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 semiquantitative method |
| LOWER LIMIT OF DETECTION | 200 ng/mL |
| SPECIFICITY | 95.3% |
| PRECISION | Intra-assay CV See Instructions For Use |
| NUMBER OF TESTS | 60 |
DIMERTEST Negative Control UK EnglishACTISCREEN™ 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 method Serial 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 OF DETECTION | 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 OF DETECTION | 2 – 4 ng/mL |