Anti-Müllerian Hormone (AMH) Quality Control

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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 -, +, ++ & +++
DescriptionPack Size AnalytesCat. Number
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 for ease-of-use stability
  • Aqueous Material
  • 4 Clinically relevant levels (including Ultra-Low)
  • Stable to expiry date at -18-24ºC storage
  • 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 ml2CQ10453
Cardiac Control Level 1Roche (NT proBNP) & Abbott (Troponin I)3 x 3 ml2CQ10454
Cardiac Control Level 2Roche (NT proBNP) & Abbott (Troponin I)3 x 3 ml2CQ10455
Cardiac Control Level 3Roche (NT proBNP) & Abbott (Troponin I)3 x 3 ml2CQ10456
Cardiac Control Ultra LowSiemens3 x 3 ml2CQ10428
Cardiac Control Level 1Siemens3 x 3 ml2CQ10429
Cardiac Control Level 2Siemens3 x 3 ml2CQ10430
Cardiac Control Level 3Siemens3 x 3 ml2CQ10431

Analytes

  • Troponin I
  • NT-proBNP

Neonatal Bilirubin External Quality Assessment

The RIQAS Neonatal Bilirubin EQA programme has been designed to assess the performance of total and direct bilirubin assays with levels tailored to neonatal bilirubin testing.

  • Lyophilised for enhanced stability
  • Monthly reporting
  • Human based serum
  • Submit results and view reports online via RIQAS.net
  • Rapid turnaround of reports allows for any necessary corrective actions to be taken with minimal disruption to laboratory output

Not accredited to ISO/IEC 17043

Cat NoKit SizeFrequencyCycle StartParameters 
RQ91912 x (6x3ml)MonthlyJuly2

Parameter

  • Direct Bilirubin
  • Total Bilirubin

Please note, product availability may vary country to country.


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 Driect and Total Bilirubin. With a 14 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 14 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

Related Products


Troponin T Quality Control

Therapeutic Drug Quality Control

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

Features & Benefits

  • Liquid for ease-of-use stability
  • Aqueous based material
  • Ultra low levels of Troponin T
  • Stable to expiry date at -18-24ºC storage
  • Thawed stability of 7 days at 2°C – 8°C
DescriptionSize AnalytesCat No 
Troponin T Control6 x 3 ml1CQ10450

Analytes

  • Ultra low Troponin T

Linearity Verifier Sets

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Challenge your Instrument Throughout the Reportable Range with Acusera Linearity Verifier Sets

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    Complimentary data reduction software is provided delivering an immediate indication of performance.
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    Samples are provided in a user-friendly format with both liquid and lyophilised options available.
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    An extended open vial stability keeps waste to a minimum and ensures availability of product for troubleshooting.
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    Supplied in a minimum of 5 levels to accurately challenge the AMR and remove the need for manual dilution.
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    Ensure specific instrument requirements are met with the availability of dedicated solution for both Roche Cobas and Beckman systems.
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    Multi-analyte calibration verifiers will reduce costs, storage space and the number of products required to cover your test menu.
Solutions for Roche Cobas Analysers

 

Solutions for Beckman Analysers

 

Calibration verification or linearity assessment is defined as the testing of materials of known concentration in the same manner as patient specimens to ensue the test system is accurately measuring samples throughout the reportable range.

CLIA recommend calibration verification once every six months and/or in the event of; a reagent lot change, major preventative maintenance, replacement of critical parts, when QC materials are outside acceptable limits or reflect an unusual trend and as part of new instrument validation.

Our Acusera range of instrument dedicated verifiers are designed to challenge the entire analytical measuring range whilst helping to meet the CLIA requirements. Our range covers Clinical Chemistry, Bilirubin, Apolipoproteins, Enzymes, CRP, Esoterics, Lipids, TDM‘s and more.

Quality Control

Resource Hub

Contact Us


Bilirubin Linearity Verifier

Therapeutic Drug Quality Control

Our Bilirubin verifier contains both Direct Bilirubin and Total Bilirubin so testing is fully covered. Dedicated for use on Roche
Cobas systems, this verifier spans five levels ensuring the instruments entire reportable range is measured.

Features & Benefits

  • Lyophilised for enhanced stability
  • 5 levels provided
  • Open vial stability of 10 days at 2ºC to 8ºC
  • Shelf life of up to 2 years from date of manufacture
DescriptionSizeAnalytesCat No 
Acusera Enzyme Linearity Verifier5 x 3mL10LV10366

Analytes

  • Direct Bilirubin
  • Total Bilirubin

Enzyme Linearity Verifier

Therapeutic Drug Quality Control

Our Enzyme Linearity Verifier contains 10 commonly tested enzymes in one unique multi-marker verifier allowing you to
consolidate testing. Spanning 5 clinical levels, this verifier ensures the systems entire reportable range is measured. Designed
specifically for use with Roche Cobas systems, our Verifier is available in a convenient liquid frozen format.

Features & Benefits

  • Convenient, liquid frozen format
  • 5 levels provided
  • 14 day stability when stored at 2ºC to 8ºC
  • Shelf life of up to 2 years from date of manufacture
DescriptionSizeAnalytesCat No 
Acusera Enzyme Linearity Verifier5 x 3mL10LV10366

Analytes

  • ALT
  • ALP
  • a-Amylase
  • Pancreatic Anylase
  • AST
  • CK
  • CKMB
  • yGT
  • LDH
  • Lipase

Clinical Chemistry Linearity Verifier

Therapeutic Drug Quality Control

Our Clinical Chemistry Linearity Verifier comprises 17 common chemistry assays, supplied in a liquid frozen format. Designed specifically for use on Roche Cobus analysers, this verifier spans five levels ensuring the instruments entire reportable range is measured.

Features & Benefits

  • Convenient, liquid frozen format
  • 5 levels provided
  • 7 day stability when stored at 2ºC to 8ºC
  • Shelf life of up to 2 years from date of manufacture
DescriptionSizeAnalytesCat No 
Acusera Verify Clinical Chemistry Linearity Verifier5 x 5mL17LV10390

Analytes

  • Albumin
  • BUN
  • Calcium
  • Chloride
  • Creatinine
  • Glucose
  • Iron
  • Lactate
  • Lithium
  • Magnesium
  • Phosphate
  • Potassium
  • Sodium
  • Total Protein
  • Triglycerides
  • Uric Acid
  • Total Cholesterol

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