DIMERTEST® Latex REF: DLHK7 IVD
CE Marked, FDA 510(K)Cleared, Health Canada Registered
DIMERTEST® Latex is an immunoagglutination assay for the rapid qualitative or semi-quantitative evaluation of derivatives of cross-linked fibrin degradation products (XL-FDP) circulating in human plasma. During blood coagulation, fibrinogen is converted to fibrin monomers by thrombin, and these fibrin monomers polymerize to form a soluble gel of non-cross-linked fibrin. This fibrin gel is then converted to cross-linked fibrin by factor XIIIa to form an insoluble fibrin clot.
Generation of plasmin, the major clot-lysing enzyme, is triggered when a fibrin clot is formed. Plasmin cleaves both fibrinogen and fibrin yielding degradation products including crosslinked fibrin degradation products (XL-FDP). Only cross-linked fibrin degradation products contain the D-dimer protein, therefore XL-FDP is a specific marker of fibrinolysis.
DIMERTEST Latex utilizes latex beads coupled with the highly specific monoclonal antibody DD3B6/22. XL-FDP present in the plasma binds to the antibody coated latex beads resulting in agglutination, visible on the test card, when the XL-FDP concentration is above the lower limit of detection of the assay.
| REAGENTS | |
|---|---|
| 1 | Vial of Latex Reagent, 2.0 mL |
| 1 | Vial of Positive Control, 0.6 mL |
| 1 | Vial of Negative Control, 0.6 mL |
| 1 | Vial of Buffer, 20 mL |
| 10 | Test cards, 8 tests/card |
| 1 | Pack of Stir Sticks, 60 |
| SPECIFICATIONS | |
|---|---|
| SAMPLES | Citrate collected plasma |
| SAMPLE PREPARATION | No dilution for the qualitative method. Serial dilutions from 1:2 to 1: 8 for the semiquantitative method |
| SAMPLE VOLUME | 20 μL of plasma |
| TOTAL ASSAY TIME | 3 minutes |
| RANGE | 200 – 3,200 ng/mL for the semiquantitativemethod |
| LOWER LIMIT OFDETECTION | 200 ng/mL |
| SPECIFICITY | 95.3% |
| PRECISION | Intra-assay CVSee Instructions For Use |
| NUMBER OF TESTS | 60 |
DIMERTEST Negative Control UK English
DIMERTEST Positive Control UK English
DIMERTEST Buffer UK English
DIMERTEST Latex Reagent UK English
DIMERTEST Negative Control USA English
DIMERTEST Positive Control USA English
DIMERTEST Buffer USA English
DIMERTEST Latex Reagent USA English
ACTISCREEN™ XL-FDP REF 800DB
FDA 510(K)Cleared, Health Canada Registered
ACTISCREEN™ XL-FDP is an immunoagglutination assay for the rapid qualitative or semi-quantitative evaluation of derivatives of cross-linked fibrin degradation products (XL-FDP) circulating in human plasma.During blood coagulation, fibrinogen is converted to fibrin monomers by thrombin, and these fibrin monomers polymerize to form a soluble gel of noncross- linked fibrin. This fibrin gel is then converted to cross-linked fibrin by factor XIIIa to form an insoluble fibrin clot. Generation of plasmin, the major clot-lysing enzyme, is triggered when a fibrin clot is formed. Plasmin cleaves both fibrinogen and fibrin yielding degradation products including crosslinked fibrin degradation products (XL-FDP). Only cross-linked fibrin degradation products contain the D-dimer protein, therefore XL-FDP is a specific marker of fibrinolysis.
ACTISCREEN XL-FDP utilizes latex beads coupled with the highly specific monoclonal antibody DD3B6/22. XL-FDP present in the plasma binds to the antibody coated latex beads resulting in agglutination, visible on the test card, when the XL-FDP concentration is above the lower limit of detection of the assay.
| REAGENTS | |
|---|---|
| 1 | Vial of Immunoagglutination Reagent, 2.0 mL |
| 1 | Vial of Positive Control, 0.6 mL |
| 1 | Vial of Negative Control, 0.6 mL |
| 1 | Vial of Buffer, 20 mL |
| 10 | Test Cards, 8 tests/card |
| 1 | Pack of Stir Sticks, 60 |
| SPECIFICATIONS | |
|---|---|
| SAMPLES | Citrate collected plasma |
| SAMPLE PREPARATION | No dilution for the qualitative methodSerial dilutions from 1:2 to 1:8 for the semi-quantitative method |
| SAMPLE VOLUME | 20 μL diluted plasma |
| TOTAL ASSAY TIME | 3 minutes |
| RANGE | 200 – 3,200 ng/mL for the semi-quantitative method |
| LOWER LIMIT OFDETECTION | 200 ng/mL |
| SPECIFICITY | 95.3% |
| PRECISION | Intra-assay CV(See Instructions For Use)Inter-assay CV(See Instructions For Use) |
| NUMBER OF TESTS | 60 |
IMUCLONE™ D-dimer ELISA REF: 602 RUO
Under normal physiological conditions, excess plasmin is rapidly neutralized by alpha-2- antiplasmin within the region of the clot. Depending on the extent of fibrinolysis, a variety of XL-FDPs are generated, of which the smallest fragment is D-dimer. Therefore the presence of D-dimer indicates the sequence of events: Thrombin activation, clot formation and subsequent clot lysis.
| REAGENTS | |
|---|---|
| 96 | Well Microtest Plate pre-coated with anti-Human D-Dimer plus storage bag with desiccant |
| 2 | Vials of Sample Diluent, 50 mL |
| 3 | Vials of D-Dimer Calibrator, 2 mL (lyophilized) |
| 1 | Vial of D-Dimer Plasma Control I, High, 0.5 mL (lyophilized) |
| 1 | Vial of D-Dimer Plasma Control II, Low, 0.5 mL (lyophilized) |
| 3 | Vials of Anti-Human D-Dimer-HRP Immunoconjugate, 7.5 mL (lyophilized) |
| 1 | Vial of Conjugate Diluent, 25 mL |
| 1 | Vial of Wash Solution (20X concentrate), 50 mL |
| 1 | Vial of TMB Substrate, 25 mL |
| 1 | Vial of Stop Solution, 0.45 M Sulfuric Acid, 6 mL |
| SPECIFICATIONS | |
|---|---|
| SAMPLES | Citrate collected plasma, EDTA collected plasma |
| SAMPLE PREPARATION | 1:50 dilution |
| SAMPLE VOLUME | 200 μL of diluted sample |
| TOTAL ASSAY TIME | 3 hours |
| STANDARD RANGE | 0 – 200 ng/mL |
| LOWER LIMIT OFDETECTION | 2 – 4 ng/mL |