BlueBLOT-LINE Borrelia. Test Characteristics. Antibody Response

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1 BlueDiver Instrument IMMUNOBLOT KITS FOR DIAGNOSIS OF LYME BORRELIOSIS INFECTIOUS SEROLOGY IN NEW AUTOMATED SYSTEM FOR THE ANALYSIS AND EVALUATION OF IMMUNOBLOTS BlueDiver Instrument, Immunoblot Software and BlueBLOT-LINE Borrelia kits - a comprihensive solution for simple, fast and accurate analysis of immunoblots including evaluation

2 BlueBLOT-LINE Borrelia Immunoblot kits are optimized and validated for detection of IgG and IgM antibodies to recombinant antigens of Borrelia species and Anaplasma phagocytophila (HGA) in human serum and plasma. Lyme borreliosis (LB) is a multisystem infectious disease caused by spirochete Borrelia burgdorferi. The infection is transmitted by ticks of the genus Ixodes. Lyme borreliosis is characterized by early and late clinical symptoms: Early localised infection lasts days to weeks. The specific clinical sign of this phase is erythema migrans (EM), which appears in only 50% of patients. Early symptoms of the disease include flu-like symptoms, headaches and lymphadenitis. Early disseminated infection lasts weeks to months. Borrelia bacteria are disseminated by blood and lymphatic system (CNS, joints, heart, eye and skin secondary EM). In this phase, neuroborreliosis, neurofacialis paresis, borrelial lymphocytoma (swollen earlobes, knucklebones, etc.) and Bannwarth syndrome are the most frequently diagnosed symptoms. Late disseminated infection lasts months to years. Immunopathological changes occur. The typical diagnostic findings are acrodermatitis chronica atrophicans (chronic skin lesions ACA), chronic neuroborreliosis and borrelial arthritis. Human granulocytic anaplasmosis (HGA) is a disease caused by Anaplasma phagocytophila bacteria. Clinically, the disease can manifest itself in various ways from entirely asymptomatic to rather serious forms. Antibody Response Test Characteristics IgM IgG IMMUNOBLOT Diagnostic sensitivity Diagnostic specificity IP* BlueBLOT-LINE Borrelia IgG 98.20% 99.00% BlueBLOT-LINE Borrelia IgM 98.40% 99.00% Month Immunoblot IgM IgG

3 Antigens Summary BlueBLOT-LINE Borrelia IgG Diagnostic importance VLSE Ba VLSE Bs p58 p41 p39 OspB OspA Ba OspA Bg OspA Bs OspC p17 NapA Variable major protein-like sequence, expressed; Species specific antigen Main antigen of early and late antibody response to LB Significantly increases test sensitivity (approx. 90% of samples of positive sera and CSF react in this antigen band) Main extracellular protein (product of p100 degradation) Late antibody response antigen Highly immunoreactive antigen, typical of neuroborreliosis OppA-2 (Oligopeptide permease 2) - membrane transporter Considered a marker of disseminated stage of Lyme disease Inner part of flagellin Highly specific antigen of early antibody response BmpA (glycosaminopeptide receptor) Antigen of late antibody response Significant antigen for advanced disseminated form of LB, often associated with Lyme arthritis Outer surface protein B Antigen of late antibody response Outer surface protein A Antigen of late antibody response, typical of neuroborreliosis Outer surface protein C Antigen of early antibody response DbpA (Decorin-Binding protein A) Antigen of early and late antibody response, typical of neuroborreliosis Neutrophil activating protein A Strong immunogen, main marker of Lyme arthritis pathogenesis TA 1 Reactive control IgG Conjugate control VLSE Bs VLSE Ba p58 p41 Bs p39 Ba OspB OspA Ba OspA Bg OspA Bs OspC Bg p17 Bg NapA Bs TpN17 BlueBLOT-LINE Borrelia IgG TpN17 Main antigen of antibody response to HGA Outer membrane protein A of Anaplasma phagocytophilum, peptidoglycan-associated lipoprotein, significant virulence marker Highly specific membrane protein of Treponema pallidum The test is based on highly specific recombinant Borrelia antigens. Nevertheless, it is sometimes possible to observe cross reactivity with other pathogens which can result in false positive results. The IgM test uses a highly specific and sensitive EBV marker (VCA-p18) to eliminate false positive Borrelia results, the IgG test uses the antigen TnN17 which is an important marker of syphilis infection.

4 BlueBLOT-LINE Borrelia IgM Diagnostic importance p41 p39 OspC Ba OspC Bg OspC Bs OspC Bsp p17 p18 Variable major protein-like sequence, expressed; Species specific antigen Main antigen of early and late antibody response to LB Significantly increases test sensitivity (approx. 90% of samples of positive sera and CSF react in this antigen band) Main extracellular protein (product of p100 degradation) Late antibody response antigen Highly immunoreactive antigen, typical of neuroborreliosis Inner part of flagellin Highly specific antigen of early antibody response BmpA (glycosaminopeptide receptor) Antigen of late antibody response Significant antigen for advanced disseminated form of LB, often associated with Lyme arthritis Outer surface protein C Antigen of early antibody response DbpA (Decorin-Binding protein A) Antigen of early and late antibody response, typical of neuroborreliosis Main antigen of antibody response to HGA Outer membrane protein A of Anaplasma phagocytophilum, peptidoglycan-associated lipoprotein, significant virulence marker Viral Capsid Antigen p18 Important marker of EBV infection TB 1 Reactive control IgM Conjugate control p41 Bs p39 Ba OspC Bs OspC Ba OspC Bsp OspC Bg p17 Bg EBV p18 BlueBLOT-LINE Borrelia IgM Protocol Summary Inserting holders with strips and reagents into the instrument Automatic batch and expiry control using the integrated barcode reader Samples pipetting Automated incubation and ing Strips drying Total assay time: 0:00 incubation with sample 30 min 1 min 3 x 2 min conjugate 20 min 3 x 2 min substrate 10 min 2 min 1:14

5 BlueDiver Instrument Simple, smart and small sized device for complete automation of the immunodot method. Parameters Dimensions: 51.5 x 29.8 x 28.9 cm (W x H x D) Weight: 16 kg Controlling: touchscreen Sample capacity: 1 24 Input voltage: 24 V Power: 40 W Communication interface: USB 2.0 connector type A use only with USB flash drive Closed system - preprogramed analysis protocol. Integrated barcode and 2D code reader. Unique Features and Advantages Space-saving small sized and compact instrument without a need for extra devices No risk of contamination no pumps, inlet hoses, handling with liquid reagents, dead volumes; disposable cartridges are ready to use High flexibility it is possible to analyze up to 24 various strips at the same time - compatibility of the whole product range of D-tek and TestLine intended for automation Easy to use and short hands on time simply insert the test strips, disposable reagent cartridges, patient samples and then follow the instructions on the touchscreen High reliability compatibility of strips and reagents automatically checked using the integrated barcode reader Extremely short analysis time through innovative patented process

6 Immunoblot Software Scanning device in combination with user friendly and intuitive evaluation software. Ordering Information Cat. No. Product No. of Tests BD-BGL024 BlueBLOT-LINE Borrelia IgG 24 BD-BML024 BlueBLOT-LINE Borrelia IgM 24 Distributor TestLine Clinical Diagnostics s.r.o. Křižíkova 68, Brno Phone: , Fax: