Glue for Manufacturing Heel Prick Filter Cards Does Not Interfere with the Measurement of Analytes for Newborn Screening

Abstract

Population-based newborn screening (NBS) using blood collected and dried on filter paper was developed in the 1960s and remains the international standard for NBS programs. Glue, used in the manufacture of dried blood collection cards, may present a source of contamination and is often considered as a possible cause of anomalous results in routine screening. Our study evaluates this potential contamination on NBS analyses. EBF#1003 glue was blotted onto dried blood collection cards made of Whatman grade 903 filter paper (Whatman#903) and adult whole blood was pipetted onto the dried glue blots. In addition, blank glue blots (i.e., no blood) and dried blood spots (DBSs) in the absence of glue were prepared. The DBSs and blank samples were run in duplicate as routine samples for NBS. DBS absorption time and diameter, the effect of glue on measurements (concentrations and variation) were assessed. DBS absorption time and shape were equivalent for DBSs prepared in the absence and presence of undiluted glue. DBS diameter increased when prepared in the presence of glue. When EBF#1003 was diluted prior to use, DBS absorption time increased, and DBSs were non-uniform. Glue, diluted or not, did not produce measurements above the established Limit of Detection (LOD) for all assays used in the current Dutch screening programme. For all analytes with concentrations in the quantifiable range, contamination with glue had no effect on measurement variation, as it appeared equivalent to variation in untreated DBSs. Our data show that, in the unlikely event of contamination of Whatman#903 with EBF#1003, there is no effect on the measured concentration of analytes.

Is Our Newborn Screening Working Well? A Literature Review of Quality Requirements for Newborn Blood Spot Screening (NBS) Infrastructure and Procedures

“…However, because of the rarity of the diseases screened, data for a sufficient number of confirmed cases to achieve optimal adjustments of all cut-off values are not always available to each laboratory or even to entire countries. Therefore, in recent years, post-analytical multivariate digital interpretation tools that combine data from numerous laboratories, such as the US-based “Collaborative Laboratory Integrated Reports” (CLIR) [ 98 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 , 108 ] or similar procedures [ 92 , 109 , 110 , 111 ], have been increasingly used worldwide with the aim of achieving “precision NBS” with “near-zero false positive rates” [ 107 ]. These tools are based on big-data analyses with machine-learning modelling from the digital reports of test results, covariates (such as gestational age, birth weight, and age at blood collection), and final diagnoses.…”

“…Our results illustrate that the challenges of NBS infrastructure are complex as NBS goes far beyond a “simple blood test”, and these organisational and ethical challenges can hardly be overcome without systematic coordination and quality management [ 2 , 5 , 7 , 21 , 31 , 36 , 81 , 174 , 180 , 182 , 183 ]. The potential offered by digital systems to facilitate, accelerate, and secure the NBS process were particularly highlighted [ 2 , 20 , 49 , 92 , 98 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 , 108 , 109 , 110 , 111 , 164 , 171 , 186 , 187 , 188 ]. In our view, the aspects presented—although partly seeming rather formal and less fascinating than new perspectives—are essential for existing NBS programmes and grow in importance with further NBS expansions.…”