Immunofluorescence Assays for Autoimmune and Infectious Disease

Transcription

1 life.science.discovery. Immunofluorescence Assays for Autoimmune and Infectious Disease PRODUCT CATALOG

2 COMPANY MBL Bion, part of the MBL, has been manufacturing high-quality kits and components for autoimmune, infectious, and viral diagnostics for more than 30 years. By focusing specifically on immunofluorescence assays, MBL Bion is unmatched in providing lot-to-lot consistency and technical expertise to laboratories around the world. Located in Des Plaines, IL, MBL Bion is FDA registered and ISO 13485:2003 certified with research and development, manufacturing, and administration operating from one facility. The vertically integrated operation improves product development and manufacturing efficiencies as well as an enhanced customer experience. Our customer service, technical support, and commercial teams are dedicated to providing world-class support whether addressing your specific product questions or to ensure efficient and accurate ordering. By providing products in convenient, user-friendly or customized formats, MBL Bion offers a wide product portfolio to meet your testing needs. COMPANY

3 TABLE OF CONTENTS Autoimmune IFA Products ANA Test Systems 3 ANA Substrate Slides & Control Sera 4 Components & Conjugates 5 Infectious Disease IFA Products Test Systems 7 Special Antigen Substrate Slides 8 Viral Antigen Substrate Slides 9 Control Sera 13 Antigen Control Slides 14 Components & Conjugates 15 Ordering Information 16 TABLE OF CONTENTS 1

4 Autoimmune IFA Products 2

5 ANA TEST SYSTEMS Antinuclear antibodies (ANA s) are a group of autoantibodies characterized by specificity for numerous antigenic determinants of cell nuclei. ANA s have been proven to be very useful as disease markers, primarily for diagnostic screening and also to monitor the course of connective tissue diseases. Kit Configurations Why Use IFA? The immunoflourescence ANA test is the preferred method for ANA testing. Since 2009, The American College of Rheumatology has recommended that the immunoflourescence ANA test should remain the gold standard for ANA testing*. The indirect fluorescent antibody (IFA) test is sensitive, screens for a wide variety of known and unknown autoantibodies and through pattern recognition offers insights into the probable identity of the antigen and associated autoimmune disorder. The MBL Bion ANA (Anti-Nuclear Antibody) Test System is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semiquantitative determination of antinuclear antibodies in human serum. The MBL Bion ANA Test System is intended for use as an aid in the diagnosis of certain autoimmune diseases. *American College of Rheumatology, Position Statement on the Methodology of Testing for Antinuclear Antibodies Diseases. Available at: pdf ANA TEST SYSTEMS 3

6 ANA SUBSTRATE SLIDES The antigen of the MBL Bion ANA substrate is a human epithelial cell (HEp-2) line. HEp-2 cells have been shown to have greater sensitivity than tissue sections and aid in sharper differential pattern recognition as well as detecting previously unreported nuclear antibodies. Each lot is tested with a panel of titered control sera to ensure sensitivity from lot to lot Each lot is tested for pattern types, and for specific antinuclear antibodies Mitotic cells are present for detection of centromere antibodies; also helps to identify other patterns Substrate is sensitive for detection of low titered specific antibodies Substrate is specific for detection of SS-A and other antibodies ANA CONTROL SERA Positive Control Sera are prepared to give a 2+ to 4+ fluorescence when used as supplied (undiluted) in MBL Bion s Immunofluorescent Test Systems. Negative Control Sera are prepared to give less than a 1+ fluorescence when used as supplied (undiluted) in MBL Bion s Immunofluorescent Test Systems. ANA SUBSTRATE SLIDES & CONTROL SERA 4

7 ANA COMPONENTS & CONJUGATES Fluorescent Antibody Conjugates Ready to use dropper bottle of fluorescein isothiocyanate (FITC) labeled goat anti-human IgG (heavy and light chain specific) to detect IgG, IgA and IgM with Evans Blue counterstain, protein stabilizer, less than than 0.1% sodium azide and 0.001% thimerosal. Available in convenient volume sizes. Phosphate Buffered Saline (PBS) Dry packets to make one liter or five liters of PBS. Mounting Medium Dropper bottle containing phosphate buffered glycerol of ph 7.4 ± 0.2. IFA Diluent IFA Diluent is intended to reduce the nonspecific fluorescence associated with some serum specimens, and thereby improves the readability of these specimens without affecting the endpoint titers of specific immunofluorescent reactions. It is strongly recommended that IFA Diluent be used to prepare the screening dilution of the serum sample for use in MBL Bion s Antinuclear Antibody Test System. ANA COMPONENTS AND CONJUGATES 5

8 Infectious Disease IFA products 6

9 INFECTIOUS DISEASE TEST SYSTEMS MBL Bion Infectious Disease IFA Test Systems are indirect fluorescent antibody assays for the qualitative and/or semi-quantitative determination of specific infectious disease antibodies in human serum. They are intended for use as an aid in the diagnosis of primary infection, re-infection or reactivation of the latent virus as well as a determination of immunological experience and/or immune status. Kit Configurations INFECTIOUS DISEASE TEST SYSTEMS 7

10 SPECIAL ANTIGEN SUBSTRATE SLIDES Each lot is tested with a panel of titered sera to ensure sensitivity lot to lot Most substrates can be used for the detection of IgG or IgM antibodies Chlamydia substrate has both Inclusions and Elementary Bodies Mycoplasma substrate consists of cells with microorganisms and colonies SPECIAL ANTIGEN SUBSTRATE SLIDES 8

11 VIRAL ANTIGEN SUBSTRATE SLIDES Each lot is tested with a panel of titered sera to ensure sensitivity lot to lot. Both Positive and Negative cells are in each well to provide a built-in control. Most substrates can be used for the detection of IgG or IgM antibodies. VIRAL ANTIGEN SUBSTRATE SLIDES 9

12 VIRAL ANTIGEN SUBSTRATE SLIDES VIRAL ANTIGEN SUBSTRATE SLIDES 10

13 VIRAL ANTIGEN SUBSTRATE SLIDES VIRAL ANTIGEN SUBSTRATE SLIDES 11

14 VIRAL ANTIGEN SUBSTRATE SLIDES VIRAL ANTIGEN SUBSTRATE SLIDES 12

15 CONTROL SERA Positive Control Serum Vial containing 0.5 ml positive IgG or positive IgM human control serum with protein stabilizer and 0.005% thimerosal and is prepared to give a 2+ or greater fluorescence when used as supplied (undiluted) in the MBL Bion Immunofluorescent Test Systems. IgM Controls sold when available. Negative Control Serum Vial containing 0.5 ml negative human control serum with protein stabilizer and 0.005% thimerosal and is prepared to give less than a 1+ fluorescence when used as supplied (undiluted) in the MBL Bion Immunofluorescent Test Systems. CONTROL SERA 13

16 ANTIGEN CONTROL SLIDES Direct identification control slides are designed to be used as quality control substrates for staining reagents (i.e. monoclonal antibodies) that are used in direct antigen detection and culture confirmation methodologies. Each slide consists of a well(s) containing the antigen infected tissue culture cells (positive control) and a well(s) containing the infected tissue culture cells (negative control). ANTIGEN CONTROL SLIDES 14

17 IFA COMPONENTS & CONJUGATES Fluorescent Antibody Conjugates Ready to use dropper bottle of fluorescent isothiocyanate (FITC) labeled goat anti-human IgG or IGM (heavy chain specific) with Evans Blue counterstain, protein stabilizer, less than 0.1% sodium azide and 0.001% thimerosal. Available in convenient volume sizes. Phosphate Buffered Saline (PBS) Dry packets to make one liter or five liters of PBS. Mounting Medium Dropper bottle containing phosphate buffered glycerol of ph 7.4 ± 0.2. IFA COMPONENTS & CONJUGATES 15

18 ORDERING INFORMATION Please provide the following information to expedite your telephone, fax or mailed orders. 1) Purchase Order Number or valid credit card (Visa, MasterCard, American Express) 2) Your name, telephone, fax number, and address. Please include Customer Account Number on the attention line 3) End User s name, telephone number, and address 4) Ship To and Bill To addresses 5) Product Catalog Number and description 6) Quantity and product size 7) Minimum order $25.00 By phone: (8:30AM to 6:00PM EST, Monday through Friday) By fax: By mail: MBL International 455 State Street, Suite 100 Des Plaines, IL If you have any questions about an order, you can reach us by via customerservice@mblintl.com Technical Support For technical assistance you may reach us via at technical@mblintl.com or by telephone at Shipping All orders received by 3:00 PM(EST) Monday through Thursday are routinely shipped the same day and delivered the next day via overnight service. Domestic orders received after 3:00 PM on Thursday cannot be shipped until the following Monday. Prepaid overnight delivery charges will be added to the invoice. International shipments will have different freight charges and transit times. If any item you have ordered is temporarily out of stock, you will be notified when that item will be available for shipment. All shipments are F.O.B Des Plaines, IL. Payment Terms Payment terms are net 30 days from the invoice date. All prices quoted are in U.S. dollars. Prices are subject to change without notice. For customer convenience, MBL Bion will accept VISA, Master Card and American Express for purchases. Credit card approval must be obtained prior to shipment. ORDERING INFORMATION 16

19 ORDERING INFORMATION Quoted Prices All requests for quotations should be directed to our Sales Department at ext. 1 or by at sales@mblintl.com. Quoted prices do not include shipping, handling or taxes. Volume Discounts The extended life of MBL Bion slides allows our customers to take advantage of our volume discount offers. Volume discounts are available. Standing Orders MBL Bion will schedule periodic shipments of any product to assure uniform customer inventory and to reduce order processing. Specific arrangements regarding product, quantity and shipping dates must be made in advance. Warranties MBL Bion guarantees the material to be of merchantable quality at the time of shipment. Our liability is limited only to replacement of products up to the amount of the purchase price. MBL Bion makes no other warranty, expressed or implied, including any implied warranty of fitness for a particular purpose or of merchantability. In no case shall MBL Bion assume any responsibility for the use or handling of the product or any liability for consequential, special, indirect, or incidental damages resulting there from. Note: We guarantee our products to perform satisfactorily for the use they are intended if stored as directed and used before the expiration date. Returns No products will be accepted for return, credit or replacement without prior authorization from an MBL Bion team member. All returns are subject to a 25% restocking charge. No product may be returned for credit after 7 days from receipt of the product. ref ORDERING INFORMATION 17

20 MBL International 15A Constitution Way Woburn, MA MBL Bion 455 State Street Suite 100 Des Plaines, IL