LUPUS ANTICOAGULANT CONFIRMATION
REAGENT™ (LACR) Platelet Extract Reagent

Lupus Anticoagulant Confirmation Reagent™: Validating Lab Results with Precision and ISTH Compliance

Lupus Anticoagulant Confirmation Reagent™ is a platelet phospholipid solution used to perform the platelet neutralization procedure. Use of the LA-CR test kit confirms that previous laboratory results have correctly flagged a sample as containing the lupus anticoagulant.

Optimized Source of Human Phosphatidyl Platelet Phospholipids
Used to Perform Platelet Neutralization Procedure (PNP) Needed as Part of a Multi-Test Investigation for the Presence of the Lupus Anticoagulant
Meets ISTH Guidelines for Confirmatory Testing by Providing Additional
Phospholipids to Patient Sample and Control Plasma

Catalog No.: 102516

Net Contents: 5 x 1.0 mL

Lupus Anticoagulant Confirmation Reagent™ serves as a crucial platelet phospholipid solution designed for the execution of the platelet neutralization procedure (PNP). This innovative LA-CR test kit plays a pivotal role in confirming the accuracy of previous laboratory results, specifically identifying samples that contain the lupus anticoagulant.

Functioning as an optimized source of human phosphatidyl platelet phospholipids, this reagent is integral for conducting the Platelet Neutralization Procedure (PNP). This procedure is a vital component of a comprehensive multi-test investigation aimed at detecting the presence of the lupus anticoagulant in patient samples. Adhering to the guidelines set forth by the International Society on Thrombosis and Haemostasis (ISTH), our test kit ensures confirmatory testing by providing additional phospholipids to both patient samples and control plasma.

Explore Product Data Sheet

In cases where an undetermined prolonged activated partial thromboplastin time (APTT) is observed, the likely culprit is the presence of the lupus anticoagulant in the plasma. The inhibitory activity of this anticoagulant is often evident in phospholipid-dependent coagulation reactions, with a higher frequency in APTT compared to Prothrombin Time (PT). The introduction of Lupus Anticoagulant Confirmation Reagent effectively shortens the APTT time that is prolonged in the presence of the lupus anticoagulant. Consequently, the platelet neutralization procedure emerges as a valuable diagnostic test, enabling the differentiation of lupus anticoagulant from specific factor inhibitors, such as Factor VIII inhibitor.

With a net contents of 5 x 1.0 mL, our Lupus Anticoagulant Confirmation Reagent™ stands as an indispensable tool in enhancing the precision and reliability of lupus anticoagulant detection, contributing to more accurate and efficient diagnostic practices in the realm of coagulation studies.

Thoroughly examine the documentation available on this page, such as the Lupus Anticoagulant Confirmation Reagent™ (LACR) Product Data Sheet. Moreover, review the Lupus Anticoagulant Confirmation Reagent™ Instruction for Use (IFU) and the Lupus Anticoagulant Confirmation Reagent™ Safety Data Sheet (SDS), both offered in six languages. For customers and distributors based in Europe and the United Kingdom, conduct a comprehensive examination of the Lupus Anticoagulant Confirmation Reagent™ EU Declaration of Conformity and UK Declaration of Conformity to ensure conformity and a nuanced understanding. A thorough review of this information is crucial for a comprehensive understanding of the product's specifications and details

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Product Description

Lupus Anticoagulant Confirmation Reagent is a lyophilized preparation of phosphatidyl enhanced platelet phospholipid.

Review Instructions For Use

Intended Purpose

Lupus Anticoagulant Confirmation Reagent is the third test component, phosphatidyl platelet phospholipid solution, used after and with other IVD reagents to confirm the prior three previous tests correctly flagged a sample as one containing the lupus anticoagulant.

Test Principle

The most common cause of an UNDETERMINED prolonged APTT is the presence of the lupus anticoagulant in the plasma. The inhibitory activity is demonstrable in phospholipid dependent coagulation reactions, but is observed more often in the APTT than in the Prothrombin Time (PT). The addition of Lupus Anticoagulant Confirmation Reagent will shorten the APTT time that is prolonged in the presence of the lupus anticoagulant. Thus, the platelet neutralization procedure system is a valuable diagnostic test to differentiate lupus anticoagulant from a specific factor inhibitor (e.g. Factor VIII inhibitor).

An anticoagulant which prolongs the activated partial thromboplastin time (APTT) and occasionally the prothrombin time (PT) of otherwise normal plasma, but does not specifically inactivate any of the known clotting factors, has been designated as the "lupus" anticoagulant (LA). Laboratory diagnosis of the lupus anticoagulant is based on the presence in plasma of inhibitory activity in phospholipid-dependent clotting tests. In addition to the PT and the APTT, other tests for LA have included the tissue thromboplastin inhibition procedure (TTI), kaolin clotting time (KCT), and recalcified clotting time of platelet-rich plasma (PCT). Additionally, use of the dilute Russell Viper Venom Time (RVVT) and the dilute phospholipid APTT assay have been described. Several of these procedures have subsequently led to definitive studies of the role of phospholipids in the assessment of the presence of the lupus anticoagulant in plasma.

In this regard, Triplett et al introduced the platelet neutralization procedure (PNP) in 1983. They noted that the inhibitory effect of the lupus anticoagulant is neutralized by products of platelet lysis. Further, the platelet neutralization procedure appears useful in differentiating the lupus anticoagulant from factor specific inhibitors. The APTT of a lupus plasma is shortened whereas the result of a factor specific inhibitor plasma is not shortened. The test is highly specific in this regard, and has been alluded to or confirmed in studies described in recent reports

READ MORE... Easily Download the Lupus Anticoagulant Confirmation Reagent Instructions for Use in Your Selected Language.

Reagents Provided

Lupus Anticoagulant Confirmation Reagent, 5 x 1.0mL.

Reagents and Materials Required but Not Provided

Activated Partial Thromboplastin Reagent (Micro Silica Activator)
Calcium Chloride, 0.025 M
Normal Control Plasma
Purified Water (Distilled, Deionized, Reagent Grade), pH 5.3 – 7.2 for reconstitution
TRIS Buffered Saline (TBS) or 0.85% physiologic saline for dilutions

NOTE: USING BLOOD BANK SALINE WILL CAUSE ERRONEOUS RESULTS.

Materials and Accessories

Coagulation Analyzer: Optical, Automated, Semi-Automated or Manual
Electronic Pipette
Pipette Tip
Plastic Sample Tubes and Caps (For Dilutions)

Reagent Storage

Upon receipt, store Lupus Anticoagulant Confirmation Reagent at 2 – 8° C in its original packaging.
Reconstituted Lupus Anticoagulant Confirmation Reagent is stable for 30 days when stored in its’ tightly capped, original container at 2 – 8° C.

Lupus Anticoagulant Confirmation Reagent 102516 Vials Clear.png

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.

View EU Declaration of Conformity

View UK Declaration of Conformity

LUPUS ANTICOAGULANT CONFIRMATION REAGENT™ (LACR) Platelet Extract Reagent

Lupus Anticoagulant Confirmation Reagent™: Validating Lab Results with Precision and ISTH Compliance

Lupus Anticoagulant Confirmation Reagent™ is a platelet phospholipid solution used to perform the platelet neutralization procedure. Use of the LA-CR test kit confirms that previous laboratory results have correctly flagged a sample as containing the lupus anticoagulant.

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Optimized Source of Human Phosphatidyl Platelet Phospholipids

Used to Perform Platelet Neutralization Procedure (PNP) Needed as Part of a Multi-Test Investigation for the Presence of the Lupus Anticoagulant

Meets ISTH Guidelines for Confirmatory Testing by Providing Additional Phospholipids to Patient Sample and Control Plasma

LUPUS ANTICOAGULANT CONFIRMATION
REAGENT™ (LACR) Platelet Extract Reagent

Meets ISTH Guidelines for Confirmatory Testing by Providing Additional
Phospholipids to Patient Sample and Control Plasma