Pre-Eclampsia Control

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Pre-Eclampsia Control

The Pre-eclampsia Control is intended for use with in vitro diagnostic assays for the quantitative determination of placental growth factor (PlGF) and soluble fms‑like tyrosine kinase‑1 (sFlt-1) in human serum and plasma.
The Pre-eclampsia Control is assayed with target values and is suitable for use on various immunoassay analysers. The Pre-eclampsia Control is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.

Features & Benefits

  • – Liquid frozen for user convenience
  • – Human based serum ensuring a commutable sample matrix
  • – 30 days open vial stability when stored at 2ºC to 8ºC keeping waste and costs to a minimum
  • – True third party control providing an unbiased assessment of performance
  • – Assayed target values provided
DescriptionSizeAnalytesCat NoContact Us
Pre-eclampsia Control Level 1 3 x 2 x 2 ml2PE10527
Pre-eclampsia Control Level 23 x 2 x 2 ml2PE10528
Pre-eclampsia Control Level 33 x 2 x 2 ml2PE10529

 

Therapeutic Drug Quality Control

Analytes

  • – sFlt-1
  • – PIGF

Active Vitamin B12 Quality Control

The Randox Acusera Active Vitamin B12 Control is designed to deliver a cost-effective, high quality solution for use in the quantitative determination of Active Vitamin B12 in human serum and plasma.

The human material based Active B12 Controls are assayed with target values provided and are suitable for use on various analysers.

Features & Benefits

  • Liquid frozen for user convenience
  • Human based serum ensuring a commutable sample matrix
  • True Third Party control providing unbiased assessment of performance
  • An impressive open vial stability of 30 days at 2° to 8°C helping to keep waste to a minimum
DescriptionSizeAnalytesCat No
Active Vitamin B12 Control Level 13 x 2 ml1VB10524
Active Vitamin B12 Control Level 23 x 2 ml1VB10525
Therapeutic Drug Quality Control

Analytes

  • Active Vitamin B12 (Holotranscobalamin/HoloTC)

Bone Markers (Serum) Control

The Lyophilised Serum Bone Marker Control is intended for use with in vitro diagnostic assays for the quantitative determination of Procollagen Type 1 N-Terminal Propeptide (P1NP), N-MID Osteocalcin (OC) and Bone Alkaline Phosphatase (B-ALP) in serum samples.

This Lyophilised Serum Bone Marker Control is assayed with target values and is suitable for use on automated analysers.

Features & Benefits

  • – Lyophilised for enhanced stability
  • – True third party control providing an unbiased assessment of performance
  • – Three clinically relevant levels available
  • – Human based serum providing a matrix similar to the patient sample
  • – 1 year shelf life from date of manufacture allowing for long term QC monitoring and a decrease in new lot validation studies
  • – 14- day reconstituted open vial stability applies for PINP and B-ALP helping to keep waste to a minimum, 1-day reconstituted stability for N-MID Osteocalcin
DescriptionSizeAnalytesCat NoContact Us
Bone Makers (Serum) Control Level 1 6 x 2ml3SBM10574
Bone Makers (Serum) Control Level 26 x 2ml3SBM10587
Bone Makers (Serum) Control Level 36 x 2ml3SBM10588

 

Therapeutic Drug Quality Control

Analytes

  • – PINP
  • – N-MID Osteocalcin
  • – Bone-ALP

*No claims are made regarding values and stability.


Ultra-Low PSA Quality Control

Therapeutic Drug Quality Control

The Acusera ultra-low PSA control delivers a true third party solution for use in monitoring the performance of in vitro diagnostic assays used in the quantitative determination of low levels of PSA.

This control is suitable for use across a variety of platforms.

Name Unit Target Analyser
Ultra-Low PSA ng/ml 0.055 * Roche Cobas e801

* Example of values for Roche Cobas e801. Other systems may vary dependent on laboratory assignment. Typical values displayed, please see control IFU for lot specific values.

Features & Benefits

  • Impressive 30-day stability at +2°C to +8°C minimising waste
  • Liquid ready-to-use control ensuring minimal sample preparation
  • True third-party control providing an unbiased assessment of performance
  • Manufactured using human based material providing a matrix similar to the patient sample
  • 1 year shelf life from date of manufacture ensuring continuity of lot supply
  • Target values for specific instruments are available

This control is for Research Use Only (RUO)

DescriptionSizeAnalytesCat No
Ultra-Low PSA Control6 x 1ml1TU10523

Analyte

  • Total PSA

Xanthochromia Quality Control

The Randox Acusera Xanthochromia Control is designed to deliver a cost-effective, true third party solution for use in monitoring the performance of Bilirubin and Oxyhaemoglobin in Cerebrospinal Fluid (CSF) using a spectrophotometer.

Aqueous based with components of human origin, the Xanthochromia Controls are unassayed and are suitable for use with various UV spectrophotometers.

Supplied in a liquid frozen format, this control should be treated in the same manner as a patient sample.

Features & Benefits

  • Liquid frozen format for convenience and reduced handling errors
  • Human Based Material
  • True Third Party control providing unbiased assessment of performance
  • An Open Vial stability of 2 days at 2° to 8°C. Stable for 11 weeks when stored unopened at -18° to -24°C helping to keep waste to a minimum.
DescriptionSizeAnalytesCat NoContact Us
Xanthochromia Positive Control6 x 4 ml2XN10505
Xanthochromia Negative Control6 x 4 ml2XN10502
Therapeutic Drug Quality Control

Analytes

  • Billirubin
  • Oxyhaemoglobin

*No claims are made regarding values and stability.


BNP Quality Control

Therapeutic Drug Quality Control

The new Acusera BNP Control is designed for use with in vitro diagnostics assays for the quantitative determination of BNP in human serum and plasma. The BNP control delivers an unbiased independent assessment of analytical performance, helping to ensure accurate and reliable patient testing for BNP.

With a 30 day open-vial stability, the BNP control will reduce waste, whilst remaining easy and convenient to use.

This tri-level control is optimised for use on Beckman, Abbott and Siemens analysers however, it can be used across other platforms.  Our control will provide accurate and reliable results that your laboratory can trust.

Features & Benefits

  • 30-day stability at +2°C to +8°C minimising waste.
  • Liquid ready-to-use control ensuring no preparation of material is required and therefore eliminates manual error.
  • True third-party control providing an unbiased assessment of performance.
  • Manufactured using human serum providing a matrix similar to the patient sample.
  • Optimised for use with Abbott, Beckman and Siemens. Also suitable for use with other platforms.
DescriptionPack SizeAnalytesCat. NumberContact Us
BNP Controls (Beckman)3 x 1 x 1 ml1CQ10520
BNP Controls (Abbott)3 x 1 x 1 ml1CQ10521
BNP Controls (Siemens)3 x 1 x 1 ml1CQ10522

Analyte

  • Brain Natriuretic Peptide (BNP)

Anti-Müllerian Hormone (AMH) Quality Control

Therapeutic Drug Quality Control

The Randox Acusera AMH control is designed for use as a third-party control for the quantitative determination of Anti-Müllerian Hormone (AMH). An AMH test is often used to check a woman’s ability to produce eggs that can be fertilized for pregnancy. Thus, helping women to make informed decisions about their health.

Available in a liquid frozen format, this control should be treated in the same manner as a patient sample.

 

Features & Benefits

  • 30-day stability at +2°C to +8°C
  • Liquid Frozen format for convenience and reduced handling errors
  • True third-party control providing an unbiased assessment of performance
  • Manufactured using human serum, ensuring commutable sample matrix
  • Assayed target values provided eliminating the need to assign values in-house
  • Control available at recommended cut-off values for AMH

 

DescriptionPack SizeCat. NumberTypical Values
Beckman DXL / Roche ng/ml
AMH Control 13 x 2mlAMH105090.5
AMH Control 23 x 2mlAMH105141.0
AMH Control 33 x 2mlAMH105156.0
AMH Control 43 x 2mlAMH1051616.0

Analyte

  • Anti-Müllerian Hormone (AMH)

Serum Indices Quality Control

Therapeutic Drug Quality Control

The Randox Acusera Serum Indices control is designed to be used to monitor an IVD instrument’s response in the detection of haemolyzed, icteric and lipemic (HIL) samples. This control can be utilised in laboratory interference testing to assist in improving error detection of pre-analytical errors affecting clinical chemistry testing.

This control provides a full range of clinically relevant testing levels, including a negative (-) and three positives (+, ++ & +++)

Features & Benefits

  • Lyophilised for enhanced stability
  • Manufactured using human serum, ensuring commutable sample matrix
  • 2-year shelf life from date of manufacture
  • True third party control providing unbiased assessment of performance
  • Reconstituted stability of 14 days at 2°C – 8°C
  • 4 separate levels available including -, +, ++ & +++
DescriptionSizeAnalytesCat No
Serum Indices Control4 x 5 ml3SI10448

Analytes

  • Haemolysis (H)
  • Icterus (I)
  • Lipemia (L)

Cardiac Quality Control

Therapeutic Drug Quality Control

Intended for use with Roche Abbott and Siemens systems, this control is manufactured using only the highest quality material and offers a 7-day thawed stability at +2ºC to +8ºC.

This control provides a full range of clinically relevant testing levels, including High Sensitivity Troponin I.

Features & Benefits

  • Liquid Frozen
  • Aqueous Material
  • 4 Clinically relevant levels (including Ultra-Low)
  • Stable to expiry date at -20ºC to -80ºC
  • Thawed stability of 7 days at 2°C – 8°C
DescriptionOptimised forSize AnalytesCat No
Cardiac Control - Ultra LowRoche (NT proBNP) & Abbott (Troponin I)3 x 3 ml1CQ10453
Cardiac Control Ultra LowSiemens6 x 1 ml2CQ10428
Cardiac Control Level 1Siemens6 x 1 ml2CQ10429
Cardiac Control Level 2Siemens6 x 1 ml2CQ10430
Cardiac Control Level 3Siemens6 x 1 ml2CQ10431

Analytes

  • Troponin I
  • NT-proBNP

Liquid Bilirubin Control

Therapeutic Drug Quality Control

Providing a true third party solution for the measurement of Bilirubin, the new Acusera Liquid Bilirubin Control is designed to deliver an unbiased, independent assessment of analytical performance helping to ensure accurate and reliable patient testing.

Two levels are available, covering the required clinically relevant decision levels for neonatal testing of Direct and Total Bilirubin. With a 7 day open vial stability and 2 year shelf life the Acusera Liquid Bilirubin Control will reduce waste, whilst remaining easy and convenient to use.

Features & Benefits

  • Liquid frozen
  • 100% human serum
  • 2 year shelf life from date of manufacture
  • Clinically relevant decision levels, recommended by ISO15189
  • Open vial stability of 7 days at 2°C – 8°C
  • Assayed Control
  • CE Marked
DescriptionSizeAnalytesCat No.
Liquid Bilirubin Control Level 13x3mLDirect Bilirubin
Total Bilirubin
BR10442
Liquid Bilirubin Control Level 23x3mLDirect Bilirubin
Total Bilirubin
BR10443

 

Analytes

  • Direct Bilirubin
  • Total Bilirubin

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