An important indicator of ovarian reserve is a blood test called Anti Mullerian Hormone. It is a very sensitive marker of ovarian reserve used by fertility clinics, with the analysis performed in the Clinical Laboratory.

The ADP Tri-Level anti-Mullerian Hormone (MIS) Quality Control set is designed to monitor the performance of AMH immunoassays.  This quality control has been validated against the Roche (ECLIA) immunoassay on the Roche Cobas analysers. This is a new product that enables clinicians to have a 3rd party QC for their laboratories. 

The quality control has been developed in conjunction with the Royal Victoria Hospital in Belfast, Northern Ireland.  The levels have been chosen to reflect critical clinical cut-off values around 12 pmol/L, a mid assay and an elevated level of 47 pmol/L, to check the linearity of the assay.

Stored frozen, defrosted it is stable for 7 days.  The kit contains 2 bottles of each level, 3 levels, and 2 mls per vial ( 2 x 3 x 2ml).

Contact ADP Diagnostics for further information or for more information on our range of niche quality controls click here.

Further references:

References: Clinical Biochemistry    Volume 49, Issue 3, February 2016, Pages 260–267

(The 2013 National Institute for Health and Care Excellence (NICE) clinical guideline for fertility and the European Society of HumanReproduction and Embryology (ESHRE) recommend AMH measurement as one method to predict ovarian response to gonadotropin stimulation [12] and [13]. The NICE guideline states that AMH concentration of ≤ 0.75 ng/ml (≤ 5.4 pmol/L) indicates a low ovarian response to stimulation, whereas AMH concentration ≥3.50 ng/ml (≥ 25.0 pmol/L) indicates a high response [12]. It follows that precise and accurate AMH measurement in these intervals is a prerequisite for reliable interpretation of AMH results in a clinical setting)         

PSA Ultra Low Quality Control is a product that we developed in response to numerous requests for a low level control to keep pace with the ever-increasing sensitivity of PSA assays. The control is widely used in Ireland by cancer testing centres as it is ideal for monitoring PSA levels post-prostatectomy. 

The control is validated against the Roche immunoassay on the Roche Cobas® analyser.

The ‘PSA: Low level’ control is manufactured as stabilised serum from human origin. The concentrations of the QC have been chosen to ensure optimal assay performance at a critical sensitivity level.

A low level or undetectable PSA level is defined as ≤0.06 ng/mL or 0.02ng/mL by the ‘American Society for therapeutic radiology and oncology consensus panel’. As defined by the intuition it is agreed that a 6-12 month ‘undetectable PSA’ level is a prediction of disease-free survival ‘DFS’. Therefore an ultra-sensitive assay is beneficial. 

Reference: Int. J. Radiation Oncology Biol. Phys Vol.37 No.5 pp 1035-1041, 1997 

The control is stable up to the expiry date when stored at 2-8°c. When opened the control is stable for a period of 14 days when stored at 2-8°c. The kit size is 10 x 1ml. 

Contact us for instrument specific values or further information. 

2018 was a fabulous year for ADP Diagnostics.  New innovative products coming on stream, like Ultra Low PSA Control, Supplying Prop Bio Qual with 3 distributions of Custom Serum Indices Controls, and continued supply of QC to SNEQAS in Slovenia.  We are all looking forward to a great 2019

Simon Boyd of PWC

I enjoyed interviewing Greg Simpson , as he discussed his exporting journey for his company ADP Diagnostics. Its refreshing that even small companies can make a difference around the world. #5daysof, #trade, #export, #LeadingNI @PwC_NI

ADP Diagnostics are proud to announce our latest export market is South Korea.  Recent discussions with a major South Korean company manufactuing Point of Care Diagnostic Tests and Readers have come to fruition, with our first shipment of Anti Mullerian Hormone Quality Controls, QCAMH.  This is our multi-level control covering values from low to elevated, ~2.5 pmol/L > 65 pmol/L.

ADP Diagnostics are proud to announce our new association withone of France's major EQA Scheme organisers.  ADP Diagnostics will be providing a bespoke Serum Indices solution for ProBioQual for their new Serum Indices scheme.  Included in this will be the world's only 3 in 1 Serum Indices material, making this scheme the first in the world to offer such a product.

We wish ProBioQual well with this venture, and we wil be working closely with them to ensure all their clients are happy.

A BIG THANK YOU TO EVERYONE

WHO VISITED OUR BOOTH AT:

AND HELPED MAKE IT A VERY

     SUCCESSFUL SHOW

In a first for ADP Diagnostics, we have secured a contract to supply the Slovenian National EQA Scheme, SNEQAS with 3 materials for different schemes.  2 of these products were custom manfactured to the Scheme's specifcations, both in terms of analyte values, and fill volumes.

If you require a speciality or custom manufactured control for your EQA scheme, please contact us.

ADP Diagnostics are pleased to announce the appointment of AKSA Medical to represent us in the Benelux countries,

AKSA Medical

Kasper Scholte Albers

Spoorakkerweg 11

5071NC Udenhout

The Netherlands

Tel:      +31 (0) 13 590 58 00                               Fax:     +31 (0) 13 590 57 44

Mobile: +31 (0) 6 305 320 86

e-mail: k.scholtealbers@aksamedical.com           www.aksamedical.com

Every day in hospital laboratories across the world, millions of patient samples are being scanned on automated analysers for compromised samples. The ‘flag’ rate for compromised samples from Serum Indices (Haemolysis, Icterus and Lipaemia) can be up to 10%. However, how do we know that the automated analysers are accurately scanning the samples for Serum Indices?

Until recently, there has been no way to routinely check the indices-scanning performance of automated analysers. As well as this, developmental trials have shown differences of up to 10% between ‘analytical lines’. One analyser can exclude 10% more results than another analyser even in the same laboratory.

ADP Diagnostics has developed the world’s first Serum Indices Quality Control material to allow laboratories to check that their analysers are accurately scanning and flagging compromised samples.

The Serum Indices Quality Control is available as a frozen liquid stable product with all 3 parameters combined into one control. The control is available in 3 levels, 1+, 2+ and 3+. We have developed instrument specific controls suitable for Roche, Abbott and Beckman analysers. Pack size is 4 x 3 levels x 5ml.

Our Serum Indices Quality Control is the only 3rd party QC sera available on the market and is therefore essential for any laboratory that needs to comply with national and international standards, such as ISO 15189 accreditation.

The product is currently being used by hospital laboratories throughout the UK and Ireland, Europe and Australia.

ADP Diagnostics will have the official international launch of the Serum Indices Quality Control sera at Medica 2016 in November where we will be participating as an exhibitor. For more information on the product and market feedback, please visit our stand in Hall 1 F07.