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.
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.
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.
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.
MC Diagnostics is a specialist molecular diagnostics company with expertise in the automation of multiplexed molecular assays and custom designed image analysis and interpretation software. Read more about our capabilities below ...
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