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T H E E X P E R T S O N Y O U R S I D E

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Antigen Catalog

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Autoimmune DiseaseAntigensOutstanding assay performance with the most completepanel of recombinant and native autoimmune antigensfor all diagnostic applications.

Infectious Disease AntigensThe newest product line, manufactured accordingto the the customary quality guidelines of DIARECT antigens.

Custom Design AntigensPurified recombinant proteins from the specialists forbaculovirus / insect cell and E. coli bacterial expression.

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Pricelist available. Please inquire: [email protected]

CUSTOMER SERVICELot-to-Lot Consistency 36

Ordering 38

Quality Management 34

Reservation System 37

Shipping 38

Temperature profiles inside dry ice packages 39

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Contents Page Page

Autoimmune Disease Antigens

■ Autoimmune Thyroid Diseases 2

■ Mixed Connective Tissue Disease /

Systemic Lupus Erythematosus 4

■ Systemic Lupus Erythematosus 6

■ Systemic Lupus Erythematosus 8

■ Sjøgren’s Syndrome / Systemic Lupus Erythematosus 10

■ Systemic Sclerosis / CREST Syndrome 12

■ Polymyositis / Dermatomyositis 14

■ Celiac Disease 16

■ ANCA Associated Diseases 18

■ Autoimmune Hepatitis 20

■ Primary Biliary Cirrhosis 22

■ Antiphospholipid Syndrome / Thromboembolic

Syndrome / Goodpasture’s Syndrome 24

■ Pernicious Anemia / Crohn’s Disease 26

Infectious Disease Antigens

■ Lyme Disease 28

■ Erythema infectiosum 30

Custom Design Antigens

■ Your Antigen / Design 32

■ Upstream / Downstream 33

Customer Service

■ Quality Management 34

■ Lot-to-lot Consistency 36

■ Reservation System 37

■ Ordering & Shipping 38

Index 40

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ANTIGENS AUTOIMMUNE DISEASES

Autoantibodies to thyroid peroxidase (TPO), an integralmembrane protein of the apical surface of thyroid epithelial cells, are characteristic of autoimmune thyroid disease in humans. These IgG antibodies, formerly known as ‘thyroid microsomal antibodies’, areassociated with thyroid destruction, hypothyroidism,and lymphocytic thyroiditis (Graves’ disease).Most patients with autoimmune thyroid diseases, especially chronic Hashimoto’s thyroiditis also produceautoantibodies to thyroglobulin, the main componentof the colloid in the thyroid follicle.

Autoimmune Thyroid Diseases

Thyroid Peroxidase (TPO)

Product Details

■ Autoimmune Thyroiditis

■ human recombinant

■ expressed in insect cells

Product 12100■ on request

Thyroglobulin (non recombinant)

Product Details

■ Autoimmune Thyroiditis

■ non recombinant

■ human, native


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Mixed connective tissue disease (MCTD) was originallydescribed as a syndrome that consisted of a combina-tion of features typically found in patients with systemiclupus erythematosus (SLE), systemic sclerosis (SSc),polymyositis / dermatomyositis (PM/DM), or rheumatoidarthritis. The characteristic serologic features that permitted differentiation of MCTD from other connective tissue diseases (CTDs) were high-titer antinuclear antibodies with a speckled IFA pattern andthe presence of U1-snRNP specific autoantibodies.Antibody titers to U1-snRNP specific targets (68/70kDa, A, and C antigens) are usually higher in MCTD

Mixed Connective Tissue Disease / Systemic Lupus Erythematosus

sera than in SLE sera. High frequencies of Raynaud’s phenomenon and anti-U1-snRNP, but low frequenciesof nephritis and anti-Sm are characteristic of MCTD(with inversely related frequencies in SLE).

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U1-snRNP 68/70 kDa

Product Details

■ MCTD / SLE


■ expressed in E. coli


U1-snRNP A

Product Details

■ MCTD / SLE




U1-snRNP C

Product Details

■ MCTD / SLE




U-snRNP B/B’

Product Details

■ MCTD / SLE




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Systemic lupus erythematosus (SLE) is a potentially fatalautoimmune disease that affects multiple organsystems and is characterized by a range of symptoms,including kidney disease, arthritis, cardiopulmonaryabnormalities, and skin photosensitivity. Anti-Sm anti-bodies are highly specific for SLE and are thereforerecorded in the classification criteria of the AmericanCollege of Rheumatology. Anti-Sm antibodies arefound in 5 to 30% of patients with SLE, the frequencyvarying on the detection system and the selection criteria for study cohorts. Also, a racial difference in theincidence of anti-Sm antibodies has been shown.The Sm antigen is part of the spliceosomal complexcatalyzing the splicing of nuclear pre-mRNA. Each

Systemic Lupus Erythematosus spliceosome snRNP consists of snRNAs (U1, U2, U4 / U6,and U5) bound to a unique set of proteins as well as ashared set of seven different Sm proteins (typicallySmB/SmB’, SmD1, SmD2, SmD3, SmE, SmF, SmG).Most frequently the SmB and SmD polypeptides aretargets of the anti-Sm specific autoimmune response,of which SmD is regarded the most SLE-specific Smantigen.

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Sm (non recombinant; bovine)

Product Details

■ SLE

■ non recombinant

■ bovine


RNP/Sm (non recombinant; bovine)

Product Details

■ SLE

■ non recombinant

■ bovine

■ in preparation


SmD2

Product Details

■ SLE




SmD

Product Details

■ SLE




SmD1

Product Details

■ SLE

■ human recombinant;symmetrically methylated



SmD3

Product Details

■ SLE

■ human recombinant;symmetrically methylated



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Systemic lupus erythematosus (SLE) is an autoimmunedisease characterized by immune dysregulation thatresults in the production of antinuclear antibodies,generation of circulating immune complexes, and activation of the complement system. Antibodies todoublestranded DNA are the serological feature ofsystemic lupus erythematosus. They are diagnosticallyand prognostically significant and play an importantrole in the pathogenesis of lupus nephritis, a majorcause of morbidity and mortality in this disease.Besides the “classical“ lupus autoantibodies like anti-dsDNA and anti-Sm, there is a range of additionalalbeit rare antigenic targets which also may be of crucial diagnostic importance. Autoantibodies toward

Systemic Lupus Erythematosusthe three ribosomal phosphoproteins P0, P1, and P2are highly specific serological markers for SLE and mayindicate CNS involvement. This is also true for anti-PCNA, a rare specificity, but when present should alertthe clinician to the presence of defined or evolvingSLE. On the other hand, anti-Ku may be associatedmost strongly with SLE and overlap syndromes but isalso present in myositis and scleroderma. Furthermore, preliminary clinical data with recombinant nucleolinshow specific reactions of sera from patients with SLEand systemic sclerosis, respectively.

Ribosomal Phosphoprotein P0

Product Details

■ SLE




Proliferating Cell Nuclear Antigen (PCNA)

Product Details

■ SLE





Product Details

■ SLE




Ku (p70/p80)

Product Details

■ Myositis / Scleroderma Overlap / SLE

■ Pulmonary Hypertension





Product Details

■ SLE




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dsDNA (plasmid)

Product Details

■ SLE

■ plasmid

■ E. coli


Nucleolin

Product Details

■ SLE




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Sjøgren’s syndrome is an autoimmune disorder charac-terized by lymphocytic infiltrates and destruction ofthe salivary and lacrimal glands. Typical for thisdisease is the systemic production of autoantibodiesto a ribonucleoprotein particle, which consists of the proteins Ro/SS-A (60 kDa and 52 kDa), La/SS-B (48kDa) and small cytoplasmic RNAs known as hY RNAs.The disease is referred to as primary Sjøgren’s syndromewhen it occurs alone and as secondary Sjøgren’s syndrome when it occurs together with other connectivetissue diseases like SLE. Anti-Ro and anti-La autoanti-bodies occur in high percentage of patients with SLE

Sjøgren’s Syndrome / Systemic Lupus Erythematosus

and Sjøgren’s syndrome, respectively. In lupus patients,these antibodies are highly associated with photo -sensitive skin lesions, particularly those of subacute,cutaneous LE and also with neonatal lupus syndrome.

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Ro/SS-A (60 kDa; recombinant)

Product Details

■ Sjøgren’s Syndrome

■ SLE / SCLE / Neonatal LE


■ expressed in E.coli


Ro/SS-A (60 kDa; non recombinant; bovine)

Product Details



■ non recombinant

■ bovine


Ro/SS-A (52 kDa)

Product Details






La/SS-B

Product Details






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Systemic sclerosis (SSc) is a generalized disorder of connective tissue affecting skin and internal organs,characterized by fibrotic arteriosclerosis of peripheraland visceral architecture. Variable degrees of extra -cellular matrix accumulation (mainly collagen) occurin both skin and viscera and is very often associatedwith specific autoantibodies, most notably anti- centromere and anti-Scl-70 (autoantibodies againstDNA topoisomerase I). Another type of autoantibodies– anti-PM/Scl – is known to characterize a subset ofautoimmune patients with myositis, scleroderma, andthe PM/Scl overlap syndrome.

Systemic Sclerosis / CREST SyndromeSystemic features of scleroderma may include fibrosisand degeneration of the heart, lungs, kidneys andgastrointestinal tract.

CREST syndrome, a limited form of SSc, is characterizedby the following clinical features:Calcinosis cutis,Raynaud’s phenomenon,Esophageal dysfunction,Sclerodactyly, andTeleangiectasia.

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Centromere Protein B (CENP-B)

Product Details

■ Systemic Sclerosis

■ CREST Syndrome




DNA Topoisomerase I (Scl-70; full length)

Product Details





DNA Topoisomerase I (Scl-70; truncated)

Product Details





PM/Scl 100

Product Details

■ Myositis / Systemic Sclerosis / Overlap




Centromere Protein A (CENP-A)

Product Details


■ CREST Syndrome




PM/Scl 75

Product Details





DNA Topoisomerase I (Scl-70; non recombinant;bovine)

Product Details


■ non recombinant

■ bovine

■ in preparation


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Inflammatory myopathies are characterized by the presence of inflammatory infiltrates within skeletalmuscle. These idiopathic myopathies encompass avariety of both common and uncommon syndromes.The common subtypes include adult polymyositis (PM)and dermatomyositis (DM), along with inclusion bodymyositis, childhood myositis, malignancy-associated myositis, and myositis in overlap with another auto -immune connective tissue disease.Autoantibodies to aminoacyl-tRNA synthetases arefound in 30% of sera from patients with myositis.They are highly specific for this disorder and strongly associated with complicat ing lung disease. Anti-SRPautoantibodies are mainly associated with a syndrome

Polymyositis / Dermatomyositisof a necrotiz ing myopathy with cardiac involvement,severe prognosis and poor response to therapy. Anti-Mi-2 autoantibodies are considered specific serological markers of DM. Detected in about 20% of myositissera they are proven markers for acute onset, goodprognosis and good response to therapy.

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Histidyl-tRNA Synthetase (Jo-1)

Product Details

■ Anti-Synthetase Syndrome

■ Myositis




Alanyl-tRNA Synthetase (PL-12)

Product Details


■ Myositis




PM/Scl 100

Product Details





Mi-2

Product Details

■ Dermatomyositis

■ Myositis




Threonyl-tRNA Synthetase (PL-7)

Product Details


■ Myositis




SRP54

Product Details

■ Polymyositis




PM/Scl 75

Product Details





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Celiac disease is an inflammatory condition of the smallintestine caused by an inappropriate immune responseto the ingestion of certain dietary cereal proteins – gliadins – in genetically susceptible individuals. Thepathogenesis of the disease involves interaction between environmental, genetic and immunologicalfactors. The only treatment at present is lifelong strictadherence to a gluten-free diet, which enables intestinalmucosa to recover.

Celiac DiseaseThe identification of tissue-type transglutaminase as theantigen toward which autoantibodies are directed hasled to a greater understanding of the pathogenesis andto the development of improved serological tests.

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Tissue Transglutaminase (tTG; expressed in Baculovirus/Sf9)

Product Details

■ Celiac Disease




Tissue Transglutaminase (tTG; expressed in E. coli )

Product Details

■ Celiac Disease


■ expressed in E.coli


Gliadin (recombinant; deamidated)

Product Details

■ Celiac Disease

■ recombinant, deamidated

■ expressed in E. coli


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The most well-known neutrophil-specific autoantibo-dies (ANCA) are those found in necrotizing small vesselvasculitis. These antibodies predominantly belong tothe IgG class and give clear positive reactions by indirectimmunofluorescence (IIF) on ethanol-fixed neutrophilsand monocytes; their main targets are proteinase 3 (PR3),which results in the so-called cytoplasmic cANCA pattern,and myeloperoxidase (MPO). Anti-MPO antibodies arefound in numerous sera that produce a perinuclearpANCA pattern. However, many sera exhibitingpANCA pattern by IIF do not contain antibodies toMPO.Antibodies directed against PR3 are a sensitiveand specific marker for ANCA-associated vasculitis

ANCA Associated Diseasesand, in particular, for Wegener’s granulomatosis. The presence of anti-MPO in the right clinical contextstrongly suggests necrotizing vasculitis or idiopathicpauci-immune necrotizing and crescentic glomerulo-nephritis.Today the role of antineutrophil cytoplasmic antibodiesin the clinical diagnostics of systemic inflammatorydisease is still increasing. Their description dates backaround some 30 years, and they have become animportant criterion in routine vasculitis testing. The currently established method for the determinationof ANCA is indirect immunofluorescence on human neutrophils and antigen-specific ELISA,line or multiplexassays

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BPI (non recombinant)

Product Details

■ ANCA target in diverse diseases

■ non recombinant

■ human leukocytes


Myeloperoxidase (MPO; non recombinant)

Product Details

■ Microscopic Polyangiitis

■ Idiopathic Crescentic Glomerulonephritis

■ Churg-Strauss-Syndrome

■ Classic Panarteritis Nodosa

■ non recombinant



Proteinase 3 (PR3; non recombinant)

Product Details

■ Wegener’s Granulomatosis

■ non recombinant



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Autoimmune hepatitis (AIH) is a disorder of unknownetiology responsible for a progressive destruction ofthe liver parenchyma. It has a high mortality rateif left untreated. One of the characteristics of this disease is the presence of circulating autoantibodies inalmost 90% of patient’s sera. Clinical and serologicaldifferences between patients lead to the classificationof AIH into two types. Type 1 is characterized by thepresence of smooth muscle antibodies and / or antinu-clear antibodies whereas those from type 2 patientsshow anti-liver-kidney micro somal antibodies (LKM 1)

Autoimmune Hepatitisand anti-liver-cytosol type 1 antibodies (LC1). LC1 auto -antibodies have been shown to be the only serologicalmarker in 10% of AIH patients.

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Cytochrome P450 2D6 (LKM 1 hp)

Product Details

■ Autoimmune Hepatitis Type 2




Formiminotransferase Cyclodeaminase (LC 1)

Product Details

■ Autoimmune Hepatitis Type 2




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Primary biliary cirrhosis (PBC) is a chronic inflammatoryautoimmune liver disease involving obstruction of intra -hepatic bile ducts, which interferes with bile secretion,causing fibrosis and eventually cirrhosis of the liver.Clinical symptoms include fatigue, pruritis and jaundice.Antimitochondrial antibodies (AMA/M2) are present in90-95 % of cases of PBC long before clinical signs orsymptoms appear. These include antibodies towardsthe E2 subunits (dihydrolipoamide transferases) of thepyruvate dehydrogenase complex (PDC-E2), branchedchain 2-BCOADC dehydrogenase complex (BCOADC-E2), and 2-oxoglutarate dehydrogenase complex(OGDC-E2). Although M2 antibodies are consideredthe hallmark diagnostic feature of primary biliary

Primary Biliary Cirrhosis cirrhosis (PBC), they are not the only disease-specificautoantibodies. A number of additional proteins havebeen identified such as the nuclear autoantigensSp100, gp210 or Nup62. These nuclear autoantibodiesare found in a subset of patients with PBC, includingthose who are AMA2-negative.

Product Details

■ Primary Biliary Cirrhosis



Product Details




Product Details




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Sp100

Product Details





gp210

Product Details





Nup62

Product Details





M2

Product Details





BCOADC-E2 (M2 component) OGDC-E2 (M2 component)

PDC-E2 (M2 component)




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Antiphospholipid antibodies, comprising lupus anti -coagulants (LA) and anticardiolipin antibodies (aCL)have been associated with thrombotic disease in patientswith SLE or without any underlying disease (primaryantiphospholipid syndrome; APS). The recently revisedcriteria for APS list three laboratory parameters: LA, aCL,and β2-glycoprotein 1 (β2-GP1; Apolipoprotein H; Apo H)whereas at present the best-characterized antigenic target for these antibodies seems to be the phospholipid-binding protein β2-GP 1.

Antiphospholipid Syndrome/ Thromboembolic Syndrome

Goodpasture’s syndrome is a rare but serious auto -immune condition that can cause severe kidney and lungdamage with rapidly progressive glomerulonephritisand pulmonary hemorrhage. The detection of auto -antibodies to glomerular basement membrane (anti-GBM) is an important part of a reliable diagnosis.The dominant epitope in the globular NC1 domain ofα3 chain of type IV collagen is a so-called cryptotope,i.e. the antibodies preferentially bind to a denaturedstructure.

Goodpasture’s Syndrome

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β2-Glycoprotein 1(Apolipoprotein H)

Product Details

■ Primary / Secondary APS




β2-Glycoprotein 1(Apo H; non recombinant; human)

Product Details


■ non recombinant

■ human


β2-Glycoprotein 1(Apo H; non recombinant; bovine)

Product Details


■ non recombinant

■ bovine


Glomerular Basement Membrane(GBM; dissociated)

Product Details

■ Goodpasture’s Syndrome




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Pernicious anemia (PA) is an autoimmune disorderthat causes neurological changes, including dementia.A condition of pernicious anemia is related to vitaminB12 deficiency, which occurs when autoantibodies tointrinsic factor or parietal cells reduce levels of intrinsicfactor by interfering with its absorption.

Pernicious AnemiaCrohn’s disease (CD) and ulcerative colitis (UC) are thetwo most frequently occurring inflammatory boweldiseases in Caucasians. Mucosal inflammation in CDappears to occur when dysregulation of the immunesystem leads to an imbalance between tolerance tocommensal microbiota or food-derived antigens andimmunity to pathogens. It has been shown that auto-immune mechanisms play a role in the developmentof CD, and exocrine pancreas autoantibodies to glyco-protein 2 (GP2) are disease-specific. Also, autoanti -bodies to GP2 have been detected in 68% of Crohn’sdisease patients with extraintestinal complications suchas idiopathic chronic pancreatitis.

Crohn’s Disease

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GP2

Product Details

■ Crohn’s Disease




Intrinsic Factor

Product Details

■ Pernicious Anemia




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ANTIGENS INFECTIOUS DISEASES

Lyme disease is a multisystemic infectious disease causedby Borrelia species. In the United States Borrelia burgdorferi is the main cause of Lyme disease, inEurope the most dominant species are Borrelia afzeliiand Borrelia garinii. Another, even though relativelyrare species is Borrelia spielmanii.Lyme disease is the most common tick-borne disease inthe Northern Hemisphere. Borrelia is transmitted bythe bite of infected ticks from the genus Ixodes. Thevarious clinical manifestations in early disease stageinclude flu-like symptoms and a characteristic circularskin rash called erythema migrans. Left untreated,the disease is characterized by chronic infection of thejoints, heart, and central nervous system. Delayed

Lyme Diseaseor inadequate treatment can lead to the serious, latemanifestations, which can be disabling and difficultto treat.

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Products

Product Details Availability

■ Lyme Disease ■ on request

Recombinant Antigens

Borrelia burgdorferiBorrelia burgdorferi p100Borrelia burgdorferi p41Borrelia burgdorferi OspCBorrelia burgdorferi DbpABorrelia burgdorferi BmpABorrelia burgdorferi DbpB

Borrelia gariniiBorrelia garinii p58

Borrelia spielmaniiBorrelia spielmanii OspC

Borrelia afzeliiBorrelia afzelii DbpABorrelia afzelii OspABorrelia afzelii BmpA

Whole Cell Detergent Extracts

Borrelia burgdorferiBorrelia gariniiBorrelia afzelii

Product 40100

Product 40200

Product 40300

Product 40400

Product 40500

Product 40600

Product 40700

Product 40800

Product 40900

Product 41000

Product 41100

Product 42000

Product 42100

Product 42200

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ANTIGENS INFECTIOUS DISEASES

Parvovirus B19 is an infective disease agent for Erythemainfectiosum, originally named fifth disease in an enumeration of childhood hemocytic rash diseases(measles, scarlet fever, German measles, Duke’s disease, erythema infectiosum, and roseola). The virusis spread primarily by infected respiratory droplets.Seropositivity for past parvovirus B19 infection is highin the population, and serious, long-term complicationsare possible. Parvovirus B19 infections in pregnancycan lead to severe fetal anemia with miscarriage(about 10% of pregnancies) or serious damage to thefetus (hydrops fetalis). Virus replication in erythroidprecursors worsens preexisting anaemic conditions andcan lead to aplastic crisis. Arthritis complications havebeen described.

Erythema infectiosumAs diagnostic tools DIARECT supplies viral capsids ofparvovirus B19. One capsid product contains both theminor VP1 and major VP2 structural proteins, and asecond product is a pure VP2 capsid.

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Parvovirus B19 VLP VP2

Product Details

■ Erythema infectiosum

■ recombinant



Parvovirus B19 VLP VP1/VP2 Co-Capsid

Product Details

■ Erythema infectiosum

■ recombinant



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ANTIGENS

For customers requiring application-specific proteinsin diagnostic products, DIARECT’s recombinant proteinexpertise is available for development and productionof customized proteins. Antigens from infectiousdisease agents, virus-like particles, calibrator materialand designed fusion proteins are just a few examplesof custom protein projects.

Your AntigenCustomer inquiries for custom proteins are handledunder project- and quality-management guidelines.Since custom proteins may require protein engineering,the scientific literature supplies important backgroundinformation for design of the exact target moleculeand expression strategy. Once the target protein hasbeen defined, DNA vectors for recombinant expressionof the target are constructed by genetic engineering,using a range of cloning methods as well as total genesynthesis. Biotechnology then takes over for large-scaleprotein expression and purification.

Design

CUSTOM DESIGN

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Setup work establishes successful production of thetarget proteins by host cells in the required amountsand with the required functionality. The main host cellsystems for expression and production of recombinantproteins at DIARECT are baculovirus / insect cells andE. coli bacteria. These systems are available at differ entculture volumes, with possible scale-up to up to bio -reactor / fermenter cultures. Since different expressionsystems have specific strengths and weaknesses, initialsetup work establishes successful production of targetproteins with the required functionality. Following successful upscaling, the process is transferred to thedownstream applications.

UpstreamHarvesting, centrifugation, cell lysis and filtration areexamples of important operations that precede the actual purification of the target protein and requirestate-of-the-art equipment. Chromatographic purificationcombines affinity separations based on engineered tagsequences with a variety of other separation methods.The final result is the custom protein, with the final formulation according to customer specifications.

Downstream

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QUALITY MANAGEMENT

DIARECT is one of the leading suppliers of antigens forautoimmune diagnostics. Focusing on our customers’ success, we are committedto having the highest level of quality in the field ofassay components for diagnostic kits and biotech service. It is our aim to provide our customers with alevel of quality and service that consistently meetsand exceeds their expectations.

Qualified employees are a prerequisite for the productionof high-quality products like components of diagnosticassays. More than two-thirds of the DIARECT employeeshold an academic degree in the fields of DNA technology,molecular biology, cell biology, protein chemistry orbiotechnical engineering. Ongoing training programsmaintain this high standard. Our employees embracethe quality management system and are active participants in our continuous improvement programs.Our laboratories were designed with quality in mind,and a full array of modern equipment enables us tomaintain our high quality standards.

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As our customers’ needs continue to change, we standcommitted to permanent and continuous improvement.The products of DIARECT are therefore developed, produced, and distributed according to our QualityManagement System that is certified for compliancewith ISO 9001 as well as ISO 13485 standards. In addition, since September 2002 DIARECT has beenlisted as a manufacturer of human recombinant anti-gens for autoimmune testing in the database of theU.S. Food and Drug Administration (FDA).

Production facilities of SurModics IVD, manufacturerof protein stabilizers / blockers and BioFX® substratesand accessory reagents, distributed in Europe by DIARECT, operate in an environment in accordanceto the ISO 9001 and ISO 13485 standards as well. In addition, the manufacturing sites of SurModics areregularly audited by DIARECT’s quality representa - tives to guarantee distribution of products of highestquality.

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LOT-TO-LOT CONSISTENCY

DIARECT recombinant antigens – always pro d ucedaccording to documented procedures (SOPs) – under-go a rigorous series of tests in our quality controllab. Each lot is subjected to various biochemical andimmunological analyses to assure conformance to ourstrict product specifications before it can be released.The goal of these extensive inspections is to ensurelot-to-lot conformance, which guarantees consistentresults. The outstanding lot-to-lot consistency of ourantigens reduces development times and efforts of ourcustomers and increases their productivity.

Lot-to-lot Consistencym

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ITG Ab (lgA): Comparison of 5 antigen lots

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We guarantee the reservation of a specified amount ofantigen(s) (up to a whole production run) without anyobligation. Usually the amount of antigen under reser-vation is sufficient for our customer’s manufacturingneeds for up to 18 months. You simply inform us ofyour antigen requirements for this period, and appro-ximately every 4 months we will give you feedbackregarding the accuracy of your estimate.

Reservation SystemThe reservation system also includes providing thecustomer early enough with samples of new lots of therespective antigen. This allows for a smooth transitionwhen evaluating for the qualification of a new lot forsubsequent reservation.

For you there are two clear advantages:■ Security of supply with no additional costs■ No need for continual readjustment and fine

tuning of your assay because of new antigen lots

RESERVATION SYSTEM

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ORDERING & SHIPPING

OrdersOrders may be placed by telephone, fax, email and standardmail. Standing orders are welcome; for bulk prices pleaseinquire.

General Terms of Business:Our General Terms and Conditions of Sale and Purchaseapply to all contracts concluded with DIARECT AG as well asto purchase orders, deliveries and services supplied by same(see www.diarect.com).

ContactPhone +49 (0)761 / 47979 - 0Fax +49 (0)761 / 47979 - [email protected]

Carrier & PaymentTransportation:We are pleased to organize your dry ice shipment individually.Please contact us for options and more details.

Payment:Terms of payment according to our General Terms andConditions of Sale (see www.diarect.com).

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We have experimentally determined temperatureprofiles in dry ice packages packed according toour standard procedures.

■ Result: We can guarantee that a package with10 kg dry ice will retain a temperature below -20ºC for 5 days

■ Result: We can guarantee that a package with14 kg dry ice will retain a temperature below -20ºC for 6,5 days

Temperature profilesinside dry ice packages

Temperature inside a package with 10 kg dry ice

Temperature inside a package with 14 kg dry ice

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INDEX

ANTIGENS AUTOIMMUNE DISEASESAlanyl-tRNA Synthetase (PL-12) 15

BCOADC-E2 (M2 component) 23

BPI (non recombinant) 19

Centromere Protein A (CENP-A) 13

Centromere Protein B (CENP-B) 13

Cytochrome P450 2D6 (LKM 1 hp) 21

DNA Topoisomerase I (Scl-70; full length) 13

DNA Topoisomerase I (Scl-70; non recombinant; bovine) 13

DNA Topoisomerase I (Scl-70; truncated) 13

dsDNA (plasmid) 9

Formiminotransferase Cyclodeaminase (LC 1) 21

Gliadin (recombinant; deamidated) 17

Glomerular Basement Membrane (GBM; dissociated) 25

GP2 27

gp210 23

Histidyl-tRNA Synthetase (Jo-1) 15

Intrinsic Factor 27

Ku (p70/p80) 9

La/SS-B 11

M2 23

Mi-2 15

Myeloperoxidase (MPO; non recombinant) 19

Nucleolin 9

Nup62 23

OGDC-E2 (M2 component) 23

PDC-E2 (M2 component) 23

PM/Scl 75 13 / 15

PM/Scl 100 13 / 15

Proliferating Cell Nuclear Antigen (PCNA) 9

Proteinase 3 (PR3; non recombinant) 19

Ribosomal Phosphoprotein P0 9



RNP/Sm (non recombinant; bovine) 7

Ro/SS-A (52 kDa) 11

Ro/SS-A (60 kDa; non recombinant; bovine) 11

Ro/SS-A (60 kDa; recombinant) 11

Sm (non recombinant; bovine) 7

SmD 7

SmD1 7

SmD2 7

SmD3 7

Sp100 23

SRP54 15

Threonyl-tRNA Synthetase (PL-7) 15

Thyroglobulin (non recombinant) 3

Thyroid Peroxidase (TPO) 3

Tissue Transglutaminase(tTG; expressed in Baculovirus/Sf9) 17

Tissue Transglutaminase(tTG; expressed in E. coli) 17

U-snRNP B/B’ 5

U1-snRNP 68/70 kDa 5

U1-snRNP A 5

U1-snRNP C 5

β2-Glycoprotein 1 (Apo H; non recombinant; bovine) 25

β2-Glycoprotein 1 (Apo H; non recombinant; human) 25

β2-Glycoprotein 1 (Apolipoprotein H) 25

ANTIGENS INFECTIOUS DISEASESBorrelia afzelii BmpA 29

Borrelia afzelii DbpA 29

Borrelia afzelii (detergent extract) 29

Borrelia afzelii OspA 29

Borrelia burgdorferi BmpA 29

Borrelia burgdorferi DbpA 29

Borrelia burgdorferi DbpB 29

Borrelia burgdorferi (detergent extract) 29

Borrelia burgdorferi OspC 29

Borrelia burgdorferi p100 29

Borrelia burgdorferi p41 29

Borrelia garinii (detergent extract) 29

Borrelia garinii p58 29

Borrelia spielmanii OspC 29

Parvovirus B19 VLP VP1/VP2 Co-Capsid 31

Parvovirus B19 VLP VP2 31

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PRODUCTS

For further information please visit www.diarect.com

Autoimmune DiseaseAntigensOutstanding assay performance with the most completepanel of recombinant and native autoimmune antigensfor all diagnostic applications.

Infectious Disease AntigensThe newest product line, manufactured accordingto the the customary quality guidelines of DIARECT antigens.

Custom Design AntigensPurified recombinant proteins from the specialists forbaculovirus / insect cell and E. coli bacterial expression.

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Pricelist available. Please inquire: [email protected]

CUSTOMER SERVICELot-to-Lot Consistency 36

Ordering 38

Quality Management 34

Reservation System 37

Shipping 38

Temperature profiles inside dry ice packages 39

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T H E E X P E R T S O N Y O U R S I D E

DIARECT AGBötzinger Strasse 29 B79111 FreiburgGermanyPhone +49 (0)761 / 4 79 79 - 0Fax +49 (0)761 / 4 79 79 - [email protected]

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