Using MALDI-ToF/PCR in urine for diagnosis of tuberculosis

• Research type

  Research Study

• Full title

  Using MALDI-ToF/PCR in urine samples to diagnose tuberculosis with a lipidomics/bacterial DNA based approach

• IRAS ID

  222934

• Contact name

  Francis Drobniewski

• Sponsor organisation

  Joint Research Compliance Office Imperial College London and Imperial College Healthcare NHS Trust

• Clinicaltrials.gov Identifier

  N/A, Account number

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Tuberculosis (TB) remains the single most important infectious cause of mortality worldwide. Accurate, timely and minimally invasive diagnosis is still elusive for this disease. The aim of this study is to ascertain whether urine from known pulmonary TB patients can be processed by MALDI-ToF a type of mass spectrometry, or PCR-based DNA amplification approach,in order to detect specific biological marker and target profiles that would distinguish between TB-infected and non-TB-infected individuals.
  Urine can be obtained in relatively large amounts and with little discomfort for the patient (particularly in children where laboratory diagnosis is currently very poor).
  However, since this approach had not been used before, it is not clear whether any signature detected is related to the presence of TB molecules or simply a refection of the the host's immune response.
  In order to try to clarify this point, urine left over from patients known to have urinary tract infection will be collected at Whipps Cross University Hospital, shipped to Imperial College where the samples will be rendered non-infectious by boiling according to local protocols and then transported to the Flowers Building at the South Kensington Campus to undergo MALDI-ToF analysis.At IC Hammersmith Campus Commonwealth Building 8th floor laboratories the urine will also be subjected to PCR-based amplification methods to detect any TB DNA.
  This results will be used as control group against both healthy volunteers and known TB patients.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  17/LO/2023

• Date of REC Opinion

  15 Feb 2018

• REC opinion

  Further Information Favourable Opinion