A Pilot Study of the ELFE Longitudinal Cohort: Feasibility and Preliminary Evaluation of Biological Collection.

Etude Longitudinale Française depuis l'Enfance (ELFE) will be a national French cohort of 20,000 children followed from birth to adulthood. Biological samples will be taken at birth to evaluate the fetal exposition to several substances. A pilot study was carried out in October 2007 to test the preanalytical factors that affected sample quality. A variety of fractions were collected by the midwife after delivery from different blood collection tubes. Options in the collection process were 2 daily transports of samples, centralized and standardized processing methodology, and storage of multiple aliquots in liquid nitrogen or at -80°C. We analyzed preanalytical factors that could have affected coagulation and then soluble CD40 Ligand (sCD40L) as a quality control tool for serum quality. Cord blood and urine were collected from 82% and 84% of women, respectively, who agreed to be followed up in the ELFE project. The use of syringe was the main factor correlated with coagulation (relative risk: 2.79 [1.47; 5.31], P<0.01). Maternity unit status was also associated with coagulation (RR: 1.48 [1.03; 2.13] in a private maternity unit vs. a public maternity) as well as time between collection and centrifugation (RR 1.03 [1; 1.07] when time between collection and centrifugation increases from 1 h). There were no extremely low sCD40L values indicating extreme exposures to room temperatures. This first evaluation study allowed us to stress the importance of carefully recording all potentially critical preanalytical variables that might be used at a large-scale level.