DVVtest® REF: 810 | REF: 825 IVD
CE Marked, FDA 510(K)Cleared, Health Canada Registered
The DVVtest reagent contains Factor X activator isolated from Russell’s Viper Venom that directly activates Factor X to Factor Xa in the presence of phospholipids and calcium. Factor Xa activates prothrombin to thrombin, which converts fibrinogen to fibrin leading to detectable clot formation in plasma. This direct activation of Factor X bypasses the contact and intrinsic pathways in the coagulation cascade, thereby excluding interference from deficiencies of Factors VIII, IX, XI and XII, or their respective inhibitors. A positive DVVtest is indicated by a significant prolongation of the phospholipiddependent clotting time. If a patient is suspected to have LA, the DVVtest may also be performed on samples with a normal APTT as the formulation of the reagent increases the test’s sensitivity and specificity to LA.
REAGENTS |
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10 Vials of DVVtest Reagent, 2.0 mL, lyophilized (REF 810) |
10 Vials of DVVtest Reagent, 5.0 mL, lyophilized (REF 825) |
SPECIFICATIONS | |
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SAMPLES | Citrate collected plasma |
SAMPLE PREPARATION | Neat |
SAMPLE VOLUME | 100 μL of plasma |
TOTAL ASSAY TIME | < 5=""> |
STANDARD RANGE | 0 – 100% |
LOWER LIMIT OFDETECTION | 4.6 IU/mL |
SENSITIVITY | 100%, used in conjunction with DVVconfirm |
SPECIFICITY | 97.9%, used in conjunction with DVVconfirm |
PRECISION | Intra-assay CV ≤ N.D.Inter-assay CV <> |
NUMBER OF TESTS | 200 for REF 810500 for REF 825 |
810/825 DVVtest – USA English
810/825 DVVtest – UK English
810/825 DVVtest – EU French
810/825 DVVtest – EU German
810/825 DVVtest – EU Italian
810/825 DVVtest – EU Spanish
DVVconfirm® REF 815 IVD | REF 815L IVD
CE Marked, FDA 510(K)Cleared, Health Canada Registered
REAGENTS | |
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10 | Vials of DVVtest Reagent, 1.0 mL, lyophilized (REF 815) |
10 | Vials of DVVtest Reagent, 2.0 mL, lyophilized (REF 815L) |
SPECIFICATIONS | |
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SAMPLES | Citrate collected plasma |
SAMPLE PREPARATION | Neat |
SAMPLE VOLUME | 100 μL of plasma |
TOTAL ASSAY TIME | < 5=""> |
STANDARD RANGE | 0 – 100% |
SENSITIVITY | 100%, used in conjunction with DVVtest |
SPECIFICITY | 97.9%, used in conjunction with DVVtest |
PRECISION | Intra-assay CV <>Inter-assay CV <> |
NUMBER OF TESTS | 100 for REF 815200 for REF 815L |
815/815L DVVconfirm – USA English
815/815L DVVconfirm – UK English
815/815L DVVconfirm – EU French
815/815L DVVconfirm – EU German
815/815L DVVconfirm – EU Italian
815/815L DVVconfirm – EU Spanish
LAtrol™ LA Control Plasmas REF 816A IVD | REF 816N IVD
CE Marked, FDA 510(K)Cleared, Health Canada Registered
REAGENTS | |
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10 | Vials of plasma, 0.5 mL, lyophilized (REF 816A) |
10 | Vials of plasma, 1.0 mL, lyophilized (REF 816N) |
SPECIFICATIONS | |
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PRECISION WHEN USED WITH DVVTEST / DVVCONFIRM | Intra-assay CV <>Inter-assay CV <> |
PRECISION WHEN USED WITH ACTICLOT dPT | Intra-assay CV <>Inter-assay CV <> |
816A LAtrol™ Abnormal Control Plasma – USA English
816A LAtrol™ Abnormal Control Plasma – UK English
816N LAtrol™ Normal Control Plasma – USA English
816N LAtrol™ Normal Control Plasma – UK English
ACTICLOT® dPT™ Dilute Prothrombin Time Test REF: 824 IVD
CE Marked, FDA 510(K)Cleared, Health Canada Registered
ACTICLOT dPT is a fully integrated dilute prothrombin time test for screening and confirming the presence of phospholipid-dependent LA autoantibodies. The screening protocol utilizes an activator reagent that contains a unique formulation of relipidated recombinant human tissue factor and calcium. The use of recombinant tissue factor in the formulation of the dPT test improves the test’s performance. In the confirmatory protocol, a uniquely formulated phospholipid reagent is used to demonstrate the phospholipid-dependent nature of the LA detected in samples that tested positive in the screening protocol.
Clotting is initiated by activating the extrinsic coagulation pathway with tissue factor in the presence of calcium ions. Tissue Factor binds to Factor VIIa resulting in the activation of Factor IX and Factor X. The subsequent conversion of prothrombin to thrombin by Factor Xa initiates clot formation by cleaving fibrinogen to fibrin. Activation of the tissue factor pathway bypasses the intrinsic (contact) pathway and excludes any interference from deficiencies of Factor XII.
REAGENTS | |
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6 | Vials of dPT Activator, 2 mL, lyophilized |
3 | Vials of LA Phospholipids, 2 mL, lyophilized |
3 | Vials of LA Buffer, 3 mL, lyophilized |
SPECIFICATIONS | |
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SAMPLES | Citrate collected plasma |
SAMPLE PREPARATION | Neat |
SAMPLE VOLUME | 100 μL of plasma |
TOTAL ASSAY TIME | < 5=""> |
NORMAL CLOT TIME | 33 – 43 seconds |
SENSITIVITY | 100% |
SPECIFICITY | 91% |
PRECISION | Intra-assay CV <>Inter-assay CV <> |
NUMBER OF TESTS | 240 tests (120 screen/120 confirm) |