EUROIMMUN Medizinische Labordiagnostika AG Anti-Bartonella henselae IIFT (IgG/IgM) Positive reaction (IgG) Negative reaction (IgG) Positive reaction (IgM) Negative reaction (IgM) Antibodies against Bartonella henselae Indications: Test sytem for the in vitro determination of antibodies against Bartonella henselae in human serum or plasma for the diagnosis of the following diseases: cat scratch disease (CSD), local lymphadentitis. Clinical significance: Bartonella henselae is a gram-negative, aerobe, facultative intracellular rod-shaped bacteria which has only been known since 1990. Today, 2 serotypes have been isolated, Bartonella henselae type I and Bartonella henselae type II. Infections with Bartonella henselae type II are predominant, whereas co-infections occur very rarely. As the causative agent of the worldwide spread cat-scratch disease (CDS, synonyms: cat scratch fever; cat scratch lymphadenitis; benign inoculation lymphoreticulosis; maladie des griffes de chat) Bartonella henselae is of great importance. Cats only transmit the disease and do not become infected with Bartonella henselae. The agent can be found in 10% to 70% of cats in Germany and is presumably carried from cat to cat by cat fleas. The generally self-limiting infection is mainly characterised by local lymphadenitis. Transmission occurs through scratches or bite wounds from mostly young cats. Following inoculation, half of patients (mostly children) develop papulopustular primary lesions within a week, which heal quickly. After an additional week, there is a painful lymph node swelling. This can reach a considerable size and can develop into a chronic abscessed granulomatous inflammation. Patients also suffer from general symptoms such as fever, headache, loss of appetite and vomiting. In cases of reduced immunity, Bartonella henselae causes disseminated forms of cat-scratch disease, which are characterised by painful, vessel-rich lesions on the skin (bacillary angiomatosis), manifestations in the liver (peliosis hepatis) or in any other visceral organ and in the central or peripheral nervous system. Application of the Anti-Bartonella henselae IIFT: Cat scratch disease is not only found in paediatrics. It must also be taken into account in differential diagnosis of lymphadenitis in adults. In HIV patients, every fever of unknown origin should be investigated for a Bartonella infection. Bartonella henselae infections are too rarely identified or frequently only diagnosed late in the clinical course. Therefore, antibodies against Bartonella henselae should be investigated using IIFT, ELISA or Westernblot in all process stages. IIFT has so far yielded the most reliable results. IgG and/or IgM antibodies are mostly detectable at the time of lymph node swelling. Low titers, however, are also found in patients without clinical symptoms. The prevalence (IgG) in healthy blood donors is between 9% and 28% (patients witch CSD: 81%). Sudden titer increases within a few weeks are particularly significant in the diagnosis. Fluorescence pattern (positive reaction IgG): Antibodies against Bartonella henselae result in a coarse granular fluorescence in the cytoplasm. The specific fluorescence appears in single to numerous cells depending on the level of infection. Fluorescence pattern (positive reaction IgM): Antibodies against Bartonella henselae cause a coarse granular fluorescence of the cytoplasm; the granula are in part perinuclear and form clusters. Individual coarse granula should be evaluated as unspecific. EUROIMMUN IIFT Infectious Serology Viruses: Adenoviruses Chikungunya virus Coxsackieviruses Crimean Congo fever virus* Cytomegalovirus (CMV) Dengue viruses types 1-4 ECHO virus Epstein-Barr virus capsid antigen (EBV-CA) Epstein-Barr virus early antigen (EBV.EA) Epstein-Barr virus nuclear antigen (EBNA) Hantaviruses (types Hantaan, Puumala, Seou Saaremaa, Dobrava, Sin Nombre, Andes)* Herpes simplex virus types 1 and 2 (HSV-1/2) Human herpes virus type 6 (HHV-6) HIV-1 and -2* Influenza virus types A and B Japanese encephalitis virus (JEV)* Measles virus Mumps virus Parainfluenza viruses types 1-4 Plasmodium falciparum HRP-2/MRP-2 (rec.)* Plasmodium vivax MSP/CSP (recombinant)* Respiratory syncytial virus (RSV) Rubella virus* Sandfly fever virus (types Sicilian, Naples, Toscana, Cyprus) SARS Coronavirus (SARS-CoV) Tick-borne encephalitis (TBE) virus Varicella zoster virus (VZV) West Nile virus (WNV) Yellow fever virus (YFV) Bacteria: Afipia felis* Bartonella henselae Bartonella quintana Bordetella parapertussis Bordetella pertussis Borrelia afzelii Borrelia burgdorferi Borrelia garinii Campylobacter coli* Campylobacter jejuni* Chlamydia pneumoniae Chlamydia psittaci Chlamydia trachomatis Haemophilus influenzae* Helicobacter pylori Klebsiella pneumoniae* Legionella bozemanii* Legionella dumoffii* Legionella gormanii* Legionella jordanis* Legionella micdadei* Legionella pneumophila serotypes 1-14 Listeria monocytogenes 1/2 a, 4b* Mycoplasma hominis Mycoplasma pneumoniae Treponema pallidum Treponema phagedenis Ureaplasma urealyticum Yersinia enterocolitica* Bacteria antigens (EUROPLUS): Borrelia VlsE (recombinant) Borrelia OspC Yeasts: Candida albicans Candida glabrata* Candida krusei* Candida parapsilosis* Candida tropicalis* Parasites: Echinococcus granulosus Leishmania donovani Plasmodium falciparum Plasmodium vivax Toxoplasma gondii Profiles: Accompanying hepatitis profile Central nervous system profile Exanthema profile Fever profile South East Asia Flavivirus profile Gastrointestinal tract profile Infectarthritis profile Infectarthritis profile (The Tropics) Lymphadenitis profile Myocarditis profile Ophthalmology profile Otitis profile Pregnancy profile Respiratory tract profile Sexually transmitted diseases (STD) profile TORCH profile * Currently not available as IVD in the EU. Special substrate combinations on request Made in Germany EUROIMMUN AG · D-23560 Luebeck (Germany) · Seekamp 31 · Phone +49 451 58550 · Fax 5855591 · E-mail [email protected] · www.euroimmun.de EUROIMMUN Medizinische Labordiagnostika AG Test Characteristics Anti-Bartonella henselae IIFT EUROIMMUN IIFT Autoimmune Diagnostics tissue/cell substrates: adrenal gland, monkey bladder, rat cartilage (trachea), monkey* cerebellum, monkey cerebrum, monkey Crithidia luciliae erythrocytes, human* eye, monkey* granulocytes, human (ethanol-fixed) granolocytes, human (formaldehyde-fixed) granulocytes, human (methanol-fixed) heart, monkey HEp-2 cells HEp-20-10 cells HUVEC hypothalamus, monkey* intestine, monkey kidney, monkey kidney, mouse kidney, rat lacrimal gland, monkey lip, monkey* liver, monkey liver, mouse liver, rat lobus temporalis, monkey* lung, monkey lymph nodes, monkey* lymphocytes, human* mamma, monkey* mouth mucosa, monkey* nerve, monkey oesophagus, monkey oesophagus, rat ovary, monkey pancreas, monkey parathyroid gland, monkey parotid gland, monkey pituitary gland, monkey placenta, monkey* prostate, monkey Saccharomyces cerevisiae skeletal muscle, monkey spermatozoa, human spleen, monkey* spinal cord, monkey stomach, monkey stomach, mouse stomach, rat synovium, monkey testis, monkey thrombocytes, human thymus, monkey thyroid gland, monkey tongue, monkey VSM47 cells umbilical cord, human EUROPLUS™ substrates: AIH (LC-1 + SLA/LP) AMA-M2 gliadin intrinsic factor myeloperoxidase (MPO) PBC (AMA M2 + Sp100) proteinase 3 (PR3) ribosomal P-proteins + Jo-1 SS-A + SS-B SS-B + ribosomal P-proteins + Jo-1 SS-B + Scl-70 + Jo-1 thyroglobulin (TG) Test principle: The indirect immunofluorescence test is a standardized in vitro assay for the determination of specific antibodies against Bartonella henselae. BIOCHIPs are coated with Bartonella henselae infected cells and fixed onto the reaction fields of a microscope slide. With EUROIMMUN BIOCHIP Mosaics™, different substrates can be positioned next to each other in one reaction field and incubated with one serum sample, allowing a detailed patient antibody profile to be established with a single test. Test procedure: EUROIMMUN BIOCHIP slides are incubated using the proprietary TITERPLANE™ Technique, which enables multiple samples to be incubated next to each other and simultaneously under identical conditions. Results are evaluated by fluorescence microscopy. Incubation of the substrate with the positive and negative control sera provided in each kit verifies correct performance of the test and aids evaluation. Incubation with the TITERPLANE™ Technique Reagent tray ;;; ;;;;; ;;;; ;;;; ;;;; ;; Slide fitted with BIOCHIPs ;;;; ;;;; ;;;; ;;;; ;; ;;;; ;;;; ;;;; ;;;; ;; Inter-lot reproducibility: Inter-lot reproducibility was tested with more than 10 different lots. In quantitative evaluation of results, the deviation amounted to no more than ± 1 fluorescence intensity level. Reference range: Sera from healthy blood donors were investigated for anti-Bartonella henselae antibodies using the EUROIMMUN IIFT. For IgG, 26.5% of the blood donors (n = 200) were positive with a cut-off titer of 1:320 or higher. For IgM, 1.0% of the blood donors (n = 200) were positive with a cut-off titer of 1:100 or higher. Specificity: The specificity of this test system for antibodies of the class IgG is 84%. Reference: Anti-Bartonella henselae IIFT (n = 215), origin of samples: Germany. The specificity for antibodies of the class IgM is 88%. Reference: Anti-Bartonella henselae IIFT (n = 37), origin of samples: Europe. Sensitivity: The sensitivity of this test system for antibodies of the class IgG is 80%. Reference: Anti-Bartonella-henselae-IIFT (n = 215), origin of samples: Germany. The sensitivity for antibodies of the class IgM is 100%. Reference: Anti-Bartonella-henselae-IIFT (n = 37), origin of samples: Europe. Technical Data: Antigen substrate Bartonella henselae infected cells (species EU 70). Sample dilution Serum or plasma. Cut-off: 1:320 (for IgG), 1:100 (for IgM) Qualitative evaluation: 1:100 (for IgG and IgM) Quantitative evaluation: 1:100/1000/10000, etc. (for IgG and IgM). Test procedure IgG: 30 min (sample) / 30 min (conjugate), room temperature. IgM: 60 min (sample) / 30 min (conjugate), 37°C Microscopy Objective 40x Excitation filter: 488 nm, colour separator: 510 nm, blocking filter: 520 nm Light source: EUROIMMUN LED or mercury vapour lamp, 100 W Reagents Ready for use, with the exception of the PBS-Tween buffer (for dilution and washing). Stability All kit components are stable for up to 18 months from the date of manufacture. Standard kit formats 10 or 20 slides, each containing 3, 5 or 10 test fields. Kits include all necessary reagents (except EUROSORB for the RFabsorption, order no.: ZF1270-0145). Made in Germany Order no. FI 219b-1005 G or M Version: 01/07 FI_219b_D_UK_A02 Related products FI 219b-1005-1 G or M (IIFT Mosaic: B. henselae and B. quintana) BIOCHIP MosaicsTM: ANA global test: HEp-20-10/monkey liver Autoantibody Profile: combination of 30 different tissues per slide CIBD Profile: monkey pancreas/intest. goblet cells (culture)/ granulocytes (EOH)/Saccharomyces cerevisiae Basic Profile: HEp-20-10/monkey liver/ rat kidney/rat stomach EUROPLUS endomysium + gladin: monkey intestine/monkey liver/gliadin Granulocyte Mosaic: granulocytes (EOH)/ granulocytes (HCHO)/HEp-2/monkey liver Liver Mosaic: HEp-2/monkey liver/rat liver rat kidney/rat stomach/monkey heart Neuronal Antibody Screen: monkey cerebellum/ monkey nerve/monkey intestine Polyendocrinopathy Mosaic: monkey thyroid/ monkey pancreas/monkey adrenal/ monkey ovary/monkey testis/monkey stomach Other mosaics also available Special substrate combinations on request * Currently not available as IVD in the EU. EUROIMMUN AG · D-23560 Luebeck (Germany) · Seekamp 31 · Phone +49 451 58550 · Fax 5855591 · E-mail [email protected] · www.euroimmun.de
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