Maternal Screening Control

Background

A maternal serum screening test (MSS) is a blood test offered to pregnant women that helps determine the risk of Down’s syndrome and other chromosomal conditions, further testing can be offered if the patient is found to be high risk. It can be performed at 10 weeks (combined first trimester screening test), and 14-20 weeks (second trimester maternal serum screening test).

MSS is generally offered to all pregnant women, but the decision to have the test is a personal decision.

Quality Control is an important part of any diagnostic test but is of particular importance in screening methods, when a disorder must be detected without the presence of symptoms. In such screening methods, errors can present as false negative or false positive results both of which can have devastating consequences.  In the case of maternal screening a false positive result could mean additional and often invasive procedures which can carry risk of harm to the unborn child. The accuracy and reliability of the laboratory test results are extremely important in minimising both false positive and false negative results.

Product Overview

The Randox Acusera Maternal Screening quality control is the only commercially available control which covers all six analytes used during first and second trimester screening of Down’s syndrome and Spina Bifida.

Instrument specific target values and ranges are provided for AFP, Inhibin A, PAPP-A, β hCG, Total hCG and Unconjugated Estriol. The inclusion of PAPP-A and Inhibin A eliminates the need to purchase additional controls at extra expense.

Key Benefits & Features

• Lyophilised for enhanced stability
• 100% human serum
• Assayed target values provided for 6 parameters
• Suitable for double, triple and quad screens
• Unconjugated Estriol present at clinically significant levels
• Reconstituted stability of 7 days at 2°C – 8°C
• Stable to expiry date at 2°C – 8°C

Consolidation

As a leading provider of multi-analyte, third party controls, Randox helps busy laboratories significantly reduce the number of controls needed to cover their test menu. Combining multiple analytes into a single control reduces cost, preparation time, and required storage space without sacrificing quality.

Analytes at key decision levels will not only ensure test system performance across the clinical range but will further aid consolidation and maximise laboratory efficiency by eliminating the need to purchase additional and often expensive low or high level controls.

First and second trimester

As the only control on the market to cover all first and second trimester analytes, you can be sure that your lab is covering all bases.

True third party control

The Acusera Maternal Screening Control is a true third party control designed to provide an unbiased assessment of performance with a range of instruments and methods, helping your laboratory meet the ISO 15189 requirements.

“the use of third party control materials should be considered,
either instead of, or in addition to, any control materials
supplied by the reagent or instrument manufacturer”.

• AFP
• PAPP-A
• Free Beta hCG

• Total hCG
• Inhibin A
• Unconjugated Oestriol