophyly for groups defined by morphology and symbiosis, and to reconstruct the evolutionary transitions of morphological and symbiotic characters. The results indicate that the morphological characters that define Macrocnemina are plesiomorphic and the characters that define its subordinate taxa are homoplasious. Symbioses with invertebrates have ancient and recent transitions with a general pattern of stability in host associations through evolutionary time. The reduction in distribution of Zoanthidea is independent of the evolution of zooxanthellae symbiosis and consistent with hypotheses of the benefits of invertebrate symbioses, indicating that the ability to persist in most habitats may have been lost with the termination of symbioses with invertebrates.     

Metals and arsenic in marine fish commercialized in the NE Brazil: Risk to human health

Abstract

Arsenic, cadmium, lead, and mercury in fish is the result of long-term biomagnification in the food chain and is of public concern, due to the toxicity they engender. The objective of this research was to determine the concentrations of arsenic, cadmium, lead, and mercury in 13 species of marine fish broadly commercialized in Aracaju, SE, Brazil and to evaluate the risks of fish consumption associated with these trace elements, using the Target Hazard Quotient (THQ). As, Cd, and Pb levels were measured with inductively coupled plasma mass spectrometry (ICP-MS), and mercury was analyzed via cold vapor atomic absorption spectrometry. The results indicate a large variability in concentrations for arsenic (0.07–2.03?mg kg^–1) and mercury (0.01–1.44?mg kg^–1), associated with the animal dietary category. Cadmium (0.04–0.19?mg kg^–1) and lead (<0.01–0.45?mg kg^–1), on the other hand showed a mild variability. None of the evaluated specimens had As, Cd, and Pb THQ values higher than 1. The THQ values for mercury were higher but indicated no consumption risk, except for amberjack, and snook fish. Overall THQ indicates lower risk of consumption in fish that are at the base of the food chain, than in those that are top predators.     

Postglacial recolonization of North America by spadefoot toads: integrating niche and corridor modeling to study species’ range dynamics over geologic time

Understanding the factors that shape species’ distributions is a key topic in biogeography. As climates change, species can either cope with these changes through evolution, plasticity or by shifting their ranges to track the optimal climatic conditions. Ecological niche modeling (ENM) is a widespread technique in biogeography that estimates the niche of the organism by using occurrences and environmental data to estimate species’ potential distributions. ENMs are often criticized for failing to take species’ dispersal abilities into consideration. Here, we attempt to fill this gap by combining ENMs with dispersal and corridor modeling to study the range dynamics of North American spadefoot toads (Scaphiopodidae) over the Holocene. We first estimated the current and past distributions of spadefoot toads and then estimated their past distributions from the Last Glacial Maximum (LGM) to the present day. Then, we estimated how each taxon recolonized North American by using dispersal and corridor modeling. By combining these two modeling approaches we were able to 1) estimate the LGM refugia used by the North American spadefoot toads, 2) further refine these projections by estimating which of the putative LGM refugia contributed to the recolonization of North America via dispersal, and 3) estimate the relative influence of each LGM refugium to the current species’ distributions. The models were tested using previously published phylogeographic data, revealing a high degree of congruence between our models and the genetic data. These results suggest that combining ENMs and dispersal modeling over time is a promising approach to investigate both historical and future species’ range dynamics.     

Colonization history of Galapagos giant tortoises: Insights from mitogenomes support the progression rule

Galapagos giant tortoises (Chelonoidis spp.) are a group of large, long-lived reptiles that includes 14 species, 11 of which are extant and threatened by human activities and introductions of non-native species. Here, we evaluated the phylogenetic relationships of all extant and two extinct species (Chelonoidis abingdonii from the island of Pinta and Chelonoidis niger from the island of Floreana) using Bayesian and maximum likelihood analysis of complete or nearly complete mitochondrial genomes. We also provide an updated phylogeographic scenario of their colonization of the Galapagos Islands using chrono-phylogenetic and biogeographic approaches. The resulting phylogenetic trees show three major groups of species: one from the southern, central, and western Galapagos Islands; the second from the northwestern islands; and the third group from the northern, central, and eastern Galapagos Islands. The time-calibrated phylogenetic and ancestral area reconstructions generally align with the geologic ages of the islands. The divergence of the Galapagos giant tortoises from their South American ancestor likely occurred in the upper Miocene. Their diversification on the Galapagos adheres to the island progression rule, starting in the Pleistocene with the dispersal of the ancestral form from the two oldest islands (San Cristóbal and Española) to Santa Cruz, Santiago, and Pinta, followed by multiple colonizations from different sources within the archipelago. Our work provides an example of how to reconstruct the history of endangered taxa in spite of extinctions and human-mediated dispersal events and provides a framework for evaluating the contribution of colonization and in situ speciation to the diversity of other Galapagos lineages.     

未来气候变化对四种木姜子地理分布的影响

该文利用最大墒模型(Maxent)和地理信息系统(ArcGIS 10.3)软件对中国木姜子属(Litsea)四种资源植物在我国当代、未来(2061年—2080年)气候条件下的潜在分布区进行预测,并对其适宜区进行分析和划分。结果表明:山鸡椒(Litsea cubeba)适宜区广泛分布在长江以南区域,在未来时段2061年—2080年两种(RCP2.6、RCP8.5)二氧化碳浓度情景下适宜区面积分别减少4.9%和0.5%; 毛豹皮樟(L. coreana)适宜区主要分布在中亚热带及北亚热带区域,分布相对偏北,其在未来2061年—2080年两种二氧化碳浓度情景下适宜区面积分别增加5.6%和4.5%; 华南木姜子(L. greenmaniana)适宜区主要分布在我国南亚热带区域; 毛叶木姜子(L. mollis)适宜区广泛分布在亚热带区域。这两种树种在未来气候RCP2.6情景下适生面积减少1.0%和3.3%,在RCP8.5情景下减少5.6%和8.3%。上述结果说明木姜子属不同种由于生态习性差异对未来的气候变化的响应不尽相同,对这些植物引种栽培须考虑气候变化的影响。     

Clinical features and hematological findings of COVID-19 patients with blood transfusion

This paper aims to illustrate the clinical characteristics, hematological findings, and blood transfusion information of Coronavirus disease 2019 (COVID-19) patients. Twenty-three COVID-19 patients were treated and transfused with blood products in Wuhan First Hospital from February 12 to March 20, 2020. The patients were divided into a survivor group and a non-survivor group, respectively, according to whether the patient had been discharged or died. The results demonstrated at the time of initial blood transfusion, that the non-survivor group possessed a lower platelet (PLT) than that of the survivor group (P<0.001), and PLT were below the normal range in 6 (85.7%) non-survivor group and in 2 (12.5%) survivor group (P<0.01). Over half of these patients had abnormalities in fibrinogen (FIB), activated partial thromboplastin time (APTT), prothrombin time (PT), and international normalized ratio (INR), but no significant difference was found between the non-survivor group and survivor group. The non-survivor group had a dramatically higher D-Dimers and disseminated intravascular coagulation (DIC) scores than those of the survivor group (P<0.01). Six (85.7%) non-survivors but none of the survivors had a DIC score greater than 6 (P<0.001). Fifteen (93.8%) survivors and 2 (28.6%) non-survivors were transfused with RBC (P<0.01). The non-survivors (5/7) possessed a higher proportion for using AP than the survivors (2/16). The study suggests that COVID-19 patients who undergo blood transfusion usually possess coagulation dysfunction, and DIC may be closely related to deteriorating clinical outcomes.