A C TI S C R E E N ™ XL- F DP www.sekisuidxcoag.com MANUAL LATEX AGGLUTINATION TEST FOR D- DI M E R / RAPID SEMI-QUANTITATIVE METHOD FEATURES AND BENEFITS 4 Accurate, Reliable, Low Cost ACTISCREEN XL-FDP TM Monoclonal antibody (MAb) based latex agglutination test for the qualitative and semi-quantitative measurement of cross-linked fibrin fragments (D-dimer) in human plasma. The MAb DD-3B6/22 is highly specific for D-dimer, the test is sensitive to 200 ng/mL of D-dimer. 4 D-dimer evaluation in three minutes 4 No instrumentation required 4 Perfect for emergency departments and stat situations where immediate D-dimer results are needed 4 Measures only the cross linked Fibrin Degradation Products (XL-FDP) D-dimer 4 Utilizes monoclonal antibody DD3B6/22, highly specific for D-dimer1,2 4 No cross-reactivity with intact fibrinogen3 4 Over 250 published studies referencing DD-3B6/22 make it the ‘Gold Standard’ MAb for In vitro quantitation of XL-FDP / D-dimer D IAG NOS T ICS A C TI S C R E E N ™ XL- F DP MA NUA L LATEX AG G L U T IN AT IO N T E S T F O R D-D I M E R IT’S AS EASY AS... 1. A DD 1 DR O P O F X L _ F DP L AT E X 2 . AD D 1 D R O P O F PATI E N T PL AS M A 3. MIX A ND I N CUBAT E 4. R E AD NEG AT I V E POSIT IVE The most accurate and sensitive manual XL-FDP / D-dimer test. www.sekisuidxcoag.com RAPID SEMI-QUAN T ITAT IVE M E T HO D 1. P REPARE SERIA L DI L UT IO N S O F T HE PAT I E N T P LASMA WITH B U F F E R 2. PL AC E O N E D R O P O F L ATE X R E AG E N T W I TH I N A C I R C L E O N TH E TE S T CAR D 3. A DD 20μL OF E ACH DI L UT E D PAT IE N T P L A S M A OR O NE DR O P O F CO NT R O L ( NO R M A L O R ABNO RMA L) IN S I DE T HE CIR CL E , NE X T TO TH E LATEX REAG E NT 4. M I X TH E S AM PL E ( O R C O N TR O L ) AN D T HE L ATE X R E AG E N T W I TH TH E S TI R R E R PR OV I DED NEG 5. G ENTLY R OCK T HE T E ST CA R D BACK A ND FOR TH FO R 3 M I N U T E S T HE N E X A M IN E T H E REAG ENT AND SA M P L E IN T HE CIR CL E AT I V E POSIT IVE 6. D E TE R M I N E X L - F D P / D - D I M E R L E V E L S BA S ED U PO N AG G L U TI N ATI O N PATTE R N S E E I N S T R UCT I O N S F O R U S E F O R F U L L PR O C E D U R E S MATERIALS SUPPLIED ACTISCREEN ™ XL-FDP 800DB CONTAINS: • Latex reagent – 1 x 2,0 mL dropper bottle, white cap • Positive control – 1 x 0,6 mL dropper bottle, yellow cap • Negative control – 1 x 0,6 mL dropper bottle, black cap • Buffer solution – 1 x 20 mL bottle • Test cards – 10 each with 8 test circles • Plastic stirrers – 60 for mixing • Instructions for Use with qualitative and quantitative methods ORDERING INFORMATION: ActiScreen™ XL-FDP, Latex kit (60 tests) (Part No. 800DB) IVD ActiScreen™ XL-FDP, Latex vial (60 tests) (Part No. 800DB-LX) IVD MANUFACTURED IN THE USA BY: Sekisui Diagnostics, LLC 500 West Avenue Stamford, CT 06902 Phone: Sales Technical Service 203 602 7777 Phone: Orders/Customer Service 800 332 1042 Fax: Orders/Customer Service 800 762 6311 Fax: Sales/Technical Service 203 602 2221 E-mail: [email protected] www.sekisuidxcoag.com REFERENCES: 1. Rylatt, D.B., et al, An Immunoassay for Human D-dimer using Monoclonal Antibodies, Thromb. Res., 31(6):767-788; 1983 2. Bick, R.L., Disseminated Intravascular Coagulation: Objective Criteria for Clinical and Laboratory Diagnosis and Assessment of Therapeutic Response, Seminars in Thrombosis & Hemostasis, 22(1):69-88; 1996 3. Greenberg, C.S., et al, Measurement of Plasma Fibrin D-dimer levels with the Use of a Monoclonal Antibody Coupled to Latex Beads, Am. J. Clin. Pathol., 87(1):94-100; 1987 ©2013 Sekisui Diagnostics, LLC – All rights reserved ActiScreen™ XL-FDP is a registered trademark of Sekisui Diagnostics, LLC ISO 13485:2003 Registered 80-7987-00-00 04/13
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