EUROIMMUN US
EUROArray
EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com
EUROIMMUN US EUROArray: DNA microarrays for molecular genetic diagnostics (IVD)
Ready-to-use PCR components Simple test procedure Numerous integrated controls Fully automated, standardized evaluation Validated according to IVD guidelines and CE labelled Preprepared LIMS connection
Parameter Indication HLA-B271 Ankylosing spondylitis (Bechterew‘s disease) HLA-DQ2/DQ8 Celiac disease (sprue) HLA-Cw 6 Psoriasis Factor V (Leiden)/Factor II1, 2 Thrombosis/thrombophilia HFE gene (HLA-H)1 Hemochromatosis
1EUROArray Direct: analysis possible either from DNA or from blood (without DNA isolation). 2 Test systems for separate analysis of factor V (Leiden) and factor II available. EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US EUROArray DNA Microarray Test Systems for Molecular Genetic Diagnostics (IVD)
Array platform based on proven BIOCHIP Technology
Ready-to-use PCR components
Simple procedure
Standardized incubation using established TITERPLANE Technique
Integrated control reactions secure sensitivity and speci city for every test sample
Fully automated standardized evaluation, interpretation and archiving of results (EUROArrayScan software)
No DNA isolation with EUROArray Direct: the analysis is performed directly from pretreated blood
Complete process from receipt of samples to issuing of results is IVD validated and CE labelled (DNA extraction, test kits, microarray scanner, software)
Pre-prepared LIMS connection
EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US What is a microarray and how does it work?
Principle of a DNA microarray
DNA microarrays consist of DNA molecules (probes) which are applied to a solid carrier material, such as glass, as microscopically small spots located at de fined The probes differ from one another by their DNA sequence – the order of their building blocks with the bases adenine, A; cytosine, C; guanine, G; thymine, T). When the DNA of a contains segments that match the microarray probes, the complementary DNA regions bind together – they hybridize. This binding is measured via a computer-generated reading and evaluated as a signal.
T C DNA strands with DNA strands containing Two fit complementary nucle- too few complementary together to form a opposite each nucleo s opposite base pair other bind together – each other do not bind A G they hybridize. together.
DNA building blocks Complementary DNA strands Non-complementary DNA strands
In order to with a microarray if a DNA con- tains sequences, the DNA must firs t be extracted from the blood. This is performed, for example, using DNA Blood sample DNA isolation Patient DNA kits.
DNA contains target sequence DNA does not contain target sequence
st 1st PCR cycle The s fied million-fold 1 PCR cycle using the polymerase chain (PCR). Tw o starter DNA Primer Primer molecules (primers) defin e the region to be copied. If the t nd DNA contains the corresponding (target sequence), the 2nd PCR cycle 2 PCR cycle primers bind and the target sequence is copied. This is repeated many so that the DNA region between the primers is greatly amplified. Th e PCR products are labelled with a fluo rescent dye, which enables them to be detected subsequently by the microarray. If the target se- Next cycles quence is not present in the sample, then the primers Next cycles cannot bind and the DNA is not amplified.
Analysis of PCR products on the microarray: Binding of PCR products to No binding without complementary DNA probes complementary PCR products of the microarray The PCR products are incubated with the microarray. They are first mixed with a buffer, which provides condi- for binding of the PCR products to the complementary probes on the microarray. This binding is measured via the fluorescence
Carrier material DNA spots Carrier material DNA spots
EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US Microarrays from EUROIMMUN for simple and reliable diagnostics
EUROArrays in IVD quality
EUROIMMUN microarrays are based on BIOCHIP Technology. They consist of numerous single-stranded DNA probes with di erent sequences, which are applied to thin glass at de ned positions. Each BIOCHIP consists of 48 DNA spots and allows duplicate deter- minations of up to 24 di erent DNA sequences, including controls. Each EUROArray slide contains ve test elds, enabling up to ve samples to be analyzed in parallel. EUROArray slide and enlargement of a BIOCHIP
Save time and money with the “EUROArray Direct“ procedure 5µl Blood 1 min For some parameters EUROIMMUN o ers a rapid procedure in which DNA isolation is not necessary. The blood sample is incu-
bated with extraction solution provided in the kit (E 1 and E 2 , see gure). The DNA extract is used directly in the PCR.
20µl E1 20 µl E Comparison EUROArray EUROArray Direct 2 5 sec Blood volume ~ 200 µl 5 µl
DNA isolation: approx. DNA extraction: Time 80 min for 40 samples < 20 min for 40 samples To be used directly for PCR No additional costs, extraction Costs For DNA isolation kit solutions contained in kit
Simple, uncomplicated and e ortless
All PCR reagent s suppied in EUROArray kits are ready for use, + including the DNA polymerase and the validated speci c primers. Thus, the number of pipetting steps is reduced to a minimum and laborious optimization processes are eliminated. The PCR works Ready for use reliably with minimal e ort: the pre-prepared PCR reagents are PCR reagents PCR master mix PCR simply combined, and the DNA is then added to this master mix.
The DNA microarray hybridization is performed under exact, Pipette samples standardized conditions using the proven TITERPLANE Technique . This procedure is simple and reliable. The samples (PCR products + hybridization bu er) are pipetted onto the reaction elds of a reagent tray. The slides are then placed into the recesses of the Reagent tray reagent tray, whereby all BIOCHIPs come into contact with the liquids simultaneously. Thanks to the hydrophobic surroundings, the uid drops remain stable on the hydrophilic reaction elds during the incubation and do not run into one another. After a Place slide onto tray one-hour incubation period in the hybridization station, the EUROArray slides are washed with a special bu er solution. The washing procedure is fast and uncomplicated : 10 slides are pro- cessed in just 5 minutes and can then be evaluated. 1 hour
Incubate Hybridization station with four EUROArray slides
EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US Fully automated standardized evaluation delivers fast and reliable results
With the EUROIMMUN Microarray Scanner and EUROArrayScan software , EUROArrays are evaluated easily, quickly and objectively without the need to study complicated manuals. EUROArrayScan software can be integrated into EUROLabO ce and other laboratory information management systems (LIMS) without any di culties.
At the start of each run, the data for the samples to be examined are entered and are then trans- ferred automatically into the working list by the software. After the incubated slides have been placed into the microarray scanner, the scanning procedure is initiated simply by a mouse click. EUROArrayScan software evaluates all data fully automatically, produces a report and documents and archives all results. Results for a EUROArray slide (up to ve samples) are obtained in less than 20 seconds! Scanning a EUROArray slide
Evaluation using EUROArrayScan (e.g. HLA-B27) Protocol for each individual report (e.g. HLA-B27)
Reliabilty of analysis is ensured by many controls
Control Used to check w hether ... Hybridization specificity control ... the PCR products have bound specifically to the DNA probes Cross contamination control ... there was any cross contamination from one test field to the other DNA positive control ... the patient DNA was intact and present in sufficient quantity PCR positive control . .. PCR was successful (funtioning of primers and PCR conditions) Negative control (automatically included) . . . the analysis was performed correctly and there are no false positives
Product overview
EUROArray test systems Indication Order no. Features HLA-B27 Bechterew‘s MN 5110-#### Highest sensitivity: detects all known HLA-B*27 alleles; HLA-B27 Direct disease MN 5110-####-V Improved speci city: di erentiates non-disease-associated HLA-B*27 alleles HLA-DQ2/DQ8 Celiac disease M N 5310-#### Detects all alleles relevant for HLA-DQ2/DQ8 HLA-Cw6 Psoriasis M N 5410-#### Detects all worldwide relevant HLA-C* 06 alleles Hemochromatosis (4 SNP) Direct MN 5510-####-V Detects H63D, C282Y, S65C and E168X Hemochromatosis Hemochromatosis (2 SNP) Direct MN 5511-####-V Detects. H63D and C282Y FV / FII Direct MN 5810-####-V Thrombosis, Detects point mutations in the factor V gene (factor V Leiden, 1691 G>A) FV Direct MN 5811-####-V thrombophilia and / or in the factor II (prothrombin) gene (20210 G>A) FII Direct MN 5812-####-V
Equipment Order no. Features M icroarray S canner Y G 0601-0101 Delivered together with EU R OArrayS can software Incubator insert for TITERPLANE reagent tray YG 0631-0101 Used to insert TITERPLANE reagent trays into the hybridization station TITER PLANE reagent tray ZM 9999-0105 S uited for parallel incubation of up to five EU R OArray slides ####: For detailed information about available test kit formats see our product catalogue or the internet at www.euroimmunus.com.
EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US EUROIMMUN IFA Autoimmune Diagnostics Tissue/cell substrates: EUROArray HLA-B27 – Direct adrenal gland, monkey bladder, rat buccal mucosa, monkey cartilage (trachea), monkey Molecular genetic microarray test system cerebellum, monkey/rat cerebrum, monkey Crithidia luciliae DNS-bound lactoferrin erythrocytes, human eye, monkey goblet cells granulocytes, human (ethanol- xed) granolocytes, human (formaldehyde- xed) granulocytes, human (methanol- xed) heart, monkey HEp-2 cells HEp-20-10 cells hippocampus, rat HUVEC hypothalamus, monkey inner ear, rat intestine, monkey kidney, monkey/mouse/rat lacrimal gland, monkey lip, monkey liver, monkey/mouse/rat lobus temporalis, monkey lung, monkey lymph nodes, monkey lymphocytes, human mamma, monkey nerve, monkey nervus opticus, monkey oesophagus, monkey/rat ovary, monkey pancreas, monkey parathyroid gland, monkey Evaluation using EUROArrayScan Protocol for each individual report parotid gland, monkey pituitary gland, monkey placenta, monkey prostate, monkey Saccharomyces cerevisiae salt-split skin, monkey Indication: Determination of disease-associated HLA-B*27 alleles in human, genomic DNA for skeletal muscle, monkey spermatozoa, human the diagnosis of rheumatic diseases, especially Bechterew’s disease (spondylitis ankylosans, spleen, monkey ankylosing spondylitis, AS), urethro-oculo-articular syndrome (Reiter’s disease, combination of spinal cord, monkey stomach, monkey/mouse/rat symptoms from urethritis, conjunctivitis/uveitis, arthritis), reactive arthritis (para-/postinfectious synovialis, monkey testis, monkey arthritis), acute uveitis anterior or acute iridocyclitis, periarthritis (periarthropathia) humeroscapu- thrombocytes, human thymus, monkey laris, arthritis psoriatica (psoriasis arthritis), juvenile idiopathic arthritis, enteropathies (chronic- thyroid gland, monkey tongue, monkey infl ammatory bowel diseases, IBD). VSM47 cells (F-actin) umbilical cord, human EUROPLUS substrates: Clinical signi cance: Human leukocyte antigens (HLA) are tissue antigens (membrane-associated AMA-M2 BP180-NC16A-4X glycoproteins) of the human major histocompatibility complex (MHC). HLA-B belongs to the HLA GBM gliadin (GAF-3X) antigens of class I (also called MHC I antigens) which are present in all nucleus-containing body intrinsic factor myeloperoxidase (MPO) cells. Their function is the control of the T-cell-mediated immune response. Due to an extreme ge- proteinase 3 (PR3) ribosomal P-proteins + Jo-1 netic polymorphism there are a large number of HLA phenotypes. For HLA-B over 1000 di erent SS-A + SS-B SS-B + ribosomal P-proteins + Jo-1 alleles have been described. The HLA-B*27 allele alone has 77 subtypes (B*27:01 to B*27:65N), SS-B + Scl-70 + Jo-1 which di er only in a few bases. thyroglobulin (TG) Transfected cells: aquaporin-4 The membrane protein HLA-B27 is associated with the occurrence of several autoimmune dis- BP230gC desmoglein 1 + 3 eases. In Western Europe the prevalence of HLA-B27 is around 6 to 9%. When HLA-B27 is present, GABA receptor B GAD65 the relative risk of Bechterew’s disease is 87.4, for the urethro-oculo-articular syndrome 37, for glutamate receptor (type NMDA, AMPA1+2) NMDA receptor reactive arthritis 14 - 21 (depending on the infectious agent), for acute uveitis anterior or acute phospholipase-A 2 receptor (PLA 2R) rPAg 1 + 2 (pancreas antigen 1 + 2) iridocyclitis 10.4, for periarthritis humeroscapularis 6.3, for arthritis psoriatica 4 and for juvenile VGKC-ass. proteins (Lgi1+Caspr2) idiopathic arthritis 3.2. Enteropathies are also associated with HLA-B27. BIOCHIP Mosaics: ANA global test: HEp-20-10/monkey liver Autoantibody Pro le: combination of 30 di erent tissues per slide Bechterew’s disease: is a chronic inflammatory rheumatic disease of the axial skeleton (spinal Autoimmune Enzephalitis Mosaic 1: glutamate receptor (type NMDA, AMPA1+2)/ column, iliosacral joints, pubic symphysis and facet joints), the extremity joints and tendon inser- VGKC-ass. proteins (LGI1+CASPR2), GABA-R. B1 Basic Pro le: HEp-20-10/monkey liver/ tions. It a ects mainly men between the ages of 15 and 30. There is a clear relationship between rat kidney/rat stomach CIBD Pro le: monkey pancreas/intest. goblet cells (culture)/ the disease and the presence of HLA-B27. Around 3-6% of HLA-B*27 carriers develop Bechterew’s granulocytes (EOH)/Saccharomyces cerevisiae Dermatology Mosaic 7:oesophagus/salt-split skin/ diseaes. Around 90% of Bechterew’s disease patients are carriers of this tissue antigen, in par- BP230gC/desmoglein 1+3/BP180-NC16A-4X EUROPLUS endomysium + gladin: ticular subtypes B*27:02, B*27:04 and B*27:05. Subtypes B*27:06 and B*27:09 are, on the other monkey intestine/monkey liver/gliadin (GAF-3X) Granulocyte Mosaic 25: granulocytes (EOH/HCHO)/ hand, not associated with this disease. Subtype di erentiation is therefore important for the con- granulocytes+HEp-2/MPO/PR3/GBM fi rmation of diagnosis in some populations. The EUROArray HLA-B27 test system meets these Neuronal Antibody Screen: monkey cerebellum/ monkey nerve/monkey intestine demands at a very high quality level. Polyendocrinopathy Mosaic: monkey thyroid/ monkey pancreas/monkey adrenal/ monkey ovary/monkey testis/monkey stomach
Other mosaics also available Application of the EUROArray HLA-B27 – Direct: HLA-B27 can be determined accurately and pre- Special substrate combinations cisely with molecular biological methods via the detection of the corresponding allele (HLA-B*27) on request Software/Automation: in the genomic DNA of the patient. The method competes with the lymphocytotoxicitiy tests used EUROStar III Plus EUROPattern up until now. In contrast to these tests, the EUROArray does not require vital cells. Transport and EUROLabLiquidHandler EUROIMMUN IF Sprinter storage of samples are considerably simplified. Blood samples can be collected and processed EUROPicture EUROIMMUN PatternSupport together, e.g. once a week. Because of cross reactions with antibodies (with e.g. HLA-B7) and po- EUROLabO ce tential false-negative results in immunophenotyping when HLA-B*27 expression is low, molecu- EUROIMMUN Microarrays Molecular Genetics: lar genetic determination of HLA-B*27 is more specific and sensitive than serological methods. EUROArray HLA-B27 EUROArray HLA-B27 Direct In particular, PCR (polymerase chain reaction) using allele-specific primers has the potential to EUROArray HLA-DQ2/DQ8 EUROArray HLA-Cw6 deliver reliable results, especially for the various HLA-B*27 subtypes. In this EUROIMMUN test EUROArray FV/FII Direct EUROArray FV Direct system the HLA-B*27 primers are chosen and optimized so that all currently known HLA-B*27 EUROArray FII Direct EUROArray Haemochromatosis (4 SNP) Direct subtypes are detected. Furthermore, when a positive result is obtained, it is indicated whether EUROArray Haemochromatosis (2 SNP) Direct subtypes HLA-B*27:06 or HLA-B*27:09 could be involved. These two subtypes are not associated Software/Automaten: with the occurrence of ankylosing spondylitis. Microarray scanner EUROArrayScan software * Check for FDA status EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROEUROIMMUN USUS EUROIMMUN IFA Infectious Serology Test characteristics Viruses: Adenoviruses EUROArray HLA-B27 – Direct Chikungunya virus Coxsackieviruses Crimean Congo fever virus (CCHFV) Cytomegalovirus (CMV) Dengue viruses types 1-4 (DENV) Principle of the test: The EUROArray is an in vitro Blood sample DNA extract Blood sample ECHO virus or sample Epstein-Barr virus capsid antigen (EBV-CA) test for molecular genetic determination of disease- Epstein-Barr virus early antigen (EBV-EA) associated HLA-B*27 alleles in human, genomic Epstein-Barr virus nuclear antigen (EBNA) Hantaviruses (types Hantaan, Puumala, Seoul, DNA. EDTA blood (direct method) or isolated genom- Direct method DNA isolation Saaremaa, Dobrava, Sin Nombre, Andes) Herpes simplex virus types 1 and 2 (HSV-1/2) ic DNA of the patient is used as sample material. (extraction sol. 1 + 2) (not included in Human herpes virus type 6 (HHV-6) test kit) uenza v. A In the direct method genomic DNA of blood cells is uenza v. B prepared for PCR by diluting the blood with the ex- Japanese encephalitis virus (JEV) PCR (polymerase Measles virus traction solution provided in the test kit and incubat- Mumps virus chain reaction) Para enza viruses types 1-4 ing it for one minute. In the fi rst reaction step, two Respiratory syncytial virus (RSV) sections (exon 2 and exon 3) of the HLA-B gene and Rift valley fever virus (RVFV) Rubella virus a -globin gene fragment as positive control are am- Sand y fever virus (types Sicilian, Naples, Toscana, Cyprus) plifi ed from the thus produced extract or, alternatively, SARS Coronavirus (SARS-CoV) from a genomic patient DNA sample using PCR. DNA microarray Sindbis virus hybridization Tick-borne encephalitis (TBE) virus The HLA-B gene sections are only amplified if the Usutu virus Varicella zoster virus (VZV) sample contains an HLA-B*27 allele. All PCR prod- West Nile virus (WNV) ucts are labelled with a fluore scence dye as they are Yellow fever virus (YFV) produced. In the second reaction step, the products Bacteria: Bartonella henselae are analyzed using a microarray, which contains im- Fully Bartonella quintana mobilized probes which are complementary to the automated Bordetella parapertussis evaluation Bordetella pertussis amplifi ed DNA. The specifi c binding (hybridization) Borrelia afzelii Borrelia burgdorferi of the fl uorescing PCR product to the corresponding Borrelia garinii Campylobacter coli microarray spot is detected using the EUROIMMUN Microarray Scanner. A flu orescence signal Campylobacter jejuni on the HLA-B*27-specific s pots indicates the presence of an HLA-B*27 allele in the patient DNA. Chlamydia pneumoniae Chlamydia psittaci Chlamydia trachomatis Hemophilu nzae Test procedure: For direct use of EDTA blood the sample is first incubated with extraction solu- Helicobacter pylori tion 1 for one minute and then extraction solution 2 is added. For PCR an aliquot of the extract Klebsiella pneumoniae Legionella bozemanii or, alternatively, a purifie d DNA sample is mixed with the ready-made PCR reagents. The PCRs Legionella dumo i Legionella gormanii are incubated in the thermocycler and then, using the TITERPLANE technique, on EUROArray Legionella jordanis slides containing microarray BIOCHIPs. Scanning and evaluation are performed using the Legionella longbeachae Legionella micdadei EUROIMMUN Microarray Scanner and the EUROArrayScan program. The program enables Legionella pneumophila serotypes 1-14 Listeria monocytogenes 1/2 a, 4b fully automated evaluation of EUROArray analyses and detailed documentation of results. Mycoplasma pneumoniae Treponema pallidum Treponema phagedenis Sensitivity and specificity: The microarray test system detects all HLA-B*27 subtypes and indicates Yersinia enterocolitica the possible presence of the non-disease associated subtypes HLA-B*27:06 and HLA-B*27:09. EUROPLUS substrates: Borrelia VlsE (recombinant) Reference Borrelia OspC Reference samples n method Sensitivity Specifi city EBV p19 + gp125 EDTA blood samples1 from blood donors, Germany Yeasts: molecular Candida albicans (12 precharacterized as HLA-B*27 positive, 88 precharacterized as 100 100% 100% Candida glabrata genetic Candida krusei HLA-B*27 negative) Candida parapsilosis Candida tropicalis DNA samples2 from the “International Histocompatibility Working Parasites: Group” (IHWG): “Sequence Polymorphism Reference Panel (SP molecular Echinococcus granulosus Reference Panel)” and “HLA (Anthropology) Reference Panel” (6 55 100% 100% Leishmania donovani genetic Plasmodium falciparum HRP-2/MSP-2 (rec.) precharacterized as HLA-B*27 positive, 49 precharacterized as HLA- Plasmodium vivax MSP/CSP (recombinant) B*27 negative) Toxoplasma gondii 1 The investigations were performed with EDTA blood using the direct method and with DNA samples isolated from EDTA blood using the “DNA whole blood kit S CE IVD”. Pro les: 2 Accompanying hepatitis pro le This investigation was not carried out for the direct method. Central nervous system pr e Exanthema pro e Fever pro le South East Asia Flavivirus pr e Accuracy: For 100 analysed EDTA blood samples the determinations were successful in all Gastrointestinal tract pr le Infectarthritis pr le cases (100%) using the direct method. For DNA samples the determinations were also successful Infectarthritis pr le (The Tropics) in all cases (100%) (n = 150). Lymphadenitis pr le Myocarditis pr e Ophthalmology pr le Otitis pro le Technical data: Pregnancy pro le Respiratory tract pro le Substrate: Single-stranded DNA probes, length: 20 to 50 nucleotides Sexually transmitted diseases (STD) pro le TORCH pro le Special substrate combinations Test procedure: Processing time for 40 samples: approx. 40 min (DNA samples) or on request 60 min (blood samples in the direct method), total time of one test run Software/Automation: with 40 samples including incubation: approx. 2 h 30 min or 2 h 50 min EUROStar III Plus EUROPattern EUROLabLiquidHandler Reagents: Ready-for-use EUROIMMUN IF Sprinter EUROPicture Controls: Integrated HLA-B27 positive control (no positive control required) EUROIMMUN PatternSupport EUROLabO ce Integrated DNA positive control * Check for FDA status CE-IVD certified: Complete process incl. DNA extraction or isolation is validated Test kit format: 10 or 20 slides, each containing 5 test fi elds Order number: MN 5110-1005-V, -2005-V
EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US
EUROIMMUN IFA EUROArray HLA-Cw6 Autoimmune Diagnostics Tissue/cell substrates: adrenal gland, monkey Molecular genetic microarray test system bladder, rat buccal mucosa, monkey cartilage (trachea), monkey cerebellum, monkey/rat cerebrum, monkey Crithidia luciliae DNS-bound lactoferrin erythrocytes, human eye, monkey goblet cells granulocytes, human (ethanol- xed) granolocytes, human (formaldehyde- xed) granulocytes, human (methanol- xed) heart, monkey HEp-2 cells HEp-20-10 cells hippocampus, rat HUVEC hypothalamus, monkey inner ear, rat intestine, monkey kidney, monkey/mouse/rat lacrimal gland, monkey lip, monkey liver, monkey/mouse/rat lobus temporalis, monkey lung, monkey lymph nodes, monkey lymphocytes, human mamma, monkey nerve, monkey Evaluation using EUROArrayScan Protocol for each individual report nervus opticus, monkey oesophagus, monkey/rat ovary, monkey pancreas, monkey parathyroid gland, monkey parotid gland, monkey pituitary gland, monkey Indication: Determination of disease-associated HLA-C*06 alleles in human genomic DNA for the placenta, monkey prostate, monkey diagnosis of psoriasis with skin manifestation (particularly psoriasis vulgaris type 1, psoriasis Saccharomyces cerevisiae salt-split skin, monkey guttata, psoriasis vulgaris type 2, joint manifestation (particularly psoriatic arthritis), etc. skeletal muscle, monkey spermatozoa, human spleen, monkey spinal cord, monkey stomach, monkey/mouse/rat Clinical significance: The EUROArray HLA-Cw6 is designed for the detection of disease-associated synovialis, monkey testis, monkey HLA-C*06 alleles coding for the tissue antigen HLA-Cw6. HLA-C*06 alleles constitute the genetic thrombocytes, human thymus, monkey component for the predisposition to the autoimmune reactions that result in psoriasis. There is thyroid gland, monkey tongue, monkey VSM47 cells (F-actin) a strong genetic component to psoriasis; around 40% of cases are familial. Monozygotic twins umbilical cord, human show a concordance rate of 62-70% and dizygotic twins of 21-23%. Recent total-genome asso- EUROPLUS substrates: AMA-M2 ciation studies have con rmed that of all gene sites HLA-C shows the highest association with BP180-NC16A-4X GBM psoriasis, and HLA-C*06 can be considered as by far the most powerful genetic marker for this gliadin (GAF-3X) intrinsic factor myeloperoxidase (MPO) disease. Around 67% of psoriasis patients carry the HLA-C*06 allele compared to a prevalence of proteinase 3 (PR3) ribosomal P-proteins + Jo-1 around 10-20% for the HLA-Cw6 antigen in the general population. Caucasians with the HLA-C*06 SS-A + SS-B SS-B + ribosomal P-proteins + Jo-1 allele have a 10-fold increased risk of developing psoriasis. SS-B + Scl-70 + Jo-1 thyroglobulin (TG) Transfected cells: aquaporin-4 In chronic in ammatory skin diseases the determination of HLA-C*06 is of great significance for BP230gC desmoglein 1 + 3 di erential diagnostics, since the presence of the HLA-Cw6 antigen is strongly associated with GABA receptor B GAD65 psoriasis vulgaris type 1 (OR 16.0) and psoriasis guttata (OR 33.6), but only comparatively weakly glutamate receptor (type NMDA, AMPA1+2) NMDA receptor associated (OR 2.6) with type 2 psoriasis vulgaris. In type 1 psoriasis vulgaris around 83% of phospholipase-A 2 receptor (PLA 2R) rPAg 1 + 2 (pancreas antigen 1 + 2) patients carry the HLA-C*06 allele, whereas in type 2 the proportion of HLA-Cw6-positive patients VGKC-ass. proteins (Lgi1+Caspr2) BIOCHIP Mosaics: is only 44%. Type 1 psoriasis vulgaris has a more severe course than type 2 psoriasis vulgaris. The ANA global test: HEp-20-10/monkey liver Autoantibody Pro le: combination of occurrence of HLA-Cw6 is therefore associated with a severe course of psoriasis. 30 di erent tissues per slide Autoimmune Enzephalitis Mosaic 1: glutamate receptor (type NMDA, AMPA1+2)/ VGKC-ass. proteins (LGI1+CASPR2), GABA-R. B1 Basic Pro le: HEp-20-10/monkey liver/ The human leukocyte antigens (HLA) are tissue antigens (membrane-associated glycoproteins) of rat kidney/rat stomach CIBD Pro le: monkey pancreas/intest. goblet cells (culture)/ the human major histocompatibility complex (MHC), which is localized on the short arm of chro- granulocytes (EOH)/Saccharomyces cerevisiae Dermatology Mosaic 7:oesophagus/salt-split skin/ mosome 6. HLA-C belongs to the HLA antigens of class I (also called MHC I antigens), along with BP230gC/desmoglein 1+3/BP180-NC16A-4X EUROPLUS endomysium + gladin: HLA-B and HLA-C. Class I represents the classic HLA tissue types which are present in all nucleus- monkey intestine/monkey liver/gliadin (GAF-3X) Granulocyte Mosaic 25: granulocytes (EOH/HCHO)/ granulocytes+HEp-2/MPO/PR3/GBM containing body cells. Their function is the control of the T-cell-mediated immune response. The Neuronal Antibody Screen: monkey cerebellum/ monkey nerve/monkey intestine determination of the HLA specificity of the HLA allele is of particular importance because of the Polyendocrinopathy Mosaic: monkey thyroid/ monkey pancreas/monkey adrenal/ existence of HLA-associated diseases. monkey ovary/monkey testis/monkey stomach
Other mosaics also available Special substrate combinations on request Application of the EUROArray HLA-Cw6: The EUROArray HLA-Cw6 has been specifically designed Software/Automation: EUROStar III Plus for the determination of HLA-C*06 alleles. It is therefore particularly easy to perform compared to EUROPattern EUROLabLiquidHandler other molecular biological methods for the detection of HLA-C*06. Molecular biological methods EUROIMMUN IF Sprinter EUROPicture compete with antibody-based microcytotoxicity tests and fl ow-through cytometrical procedures, EUROIMMUN PatternSupport EUROLabOce which detect the HLA antigen on the cell surface. Because of the cross reactions that occur with EUROIMMUN Microarrays Molecular Genetics: antibodies and potential false-negative results in immunophenotyping when HLA-Cw6 expres- EUROArray HLA-B27 EUROArray HLA-B27 Direct sion is low, molecular genetic determination of HLA-C*06 is more specifi c and sensitive than EUROArray HLA-DQ2/DQ8 EUROArray HLA-Cw6 serological methods, as long as a well designed and validated test is used. In this test system EUROArray FV/FII Direct EUROArray FV Direct EUROArray FII Direct (EUROArray HLA-Cw6) the PCR primers have been chosen and optimized so that all relevant EUROArray Haemochromatosis (4 SNP) Direct HLA-C*06 subtypes are detected. EUROArray Haemochromatosis (2 SNP) Direct Software/Automaten: Microarray scanner EUROArrayScan software * Check for FDA status EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US EUROIMMUN IFA Infectious Serology Test characteristics Viruses: Adenoviruses Chikungunya virus Coxsackieviruses EUROArray HLA-Cw6 Crimean Congo fever virus (CCHFV) Cytomegalovirus (CMV) Dengue viruses types 1-4 (DENV) ECHO virus Epstein-Barr virus capsid antigen (EBV-CA) Epstein-Barr virus early antigen (EBV-EA) Test principle: The EUROArray is an in vitro test for DNA sample Epstein-Barr virus nuclear antigen (EBNA) molecular genetic determination of disease-associat- Hantaviruses (types Hantaan, Puumala, Seoul, Saaremaa, Dobrava, Sin Nombre, Andes) ed HLA-C*06 alleles in human genomic DNA. In the Herpes simplex virus types 1 and 2 (HSV-1/2) Human herpes virus type 6 (HHV-6) fi rst reaction step, one section of the HLA-C gene uenza v. A and a -globin gene fragment as positive control are uenza v. B PCR (polymerase Japanese encephalitis virus (JEV) amplifi ed by polymerase chain reaction (PCR) from Measles virus chain reaction) Mumps virus a purified genomic patient DNA sample. The HLA-C Para enza viruses types 1-4 gene section is only amplified if the sample contains Respiratory syncytial virus (RSV) Rift valley fever virus (RVFV) an HLA-C*06 allele. All PCR products are labelled with Rubella virus Sand y fever virus a fl uorescence dye as they are produced. In the sec- (types Sicilian, Naples, Toscana, Cyprus) ond reaction step, the products are analyzed using the SARS Coronavirus (SARS-CoV) Sindbis virus microarray, which contains immobilized probes that DNA microarray Tick-borne encephalitis (TBE) virus Usutu virus are complementary to the amplified DNA. The specific hybridization Varicella zoster virus (VZV) binding (hybridization) of the fluorescing PCR prod- West Nile virus (WNV) Yellow fever virus (YFV) uct to the corresponding microarray spot is detected using a EUROIMMUN Microarray Scanner. A fluores- Bacteria: Bartonella henselae cence signal on the HLA-C*06-specific sp ots indicates Bartonella quintana Bordetella parapertussis the presence of an HLA-C*06 allele in the patient DNA Fully automated Bordetella pertussis sample. The spot signals are evaluated automatically evaluation Borrelia afzelii Borrelia burgdorferi using the EUROArrayScan program. Borrelia garinii Campylobacter coli Campylobacter jejuni Test procedure: The PCRs are fi rst incubated in the thermocycler and then, using the Chlamydia pneumoniae Chlamydia psittaci TITERPLANE™ technique, on EUROArray slides containing microarray BIOCHIPs. Scanning and Chlamydia trachomatis Hemophilu nzae evaluation are performed using the EUROIMMUN Microarray Scanner and the EUROArrayScan Helicobacter pylori program. The program enables fully automated evaluation of EUROArray analyses and detailed Klebsiella pneumoniae Legionella bozemanii documentation of results. Legionella dumo i Legionella gormanii Legionella jordanis Sensitivity and specifi city: The microarray test system detects all relevant HLA-C*06 alleles. The Legionella longbeachae Legionella micdadei investigation of reference samples precharacterized by a molecular genetic method yielded a Legionella pneumophila serotypes 1-14 Listeria monocytogenes 1/2 a, 4b sensitivity and specificity of 100%. Mycoplasma pneumoniae Treponema pallidum Treponema phagedenis Reference Reference samples n Sensitivity Specificity Yersinia enterocolitica method EUROPLUS substrates: Borrelia VlsE (recombinant) Blood donor samples, Germany molecular Borrelia OspC 20 100% 100% EBV p19 + gp125 (10 precharacterized as HLA-C*06 positive, 10 as HLA-C*06 negative) genetic Yeasts: Candida albicans DNA samples from the International Histocompatibility Working Candida glabrata Group (IHWG): “Sequence Polymorphism Reference Panel (SP Refer- Candida krusei molecular ence Panel)” and “HLA (Anthropology) Reference Panel” 55 100% 100% Candida parapsilosis genetic Candida tropicalis (8 precharacterized as HLA-C*06 positive, 47 as HLA-C*06 negative), www.ihwg.org Parasites: Echinococcus granulosus Leishmania donovani Plasmodium falciparum HRP-2/MSP-2 (rec.) Plasmodium vivax MSP/CSP (recombinant) Toxoplasma gondii Accuracy: 10 9 DNA samples from blood donors were analyzed simultaneously in one test run. All determinations were successful. Pro les: Accompanying hepatitis pro le Central nervous system pr e Prevalence: In the investigation of 100 randomly selected samples 18% of cases were positive. Exanthema pro e Fever pro le South East Asia This value corresponds to the known prevalence of the marker in the Central European population. Flavivirus pr e Gastrointestinal tract pr le Infectarthritis pr le Infectarthritis pr le (The Tropics) Technical data: Lymphadenitis pr le Myocarditis pr e Substrate: Single-stranded DNA probes, length: 20 to 50 nucleotides Ophthalmology pr le Otitis pro le Pregnancy pro le Test procedure: 60 min (PCR) / 60 min (hybridization) / 5 min (automated evaluation) Respiratory tract pro le Sexually transmitted diseases (STD) pro le TORCH pro le Reagents: Ready for use Special substrate combinations on request Controls: Integrated HLA-C*06 positive control (no additional positive control Software/Automation: EUROStar III Plus required), integrated DNA positive control EUROPattern EUROLabLiquidHandler CE-IVD certified: EUROIMMUN IF Sprinter Complete process is validated, including DNA extraction EUROPicture EUROIMMUN PatternSupport EUROLabO ce Test kit format: 5, 10 or 20 slides, each containing 5 test fields * Check for FDA status Order numbers: MN 5410 - 0505, -1005 , - 2005 EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US EUROIMMUN IFA EUROArray HLA-DQ2/DQ8 Autoimmune Diagnostics Tissue/cell substrates: adrenal gland, monkey bladder, rat Molecular genetic microarray test system buccal mucosa, monkey cartilage (trachea), monkey cerebellum, monkey/rat cerebrum, monkey Crithidia luciliae DNS-bound lactoferrin erythrocytes, human eye, monkey goblet cells granulocytes, human (ethanol- xed) granolocytes, human (formaldehyde- xed) granulocytes, human (methanol- xed) heart, monkey HEp-2 cells HEp-20-10 cells hippocampus, rat HUVEC hypothalamus, monkey inner ear, rat intestine, monkey kidney, monkey/mouse/rat lacrimal gland, monkey lip, monkey liver, monkey/mouse/rat lobus temporalis, monkey lung, monkey lymph nodes, monkey lymphocytes, human mamma, monkey nerve, monkey nervus opticus, monkey oesophagus, monkey/rat Evaluation using EUROArrayScan Protocol for each individual report ovary, monkey pancreas, monkey parathyroid gland, monkey parotid gland, monkey pituitary gland, monkey Indication: Determination of disease-associated HLA-DQA1 and HLA-DQB1 alleles in human placenta, monkey prostate, monkey genomic DNA for the diagnosis of gluten-sensitive enteropathy (celiac disease, non-tropical Saccharomyces cerevisiae salt-split skin, monkey skeletal muscle, monkey sprue) and dermatitis herpetiformis. spermatozoa, human spleen, monkey spinal cord, monkey stomach, monkey/mouse/rat Clinical signficance: The EUROArray HLA-DQ2/DQ8 is designed for the detection of the disease- synovialis, monkey testis, monkey associated alleles HLA-DQA1 and HLA-DQB1, which code for the two subunits of the heterodimeric thrombocytes, human thymus, monkey human leukocyte antigens DQ2 and DQ8. As genetic components, DQ2 and DQ8 are associated thyroid gland, monkey tongue, monkey with celiac disease, although between 20% and 40% of the healthy population carry at least one VSM47 cells (F-actin) of these two antigens. umbilical cord, human EUROPLUS substrates: AMA-M2 BP180-NC16A-4X HLA antigens play a decisive role in celiac disease and possibly also dermatitis herpetiformis, GBM gliadin (GAF-3X) whereby there are regional di erences in frequency and gene combinations. Over 98% of celiac intrinsic factor myeloperoxidase (MPO) disease patients possess the genetic risk factors HLA-DQ2 or HLA-DQ8. These are heterodimeric proteinase 3 (PR3) ribosomal P-proteins + Jo-1 surface receptors consisting of an alpha and a beta chain. The genetic relationship becomes clear SS-A + SS-B SS-B + ribosomal P-proteins + Jo-1 when families are analyzed. The prevalence of celiac disease in first-degree relatives is around SS-B + Scl-70 + Jo-1 thyroglobulin (TG) 10%, in identical twins 70% and in non-identical twins only about 11%. Transfected cells: aquaporin-4 BP230gC desmoglein 1 + 3 The determination of HLA-DQ2 and HLA-DQ8 is, above all, significant for the following: doubt- GABA receptor B GAD65 ful biopsy results, ambiguous serology (especially in children under 2 years old), patients on a glutamate receptor (type NMDA, AMPA1+2) NMDA receptor gluten-free diet with inconclusive diagnosis, clarification of the genetic predisposition of first phospholipase-A 2 receptor (PLA 2R) rPAg 1 + 2 (pancreas antigen 1 + 2) degree relatives, and di erentiation from other intestinal diseases. Around 95% of celiac dis- VGKC-ass. proteins (Lgi1+Caspr2) ease patients have the HLA-DQ2 genotype, which is composed of the alleles HLA-DQA1*0501 (or BIOCHIP Mosaics: ANA global test: HEp-20-10/monkey liver DQA1*0505) and HLA-DQB1*0201 (or DQB1*0202). Those who are not HLA-DQ2 positive exhibit Autoantibody Pro le: combination of 30 di erent tissues per slide the genotype HLA-DQ8, which is determined by the presence of the alleles HLA-DQA1*0301 and Autoimmune Enzephalitis Mosaic 1: glutamate receptor (type NMDA, AMPA1+2)/ HLA-DQB1*0302. VGKC-ass. proteins (LGI1+CASPR2), GABA-R. B1 Basic Pro le: HEp-20-10/monkey liver/ rat kidney/rat stomach CIBD Pro le: monkey pancreas/intest. goblet cells (culture)/ The detection of the two leukocyte antigens is important in the diagnosis of celiac disease, since granulocytes (EOH)/Saccharomyces cerevisiae Dermatology Mosaic 7:oesophagus/salt-split skin/ almost 100% of celiac disease patients are positive for either DQ2 or DQ8. Although these markers BP230gC/desmoglein 1+3/BP180-NC16A-4X EUROPLUS endomysium + gladin: are not particularly specific, the presence of these risk factors is an important exclusion criterion, monkey intestine/monkey liver/gliadin (GAF-3X) Granulocyte Mosaic 25: granulocytes (EOH/HCHO)/ since they possess a high negative predictive value amounting to over 98%. Thus, if neither DQ2 granulocytes+HEp-2/MPO/PR3/GBM Neuronal Antibody Screen: monkey cerebellum/ monkey nerve/monkey intestine nor DQ8 are detected in a patient, then celiac disease can be virtually excluded. Polyendocrinopathy Mosaic: monkey thyroid/ monkey pancreas/monkey adrenal/ monkey ovary/monkey testis/monkey stomach
Application of the EUROArray HLA-DQ2/DQ8: The EUROArray HLA-DQ2/DQ8 has been specially Other mosaics also available Special substrate combinations designed for the determination of HLA-DQA1 and HLA-DQB1 alleles. It is therefore particularly on request Software/Automation: easy to perform compared to other molecular biological methods for the detection of these EUROStar III Plus EUROPattern alleles – no special molecular biology knowledge is required. EUROArrays from EUROIMMUN EUROLabLiquidHandler EUROIMMUN IF Sprinter function without time-consuming agarose gel electrophoresis. Thus, subjective interpretation of EUROPicture EUROIMMUN PatternSupport gel bands is avoided, and no toxic substances such as ethidium bromide or tetramethylammo- EUROLabOce nium chloride are used. The PCR primers in this test system have been chosen and optimized EUROIMMUN Microarrays Molecular Genetics: so that all relevant HLA-DQA1 and HLA-DQB1 alleles are detected. The accurate analysis of EUROArray HLA-B27 EUROArray HLA-B27 Direct the α and subunits of the DQ2 and DQ8 molecules ensures reliable and unambiguous results. EUROArray HLA-DQ2/DQ8 EUROArray HLA-Cw6 In combination with antibody diagnostics (IFA: Anti-Endomysium; ELISA: Anti-Gliadin and Anti- EUROArray FV/FII Direct EUROArray FV Direct Tissue Transglutaminase; new highly specific tests: Anti-Gliadin (GAF-3X) ELISA and EUROPLUS EUROArray FII Direct EUROArray Haemochromatosis (4 SNP) Direct Anti-Gliadin (GAF-3X) IFA), the EUROArray HLA-DQ2/DQ8 provides precise and reliable diagnos- EUROArray Haemochromatosis (2 SNP) Direct Software/Automaten: tics for celiac disease and dermatitis herpetiformis. Microarray scanner EUROArrayScan software * Check for FDA status
EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US EUROIMMUN IFA Infectious Serology Test characteristics Viruses: Adenoviruses Chikungunya virus EUROArray HLA-DQ2/DQ8 Coxsackieviruses Crimean Congo fever virus (CCHFV) Cytomegalovirus (CMV) Dengue viruses types 1-4 (DENV) ECHO virus Test principle: The EUROArray is a test system for in vitro Epstein-Barr virus capsid antigen (EBV-CA) molecular genetic determination of disease-associated HLA- DNA sample Epstein-Barr virus early antigen (EBV-EA) Epstein-Barr virus nuclear antigen (EBNA) DQA1 and HLA-DQB1 alleles in human genomic DNA. In the Hantaviruses (types Hantaan, Puumala, Seoul, Saaremaa, Dobrava, Sin Nombre, Andes) fi rst step of the analysis, in two parallel reactions, several Herpes simplex virus types 1 and 2 (HSV-1/2) sections of the HLA-DQA1 and HLA-DQB1 genes are ampli- Human herpes virus type 6 (HHV-6) PCR (polymerase In uenza v. A fi ed from patient genomic DNA using the polymerase chain In uenza v. B chain reaction) Japanese encephalitis virus (JEV) reaction (PCR). For each reaction, a fragment of the N-acetyl- Measles virus Mumps virus transferase 2 (NAT2) gene is also amplified as a positive con- Parain uenza viruses types 1-4 trol. Amplification of the HLA-DQA1 and HLA-DQB1 gene sec- Respiratory syncytial virus (RSV) Rift valley fever virus (RVFV) tions only occurs if the sample contains one or more of the Rubella virus DNA microarray Sand y fever virus alleles being investigated. All PCR products are labelled with (types Sicilian, Naples, Toscana, Cyprus) a fl uorescence dye as they are produced. In the second reac- hybridization SARS Coronavirus (SARS-CoV) Sindbis virus tion step, the products are analyzed using the microarray, Tick-borne encephalitis (TBE) virus Usutu virus which contains immobilized probes that are complementary Varicella zoster virus (VZV) to the amplified DNA. The specific binding (hybridization) of West Nile virus (WNV) Fully automated Yellow fever virus (YFV) the fluorescing PCR products to the corresponding micro- evaluation Bacteria: array spots is detected using a special microarray scanner Bartonella henselae (EUROIMMUN). Fluorescence signals at the HLA-DQA1 or Bartonella quintana Bordetella parapertussis HLA-DQB1 specific spots indicate the presence of the corresponding HLA-DQA1 or HLA-DQB1 Bordetella pertussis Borrelia afzelii allele in the DNA sample of the patient, and therefore also the presence of DQ2 and/or DQ8 where Borrelia burgdorferi Borrelia garinii applicable. All spot signals are evaluated automatically using the EUROArrayScan program. Campylobacter coli Campylobacter jejuni Chlamydia pneumoniae Test procedure: The PCR samples are first incubated in the thermocycler and then, using the Chlamydia psittaci Chlamydia trachomatis TITERPLANE technique, on EUROArray slides containing microarray BIOCHIPs. Scanning and Hemophilus in uenzae evaluation are performed using the EUROIMMUN Microarray Scanner and the EUROArrayScan Helicobacter pylori Klebsiella pneumoniae program. The program enables fully automated evaluation of EUROArray analyses and Legionella bozemanii Legionella dumo i detailed documentation of results. Legionella gormanii Legionella jordanis Legionella longbeachae Sensitivity and specificity: The specifici ty and sensitivity of the test system were investigated using Legionella micdadei Legionella pneumophila serotypes 1-14 molecular genetically precharacterized samples. Listeria monocytogenes 1/2 a, 4b Mycoplasma pneumoniae Reference Treponema pallidum Reference samples n Sensitivity Specificity Treponema phagedenis method Yersinia enterocolitica molecular EUROPLUS substrates: DNA samples from blood donors, Germany (various genotypes) 37 100% 100% Borrelia VlsE (recombinant) genetic Borrelia OspC EBV p19 + gp125 DNA samples from the International Histocompatibility Working Yeasts: Group (IHWG): HLA-DQ/DP Reference Panel and Sequence Poly- molecular Candida albicans 44 100% 100% Candida glabrata morphism Reference Panel, www.ihwg.org genetic Candida krusei Candida parapsilosis (various genotypes) Candida tropicalis Parasites: Echinococcus granulosus Prevalence: In the investigation of 101 randomly selected samples, the prevalence of the celiac Leishmania donovani Plasmodium falciparum HRP-2/MSP-2 (rec.) disease-associated genotypes DQ2 and DQ8 amounted to 47%. This value is slightly higher than Plasmodium vivax MSP/CSP (recombinant) the known prevalence of 20-40% in the Central European population. Toxoplasma gondii
Pro les: Accompanying hepatitis prole Technical data: Central nervous system prole Exanthema prole Fever prole South East Asia Substrate: Single-stranded DNA probes, length: ~ 20 nucleotides Flavivirus prole Gastrointestinal tract prole Infectarthritis prole Test procedure: 90 min (PCR) / 60 min (hybridization) / 5 min (automated evaluation) Infectarthritis prole (The Tropics) Lymphadenitis prole Myocarditis prole Ophthalmology prole Reagents: Ready for use Otitis prole Pregnancy prole Respiratory tract prole Controls: Integrated NAT2 PCR positive controls Sexually transmitted diseases (STD) prole TORCH prole Special substrate combinations CE-IVD certified Complete process is validated, including DNA extraction on request Software/Automation: Test kit format: 5, 10 or 20 slides, each containing 5 test fields EUROStar III Plus EUROPattern EUROLabLiquidHandler EUROIMMUN IF Sprinter Order number: MN 5310 - 0505, MN 5310 - 1005, MN 5310 - 2005 EUROPicture EUROIMMUN PatternSupport EUROLabO ce * Check for FDA status
EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US EUROIMMUN IFA EUROArray Hemochromatosis Direct Autoimmune Diagnostics Tissue/cell substrates: adrenal gland, monkey bladder, rat Molecular genetic microarray test systems buccal mucosa, monkey cartilage (trachea), monkey cerebellum, monkey/rat cerebrum, monkey Crithidia luciliae DNS-bound lactoferrin erythrocytes, human eye, monkey goblet cells granulocytes, human (ethanol- xed) granolocytes, human (formaldehyde- xed) granulocytes, human (methanol- xed) heart, monkey HEp-2 cells HEp-20-10 cells hippocampus, rat HUVEC hypothalamus, monkey inner ear, rat intestine, monkey kidney, monkey/mouse/rat lacrimal gland, monkey lip, monkey liver, monkey/mouse/rat lobus temporalis, monkey lung, monkey lymph nodes, monkey lymphocytes, human mamma, monkey nerve, monkey nervus opticus, monkey Evaluation using EUROArrayScan Protocol for each individual report oesophagus, monkey/rat ovary, monkey pancreas, monkey parathyroid gland, monkey parotid gland, monkey pituitary gland, monkey Indication: Determination of either two or four mutations in the HFE (high iron) gene in human placenta, monkey prostate, monkey genomic DNA for the detection or exclusion of the genetically caused iron storage disease heredi- Saccharomyces cerevisiae salt-split skin, monkey tary haemochromatosis in cases with suspicious personal or family anamnesis. skeletal muscle, monkey spermatozoa, human spleen, monkey Clinical signific ance: Hereditary hemochromatosis is the most frequent autosomal (gender- spinal cord, monkey stomach, monkey/mouse/rat independent), recessive inherited metabolic disorder. It results from increased resorption of iron synovialis, monkey testis, monkey in the upper small intestine. In a ected individuals the augmented iron uptake from food leads to thrombocytes, human thymus, monkey an increase in the total iron content in the body from around 2 –6 g (normal value) to up to 80 g thyroid gland, monkey tongue, monkey with deposition of the iron in the liver, pancreas, spleen, thyroid gland, pituitary gland, heart and VSM47 cells (F-actin) joints. In untreated patients irreversible damage occurs, resulting in an increased risk of cardio- umbilical cord, human EUROPLUS substrates: myopathy, arthropathy, diabetes mellitus, liver cirrhosis and liver and pancreas carcinoma. AMA-M2 BP180-NC16A-4X GBM Two mutations in the HFE gene are directly associated with this disease. They lead to a loss or gliadin (GAF-3X) intrinsic factor reduction of the physiological function of the Hfe protein. The two mutations result in the amino myeloperoxidase (MPO) proteinase 3 (PR3) acid substitutions C282Y and H63D, which represent the most frequent hemochromatosis- ribosomal P-proteins + Jo-1 SS-A + SS-B associated mutations (90%). The penetrance of the mutations is dependent on age and gender. SS-B + ribosomal P-proteins + Jo-1 SS-B + Scl-70 + Jo-1 Thus the disease does not necessarily manifest in all carriers of these mutations. The strongest thyroglobulin (TG)
disease association is observed in patients with a homozygous C282Y mutation, whereby the Transfected cells: aquaporin-4 penetrance is much lower in young women than in men due to menstruation. While 80% of men BP230gC desmoglein 1 + 3 under 40 with this gene defect develop hemochromatosis, less than 40% of women do so. The GABA receptor B GAD65 penetrance increases to 95% of men and 80% of women for the population group of over 40 year glutamate receptor (type NMDA, AMPA1+2) NMDA receptor olds. Besides C282Y and H63D there are two additional rare mutations in the HFE gene that are phospholipase-A 2 receptor (PLA 2R) rPAg 1 + 2 (pancreas antigen 1 + 2) also associated with the development of hemochromatosis. These cause either a change in the VGKC-ass. proteins (Lgi1+Caspr2)
amino acid sequence (S65C) of the Hfe protein or early termination of protein synthesis (E168X). BIOCHIP Mosaics: ANA global test: HEp-20-10/monkey liver Autoantibody Pro le: combination of Around 10% of the northern European population is heterozygous for one of the disease-associated 30 di erent tissues per slide Autoimmune Enzephalitis Mosaic 1: mutations in the HFE gene and 0.3–0.5% is homozygous. New studies show that 90–100% of glutamate receptor (type NMDA, AMPA1+2)/ VGKC-ass. proteins (LGI1+CASPR2), GABA-R. B1 hemochromatosis patients exhibit homozygous gene defects. Even a mutation in one HFE allele Basic Pro le: HEp-20-10/monkey liver/ rat kidney/rat stomach is suffi cient to cause at least minor abnormalities in iron metabolism. In Germany more than CIBD Pro le: monkey pancreas/intest. goblet cells (culture)/ granulocytes (EOH)/Saccharomyces cerevisiae 200,000 people currently su er from hereditary hemochromatosis. This condition is one of the Dermatology Mosaic 7:oesophagus/salt-split skin/ BP230gC/desmoglein 1+3/BP180-NC16A-4X most frequent genetically caused diseases in northern Europe. Di erent mutations have a varying EUROPLUS endomysium + gladin: monkey intestine/monkey liver/gliadin (GAF-3X) regional distribution. Numerous mutations that do not occur in the western population have been Granulocyte Mosaic 25: granulocytes (EOH/HCHO)/ granulocytes+HEp-2/MPO/PR3/GBM detected in persons of Asian origin, while some very rare hemochromatoses, which are not asso- Neuronal Antibody Screen: monkey cerebellum/ monkey nerve/monkey intestine ciated with an HFE mutation, occur for example in Italy. Polyendocrinopathy Mosaic: monkey thyroid/ monkey pancreas/monkey adrenal/ monkey ovary/monkey testis/monkey stomach
Other mosaics also available Application of the EUROArray Hemochromatosis Direct Tests: The E UROArray Hemochromatosis Special substrate combinations on request (2 SNP) Direct is specially optimised for reliable determination of the two most frequent hemo- Software/Automation: EUROStar III Plus chromatosis-associated mutations C282Y and H63D in the HFE gene. The EUROArray Hemochro- EUROPattern matosis (4 SNP) Direct o ers a more extensive analysis, which includes in addition the two rarer EUROLabLiquidHandler EUROIMMUN IF Sprinter mutations and encompasses in total C282Y, H63D, S65C and E168X. Both analyses are extremely EUROPicture EUROIMMUN PatternSupport easy to perform – no special molecular biology knowledge is required. The PCR primers and micro- EUROLabO ce array probes in this test system have been chosen so that the mutations in the HFE gene described EUROIMMUN Microarrays Molecular Genetics: above are clearly identified. The EUROArrayScan program provides fully automated evaluation EUROArray HLA-B27 EUROArray HLA-B27 Direct of the tests and for each sample documents the identified genotype in a results report. The deter- EUROArray HLA-DQ2/DQ8 EUROArray HLA-Cw6 mination of mutations in the HFE gene allows a predisposition for hereditary hemochromatosis EUROArray FV/FII Direct EUROArray FV Direct to be identified, even in childhood. This enables early implementation of preventative measures EUROArray FII Direct EUROArray Haemochromatosis (4 SNP) Direct (e. g. reduced consumption of high-iron-containing foods). EUROArray Haemochromatosis (2 SNP) Direct Software/Automaten: Microarray scanner EUROArrayScan software * Check for FDA status EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US EUROIMMUN IFA Infectious Serology Test characteristics: Viruses: Adenoviruses Chikungunya virus EUROArray Hemochromatosis Direct Coxsackieviruses Crimean Congo fever virus (CCHFV) Cytomegalovirus (CMV) Dengue viruses types 1-4 (DENV) Test principle: This test system is designed for the mo- DNA sample DNA extract ECHO virus or sample Epstein-Barr virus capsid antigen (EBV-CA) lecular g enetic in vitro determination of 2 or 4 point mu- Epstein-Barr virus early antigen (EBV-EA) Epstein-Barr virus nuclear antigen (EBNA) tations in the HFE (high iron) gene. (The mutations result Hantaviruses (types Hantaan, Puumala, Seoul, in the following amino acid substitutions: H63D, C282Y Saaremaa, Dobrava, Sin Nombre, Andes) Direct method Herpes simplex virus types 1 and 2 (HSV-1/2) and further S65C and E168X.) EDTA blood (direct method) (extraction sol. 1 + 2) Human herpes virus type 6 (HHV-6) In uenza v. A or isolated genomic DNA of the patient is used as sample In uenza v. B material. In the direct method the genomic DNA of the Japanese encephalitis virus (JEV) Measles virus blood cells is prepared for the polymerase chain reac- Mumps virus PCR (polymerase Parain uenza viruses types 1-4 tion (PCR). For this, the blood is pretreated according to chain reaction) Respiratory syncytial virus (RSV) Rift valley fever virus (RVFV) a special procedure using extraction solutions provided Rubella virus in the test system. In the first reaction step, several sec- Sand y fever virus (types Sicilian, Naples, Toscana, Cyprus) tions of the HFE gene are amplified from the extract or, SARS Coronavirus (SARS-CoV) Sindbis virus alternatively, from a genomic patient DNA sample by Tick-borne encephalitis (TBE) virus PCR. The PCR products are labelled with a fluorescenc e Usutu virus DNA microarray Varicella zoster virus (VZV) dye as they are produced. In the second reaction step, West Nile virus (WNV) hybridization Yellow fever virus (YFV) the products are analysed using a microarray containing immobilized probes, which are complementary to the Bacteria: Bartonella henselae amplifi ed DNA. The specific binding (hybridization) of Bartonella quintana Bordetella parapertussis the fl uorescing PCR products to the corresponding mi- Bordetella pertussis croarray spots is detected using the special Microarray Borrelia afzelii Fully automated Borrelia burgdorferi Scanner (EUROIMMUN). All spot signals are automatically Borrelia garinii evaluation Campylobacter coli evaluated using the EUROArrayScan program, and the Campylobacter jejuni genotype for each of the four positions is established. Chlamydia pneumoniae Chlamydia psittaci Chlamydia trachomatis Hemophilus in uenzae Test procedure: For direct use of EDTA blood the sample is first incubated with extraction solu- Helicobacter pylori Klebsiella pneumoniae tion 1 for one minute and then extraction solution 2 is added. For PCR an aliquot of the extract Legionella bozemanii or, alternatively, a purified DNA sample is mixed with the ready-made PCR reagents. The PCRs Legionella dumo i Legionella gormanii are incubated in the thermocycler and then, using the TITERPLANE technique, on EUROArray Legionella jordanis Legionella longbeachae slides containing microarray BIOCHIPs. Scanning and evaluation are performed using the Legionella micdadei EUROIMMUN Microarray Scanner and the EUROArrayScan program. The program enables Legionella pneumophila serotypes 1-14 Listeria monocytogenes 1/2 a, 4b fully automated evaluation of EUROArray analyses and detailed documentation of results. Mycoplasma pneumoniae Treponema pallidum Treponema phagedenis Sensitivity and specificity: The specificity and sensitivity of the test system were investigated using Yersinia enterocolitica molecular genetically precharacterized samples. EUROPLUS substrates: Borrelia VlsE (recombinant) Borrelia OspC Accuracy: 101 DNA samples from blood donors were analysed simultaneously in one test run. EBV p19 + gp125 All determinations were successful.The investigations were performed with EDTA blood using the Yeasts: Candida albicans direct method and with DNA isolated from EDTA blood using the “DNA whole blood kit S CE IVD“ Candida glabrata (FUJIFILM Europe GmbH). Candida krusei Candida parapsilosis Candida tropicalis Reference samples n Reference method Sensitivity Speci city Parasites: Echinococcus granulosus Leishmania donovani Plasmodium falciparum HRP-2/MSP-2 (rec.) 1 Plasmodium vivax MSP/CSP (recombinant) EDTA blood samples , Germany 44 molecular genetic 100 % 100 % Toxoplasma gondii Pro les: 1 The investigations were performed with DNA samples isolated from EDTA blood using the “DNA whole blood kit S CE IVD” (FUJIFILM Europe GmbH). Accompanying hepatitis prole Central nervous system prole Exanthema prole Fever prole South East Asia Technical data: Flavivirus prole Gastrointestinal tract prole Infectarthritis prole Substrate: Single-stranded DNA probes, length: 20 to 30 nucleotides Infectarthritis prole (The Tropics) Lymphadenitis prole Myocarditis prole Test procedure: Processing time for 40 samples: approx. 40 min (DNA samples) or 60 min Ophthalmology prole Otitis prole (blood samples in the direct method), total time for one test run with Pregnancy prole Respiratory tract prole 40 samples including incubation: approx. 2 h 40 min or 3 h, respectively. Sexually transmitted diseases (STD) prole TORCH prole Special substrate combinations Reagents: Ready for use on request Software/Automation: Controls: DNA negative control EUROStar III Plus EUROPattern EUROLabLiquidHandler EUROIMMUN IF Sprinter CE-IVD certified: Complete process incl. DNA extraction or isolation is validated EUROPicture EUROIMMUN PatternSupport EUROLabO ce Test kit format: 5, 10 or 20 slides, each containing 5 test fields * Check for FDA status Order number: MN 5510-####-V: EUROArray Hemochromatosis (4 SNP) Direct MN 5511-####-V: EUROArray Hemochromatosis (2 SNP) Direct
EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US EUROIMMUN IFA Autoimmune Diagnostics Tissue/cell substrates: EUROArray FV / FII Direct adrenal gland, monkey bladder, rat buccal mucosa, monkey cartilage (trachea), monkey Molecular genetic microarray test system cerebellum, monkey/rat cerebrum, monkey Crithidia luciliae DNS-bound lactoferrin erythrocytes, human eye, monkey goblet cells granulocytes, human (ethanol- xed) granolocytes, human (formaldehyde- xed) granulocytes, human (methanol- xed) heart, monkey HEp-2 cells HEp-20-10 cells hippocampus, rat HUVEC hypothalamus, monkey inner ear, rat intestine, monkey kidney, monkey/mouse/rat lacrimal gland, monkey lip, monkey liver, monkey/mouse/rat lobus temporalis, monkey lung, monkey lymph nodes, monkey lymphocytes, human mamma, monkey nerve, monkey nervus opticus, monkey oesophagus, monkey/rat ovary, monkey Evaluation using EUROArrayScan Protocol for each individual report pancreas, monkey parathyroid gland, monkey parotid gland, monkey pituitary gland, monkey placenta, monkey prostate, monkey Indication: Determination of point mutations in the factor V gene (factor V Leiden, 1691G>A) and/ Saccharomyces cerevisiae salt-split skin, monkey or the factor II (prothrombin) gene (20210G>A) in human genomic DNA for assessing the genetic skeletal muscle, monkey spermatozoa, human risk for thrombosis in patients with suspicious personal or family history, recurrent miscarriages spleen, monkey of unknown genesis, biochemically proven resistance to activated protein C (APC resistance) or spinal cord, monkey stomach, monkey/mouse/rat proven protein C or S defi ciency, and before prescribing oral contraceptives to women, particular- synovialis, monkey testis, monkey ly young smokers, with a familial tendency to thrombosis (thrombophilia) or before implement- thrombocytes, human thymus, monkey ing postmenopausal hormone replacement therapy. thyroid gland, monkey tongue, monkey VSM47 cells (F-actin) Clinical significance: The most important and most frequent genetic risk factors for thrombosis/ umbilical cord, human EUROPLUS substrates: embolism are the factor V Leiden mutation (APC resistance) and the factor II 20210G>A mutation AMA-M2 BP180-NC16A-4X in the prothrombin gene. Deep and superficial venous thrombosis and thromboembolism of GBM gliadin (GAF-3X) the brain, lung and coronary vessels are among the most frequent causes of death in western intrinsic factor myeloperoxidase (MPO) industrialized countries. These conditions result from a combination of genetic and exogenous proteinase 3 (PR3) ribosomal P-proteins + Jo-1 factors. More than half of all thromboembolic cases are caused by genetic risk factors, particu- SS-A + SS-B SS-B + ribosomal P-proteins + Jo-1 larly if the disease occurs before the age of 45 without any noticeable external factors or at an SS-B + Scl-70 + Jo-1 atypical location. thyroglobulin (TG) Transfected cells: aquaporin-4 To prevent blood from coagulating, activated factor V undergoes proteolytic cleavage - a process BP230gC desmoglein 1 + 3 which is normally catalyzed by activated protein C (APC), a serine protease, and the cofactor GABA receptor B GAD65 protein S. The presence of the FV Leiden mutation results in a change at position 506 of the amino glutamate receptor (type NMDA, AMPA1+2) NMDA receptor acid sequence from arginine to glutamine. The altered structure of the blood coagulation factor phospholipase-A 2 receptor (PLA 2R) rPAg 1 + 2 (pancreas antigen 1 + 2) makes it resistant to inactivation by APC (APC resistance), which leads to hypercoagulability VGKC-ass. proteins (Lgi1+Caspr2) and an increased risk of thrombosis. More than 95% of cases of APC resistance are caused BIOCHIP Mosaics: ANA global test: HEp-20-10/monkey liver by the autosomal, dominant FV Leiden mutation. In Europe around 3-7% of the population is Autoantibody Pro le: combination of 30 di erent tissues per slide a heterozygous carrier. In these individuals the thrombosis risk is 3-8 times higher, and if oral Autoimmune Enzephalitis Mosaic 1: glutamate receptor (type NMDA, AMPA1+2)/ contraceptives are taken up to 30-fold higher. The homozygous FV Leiden mutation occurs in VGKC-ass. proteins (LGI1+CASPR2), GABA-R. B1 Basic Pro le: HEp-20-10/monkey liver/ around 0.2% of the European population and is associated with a 50-100-fold increased risk of rat kidney/rat stomach CIBD Pro le: monkey pancreas/intest. goblet cells (culture)/ thrombosis. granulocytes (EOH)/Saccharomyces cerevisiae Dermatology Mosaic 7:oesophagus/salt-split skin/ BP230gC/desmoglein 1+3/BP180-NC16A-4X EUROPLUS endomysium + gladin: The FII 20210G>A mutation leads to an increased plasma concentration of the coagulation factor monkey intestine/monkey liver/gliadin (GAF-3X) Granulocyte Mosaic 25: granulocytes (EOH/HCHO)/ prothrombin via an as yet unidentified me chanism. The resulting thrombosis can be venous or granulocytes+HEp-2/MPO/PR3/GBM arterial. The heterozygous genotype is present in 1-3% of the population in Europe and is associ- Neuronal Antibody Screen: monkey cerebellum/ monkey nerve/monkey intestine ated with a 3-fold higher risk of deep venous thrombosis. If oral contraceptives are taken, the risk Polyendocrinopathy Mosaic: monkey thyroid/ monkey pancreas/monkey adrenal/ monkey ovary/monkey testis/monkey stomach of venous thrombosis is increased 16 fold and of brain venous thrombosis up to 150 fold. Throm- Other mosaics also available bophilia patients who exhibit the FII 20210G>A mutation often also have the FV Leiden mutation. Special substrate combinations In these cases the risk of venous thrombosis is 20-fold higher, demonstrating the additive genetic on request Software/Automation: e ect of these point mutations. EUROStar III Plus EUROPattern EUROLabLiquidHandler EUROIMMUN IF Sprinter Application of the EUROArray FV / FII Direct: The EUROArray FV / FII Direct has been optimized to EUROPicture EUROIMMUN PatternSupport provide secure determination of the most important genetic risk factors for thrombosis. It is EUROLabO ce extremely easy to perform – no special molecular biology knowledge is required. The PCR primers EUROIMMUN Microarrays Molecular Genetics: and microarray probes in this test system have been chosen so that the mutations in the factor V and/ EUROArray HLA-B27 EUROArray HLA-B27 Direct or factor II gene described above are clearly identified. The EUROArrayScan program provides EUROArray HLA-DQ2/DQ8 EUROArray HLA-Cw6 fully automated evaluation of the test and for each sample documents the identified genotype EUROArray FV/FII Direct EUROArray FV Direct in a results report. The determination of mutations using the EUROArray FV / FII Direct can, for EUROArray FII Direct EUROArray Haemochromatosis (4 SNP) Direct example, help decisions concerning the early implementation of suitable anticoagulation therapy EUROArray Haemochromatosis (2 SNP) Direct or preventative measures (e.g. use of compression hosiery, avoidance of oral contraceptives and Software/Automaten: smoking). Microarray scanner EUROArrayScan software * Check for FDA status
EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com EUROIMMUN US EUROIMMUN IFA Infectious Serology Viruses: Test characteristics Adenoviruses Chikungunya virus Coxsackieviruses EUROArray FV / FII Direct Crimean Congo fever virus (CCHFV) Cytomegalovirus (CMV) Dengue viruses types 1-4 (DENV) ECHO virus Epstein-Barr virus capsid antigen (EBV-CA) Test principle: The EUROArray is an in vitro test for DNA sample DNA extract Epstein-Barr virus early antigen (EBV-EA) molecular genetic determination of point mutations in or sample Epstein-Barr virus nuclear antigen (EBNA) Hantaviruses (types Hantaan, Puumala, Seoul, the factor V gene (factor V Leiden mutation, 1691G>A) Saaremaa, Dobrava, Sin Nombre, Andes) and / or the factor II (prothrombin) gene (20210G>A). Herpes simplex virus types 1 and 2 (HSV-1/2) Direct method Human herpes virus type 6 (HHV-6) EDTA blood (direct method) or extracted genomic DNA In uenza v. A (extraction sol. 1 + 2) In uenza v. B of the patient is used as sample material. In the direct Japanese encephalitis virus (JEV) Measles virus method the blood is treated with the extraction solutions Mumps virus Parain uenza viruses types 1-4 provided in the test system. In the first reaction step, a Respiratory syncytial virus (RSV) section of the factor V and a section of the factor II gene PCR (polymerase Rift valley fever virus (RVFV) chain reaction) Rubella virus are amplified from the extract or, alternatively, from Sand y fever virus (types Sicilian, Naples, Toscana, Cyprus) a genomic patient DNA sample using the polymerase SARS Coronavirus (SARS-CoV) chain reaction (PCR). The PCR products are labelled with Sindbis virus Tick-borne encephalitis (TBE) virus a fl uorescence dye as they are produced. In the second Usutu virus Varicella zoster virus (VZV) reaction step, the products are analyzed using a microar- West Nile virus (WNV) ray containing immobilized allele-specific probes, which DNA microarray Yellow fever virus (YFV) are complementary to the amplified DNA, in the form hybridization Bacteria: Bartonella henselae of small, round spots. The binding (hybridization) of a Bartonella quintana fl uorescing PCR product to its corresponding microarray Bordetella parapertussis Bordetella pertussis spot is detected using the special Microarray Scanner Borrelia afzelii Borrelia burgdorferi (EUROIMMUN). All spot signals are automatically evalu- Borrelia garinii ated using the EUROArrayScan program. The genotype Fully automated Campylobacter coli evaluation Campylobacter jejuni is determined for each parameter from the intensities of Chlamydia pneumoniae Chlamydia psittaci the signals originating from the allele-specific probes . Chlamydia trachomatis Hemophilus in uenzae Helicobacter pylori Test procedure: For direct use of EDTA blood the sample is first incubated with extraction solu- Klebsiella pneumoniae Legionella bozemanii tion 1 for one minute and then extraction solution 2 is added. For PCR an aliquot of the extract Legionella dumo i Legionella gormanii or, alternatively, a purified DNA sample is mixed with the ready-made PCR reagents. The PCRs Legionella jordanis are incubated in the thermocycler and then, using the TITERPLANE technique, on EUROArray Legionella longbeachae Legionella micdadei slides containing microarray BIOCHIPs. Scanning and evaluation are performed using the Legionella pneumophila serotypes 1-14 Listeria monocytogenes 1/2 a, 4b EUROIMMUN Microarray Scanner and the EUROArrayScan program. The program enables Mycoplasma pneumoniae fully automated evaluation of EUROArray analyses and detailed documentation of results. Treponema pallidum Treponema phagedenis Yersinia enterocolitica Sensitivity and specificity: The specificity and sensitivity of the test system were investigated using EUROPLUS substrates: molecular genetically precharacterised samples. Borrelia VlsE (recombinant) Borrelia OspC EBV p19 + gp125 Reference Reference samples n Sensitivity Specificity Yeasts: method Candida albicans Candida glabrata molecular Candida krusei 1 57 100 % 100 % Candida parapsilosis EDTA blood samples , Germany genetic Candida tropicalis Parasites: Echinococcus granulosus 1 Leishmania donovani Accuracy : 11 9 DNA samples from blood donors were analyzed simultaneously in one test run. All Plasmodium falciparum HRP-2/MSP-2 (rec.) Plasmodium vivax MSP/CSP (recombinant) determinations were successful. Toxoplasma gondii 1 The investigations were performed with EDTA blood using the direct method and with DNA samples isolated from EDTA blood using the “DNA whole blood kit S CE
Pro les: IVD” (FUJIFILM Europe GmbH). Accompanying hepatitis prole Central nervous system prole Exanthema prole Technical data: Fever prole South East Asia Flavivirus prole Gastrointestinal tract prole Substrate: Single-stranded DNA probes, length: 20 to 50 nucleotides Infectarthritis prole Infectarthritis prole (The Tropics) Lymphadenitis prole Myocarditis prole Test procedure: Processing time for 40 samples: approx. 40 min (DNA samples) or 60 min Ophthalmology prole (blood samples in the direct method), total time for one test run with Otitis prole Pregnancy prole 40 samples including incubation: approx. 2 h 40 min or 3 h, respectively. Respiratory tract prole Sexually transmitted diseases (STD) prole TORCH prole Reagents: Ready for use Special substrate combinations on request Controls: DNA negative control Software/Automation: EUROStar III Plus EUROPattern EUROLabLiquidHandler CE-IVD certified: Complete process incl. DNA extraction or isolation is validated EUROIMMUN IF Sprinter EUROPicture EUROIMMUN PatternSupport Test kit format: 5, 10 or 20 slides, each containing 5 test fields EUROLabO ce * Check for FDA status Order numbers: MN 5810 - 0505-V, -1005-V, -2005-V: EUROArray FV / FII Direct M N 5811 - 0505-V, -1005-V, -2005-V: EUROArray FV Direct M N 5812 - 0505-V, -1005-V, -2005-V: EUROArray FII Direct
EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com
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EUROIMMUN US • Morris Plains, New Jersey • Phone: 800-913-2022 • Fax: 973-656-1098 • [email protected] • www.euroimmunus.com