Dried spot assay for diagnosis of invasive meningococcal disease
Research type
Research Study
Full title
Evaluating the use of dried blood and CSF spots as a means of storing and transporting clinical material for molecular diagnosis of invasive meningococcal disease
IRAS ID
281567
Contact name
Brenda Kwambana
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
0 years, 11 months, 26 days
Research summary
Over the last century, populations resident in Africa’s "meningitis belt", a region spanning 26 contiguous countries, have borne the brunt of Neisseria meningitidis (meningococcus) meningitis outbreaks. In most recent large meningococcal outbreaks in Africa’s meningitis belt, laboratory examination of blood and CSF has been hampered by a lack of bacteriology capacity. A meningitis diagnostic assay that allows for samples to be stored for long periods at room temperature while awaiting transport to central laboratories could improve case ascertainment in low resource settings. An approach that warrants exploration is screening dried blood (DBS) and CSF (CDS) collected on filter paper.
This is a retrospective study which will test the performance of a dried spot assay for diagnosing and serogrouping meningococcal infections from blood and CSF. An equal number of blood (n=276) and CSF (n=276) specimens that previously tested negative for N. meningitidis will be selected and included in the evaluation. Dried blood and CSF spots will be prepared on Whatman Protein Saver cards at the PHE Meningococcal Reference Unit. Nucleic acids will be purified from punches of the dried spots and tested using standard Taqman® real time PCR assays targeting the N. meningitidis ctrA gene and the genogroup-determining siaD gene. Genetic analysis of the bacteria will be performed from the dried blood and CSF filter spots.
The development of a sensitive dried spot assay could increase the diagnostic yield of confirmed IMD in Africa while reducing the need for cold chain or large volumes of clinical specimens. This approach could hasten the appropriate public health responses during public health emergencies in Africa.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
21/SC/0104
Date of REC Opinion
24 Mar 2021
REC opinion
Favourable Opinion