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Pooled Normal Plasma

Normal Factor Activity

Pooled Normal Plasma (PNP) contains plasma from 30 or more carefully screened normal human donors. Our PNP is plaet poor with no buffers or preservatives making it most like your patient plasma. An approximay equal number of male and female donors are included. A Certificate of Analysis (CofA) accompanies each shipment of PNP. This lot specific CofA certifies the normalcy of this plasma satisfying regulatory guidelines. Assay values are assigned and reported on the CofA for Prothrombin Time (PT) and activated Partial Thromboplastin Time (aPTT). Fibrinogen and Factors II, V, VII, VIII, IX, X, XI and XII are assayed and certified to be within the normal range. This product is registered with the FDA as in in vitro diagnostic product and can be used without limitations.

Uses:

·         Mixing studies

·         Control for coagulation factor assays

·         Control for specialty coagulation/thrombosis testing

·         Negative control for lupus anticoagulant testing

·         Base plasma for preparing heparin spiked samples

Primary advantages of PNP:

·         Most like patient plasma

·         Ready to use — No reconstitution

·         No buffers or preservatives

·         Certified Normal

·         FDA Registered — Use without limitation

 

FACT – Factor Assay Control Plasma

FACT is Pooled Normal Plasma with assigned assay values for a wide variety of tests. This product includes plasma from 30 or more carefully screened normal human donors. An approximay equal number of male and female donors are included. Values are published for PT, aPTT, Thrombin Time, , Fibrinogen (Clauss) and Fibrinogen Antigen, Factors II, V, VII, VIII, IX, X, XI, XII, ATIII Antigen, ATIII Activity, vWF Antigen, vWF Activity, Protein C Antigen, Protein C Functional, Protein S Functional, Protein S Antigen and Plasminogen. This product is registered with the FDA as an in vitro diagnostic product and can be used without limitations.

Uses for FACT:

·         Standard/Calibrator for coagulation factor assays

·         Assayed control for coagulation factor assays

·         Assayed control for coagulation/thrombosis specialty assays

·         Mixing studies

·         Negative control for lupus anticoagulant testing

·         Base plasma for preparing heparin spiked samples

Primary advantages of FACT:

·         Most like patient plasma

·         Ready to use — No reconstitution

·         No buffers or preservatives

·         Comprehensive coagulation/thrombosis control

·         FDA Registered – use without limitation

Important Note:

Using FACT with B-FACT (Borderline Factor Assay Control) and A-FACT (Abnormal Factor Assay Control) provides effective monitoring of all three sections of the factor assay standard curve.

 

 

B-FACT – Borderline Factor Assay Control Plasma

B-FACT is a borderline factor assay control designed to assess the sensitivity of the mid range section of the standard curve. Lot specific assigned assay values for a wide variety of tests are included with each shipment. Published assay values include PT, APTT, Fibrinogen (Clauss), Fibrinogen Antigen, Factors II, V, VII, VIII, IX, X, XI, XII, ATIII Antigen, ATIII Activity, vWF:Antigen, vWF:Activity, Protein C Antigen, Protein C Functional, Protein S Functional, Protein S Antigen and Plasminogen.This product is registered with the FDA as an in vitro diagnostic product and can be used without limitations.

Uses for B-FACT:

·         Mid range borderline coagulation factor assay control

·         Mid range borderline control for coagulation/thrombosis specialty assays

Primary advantages of B-FACT:

·         Most like patient plasma

·         Ready to use — No reconstitution

·         No buffers or preservatives

·         Comprehensive coagulation/thrombosis control

·         FDA Registered

 

 

A-FACT – Abnormal Factor Assay Control Plasma

A-FACT is an abnormal factor assay control designed to assess the sensitivity of the lower section of the standard curve. Lot specific assigned assay values for a wide variety of tests are included with each shipment. Published assay values include PT, APTT, Thrombin Time, Fibrinogen (Clauss) , Fibrinogen Antigen, Factors II, V, VII, VIII, IX, X, XI, XII, ATIII Antigen, ATIII Activity, vWF:Antigen, vWF:Activity, Protein C Antigen, Protein C Functional, Protein S Functional, Protein S Antigen and Plasminogen. This product is registered with the FDA as an in vitro diagnostic product and can be used without limitations.

Uses for A-FACT:

·         Abnormal control for coagulation factor assays

·         Abnormal control for coagulation and thrombosis specialty assays

Primary advantages of A-FACT:

·         Most like patient plasma

·         Ready to use — No reconstitution

·         No buffers or preservatives

·         Comprehensive coagulation/thrombosis control

·         FDA Registered

Important Note:

Using A-FACT with FACT (Normal Factor Assay Control) and B-FACT (Borderline Factor Assay Control) provides effective monitoring of the factor assay standard curve.

上海金畔生物科技有限公司

King Bio-Medical代理01

详细介绍

产品咨询

King Bio-Medical代理，King Bio-Medical上海代理，King Bio-Medical北京代理，King Bio-Medical 代理，King Bio-Medical一级代理，King Bio-Medical国内代理

上海金畔生物科技有限公司King Bio-Medical专业代理，具体产品信息欢迎电询：

CORE Set (Control of Range Evaluation Set)

Establish your normal range. Each CORE Set contains plasma from each of thirty or fifty carefully pre-screened Normal donors. An equal number of male and female donors are represented. Donors are non-smoking, non-medicated and collected from a geographically diverse population. Each donor is prescreened and must pass strict criteria to participate in our donor program. All plasmas are tested and found non-reactive for HIV, HCV and HBsAg. This product is registered with the FDA as an in vitro diagnostic product and can be used without limitations.

Uses for the CORE Set:

·         Establish Normal Range for PT and aPTT for new lot of reagent

·         Establish Normal Range for PT and aPTT new instrument

·         Establish Normal Range for other coagulation and thrombosis assays

·         Correlate Normal Ranges between multiple instruments in same location

·         Correlate Normal Ranges between multiple instruments in multiple locations

·         Correlate Normal Range on new instrument with current instrument

·         Correlate Normal Range using new reagent with current reagent

Primary advantages of the CORE Set:

·         Convenience – Plasmas collected, tested and pre-packaged

·         Cost saving

·         Ready to use — No reconstitution

·         No buffers or preservatives

·         FDA Registered – Use without limitation

·         Identical lots available

Important Note:

Using the CORE Set in conjunction with the SysCOR Set or the SysCOR Set Plus provides laboratories with an extensive set of normal and abnormal plasmas to perform complete lot conversions in one laboratory or between a number of laboratories.

 

 

SysCOR Set (Systems CORrelation Set)

Correlate your instruments. The SysCOR Set contains 10 different normal plasmas and 20 different abnormal plasmas for performing correlation studies. Data sheet is included with each shipment listing assigned values for PT, aPTT and Fibrinogen.

Uses for the SysCOR Set are:

·         Correlate values between multiple instruments in same location

·         Correlate values between multiple instruments in multiple locations

·         Correlate values on new instrument with current instrument

·         Correlate values using new reagent with current reagent

Primary advantages of the SysCOR Set:

·         30 different plasma samples and 90 different test values PT, APTT, Fibrinogen reported for every sample

·         Convenience – Plasmas collected, tested and pre-packaged

·         Cost saving

·         Ready to use — No reconstitution

·         No buffers or preservatives

·         FDA Registered – Use without limitation

·         Identical lots available

·         Ideal for integrated health networks

Important Note:

Using the SysCOR Set in conjunction with the CORE Set provides laboratories with an extensive set of normal and abnormal plasmas to perform complete lot conversions in one laboratory or between a number of laboratories.

 

 

Positive Lupus Anticoagulant

Positive control for Lupus Anticoagulant. Our plasma is drawn from a human donor exhibiting the presence of an anti-phospholipid antibody. Different donors are available including donors on Coumadin® therapy and those with no anticoagulant therapy. Positive Lupus Anticoagulant plasma is tested and found non-reactive for HIV, HCV and HBsAg.

 

 

Coumadin Plasma

Do you have patients on anticoagulant therapy? Finding controls is now easier than ever. We offer a complete range of plasmas for PT quality control from patients on therapeutic doses of Coumadin®. The INR values vary by lot number. Coumadin® Plasma is tested and found non-reactive for HIV, HCV and HBsAg.

 

 

Multi Coumadin Set

The MULTI COUMADIN® SET includes 5 x 1.0 ml vials each of five different plasmas with varied INR values. Donors are on therapeutic doses of Coumadin®. This set of plasmas may be used for a variety of applications in the coagulation and thrombosis laboratory. Plasmas in this set are tested and found non-reactive for HIV, HCV and HBsAg.

上海金畔生物科技有限公司