Multichem NB

Third party, single elevated level, liquid stable quality control material to monitor the precision of laboratory testing procedures for Bilirubin and Theophylline Assays.

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Multichem NB third-party quality control vial

Product Description

Technopath's Multichem NB (Neonatal Bilirubin) Control is intended for use as a third party, single level, liquid stable quality control material to monitor the precision of laboratory testing procedures for Bilirubin and Theophylline Assays.

An important patient population is Neonates, where a requirement has been identified for testing conditions associated with Neonatal hyperbilirubinemia. The product also contains Theophylline, a therapeutic drug that is given to Neonates to improve lung capacity and where it would be required to monitor for toxicity risk. Caffeine is a listed analyte that is added gravimetrically, and this has a clinical function as the primary treatment of the breathing disorders apnea of prematurity.

Another important population is with any patient that has liver failure. It is important if  the laboratory tests hyperbilirubinemia patient samples that they analyze QC regularly to monitor this range to ensure accuracy and precision at these elevated  levels.

The requirement for a high concentration of Bilirubin presents a conflict for consolidation of multi-analytes. This means that not only is a separate paediatric control required, but a control matrix that is treated with antioxidants to inhibit the oxidation of Bilirubin. The application of the most appropriate measures to reduce the effect of oxidation on the high levels of Bilirubin in the Control have been researched to ensure that open vial and closed stability is maintained.

Multichem NB Control is designed as a single level, liquid stable frozen product. The product will typically be run as a supplementary high level control, in conjunction with at least one of the Multichem Serum Control levels, (S or S Plus) to provide a minimum of 2 levels of control to allow assay system performance monitoring within the analytical ranges. It will be run after reagent calibration and at a frequency dictated by laboratory QC procedures and reagent / instrument manufacturer instructions. The product should be treated the same as patient specimens and run in accordance with the instructions accompanying the instrument, kit or reagent being used. The control is to be stored at -20°C to –80°C and thawed as per IFU prior to use. The product is to be stored at 2 to 8°C between use. 

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Benefits

Satisfies regulatory guidelines for use of independent controls

Concentrations targeted at clinically relevant values

Long shelf life extends lot availability

Track product performance with IAMQC

Features

Frozen, Liquid stable, single level control

14 days open vial stability once thawed and stored at 2 to 8 degrees

36 months shelf life once stored at -20 to -80°C degrees

Third party independent quality control

Optimised and assayed for major IVD platforms

Human based materials used as part of manufacturing process

Mimics performance of commutable patient samples

Analyte List

Caffeine*

Total Bilirubin

Direct Bilirubin

Theophylline

*Please refer to lot specific package inserts for stability and performance claims.

Ordering

Name

Description

Kit

Part Code

Multichem NB

Assayed Single Level

12 x 2mL

NB800A

Multichem NB

Unassayed Single Level

12 x 2mL

NB800X

Multichem NB

Mini Kit - Unassayed Single Level

3 x 2mL

NB800MX

Name

Multichem NB

Description

Assayed Single Level

Kit

12 x 2mL

Part Code

NB800A

Name

Multichem NB

Description

Unassayed Single Level

Kit

12 x 2mL

Part Code

NB800X

Name

Multichem NB

Description

Mini Kit - Unassayed Single Level

Kit

3 x 2mL

Part Code

NB800MX

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Instructions For Use (IFU)

Multichem NB vial

Instructions For Use (IFU)

Log in to our Technical Library to access Multichem NB Instructions for Use (IFUs) and Data Sheets.

Technical Library

Safety Data Sheet

Multichem NB Neonatal Bilirubin quality control vial

Safety Data Sheet

Click below to access the general Technopath Safety Data Sheet (SDS) for Multichem NB.

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Why Technopath

Technopath was the first company in the world to develop truly consolidated third party quality controls for hospital laboratories.

Through the benefits of test consolidated QC, Technopath’s Multichem® customers have increased their laboratory efficiencies and reduced the cost of their quality control program.

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Our Clients

The main driver for change was a mandate to consolidate and improve workflow efficiencies. Reduced physical cost, coupled with a reduction in staff time, proved significant.

Blackrock Clinic Dublin - Eoin O’Rourke, Head of Pathology, Blackrock Clinic Ltd., Blackrock, Co. Dublin, Ireland

In 2017, Technopath signed a global agreement with Beckman Coulter Diagnostics.

"Technopath’s highly efficient QC solution will help Beckman Coulter customers address the strong and growing demand for multi-constituent quality control products, and meets the requirements of lab accreditation."

John Blackwood - Senior Vice President of Products and Services at Beckman Coulter.

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