Lyphochek Coagulation Control

Lyphochek Coagulation Control

Overview

Designed to monitor the precision of routine coagulation assays, including levels of PT, APTT, Fibrinogen, Antithrombin III and Thrombin Time

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Description

Description

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Lyphochek Coagulation Control is an assayed, lyophilized, human-plasma control designed to monitor the precision of routine coagulation tests, including normal and abnormal levels of PT, APTT, Fibrinogen, Antithrombin III and Thrombin Time. The product is provided in lyophilized form for ease of storage and increased stability. Extended open-vial stability helps to reduce the cost of daily QC and offers even more value where QC testing must be performed on every shift.

The control is available in three levels, which allows for monitoring of test system reliability. The independent Lyphochek Coagulation Control can be used on a variety of systems, including Siemens BCS, Sysmex CA, Diagnostica Stago STA, Instrumentation Laboratory ACL and ELECTRA, and Trinity Biotech AMAX.

 

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Features

  • Consolidated menu of analytes—Contains multiple analytes for routine coagulation assays, including PT, APTT, Fibrinogen, Antithrombin III and Thrombin Time
  • Patient-like material—Lyophilized, human-plasma control
  • Multiple levels— Trilevel control offers test system reliability monitoring
  • Ease of use—Can be easily stored and offers increased stability
  • Long shelf life—Reduces crossover studies which helps simplify workflow

 

Storage & Stability

Configuration Stability Shelf life Levels Format
1 mL (x12) • 48 hour open-vial stability at 2-25°C
3 year shelf life at 2-8°C 1, 2, 3 Standard vial
1 mL (x3) one of each level • 48 hour open-vial stability at 2-25°C
3 year shelf life at 2-8°C  MiniPak Standard vial

 

Analytes

  • Activated Partial Thromboplastin Time (APTT)
  • Antithrombin III (AT III)
  • Fibrinogen
  • Prothrombin Time (PT)
  • Thrombin Time (TT)

Refer to My eInserts or the product insert (IFU) of currently available lots for specific analyte and stability claims.

 

Application & Use

This product should be treated the same as patient specimens and used in accordance with the instructions accompanying the instrument, kit or reagent.

Using a volumetric pipette or equivalent, reconstitute each vial with 1.0 mL of distilled or deionized water. Replace the stopper and allow this product to stand for approximately 10 to 15 minutes swirling occasionally. Before sampling, gently swirl the vial several times to ensure homogeneity. After each use, promptly replace the stopper and return to the appropriate storage condition.

If the reconstituted product has been stored frozen, allow it to reach room temperature (18°C to 25°C) before use. Before sampling, gently swirl the vial several times.

 

Related Products

Lyphochek Hemostasis Control
Liquichek D-Dimer Control

 

Frequently Asked Questions

After use, how long can the control product be left out before return to refrigerator?
Typically, if the product has been stored refrigerated, allow the product to reach room temperature (18°C to 25°C) before use (specific time limitations may apply, depending on the product). For optimal analyte stability, promptly return the product to the recommended storage temperature after each use.
What type of water should be used to reconstitute lyophilized control products?
Typically, distilled or deionized water is used. Please refer to the product insert (IFU) for product specific reconstitution instructions.
How long should the reconstituted control remain at room temperature prior to use?
Upon reconstitution, the stopper should be replaced and the product should be allowed to stand at room temperature for the time period indicated in the product insert (IFU). Prior to use, gently swirl the vial to ensure homogeneity. Refer to the procedure section of the package insert for product-specific handling instructions.
How long should frozen liquid controls sit at room temperature in order to thaw?
Typically, the frozen product should be allowed to thaw at room temperature (18°C to 25°C) for the time indicated in the product insert (IFU) or until completely thawed prior to use. The product vial should be swirled gently to ensure homogeneity prior to use. Refer to the procedure section of the package insert for product-specific handling instruction.
What are the acceptable limits for room, refrigerator, and freezer temperature?
This information is stated in the product insert (IFU):
  • Room temperature: 18°C to 25°C
  • Refrigerator temperature: 2-8°C
  • Freezer temperature: -20°C to -70°C/-20°C to -50°C for 2.5 mL vial

Most frozen products recommend avoidance of frost-free freezers. There are exceptions, so refer to specific control insert.

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744
Assayed, lyophilized human plasma control for monitoring precision of routine coagulation assays; level 1 of 3 (12 x 1 mL)
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745
Assayed, lyophilized human plasma control for monitoring precision of routine coagulation assays; level 2 of 3 (12 x 1 mL)
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746
Assayed, lyophilized human plasma control for monitoring precision of routine coagulation assays; level 3 of 3 (12 x 1 mL)
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745X
Assayed, lyophilized human plasma control for monitoring precision of routine coagulation assays; trilevel MiniPak (3 x 1 mL)

Accessories

Accessories

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987000
Disposable plastic tip accessories for quality controls fitted with a screw cap closure. Enables fluid delivery directly from glass vial. 100/Package.

Documents

Documents

Number Description Options
Q-1118
Quality Control Products & Services Catalog
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