QuikCoag® APTT-EA IVD
CE Marked, FDA 510(K)Cleared, Health Canada Registered
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QuikCoag APTT-EA (Ellagic Acid) reagent is an in vitro diagnostic assay intended for use in determining activated partial thromboplastin time (APTT) and coagulationfactor assays that are based on a modified APTT. Used as a general screening test for the detection of coagulation abnormalities in the intrinsic (contact) pathway, the APTT is sensitive to deficiencies or abnormalities of Factors VIII, IX, XI, XII, X, and II, prekallikrein, high molecular weight kininogen (HMWK), and fibrinogen. It is also sensitive to inhibitors of blood coagulation such as lupus inhibitor and fibrin/fibrinogen degradation products. The APTT is the most widely used method for monitoring intravenous heparin anticoagulation therapy. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation Factors I, II, V, VIII, IX, X, XI and XII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.
QuikCoag APTT-EA (Ellagic Acid) reagent is an in vitro diagnostic assay intended for use in determining activated partial thromboplastin time (APTT) and coagulationfactor assays that are based on a modified APTT. Used as a general screening test for the detection of coagulation abnormalities in the intrinsic (contact) pathway, the APTT is sensitive to deficiencies or abnormalities of Factors VIII, IX, XI, XII, X, and II, prekallikrein, high molecular weight kininogen (HMWK), and fibrinogen. It is also sensitive to inhibitors of blood coagulation such as lupus inhibitor and fibrin/fibrinogen degradation products. The APTT is the most widely used method for monitoring intravenous heparin anticoagulation therapy. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation Factors I, II, V, VIII, IX, X, XI and XII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.
- Ready-to-use liquid format
- Tissue based reagent
- May be used on any open system
- Stable for three years from the date of manufacture when properly stored in the original container at 2° to 8°C Insensitive to Heparin up to 0.5 IU/mL
- Unique Device Identifiers (UDI) with scannable and human readable bar codes on the box andvial labels
- OEM options available
| AVAILABLE AS | |
|---|---|
| REF | PACKAGING |
| C.BMD.APTT-04ML | 10 x 4 mL vials |
| C.BMD.APTT-10ML | 10 x 10 mL vials |
Safety Data Sheets
Download Safety Data Sheet QuikCoag APTT-EAQuikCoag® PT-HS
CE Marked, FDA 510(K)Cleared, Health Canada Registered
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The QuikCoag PT-HS reagent is an in vitro diagnostic assay intended for use in performing the one stage prothrombin time (PT) test and assays which are based on a modified prothrombin time. The PT test is the method of choice for monitoring oral anticoagulation therapy and is a fundamental screening test for acquired or inherited bleeding disorders. During oral anti-coagulation therapy, the activity of vitamin K-dependant clotting Factors (II, VII, IX, X, Protein C and Protein S) is reduced and PT time is increased. The test is used for quantitative determination of blood clotting Factors in the extrinsic (Tissue Factor) and common pathways (II, V and X) of coagulation. The capacity of blood to form a fibrin clot via the extrinsic hemostatic pathway requires thromboplastin, calcium, Factors I, II, V, VII and X. The QuikCoag PT-HS reagent provides a source of tissue thromboplastin and calcium that specifically activate Factor VII in the extrinsic coagulation pathway. The Factors involved in the intrinsic coagulation pathway are bypassed, therefore deficiencies of intrinsic pathway Factors (VIII, IX and XII) are not detected using the PT test.
The QuikCoag PT-HS reagent is an in vitro diagnostic assay intended for use in performing the one stage prothrombin time (PT) test and assays which are based on a modified prothrombin time. The PT test is the method of choice for monitoring oral anticoagulation therapy and is a fundamental screening test for acquired or inherited bleeding disorders. During oral anti-coagulation therapy, the activity of vitamin K-dependant clotting Factors (II, VII, IX, X, Protein C and Protein S) is reduced and PT time is increased. The test is used for quantitative determination of blood clotting Factors in the extrinsic (Tissue Factor) and common pathways (II, V and X) of coagulation. The capacity of blood to form a fibrin clot via the extrinsic hemostatic pathway requires thromboplastin, calcium, Factors I, II, V, VII and X. The QuikCoag PT-HS reagent provides a source of tissue thromboplastin and calcium that specifically activate Factor VII in the extrinsic coagulation pathway. The Factors involved in the intrinsic coagulation pathway are bypassed, therefore deficiencies of intrinsic pathway Factors (VIII, IX and XII) are not detected using the PT test.
- Target ISI value range of 0.90 – 1.50, with a specific ISI assigned to each lot
- Convenient lyophilized format
- Rabbit brain based reagent
- May be used on any open system
- Lyophilized reagent is stable for three years from the date of manufacture when properly stored in the original container at 2° to 8°C. Reconstituted reagent is stable for five days when properly stored in the original container at 2° to 8°C
- Unique Device Identifiers (UDI) with scannable and human readable bar codes on the box and vial labels
- OEM options available
| AVAILABLE AS | |
|---|---|
| REF | PACKAGING |
| C.BMD.PTHS-02ML-8A | 10 x 2 mL vials |
| C.BMD.PTHS-04ML-8A | 10 x 4 mL vials |
| C.BMD.PTHS-1-ML-8A | 10 x 10 mL vials |
Safety Data Sheets
QuikCoag® Fibrinogen CE, Health Canada Registered
CE Marked, Health Canada Registered
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QuikCoag™ Fibrinogen is an in vitro diagnostic assay intended for quantitative determination of fibrinogen in plasma. Thrombin converts soluble fibrinogen into insoluble fibrin, which, when cross-linked becomes the fibrin clot as the last step in the coagulation cascade. A Clauss based assay, QuikCoag Fibrinogen measures the rate of fibrinogen to fibrin conversion in the presence of excess thrombin. When diluted plasma is clotted with excess thrombin, the fibrinogen level is inversely proportional to the clotting time. A calibration curve is prepared from a fibrinogen reference and plotted on log-log paper. This calibration curve is used to determine the fibrinogen concentration in the test sample. Fibrinogen is an acute-phase reactant protein in that the concentration rises sharply in response to various physiological stimuli such as tissue inflammation or injury. High fibrinogen levels are associated with atherosclerotic cardiovascular disease, the occurrence of myocardial infarction and stroke, cancers of the breast, kidney and stomach, and inflammatory disorders such as rheumatoid arthritis. Reduced fibrinogen levels are prevalent in liver disease, prostate cancer, lung disease, bone marrow lesions, malnourishment, and disseminated intravascular coagulation.
QuikCoag™ Fibrinogen is an in vitro diagnostic assay intended for quantitative determination of fibrinogen in plasma. Thrombin converts soluble fibrinogen into insoluble fibrin, which, when cross-linked becomes the fibrin clot as the last step in the coagulation cascade. A Clauss based assay, QuikCoag Fibrinogen measures the rate of fibrinogen to fibrin conversion in the presence of excess thrombin. When diluted plasma is clotted with excess thrombin, the fibrinogen level is inversely proportional to the clotting time. A calibration curve is prepared from a fibrinogen reference and plotted on log-log paper. This calibration curve is used to determine the fibrinogen concentration in the test sample. Fibrinogen is an acute-phase reactant protein in that the concentration rises sharply in response to various physiological stimuli such as tissue inflammation or injury. High fibrinogen levels are associated with atherosclerotic cardiovascular disease, the occurrence of myocardial infarction and stroke, cancers of the breast, kidney and stomach, and inflammatory disorders such as rheumatoid arthritis. Reduced fibrinogen levels are prevalent in liver disease, prostate cancer, lung disease, bone marrow lesions, malnourishment, and disseminated intravascular coagulation.
- Ready-to-use liquid format
- Clauss-based method
- May be used on any open system
- Stable for three years from the date of manufacture when properly stored in the original container at 2° to 8°C
- Unique Device Identifiers (UDI) with scannable and human readable bar codes on the box and vial labels
- OEM options available
| AVAILABLE AS | |
|---|---|
| REF | PACKAGING |
| CC.BMD.FIBR-02ML | 100 tests (includes Fibrinogen Reagent, Imidazole Buffer, Fibrinogen Normal Control) |
| C.BMD.FIBR-02ML-8A | 10 x 2 mL vials (Fibrinogen Reagent Only) |
Safety Data Sheets
QuikCoag® Thrombin Time
CE Marked, Health Canada Registered
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QuikCoag Thrombin is a thrombin reagent (bovine) for use in the determination of the Thrombin Time (TT) in human plasma. The TT assay is based on the ability of thrombin to catalyze the polymerization of fibrinogen into a fibrin clot. Following the cleavage of
fibrinopeptides A and B from the amino-terminal ends of the alpha and beta chains of fibrinogen by thrombin, the resulting fibrin monomers ultimately polymerize into a fibrin clot. The TT assay is a qualitative screening assay used to detect abnormalities in this phase of coagulation. The assay is performed by adding a known quantity of low concentration thrombin reagent to the sample and measuring the time required for clot formation to occur. Abnormalities affecting this stage of coagulation include quantitative and qualitative alterations in fibrinogen, increased fibrinolytic activity causing variations in Fibrin Degradation Products (FDP), and interferences with fibrinogen polymerization. The TT assay is also sensitive to heparin and other circulating antithrombins.
- Convenient lyophilized format
- May be used on any open system
- Stable for three years from the date of manufacture when properly stored in the original container at 2° to 8°C. Reconstituted reagent is stable for seven days when properly stored at 2° to 8°C and 30 days at -20°C
- Unique Device Identifiers (UDI) with scannable and human readable bar codes on the box and vial labels
- OEM options available
| AVAILABLE AS | |
|---|---|
| REF | PACKAGING |
| C.BMD.TT-01ML | 10 x 1 mL vials |
Safety Data Sheets
QuikCoag® Calcium Chloride IVD
CE Marked, FDA 510(K)Cleared, Health Canada Registered
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QuikCoag Calcium Chloride is a reagent for use in the in vitro determination of prothrombin time (PT) test, activated partial thromboplastin time (APTT) and recalcification (plasma clotting) time, as well as various coagulation factor assays.
QuikCoag Calcium Chloride is a reagent for use in the in vitro determination of prothrombin time (PT) test, activated partial thromboplastin time (APTT) and recalcification (plasma clotting) time, as well as various coagulation factor assays.
- Ready-to-use liquid format
- Stable for three years from date of manufacture when stored in the original container at 2 to 8°C
- Unique Device Identifiers with scannable and human readable bar codes on box and vial labels
- OEM and customized options available
| AVAILABLE AS | |
|---|---|
| REF | PACKAGING |
| C.BMD.CACL2-04ML | 10 x 4 mL vials |
| C.BMD.CACL2-10ML | 10 x 10 mL vials |
Safety Data Sheets
QuikCoag® Imidazole Buffer IVD
CE Marked, Health Canada Registered
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QuikCoag Imidazole Buffer is intended for use in conjunction with QuikCoag Fibrinogen. It is used to dilute the plasma samples prior to doing the fibrinogen testing. QuikCoag Imidazole Buffer is a liquid preparation containing imidazole, sodium chloride and sodium azide.
| AVAILABLE AS | |
|---|---|
| REF | PACKAGING |
| C.BMD.IMID-125ML-B | 1 x 125 mL bottle |
Safety Data Sheets
QuikCoag® Controls IVD
CE Marked, Health Canada Registered
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QuikCoag Routine Controls are intended for use for quality assurance of in vitro diagnostic coagulation tests.
The controls are suitable for use in the one-stage prothrombin time (PT) test and in the activated partial
thromboplastin time (APTT) test. Controls are available at three levels:
QuikCoag Routine Controls are intended for use for quality assurance of in vitro diagnostic coagulation tests.
The controls are suitable for use in the one-stage prothrombin time (PT) test and in the activated partial
thromboplastin time (APTT) test. Controls are available at three levels:
| 3 LEVEL CONTROLS | |
|---|---|
| QuikCoag Control Level 1 (Normal) | for use as a normal coagulation time control |
| QuikCoag Control Level 2 (Low Abnormal) | for use as a moderately elevated coagulation time control |
| QuikCoag Control Level 3 (High Abnormal) | for use as a highly elevated coagulation time control |
- Human plasma-based controls
- Convenient lyophilized format
- Available in standard 1.0 mL fill volumes
- Stable for three years from the date of manufacture when properly stored in the original vial at 2° to 8°C
- Stable for six hours following reconstitution when stored in the original vial at 2° to 8°C
- Unique Device Identifiers (UDI) with scannable and human readable bar codes on the box and vial labels
- OEM options available
| AVAILABLE AS | |
|---|---|
| REF | PACKAGING |
| C.BMD.CON1-01ML-8A | 10 x 1 mL vials |
| C.BMD.CON2-01ML-8A | 10 x 1 mL vials |
| C.BMD.CON3-01ML-8A | 10 x 1 mL vials |
Special Coagulation Controls (18 Parameter)
CE Marked
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Special Coagulation Controls are intended to be used as unassayed controls for monitoring the performance of special and routine coagulation assays on analyzers in a clinical setting. The controls are to be tested in the same manner as freshly drawn citrated patient plasma.The controls are available within the normal and abnormal ranges and suitable for use in eighteen (18) parameters.
Special Coagulation Controls are intended to be used as unassayed controls for monitoring the performance of special and routine coagulation assays on analyzers in a clinical setting. The controls are to be tested in the same manner as freshly drawn citrated patient plasma.The controls are available within the normal and abnormal ranges and suitable for use in eighteen (18) parameters.
| AVAILABLE AS | |
|---|---|
| REF | PACKAGING |
| SCCN-180 (Normal Control) | 10 x 1.0 mL vials |
| SCCA-180 (Abnormal Control) | 10 x 1.0 mL vials |
- Convenient lyophilized format
- Lyophilized controls are stable until the stated expiration date when properly stored in the original vial at 2° to 8°C
- Reconstituted controls are for eight hours at room temperature
- OEM options available
| COAGULATION TEST | NORMAL CONTROL TARGET RANGE | ABNORMAL CONTROL TARGET RANGE |
|---|---|---|
| PROTHROMBIN TIME | 10.0 – 14.0 seconds | 18.0 – 26.0 seconds |
| ACTIVATED PARTIAL THROMBIN TIME | 23.0 – 35.0 seconds | 50.0 – 70.0 seconds |
| THROMBIN TIME | 13.0 – 19.0 second | 22.0 – 35.0 seconds |
| FIBRINOGEN CONCENTRATION | 200 – 400 mg/dL | < 200 mg/dL |
| FACTOR II ACTIVITY | >60% | ≤ 60% |
| FACTOR V ACTIVITY | >60% | ≤ 60% |
| FACTOR VII ACTIVITY | >60% | ≤ 60% |
| FACTOR VIII ACTIVITY | >60% | ≤ 60% |
| FACTOR IX ACTIVITY | >60% | ≤ 60% |
| FACTOR X ACTIVITY | >60% | ≤ 60% |
| FACTOR XI ACTIVITY | >60% | ≤ 60% |
| FACTOR XII ACTIVITY | >60% | ≤ 60% |
| FACTOR XIII ACTIVITY | >60% | ≤ 60% |
| PROTEIN S ACTIVITY | >50% | ≤ 50% |
| PROTEIN C ACTIVITY | >60% | ≤ 60% |
| ANTITHROMBIN III ACTIVITY | >60% | ≤ 60% |
| PLASMINOGEN ACTIVITY | >60% | ≤ 60% |
| ALPHA2-ANTIPLASMIN ACTIVITY | >60% | ≤ 60% |
Safety Data Sheets
Routine Coagulation Controls (4 Parameter)
CE Marked
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Routine Coagulation Controls are intended to be used as unassayed controls for monitoring the performance of routine coagulation assays on analyzers in a clinical setting. The controls are to be tested in the same manner as freshly drawn citrated patient plasma. The controls are available within the normal and abnormal ranges and suitable for use in four (4) parameters.
| AVAILABLE AS | |
|---|---|
| REF | PACKAGING |
| RCCN-040 (Normal Control) | 10 x 1.0 mL vials |
| RCCA-040 (Abnormal Control) | 10 x 1.0 mL vials |
- Convenient lyophilized format
- Lyophilized controls are stable until the stated expiration date when properly stored in the original vial at 2° to 8°C
- Reconstituted controls are for eight hours at room temperature
- OEM options available
| COAGULATION TEST | NORMAL CONTROL TARGET RANGE | ABNORMAL CONTROL TARGET RANGE |
|---|---|---|
| PROTHROMBIN TIME | 10.0 – 14.0 seconds | 18.0 – 26.0 seconds |
| ACTIVATED PARTIAL THROMBIN TIME | 23.0 – 35.0 seconds | 50.0 – 70.0 seconds |
| THROMBIN TIME | 13.0 – 19.0 second | 22.0 – 35.0 seconds |
| FIBRINOGEN CONCENTRATION | 200 – 400 mg/dL | < 200 mg/dL |
Safety Data Sheets
IMUBIND® Factor VIIa ELISA REF 827 RUO
CE Marked, FDA 510(K)Cleared, Health Canada Registered
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The IMUBIND® Factor VIIa ELISA is an enzyme-linked immunoassay for the quantitation of activated human Factor VII (FVIIa) in plasma as well as in cell culture supernatants. The ELISA detects FVIIa as well as FVIIa complexed with Tissue Factor (TF/FVIIa). The assay is For Research Use Only, not for use in diagnostic procedures. Factor VII (FVII) is the first zymogen of the extrinsic pathway of blood coagulation. Activation of FVII occurs via cleavage of the proenzyme by proteases (e.g. Factors IXa, Xa, XIIa and thrombin). Factor VII is also subject to auto-activation by Factor VIIa (FVIIa). When FVIIa complexes with Tissue Factor, an enhanced enzymatic complex is formed that rapidly promotes coagulation.
| REAGENTS | |
|---|---|
| 96 | Anti-Human FVII/FVIIa IgG coated microwells with acetate cover sheet |
| 96 | microwell plate, uncoated |
| 2 | Vials of FVIIa Standard, 200 ng/mL, lyophilized |
| 1 | Vial of FVII Deficient Plasma, 300 μL, lyophilized |
| 1 | Vial of FVIIa Inhibitor, 160 μL, lyophilized |
| 1 | Vial of Assay Diluent, 22 mL, lyophilized |
| 1 | Vial of Reference Plasma, 300 μL, lyophilized |
| 1 | Vial of Stabilizer, 3.5 mL, lyophilized |
| 1 | Vial of Enzyme Conjugate, Streptavidin-Horseradish peroxidase, 120 μL |
| 1 | Vial of Substrate, TMB, 11 mL |
| 1 | Packet of Wash Buffer, PBS with 0.05% Tween 20, 1 Liter, powder |
| SPECIFICATIONS | |
|---|---|
| SAMPLES | Citrate or EDTA collected plasma, cell culture supernatants |
| SAMPLE PREPARATION | Neat |
| SAMPLE VOLUME | 12.5 μL of plasma |
| TOTAL ASSAY TIME | 3 hours |
| STANDARD RANGE | 33 – 43 seconds |
| LOWER LIMIT OF DETECTION | 200 ng/mL |
| SPECIFICITY | < 5 ng/mL |
| PRECISION | Intra-assay CV = N.D. Inter-assay CV = N.D. |
| NUMBER OF TESTS | 96 |
Safety Data Sheets - UK
Safety Data Sheets - USA