DIARECT Newsletter

SUMMARY

Dear Madam or Sir,

AACC (July 25-29, 2010; Anaheim, CA) and AMLI (August 7-10, 2010; Orlando, FL) meetings are coming up, hence the DIARECT team would like to invite customers and interested parties to meet and discuss latest research findings and new projects.

Furthermore, DIARECT would like to announce that it is presenting two scientific posters on the use of recombinant autoantigens for the detection of disease specific autoantibodies.
On behalf of DIARECT AG, Prof. Liedvogel will be presenting a poster titled: Detection of autoantibodies to GP2, the major zymogen granule membrane glycoprotein, by novel test systems.
The poster will be illustrating that a recombinant antigen is suitable for application in variable test formats. The development of an ELISA was already successful. Provided that more parameters suitable for diagnosis of Crohn's and related diseases will be established, recombinant GP2 might be employed in commercially available multiparameter assays.

The second poster Prof. Liedvogel will be presenting is titled: Use of recombinant autoantigens in profiling of PBC-associated autoantibodies.
The aim of this study was the establishment of a novel multiparameter assay for the detection of PBC-specific (primary biliary cirrhosis) autoantibodies. By employing the most complete panel of recombinant autoantigens available, a PBC-specific microarray was developed providing a novel tool for PBC diagnostics. Preliminary results applying the novel microarray for the detection of PBC-specific autoantibodies are convincing and reproducible. Clinical trials are to be performed to prove applicability in routine diagnostics.

To learn more about DIARECT's human recombinant autoantigens, please visit with Prof. Liedvogel following the presentations, visit our website (www.diarect.com), or contact customer service at +49-761-479790 or info@diarect.com.

Sincerely,

Your DIARECT Team

Autoantibodies in Systemic Lupus Erythematosus (English)


Systemic Lupus Erythematosus (SLE) is a chronic, inflammatory autoimmune connective tissue disease, which can affect virtually any part of the human body. SLE like other autoimmune diseases has a multifactorial etiology. Endogenous factors like genetic predisposition or hormonal status, and exogenous factors like drugs, UV-light or viral infection may be implicated.

Many of the common autoantigens attributed to SLE are in DIARECT's repertoire of recombinant proteins, known for their high purity and lot-to-lot consistency.
Autoantibodies to double stranded DNA (dsDNA) are the serological feature of SLE. They are present in 70% of the patients. Proliferating cell nuclear antigen (PCNA) is a nuclear protein that mediates DNA processing, the regulation of cell cycle and even apoptosis. Consequently, if antibodies to PCNA occur in SLE, this antigen is of high diagnostic value as one can expect very small inter-individual variations.

An antibody may occur in several different autoimmune diseases, in contrast, one immune disease may imply the occurrence of different antibodies, too. Research findings indicate, that Ro/SS-A and Ro/SS-B autoantibodies are important diagnostic markers for SLE with Sjøgren’s Syndrome (SS), SCLE and also Neonatal LE.

High antibody titers to U1-snRNP specific targets (68/70 kDa, protein A and protein C antigens) are a hallmark for MCTD (95-100%), but they are also found in 30-40% of the SLE sera.

Autoantibodies to ribonucleoproteins (ribosomal phosphoproteins P0, P1 and P2) are present in 10% of SLE patients. It has been reported that lupus patients positive for anti-ribosomal P autoantibodies have a high frequency of CNS involvement, suggesting a marker use for these antibodies. Ku antigen consists of two polypeptides (70 kDa and 80 kDa). This heterodimer provides DNA-binding and regulatory functions to DNA-dependent protein kinase. Antibodies to Ku were originally reported in scleroderma-polymyositis overlap syndrome (up to 20% of patients), but have also been detectable in 5-10% of SLE and MCTD patients, and in up to 20% of patients with primary Sjøgren's syndrome.

Providing customers with products and services of constantly high quality is one of the cornerstones of DIARECT's philosophy. The recombinant autoantigens are mainly produced in the baculovirus/Sf9 expression system. DIARECT assures lot-to-lot consistency for all products. Furthermore, DIARECT's autoantigens have a proven track record for quality and sensitivity.


         Dot blot analyses of sera from patients with presumed SLE                
                      Dot blot analyses of sera from patients with presumed SLE (BD: Blood donor).
    

DIARECT offers the most complete panel of recombinant human targets for SLE autoantibody testing:

                   Dot blot analyses of sera from patients with presumed SLE                 
                   Human Monoclonal dsDNA Standards

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Autoantibodies in Systemic Lupus Erythematosus (Chinese)


免疫检测就是利用抗原与抗体互相结合的特异性反应来进行定性或定量的诊断。 DIARECT是一家专注于人重组抗原生产的高科技企业。公司成立于1998年，由有着20多年自身抗原研发经验的Liedvogel教授和 Haubruck博士创建。在过去的20年里，DIARECT的专家们始终致力于自身免疫抗原的研发及生产。致病自身抗原的面世有助于我们了解自身免疫疾 病的发病机制，为疾病的早期诊断及病程监控提供了有力的依据。
 
系统性红斑狼疮（Systemic Lupus Erythematosus，SLE）是一种慢性、缓解与加重交替，可累及多器官、多系统的自身免疫炎性疾病。和其它的免疫疾病一样，SLE也由多种因素 导致。既有内在因素如遗传基因或内分泌，也有外在因素如紫外线、病毒感染、药物等都可能导致红斑狼疮的产生。
 
DIARECT提供多种常见的SLE特异性重组抗原（请参见英文版中的表格），并切确保各批次产品之间的一致性。双链DNA（dsDNA）是系统性红斑狼 疮重要的自身抗原，其相应的自身抗体是SLE标志性抗体，阳性率约为70％。增殖细胞核抗原（PCNA）是一个核蛋白，调控DNA复制，细胞周期及凋亡。 抗PCNA抗体也是系统性红斑狼疮的特异性抗体，但阳性率很低。
 
一种抗体可能出现在多种自身免疫疾病中，而在一种免疫疾病中也有可能有多种抗体存在。经研究显示，Ro/SS-A（60 kDa和52 kDa）和La/SS-B自身抗体对SLE合并干燥综合征，亚急性皮肤型红斑狼疮（SCLE）以及新生儿红斑狼疮的检测有着重要的诊断价值。
 
虽然高滴度抗U1-snRNP（蛋白68/70 kDa, 蛋白 A 和蛋白 C 抗原）抗体是混合性结缔组织病（MCTD）的标志（阳性率为95-100%），但在30-40%的系统性红斑狼疮患者中也可检测出抗U1-snRNP抗体。
 
核糖核蛋白（Ribosomal Phosphoprotein P0，P1和P2）自身抗体存在于10%的SLE患者中。研究表明，核糖核蛋白自身抗体呈阳性预示着系统性红斑狼疮患者很可能并发中枢神经系统病变，因此 核糖核蛋白也是SLE血清学检测的重要标记。Ku(p70/p80)抗原由分子量为70 kDa和80 kDa的两个蛋白亚基组成。这个异二聚体可以帮助对DNA依赖的蛋白激酶 ( DNA-Protein Kinase ) 结合到DNA链上，继而起到调节作用。抗Ku抗体最初是在硬皮病/多发性肌炎重叠综合征患者血清中发现的，阳性率为20%，此外也可见于5－10％的系统 性红斑狼疮和混合性结缔组织病（MCTD），以及20％的原发性干燥综合征患者中。

英文版中的图描述了：斑点杂交法检测未确诊的SLE患者血清。

为客户提供稳定高质的产品与服务是DIARECT的根本理念之一。DIARECT生产的重组自身抗原在杆状病毒-昆虫细胞系统中表达，确保各批次产品之间的一致性。我公司生产的抗原在质量和敏感度方面都有良好的记录。欢迎您来索取产品目录。
 
中文版资料若有任何出入，请以英文版为准。

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DIARECT's Quality Management - DIN EN ISO 9001 and ISO 13485

                                                                    
DIARECT is committed to having the highest level of quality in the field of assay components for diagnostic kits and biotech service.  Consequently, DIARECT has implemented a quality management system to continuously improve processes, products and services.

Products are manufactured at modern, state-of-the-art facilities by qualified staff. Product quality is assured through a strictly controlled development process and monitoring of the manufacturing workflow by defined in-process controls. In addition to the testing of raw materials, each step of the production process is closely monitored to confirm compliance with established specifications. Finished goods undergo various biochemical and immunological analyses in our quality control lab in order to ensure lot-to-lot conformance.
One of the most effective tools for improvement are the periodically conducted quality audits. They lead to better products, processes, and systems, and, as a result, enhanced customer satisfaction.
Consequently, our quality management system has been certified according to the DIN EN ISO 9001:2000 standard in July 2002 (Reg. Nr. DE-251655QM; recertification in July 2008; follow this link to pdf of certificate).
However, certification to an ISO 9001 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied.
In 2006 DIARECT began incorporating techniques of Six Sigma and EFQM into the continuous improvement program of the quality management system. As one step in this process, DIARECT's quality management system has been certified according to the DIN EN ISO 13485:2003 standard in July 2008 (Reg. Nr. DE-251655 MP23; follow this link to pdf of certificate). ISO 13485:2003 specifies requirements for a quality management system for medical devices and related services. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.

SurModics, manufacturer of the immunoassay stabilization product line distributed by DIARECT in Europe and distributor of the DIARECT antigens in North America, also maintains a Quality Management System in accordance to the ISO 9001:2000 and ISO 13485:2000 standards. To see SurModics' ISO 9001:2000 or ISO 13485:2003 certificates, please click on the corresponding links.
 

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Upcoming Events - Meet the DIARECT Team!


                                                              
AACC Logo   
    AACC Annual Meeting 2010
    Date:        July 25 – 29, 2010  
    Location: Anaheim, California
    (@ SurModics booth #3424)


 AMLI Logo 
   AMLI 23rd Annual Meeting
    Date:        August 7 – 10, 2010  
    Location: Orlando, Florida

 

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North American Distributor




SurModics In Vitro Diagnostic Products

9924 West 74th Street
Eden Prairie, MN 55344 USA
Fax: (952) 829-2743 (Attention: IVD)

North America
Phone: (952) 829-2709
Toll-free: (800) 755-7793

Outside North America
Phone: (952) 829-2904

www.surmodicsivd.com

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