MC Diagnostics

HAS YOUR COVID VACCINATION WORKED?

Mon, 08 Mar 2021 14:27:59 GMT

H as your Covid vaccination worked?

M C Diagnostics Ltd, a North Wales based company, has introduced the ability for individuals to check for COVID antibodies – both from natural infection and through vaccination. The results are reported to individuals through the V Health Passport App, which will allow any venue to check the antibody status of everyone using a simple scanner.

This development opens significant possibilities for the “return to normal” in many walks of life – spots events, theatres, festivals, pubs, clubs, large employers returning people to offices and international travel.

MCD originally developed the system for matching donors and recipients for transplantation. The system has been adapted to show whether or not the test subject has COVID antibodies and whether or not the antibodies are derived from natural infection or from vaccination.

Peter Maguire, CEO at MCD commented “The roll out of vaccination in the UK has been a tremendous effort. This service now offers individuals the chance to check that their own vaccination has been successful in providing protection from COVID and opens the potential for all crowd related events and international travel to begin returning to normal.”

The test, which can be booked online, involves the individual receiving a sampling kit through the post, taking a very small finger prick blood sample and returning it to the laboratory. Once the test is run, the individual will receive notification that their result has been incorporated into their V Health passport. Should the individual test negative for antibodies, they will be directly informed, with a recommendation to inform their GP in the event that they have already received a vaccination. For full information and to book a test, visit www.mcdiagnostics.co.uk and for information on the v health passport , visit www.v-healthpassport.co.uk or download the Vpassport app.

Further information : Peter Maguire Tel 07710 992480 or email peter.maguire@mcdiagnostics.co.uk

CE Certified COVID-19 Test Now Available

Thu, 30 Apr 2020 23:00:00 GMT

From MAY 1st 2020 VirQ SARS-CoV-2 Fast One-Step PCR Test for the Detection of COVID-19 has been CE certified.

Unlike most assays on the market, it is able to exclude false negative results caused by lack of cell material taken during sample collection.

This multiplex-PCR with 3 colour detection is compatible with most common thermalcyclers

Learn More on our COVID-19 page.

MCD Gain ISO 13485:2016 Certification

Thu, 17 Jan 2019 00:00:00 GMT

MC Diagnostics are delighted to announce that our Quality Management System has been certified to ISO 13485:2016 by the leading UK Based EU Medical Body, BSI.

What is ISO 13485:2016 ?

ISO 13485 is a stand-alone, international quality standard which supports Medical Device manufacturers to implement Quality Management Systems, that establishes and maintains effectiveness to their processes. Specifically, ensuring consistent design, development, production and delivery of Medical Devices that are safe and to their intended purpose.

What does this mean for our customers?

By obtaining this quality standard accreditation, this demonstrates MC Diagnostics true understanding of the requirements and highlights our commitment to conduct high-level quality control, product traceability, risk-management and the importance of meeting customer and regulatory requirements. Overall, giving our customers peace of mind that our products are designed, manufactured and delivered to a high-standard but also, that we are in full control of our processes.

What’s next for MC Diagnostics?

We at MC Diagnostics, are very proud to have our Quality Management System compliant to ISO 13485:2016. The ‘quality-culture’ adapted by our team has led to this milestone being reached, achieving one of MC Diagnostics core business quality objectives.

The next step for MC Diagnostics is to continue to improve our existing products and processes, taking an active role in Post-Market Surveillance, whilst remaining to be a trusted and high-valued company, where quality is kept at its core.

Katee Houston - Quality Assurance Manager, MC Diagnostics

Haemolytic Reactions In Blood Transfusion

Tue, 07 Aug 2018 23:00:00 GMT

Haemovigilance is an important aspect of transfusion science concerning the minimization of adverse effects and adverse events. One of the more serious complications following a blood transfusion is a haemolytic transfusion reaction, where donor blood contains antibodies incompatible with patient blood. The adverse event occurs when red blood cells given during the transfusion are destroyed by the recipient’s immune system.

Acute haemolytic transfusion reactions (AHTRs) occur shortly after a transfusion and is typically a result of an ABO incompatible transfusion. Delayed haemolytic transfusion reactions (DHTRs) occur more than 24 hours after transfusion in a patient who has previously been alloimmunised to a red cell antigen by blood transfusion or pregnancy. The antibody may have fallen to a level that is undetectable by the pre-transfusion antibody screen and the patient is then inadvertently re-exposed to red cells of the immunising group. Antibodies to the Kidd (Jk) blood group system are the most common cause of DHTRs reported to the MHRA via the Serious Hazards of Transfusion network (SHOT), followed by antibodies to Rh (D) antigens.

Haemolytic transfusion can cause major morbidity (requiring intensive care or renal dialysis) which occurs in up to 30% of cases and 5–10% of episodes contribute to the death of the patient. DHTRs caused 21.7% of transfusion related deaths in the UK between 2010 and 2016 with 35 cases of DHTRs in 2015-16 which possibly could have been avoided with better practice and diagnostic technology (SHOT annual report, 2016).

Blood banks routinely type blood donors and patients for ABO and Rh(D) as these are the most significant antigens to ensure a safe transfusion. The common (Kell, Kidd, Duffy, MNS) and rare blood group systems (Colton, Diego, Dombrock, Lutheran, Vel, KEL*3/4, KEL*6/7) and partial or weak-D alleles are not routinely typed for, but recipient plasma will be screened prior to transfusion for antibodies against rare antigens. If a patient has a positive cross match for a rare antibody or are transfusion-dependant they must receive blood units which lack the antigen(s) - necessitating the need for red cell phenotyping of the donor units.

The conventional method for preventing DHTRs is serological typing, which uses antisera to detect antigen presence on red cells. Although this method is simple, it requires reliable antisera which can reaches its limits when it comes to the determination of rare blood group characteristics. Molecular blood group typing can provide a qualitative and selective result to better genotype patients phenotypical antigen characteristics. Molecular blood group typing enables a safe on-demand supply of blood preservations for patients with antibodies against clinically relevant, weak or rare blood group antigen specificities.

The molecular determination of blood group characteristics can be applied to on-demand situations and also used for pre-typing of blood donors. Pre-typing of blood donors has the advantage of increasing patient safety by preventing alloimmunisation, which in turn increases cost-effectiveness. In addition, due to its molecular based technology it works independently of antisera for rare antigens, which are often difficult to obtain and suboptimal in quality. For more information about our molecular blood group typing products - click here .

Coeliac Disease - Disease Association Testing

Sun, 29 Jul 2018 23:00:00 GMT

Coeliac disease is a T-cell-mediated chronic autoimmune disease which effects the absorption of nutrients in the small intestine due to surface inflammation. The symptoms are caused by disease-specific antibodies against endomysium or tissue transglutaminase, which inflict damage to the lining of the intestine upon ingestion of gluten. Commonly reported symptoms include stomach pain and cramping, nausea, ongoing fatigue, constipation, diarrhoea, weight loss, mouth ulcers and bloating.

Around 1 in 100 people has coeliac disease although this can be easily misdiagnosed for other GI problems. Early diagnosis is critical, as the intake of gluten can have destructive effects on the small intestine causing malabsorption, malnutrition, lactose intolerance which can cause health complications including osteoporosis, iron deficiency anemia, vitamin B12 deficiency and bowel cancer.

Coeliac susceptibility is associated with the DQA1*05:01- DQB1*02:01 (DQ2) and DQA1*03-DQB1*03:02 (DQ8) haplotype and is dominantly inherited. Additionally, DR3, DR7 and DR11 alleles can be used as genetic markers. Of patients with coeliac disease, 99.6% of those will carry DQ8 or DQ2 [1]. HLA-DQ genotyping can be useful in accompanying a clinical disease diagnosis and to evaluate the risk of disease in relatives of a patient.

To effectively treat coeliac disease a strict gluten-free diet must be followed, helping the intestines heal - which should lead to complete resolution of symptoms and decrease the risk of complications from long term malabsorption.

CLICK HERE to find out more about our SSP and SSO kits used for coeliac testing.

If you think you might have Coeliac Disease and need to find out if you might be susceptible - please Contact us without delay and we will be glad to assist you.

1. Karell K, et al. Hum Immunol 2003; Apr;64(4):469-77

Molecular Contamination Control

Wed, 11 Jul 2018 23:00:00 GMT

Polymerase chain reaction (PCR) is a highly sensitive technique to amplify a single copy of DNA into millions to billions of copies of a targeted sequence. Whilst its sensitivity is advantageous it can also create a number of issues if the correct contamination control is not followed. During PCR, even the smallest amount of contaminating DNA can be amplified resulting in the wrong template amplification and causing false positive or ambiguous results. Contamination can arise from work surfaces, equipment or reagents which have been exposed to PCR products. To minimize the risk of contamination there are several preventative methods and aseptic techniques which must be carefully performed.

Establishing a unidirectional workflow and physically separating amplification setup pre-PCR from post-PCR is optimal to reduce the risk of contamination. Ideally PCR preparation and amplification should be physically separated or at least substantially separated within the same lab. Samples and reagents used in PCR setup should be in a different lab to the amplicon. This includes equipment and materials used for amplifying samples, such as thermal cyclers and instruments used for analysis (e.g. ALDAS & MR. SPOT processors). Each area should have its own designated equipment, including consumables and PPE to prevent cross-contamination occurring. The workflow should also continue in one direction: pre- to post-PCR, if possible, ensuring airlock doors are in place.

Maintaining a sterile environment is recommended for both pre- and post-amplification. Deep cleans should be implemented regularly as a standard procedure within the laboratory and bench tops, pipettes, fridge/freezer handles and containers for consumables should regularly be sterilised before and after PCR using a bleaching agent. Improving pipetting techniques is another factor which can help prevent contamination by ensuring samples are aspirated and dispensed correctly, avoiding uncontrolled samples splashing.

As the use of PCR within HLA typing has become routine, the European Federation for Immunogenetics (EFI) standards suggest wipe tests should be performed every 2 months. We recommend the HISTO SPOT SSP Wipe Test, which has the capacity to detect human genomic DNA and amplificates generated from sequences containing exon 2 and/or exon 3 of HLA A, B, C and exon 2 of the DRB, DQA, DQB, DPA, DPB genes. The test procedure is based on the Sequence Specific Primers (SSP)-PCR. Monitoring can also be performed by running negative controls alongside samples and is another EFI standard - to ensure no false positives are detected from contamination with amplificates (1).

Download our Wipe Test Protocol PDF

BSHI Conference

Tue, 10 Jul 2018 23:00:00 GMT

The 29th Annual British Society for Histocompatibility and Immunogenetics (BSHI) Conference will take place in Cardiff at the Royal Welsh College of Music and Drama on 5th and 6th September 2018.

For more information visit the conference website : http://www.bshiconference.org.uk

Assay Standardisation

Thu, 07 Jun 2018 23:00:00 GMT

Clinical laboratory measurements can be used for disease diagnosis, to guide pharmaceutical therapy, monitor disease progression and assess risk of recurrence. As an integral part of this, test procedure standardisation is essential to produce verifiable results, referring to the ability of an assay methodology to produce results which are both repeatable and reproducible. Inconsistent test procedures can lead to inconsistent assessment of a patient and, in some situations, incorrect diagnosis or treatment.

A barrier which assay standardisation faces is the consequence of manual handling errors on test variability. Many of the issues with consistency can be considerably reduced with the removal or reduction of human error by manual handling using automated assay technology.

The ALDAS technology provides a complete platform to deliver simple, rapid, fully automated molecular diagnostics, that can easily be applied to a variety of application fields including immunogenetics, immunology, blood banking and microbiology. MCD has designed and developed the 3 elements of the system and can offer a tailored solution to meet your individual assay requirements.

The ALDAS instrument allows the complete automation of your assay by performing all hybridisation, pipetting and wash steps. The resulting reactivity pattern is visualised using colorimetric detection and an image captured by the on-board camera. The image is then transferred to our interpretation software for results analysis. PCR based assays can also be fully automated by the addition of a thermalcycler integrated into the instrument.

For more information about how our technology could improve your laboratory workflow click here to enquire.

Ankylosing Spondylitis - Disease Association Testing

Wed, 06 Jun 2018 23:00:00 GMT

Bechterew’s disease or Ankylosing Spondylitis is a chronic autoimmune disease effecting sacroiliac joints, spine, and peripheral arthritis. The incidence of disease generally occurs during teenage years and is three times more prevalent in males than females (3:1 ratio) (1). Common symptoms of Ankylosing Spondylitis include back pain and joint swelling, stiffness and extreme fatigue.

The HLA-B*27 protein is a variant of the human leukocyte antigen-B (HLA-B) and has a strong association with this autoimmune disease and is therefore, used as part of the diagnostic procedure (2, 3). A positive HLA-B*27 result is associated with a very high disease risk. In suspected cases of Ankylosing Spondylitis, a HLA-B*27 diagnosis provides an important contribution to the therapy of the patient. Around 3% to 6% of the people carrying the HLA-B*27 gene develop Anklylosing Spondylitis and more than 90% of all patients with a seronegative arthritis have this gene.

From April 2018 our new HISTO TYPE B*27 realtime PCR kit for fast and easy detection of HLA-B*27 is available. The HISTO TYPE B*27 Q kit covers all common HLA-B*27 sub types. Moreover, the kit differentiates between the disease associated alleles and the sub types HLA-B*27:06 or HLAB*27:09, which are not associated with Ankylosing spondylitis (4).

An easily implementable test compatible with most common realtime cyclers.

Visit our Technical Page for further information on how this test is applied.

1. Braun, J et al., 1998. Arthritis & Rheumatism , 41 (1), 58-67

2. Brewerton, DA et al., 1973. Lancet i:904-907

3. Schlosstien L et al., 1973. N. Engl. J. Med. 288:704-706

4. Kahn, MA et al., 2007. Autoimmunity Reviews 6: 183–189

32nd European Immunogenetics and Histocompatibility Conference

Fri, 04 May 2018 23:00:00 GMT

The 32nd European Immunogenetics and Histocompatibility Conference (EFI) will be held in Venice, Italy from 9th to 12th of May, 2018. The BAG healthcare Lunch-Symposium will take place on Friday, May 11th from 12:00 to 13:00h on the third floor of Palazzo del Casinò, Sala Mosaici1.

NEW: HLA B*27 realtime PCR testing

Sat, 31 Mar 2018 23:00:00 GMT

From April 2018 HISTO TYPE B*27*Q kit for fast and easy detection of HLA-B*27 is available. All CWD alleles are detected in one PCR Mix and the alleles B*27:06 and B*27:09 that are not associated with Morbus Bechterew are discriminated.

Due to the flexible liquid format the kit can be used with most of the common realtime cylers available in the market. The kit works reliably over a wide range of DNA concentrations making measuring and diluting DNAs unnecessary.

Learn More...

Partner Labs North America

Wed, 13 Apr 2016 15:13:00 GMT

MC Diagnostics - the leading provider in the automation of multiplexed molecular assays and custom designed image analysis and interpretation software, is seeking Partner Laboratory's in North America.

Further information on this exciting opportunity can be provided on request. Please act quickly, as we are offering regional/local exclusivity to Partner laboratory's on a 'first come first served' basis. Contact us and one of our Management Team will be happy to speak with you.

Welcome to our new website

Thu, 31 Mar 2016 23:00:00 GMT

MC Diagnostics Limited are delighted to be working once again with Dezines Internet Solutions Limited - a leading UK Ecommerce Agency, who have built us another new PaaS (Platform as a Service) fully integrated website, due to be formally launched during February 2021. This new website replaces the previous version built by Dezines in early 2016.

Dezines Internet Solutions Limited are a professional ecommerce development and marketing agency, serving customers across the UK and internationally. Their focus is on secure and fully integrated Platform as a Service (PaaS) ecommerce and marketing portal website developments, all hosted on world class and highly secure server technology.

Simply put their reputation is well deserved, because they are trusted to deliver powerful, professionally designed and secure, Ecommerce, Sales & Distribution and Marketing website portals, digital video and commercial imaging assets, all of which have generated millions of pounds in new revenue streams, for the small, medium, large companies and global brands they work closely with throughout the UK and internationally!

DEZINES offer an end-to-end set of products and services for multi-channel commerce; including advertising, design consultation, digital video display and DOOH services, responsive ecommerce and marketing website platform design & development, PCI DSS compliant secure payment integration - hosted in high security data-centres around the world, using the Amazon Web Services framework, all of which is wrapped within 256 bit encrypted Organisational Transport Layer Security (TLS), fully managed from one single supplier.

Please take a look at Dezines Internet Solutions Limited's main website www.dezines.co.uk to learn more about their integrated PaaS website technology. Alternatively, call them on 0333 444 7 800 within the UK or on +44 1633 212388 from outside the UK ..... they'd be very happy to talk you through their simple 5 Step Design Process, and how their solution will deliver proven and powerful results for your business.

NEW: ERY SPOT® Weak D-TYPE

Wed, 02 Jul 2014 23:00:00 GMT

BAG Health Care would like to introduce a new product of the ERY SPOT® Weak D-TYPE, available from January 2018 . The ERY SPOT® SSO system is a fast, simple and cost effective method for molecular typing of blood group antigens. ERY SPOT® Weak D-TYPE kits safely define the Rhesus Weak D allele. The kit types more than 25 different Weak D alleles and also identifies, if the Rhesus D antigen is present or not (RhD positive/negative).

Combining high efficiency and traceability, the ERY SPOT® kits type many different blood group systems in a single well, ensuring reliable results with minimal hands-on-time. Its flexibility, (from 1 to 96 samples), makes the system perfect for both patient and high throughput donor typing.