Lyphochek Tumor Marker Plus Control

Lyphochek Tumor Marker Plus Control

Overview

A lyophilized, human serum-based control for monitoring the precision of both routine and esoteric tumor marker testing procedures

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Description

Description

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Lyphochek Tumor Marker Plus Control is a lyophilized, human serum-based control that is designed to monitor the precision of tumor marker testing procedures in clinical labs. This multi-analyte control features 24 routine and esoteric cancer antigens and popular tumor markers. The product is provided in lyophilized form for ease of storage and increased stability, and it offers additional analytes compared to the liquid control.

Lyphochek Tumor Marker Plus Control offers a comprehensive menu of cancer antigens and tumor marker analytes designed to cover a variety of cancer-related disease states, and it can be used on most major testing platforms for cancer screening. The control is available in three levels. Multiple levels allow for monitoring of test system reliability. 

 

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Features

  • Consolidated menu of analytes—Contains more than 20 serum proteins and analytes, including cancer antigens and Ferritin for monitoring clinical tumor marker testing 
  • Patient-like material—Lyophilized, human serum-based control 
  • Multiple levels—Trilevel control offers increased assay range monitoring  
  • Extensive value assignment listings—Allows for use across major immunoassay platforms to help consolidate and streamline workflows 
  • 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
2 mL 14 day reconstituted stability at 2-8°C for most analytes 3 year shelf life at 2-8°C 1, 2, 3 & Trilevel MiniPak Standard vial

 

Analytes

    • β-2-Microglobulin
    • ACTH
    • Aldosterone
    • Alphafetoprotein (AFP)
    • CA 15-3
    • CA 19-9
    • CA 27.29
    • CA 50*
    • CA 72-4*
    • CA 125
    • Calcitonin
    • Carcinoembryonic Antigen (CEA)
    • CASA*1
    • Cyfra 21-1*
    • Ferritin
    • hCG
    • hCG-β Subunit
    • Neuron Specific Enolase (NSE)*
    • PAP
    • Prolactin
    • PSA (Free)
    • PSA (Total)
    • S-100*
    • Thyroglobulin (Tg)

*International Use Only. Not available for diagnostic use in the United States.

1 No claim is made for expected values or stability

Refer to My eInserts or the package 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 2.0 mL of distilled or deionized water. Replace the stopper and allow this product to stand for approximately 15 minutes swirling occasionally. Gently swirl the vial several times to ensure homogeneity. After each use, promptly replace the stopper and return to 2-8°C storage.

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

 

Related Products

Immunoassay Controls 
Immunology/Protein Controls
InteliQ Controls

 

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 package insert (IFU) for product specific diluent and 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 package insert (IFU). Prior to use, gently swirl the vial to ensure homogeneity. Refer to the procedure section of the package insert (IFU) 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 package 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 (IFU) for product-specific handling instruction.
What are the acceptable limits for room, refrigerator, and freezer temperature?
This information is stated in the package insert:
  • 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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367
Assayed, human serum based control for monitoring the precision of cancer antigen and tumor marker assays; level 1 of 3 (6 x 2 mL)
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368
Assayed, human serum based control for monitoring the precision of cancer antigen and tumor marker assays; level 2 of 3 (6 x 2 mL)
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369
Assayed, human serum based control for monitoring the precision of cancer antigen and tumor marker assays; level 3 of 3 (6 x 2 mL)
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368X
Assayed, human serum based control for monitoring the precision of cancer antigen and tumor marker assays; Trilevel MiniPak (3 x 2 mL)

Accessories

Accessories

Image
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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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