LTA CHECK™ √ Performance Monitoring Test Kit

< Return To Reagents

LTA Check™ √: A Performance Monitoring Test Kit for Ensuring Precision and Compliance in Light Transmission Aggregometers

LTA Check™ is a Performance Monitoring Test Kit used to verify the operation of Light Transmission Aggregometers (LTA) and provide instrument system quality control in the laboratory.

Verify Light Transmission Aggregometer Function
Standardize Instrument to Instrument and Site to Site Performance
Document Operator Proficiency
Identify and Reduce QC Variables
Ensure Precision and Reliability of Test Results
Comply with Laboratory Regulations

Catalog No.: 107117

Net Contents: Reagent 1 1 x 0.5 mL

Reagent 2 1 x 4.0 mL

Reagent 3 1 x 1.0 mL

LTA Diluent 1 x 10.0 mL

Ultrapure Water 1 x 1.0 mL

Laboratory testing demands a steadfast commitment to precision, and the LTA Check™ Performance Monitoring Test Kit emerges as a crucial asset in achieving this objective. Specifically engineered to validate and maintain the operational excellence of Light Transmission Aggregometers (LTAs), this innovative kit serves as a comprehensive solution for instrument system quality control.

Explore Product Data Sheet

Please explore the literature provided, encompassing the LTA Check™ Test Kit Product Data Sheet, the LTA Check™ Test Kit Instruction for Use (IFU), and the LTA Check™ Test Kit Safety Data Sheet (SDS) — available in seven languages. Additionally, for our European and United Kingdom customers and distributors, review the LTA Check™ Test Kit EU Declaration of Conformity and the LTA Check™ Test Kit UK Declaration of Conformity, to ensure compliance and understanding tailored specifically for these regions. This information is crucial for a comprehensive grasp of the product details and specifications.

Bio/Data Corporation’s Aggregation Reagents: Accessible Safety Data Sheets for Secure Handling

Bio/Data Corporation provides comprehensive Safety Data Sheets (SDS) for each of its carefully formulated aggregation reagents. These essential documents ensure safe handling, storage, and spill management while offering clear instructions on potential hazards. Designed for easy viewing, saving, and printing, the SDS are readily accessible to support a safe work environment and responsible chemical management.

Access Safety Data Sheet

Product Function

LTA Check™ Performance Monitoring Test Kit is designed to verify the performance and proper operation of Light Transmission Aggregometers. The system generates defined aggregation and slope responses that enable evaluation of instrument functionality, precision, and reproducibility under controlled conditions.

Review Instructions For Use

Specific Information Provided
LTA Check™ Performance Monitoring Test Kit is not intended for the detection of a specific disorder, condition, or risk factor.

This test kit provides information related to the performance of Light Transmission Aggregometers, including the consistency, precision, and reproducibility of aggregation parameters generated under defined test conditions. The results reflect instrument system functionality and are used to verify proper operation of the aggregation system.

Automation
LTA Check™ Performance Monitoring Test Kit is intended for use with semi-automated and automated Light Transmission Aggregometers (LTA).

Quality / Quantity
There are no primary standards for LTA Check™ Performance Monitoring Test Kit. The responses generated by this system are concentration dependent.

LTA Check™ Performance Monitoring Test Kit comes packaged as 1 x 0.5 mL vial of Reagent 1, 1 x 4.0 mL vial of Reagent 2, 1 x 1.0 mL vial of Reagent 3, 1 x 10.0 mL vial of LTA Diluent, and 1 x 1.0 mL vial of Ultra Pure Water.

Specimen Type
No patient specimen is required for use with the LTA Check™ Performance Monitoring Test Kit. The test system utilizes the reagents and diluent provided within the kit to generate controlled reactions for performance verification of Light Transmission Aggregometers.

In Vitro Diagnostic
LTA Check™ Performance Monitoring Test Kit is an in vitro diagnostic test kit intended for Professional Laboratory Use Only. It is not intended for injection or ingestion.

Test Principle
LTA Check™ Performance Monitoring Test Kit evaluates the performance of Light Transmission Aggregometers by generating a controlled agglutination reaction within the test system. When the reagents are combined under defined conditions and stirred at 37°C, agglutination occurs, resulting in measurable changes in light transmission. The Light Transmission Aggregometer detects these changes and expresses the reaction as functional parameters, including Final Aggregation (FA) and Slope (PS), which represent the extent and rate of the reaction. These parameters are used to verify the proper operation and performance of the instrument system.

READ MORE... Easily Download the LTA Check™ Test Kit Instructions for Use in Your Selected Language.

Reagents Provided
1 vial of Reagent 1 (0.5 mL)
1 vial of Reagent 2 (4.0 mL)
1 vial of Reagent 3 (1.0 mL)
1 vial of LTA Diluent (10.0 mL)
1 vial of Ultra Pure Water (1.0 mL)

Materials and Accessories
No additional reagents are required for use with the LTA Check™ Performance Monitoring Test Kit. All necessary reagents and diluents are provided.

Materials and Accessories

Platelet Aggregometer (Follow the Manufacturer’s Instructions for Use)
Electronic Pipette
Pipette Tips
Aggregometer Test Tubes (Siliconized)
Aggregometer Stir Bars (Plastic Coated)
Plastic Sample Tubes and Caps (for Dilutions)

Storage and Stability

LTA CheckTM Performance Monitoring Test Kit does not require temperature protection during shipment.
Upon receipt, store Reagent 1, Reagent 2, Reagent 3, LTA Diluent, and Ultra Pure Water at 2 – 8° C in their original packaging.
Reconstituted Reagent 1 is stable for 7 days when stored in its tightly capped, original container at 2 – 8° C.
Reconstituted Reagent 2 is stable for 30 days when stored in its tightly capped, original container at 2 – 8° C.
Reconstituted Reagent 3 is stable for 8 hours when stored in its tightly capped, original container at 2 – 8° C.

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

LTA CHECK™ √ Performance Monitoring Test Kit

LTA Check™ √: A Performance Monitoring Test Kit for Ensuring Precision and Compliance in Light Transmission Aggregometers

LTA Check™ is a Performance Monitoring Test Kit used to verify the operation of Light Transmission Aggregometers (LTA) and provide instrument system quality control in the laboratory.

Verify Light Transmission Aggregometer Function

Standardize Instrument to Instrument and Site to Site Performance

Document Operator Proficiency

Identify and Reduce QC Variables

Ensure Precision and Reliability of Test Results

Comply with Laboratory Regulations