CEPHALINEX® APTT Reagent

Cephalinex® Advances APTT Monitoring in Coagulation Studies

Cephalinex® is a lyophilized preparation of rabbit brain cephalin and particulate (microsilica) activator. Cephalinex supplies the platelet phospholipid substitute and negatively charged surface required for plasma coagulation to occur by way of the intrinsic hemostatic pathway.

Perform Activated Partial Thromboplastin Time
Monitor Intravenous Heparin Anticoagulation Therapy
Screen for Deficiencies or Abnormalities of Coagulation Factors
Lyophilized for Long Term Storage & Stability

Catalog No.: 101162

Net Contents: 20 x 3.0 mL

Cephalinex® (APTT Reagent) represents a groundbreaking lyophilized preparation derived from rabbit brain cephalin and a microsilica activator. This innovative formulation plays a pivotal role in facilitating plasma coagulation through the intrinsic hemostatic pathway. By serving as a platelet phospholipid substitute and providing a negatively charged surface, Cephalinex® ensures the essential elements for effective coagulation are in place.

Explore Product Data Sheet

Activated Partial Thromboplastin Time (APTT) assessments are seamlessly conducted with Cephalinex®, allowing for precise monitoring of the intrinsic capability of blood to form a fibrin clot. This comprehensive evaluation encompasses the intrinsic coagulation factors XII (Hageman), XI (plasma thromboplastin antecedent), IX (Christmas), VIII (anti-hemophiliac), X (Stuart-Prower), V (proaccelerin), II (prothrombin), I (fibrinogen), along with platelet phospholipid and calcium.

In addition to its role in APTT, Cephalinex® proves indispensable in the vigilant monitoring of Intravenous Heparin Anticoagulation Therapy. This crucial application ensures the therapeutic efficacy of heparin, a vital anticoagulant, and contributes to the overall management of coagulation-related conditions.

Furthermore, Cephalinex® serves as a valuable tool in screening for deficiencies or abnormalities of coagulation factors. By offering a comprehensive assessment of these factors, healthcare professionals can identify potential issues and tailor treatment strategies to address specific coagulation challenges.

To enhance convenience and flexibility, Cephalinex® is lyophilized, ensuring long-term storage and stability. This characteristic not only facilitates ease of use but also ensures that the product remains potent and effective over an extended period, contributing to the reliability of coagulation testing procedures.

Cephalinex® stands as a multifaceted and advanced solution in the realm of coagulation management, offering a versatile platform for APTT assessment, Intravenous Heparin Anticoagulation Therapy monitoring, and comprehensive screening for coagulation factor deficiencies. Its lyophilized nature further underscores its commitment to long-term storage and stability, making it an invaluable asset in the field of hemostasis management.

Take a moment to review the provided documentation, encompassing the Cephalinex® Product Data Sheet. Additionally, check the Cephalinex® Instruction for Use (IFU) and the Cephalinex® Safety Data Sheet, accessible in six languages. A careful review of this information is essential to grasp the comprehensive details and specifications of the product.

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PRODUCT DESCRIPTION

Cephalinex® is a lyophilized preparation of rabbit brain cephalin and particulate (microsilica) activator. Cephalinex supplies the platelet phospholipid substitute and negatively charged surface required for plasma coagulation to occur by way of the intrinsic hemostatic pathway.

Review Instructions For Use

INTENDED USE

Cephalinex is for use in performing a silica activated partial thromboplastin time (APTT) and coagulation factor assays which are based on a modified APTT. The APTT is the most widely used method for monitoring intravenous heparin anticoagulation therapy. It is also a fundamental screening test for deficiencies or abnormalities of the intrinsic coagulation factors: VIII, IX, XI, XII, and factors common to both the intrinsic and extrinsic pathways: I (fibrinogen), II, V, X. When used in conjunction with a deficient substrate plasma, the APTT provides the basis for the quantitation of specific coagulation factor activities.

PRINCIPLE
The intrinsic capability of blood to form a fibrin clot requires coagulation factors XII (Hageman), XI (plasma thromboplastin antecedent), IX (Christmas), VIII (anti-hemophiliac), X (Stuart-Prower), V (proaccelerin), II (prothrombin), I (fibrinogen), platelet phospholipid, and calcium.

Historically, intrinsic coagulation was measured by timing fibrin clot formation upon the recalcification of citrated, anti-coagulated, platelet rich plasma. Measurement with platelet rich plasma, however, relied on the platelets as a source of phospholipid. Variables such as centrifugation and patient platelet count had significant bearing on the test results.

The partial thromboplastin time (PTT), which is a modification of the plasma recalcification time, introduces a platelet substitute which eliminates test variability due to the availability of platelet phospholipid. By adding a substance to activate factors XII and XI, the contact factors, the partial thromboplastin time becomes the activated partial thromboplastin time (APTT). Because coagulation endpoints are shorter and sharper than with the PTT, the APTT has proven to be a simple and highly reliable measurement of the intrinsic coagulation mechanism.

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MATERIALS PROVIDED

Cephalinex Reagent, 20 x 3.0mL.

Reagents and Materials Required but Not Provided

Purified Water (Distilled, Deionized, Reagent Grade), pH 5.3 – 7.2 for reconstitution
Pipettes (3.0mL and 0.1mL volume capacities)
Citrated control plasmas
Calcium Chloride, 0.025M

REAGENT STORAGE

Upon receipt, store Cephalinex Reagent at 2 – 8° C in its original packaging.
Reconstituted Cephalinex Reagent is stable for 7 days when stored in its’ tightly capped, original container at 2 – 8° C.

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Bio/Data Corporation's Commitment to IVDR Compliance
Bio/Data Corporation proudly complies with the stringent EU In Vitro Diagnostic Regulation (IVDR) 2017/746 and other relevant legislation. Through its Declaration of Conformity (DOC), the company ensures that its devices meet essential health, safety, and environmental standards.

Bio/Data Corporation's Commitment to UKCA Compliance
Bio/Data Corporation ensures product excellence by strictly adhering to UKCA regulations. The company's Declaration of Conformity (DOC) affirms its dedication to meeting health, safety, and environmental standards outlined in UKCA directives and any related updates, demonstrating its unwavering commitment to compliance.

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CEPHALINEX® APTT Reagent

Cephalinex® Advances APTT Monitoring in Coagulation Studies

Cephalinex® is a lyophilized preparation of rabbit brain cephalin and particulate (microsilica) activator. Cephalinex supplies the platelet phospholipid substitute and negatively charged surface required for plasma coagulation to occur by way of the intrinsic hemostatic pathway.

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Perform Activated Partial Thromboplastin Time

Monitor Intravenous Heparin Anticoagulation Therapy

Screen for Deficiencies or Abnormalities of Coagulation Factors

Lyophilized for Long Term Storage & Stability