Abbott/Cholestech Cholestech Quality Control

Yes, this quality control material is specifically formulated for precise diagnostic calibration and quality assurance when used with the Abbott/Cholestech LDX system.

It is an essential reagent for maintaining the reliability and accuracy of your test results.

Key details about this product line:

• Intended Use: Quality Control and Calibration Verification.
• Analytes: Configurations are available for testing high-sensitivity C-Reactive Protein (hs-CRP), as well as Multianalyte Controls covering Lipid, Glucose, ALT, and AST.
• Storage Requirement: To maintain integrity, the material must be shipped and stored refrigerated, specifically between 36
  T0 46
  F.
• Shelf Life: The general shelf life is 12 months from the date of manufacture.

Yes, the quality control materials, including the hs-CRP Control, are specifically designed and formulated for essential quality control and calibration verification using the Abbott/Cholestech LDX system.

These materials are vital for ensuring the accuracy and reliability of diagnostic results. The product line includes variants that verify performance for several critical analytes, such as:

• High-Sensitivity C-Reactive Protein (hs-CRP)
• Lipid
• Glucose
• ALT
• AST

Note: These control materials require specific handling, including refrigerated shipping and storage between 36°F to 46°F (2.2°C to 7.8°C).

Yes, these Abbott/Cholestech Quality Control materials are subject to strict requirements, as they are specifically designed for professional laboratory use with the LDX system.

Key purchasing and usage restrictions include:

• Prescription Required (Rx): These controls are classified as Rx products, meaning professional authorization or a valid prescription is mandatory for purchase.
• Dealer Restriction: Specific configurations and variants are only available for purchase by Authorized Dealers.
• System Specificity: The materials are validated and intended exclusively for use with the Abbott/Cholestech LDX system.

Yes, this quality control material is essential for maintaining regulatory compliance and ensuring the accuracy of the Abbott/Cholestech LDX system.

It must be integrated into laboratory quality assurance protocols for calibrating and monitoring system performance.

• Primary Function: The standard control targets hs-CRP (high-sensitivity C-Reactive Protein) assays.
• Other Configurations: Multianalyte control variants are available to verify measurements for Lipid, Glucose, ALT, and AST.

The Cholestech LDX system requires specialized quality control and calibration materials to ensure accurate and reliable results. Several configurations are available, catering to different verification needs:

• Multianalyte Controls: Offered in Level 1 and 2 sets, these comprehensive controls verify multiple critical assays, including Lipid, Glucose, ALT, and AST.
• Calibration Verification Material: This material validates the system’s calibration across Levels 1 through 4, typically for Lipid and Glucose assays.
• hs-CRP Control: This is a dedicated control material used specifically to monitor the performance of the high-sensitivity C-Reactive Protein (hs-CRP) diagnostic assay.

These controls are generally available in different vial volumes, such as 2mL or 0.25mL, depending on the specific configuration chosen.

Yes, strict cold chain management is mandatory to maintain the integrity and accuracy of these quality control materials for the Cholestech LDX system.

• Required Storage Temperature: The reagents must be stored under refrigeration, specifically between 36°F and 46°F.
• Shipping Requirements: These materials require refrigerated shipping (expedited shipment is required for specific variants, such as the 0.25mL Multianalyte Controls, to ensure the temperature is maintained during transit).

The standard shelf life for the Abbott/Cholestech quality control materials is generally 12 months from the date of manufacture. The precise expiration date is always printed on the product label.

Note on Specific Variants: Please be aware that some configurations, such as the 0.25mL Multianalyte Controls, may have a shorter maximum shelf life (e.g., 7 months), or may be short-dated upon purchase.

Required Handling and Storage

To ensure the stability and accuracy of the controls, strict cold chain requirements must be followed:

• Storage: Materials must be stored within the refrigerated temperature range of 36°F to 46°F.
• Shipping: Certain configurations require refrigerated and expedited shipment.

Yes, access to the Abbott/Cholestech Quality Control materials is restricted. Most configurations are For Authorized Dealers Only, and all listed variants also require Rx (prescription) status for purchase.

The Multianalyte Controls for the Cholestech LDX system cover comprehensive assays for the following analytes:

• Lipid
• Glucose
• ALT
• AST

These quality control materials are typically offered in Level 1 and Level 2 configurations.

Yes, the comprehensive Calibration Verification Material is available in multiple levels to ensure thorough quality control on the Cholestech LDX system.

This material is offered in a set covering Levels 1 through 4. These levels are specifically designed for the Lipid and Glucose assays.