4. Effect of sample quality on outcome.
Research type
Research Study
Full title
Effect of sample taking technique on analyte recovery from dried blood spot samples.
IRAS ID
299690
Contact name
Sarah Smith
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Newborn bloodspot screening (NBS) is a national public health programme which screens for nine different diseases in babies. The analytical process of newborn screening uses a dried blood spot (DBS) sample. A DBS samples is taken by using a lancet to make a small incision in the baby’s heel and allowing capillary blood to drop onto specially designed filter paper. With improvements in the analytical methods of performing newborn bloodspot screening the quality of the sample has become a concern as research suggest that sample quality may alter the results of these highly sensitive screening processes. The way the DBS sample should be taken is described by Public Health England (PHE) as “a single, evenly saturated drop of blood that fills the circle completely and soaks through to the back of the blood spot card. Midwives find taking the bloodspot sample challenging and this can be seen in the high number of samples that are rejected. This has an impact on the newborn screening programme by causing additional harm to newborns, possible treatment delays and increasing the cost of the programme. Midwives often use different techniques to obtain the bloodspot sample and the consequence of this is not fully understood. The aim of this research is to investigate if samples taken for the purposes of newborn screening produce different results depending on the technique used to apply the blood. This will be done by looking at different sample types as they come to the laboratory for routine screening and comparing these to establish the effect on analyte level and screening outcome.
REC name
London - Chelsea Research Ethics Committee
REC reference
22/PR/0822
Date of REC Opinion
28 Jun 2022
REC opinion
Favourable Opinion