Abstract
Background: Secondary use of newborn screening dried blood spot samples include use for biomedical or epidemiological research. However, the effects of storage conditions on archival samples requires further examination. The objective of this study was to determine the utility of residual newborn samples for deriving reliable metabolic gestational age estimates. Methods: Residual newborn dried blood spot samples that had been stored for 2-, 4-, 6-, or 12-months in temperature controlled (21°C) conditions were re-analyzed for the full panel of newborn screening analytes offered by a provincial newborn screening lab in Ottawa, Canada. Data from re-analyzed samples were compared to corresponding baseline newborn screening values for absolute agreement, and Pearson and intraclass correlation. Performance of a gestational age estimation algorithm originally developed from baseline newborn screening values was then validated on data derived from stored samples. Results: A total of 307 samples were used for this study. 17-hydroxyprogesterone and newborn hemoglobin profiles measured by immunoassay and high-performance liquid chromatography, respectively, were among the most stable markers across all time points of analysis. Acylcarnitines exhibited the greatest degree of variation in stability upon repeat measurement. The largest shifts in newborn analyte profiles and the poorest performance of metabolic gestational age algorithms were observed when samples were analyzed 12-months after sample collection. Conclusions: Duration of sample storage, independent of temperature and humidity, affects newborn screening profiles and gestational age estimates derived from metabolic gestational dating algorithms. When considering use of dried blood spot samples either for clinical or research purposes, care should be taken when interpreting data stemming from secondary use.
Highlights
Newborn screening is a public health initiative that tests infants shortly after birth for rare but treatable diseases
Gestational age estimation algorithms based on a combination of newborn screening analytes and clinical covariates such as sex and birthweight have emerged as novel alternatives for accurately categorizing infants across preterm birth categories
Given the breadth of possible secondary uses of newborn screening samples, it is important to understand the effect of storage conditions on newborn screening samples
Summary
Newborn screening is a public health initiative that tests infants shortly after birth for rare but treatable diseases. Postnatal gestational age dating based on newborn metabolic profiles generated from dried blood spot samples provides the opportunity to establish preterm birth estimates[3,4,5] for jurisdictions for which data on preterm birth are currently lacking or inaccurate due to bias in population sampling and non-standardized use of clinical preterm birth thresholds[6]. Secondary use of newborn screening dried blood spot samples include use for biomedical or epidemiological research. Performance of a gestational age estimation algorithm originally developed from baseline newborn screening values was validated on data derived from stored samples. Conclusions: Duration of sample storage, independent of temperature and humidity, affects newborn screening profiles and gestational age estimates derived from metabolic gestational dating algorithms. When considering use of dried blood spot samples either for clinical or research purposes, care should be taken when interpreting data stemming from secondary use
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