title: Comparative evaluation of newborn bloodspot specimen cards by experienced laboratory personnel and by an optical scanning instrument.
abstract: A major factor in determining the suitability of a dried blood spot (DBS) specimen is the subjective nature of evaluation by laboratory personnel. Using newborn screening DBS specimen cards as they were submitted to a public health NBS program, we conducted a systematic pilot study of DBS evaluation by multiple experienced laboratory personnel (ELP) and by an automated optical scanning instrument (OSI) (CardScan (tm), BSD Robotics). OSI confirmed the satisfactory status of all newborn DBS specimen cards that passed initial review by the first ELP. Among the questionable cards selected for further review, 58% passed multiple ELP consensus assessment, and 62% passed OSI evaluation. The overall agreement between ELP and OSI was 86%. Among questionable specimen cards, ELP and OSI were more strongly correlated when multiple ELP assessment was unanimous. We conclude that subjective assessment by ELP is essential and that OSI evaluation is a useful adjunct when ELP assessment does not reach consensus. OSI further allows the selection of optimal locations for punching DBS from unsatisfactory or questionable specimens, optimizing the quality of interim analyses that may be conducted while repeat specimens are being collected. Instrument evaluation of specimen cards would also be valuable as an independent reference method for training laboratory and specimen collection personnel. OSI technology merits further studies to confirm and extend our findings.
authors.affiliation: Newborn Screening and Molecular Biology Branch, CDC, Atlanta, GA 30341, USA.
authors.forename: Paul D
authors.initials: PD
authors.lastname: Dantonio
authors.affiliation: Newborn Screening Laboratory, Georgia Department of Public Health, Decatur, Ga 30030, USA.
authors.forename: Germaine
authors.initials: G
authors.lastname: Stevens
authors.affiliation: Newborn Screening Laboratory, Georgia Department of Public Health, Decatur, Ga 30030, USA.
authors.forename: Arthur
authors.initials: A
authors.lastname: Hagar
authors.affiliation: Newborn Screening Laboratory, Georgia Department of Public Health, Decatur, Ga 30030, USA.
authors.forename: David
authors.initials: D
authors.lastname: Ludvigson
authors.affiliation: BSD Robotics, Brisbane, Australia.
authors.forename: Daron
authors.initials: D
authors.lastname: Green
authors.affiliation: Senior Consultant, Newborn Screening Translation Research Initiative, CDC Foundation, Atlanta, GA 30303, USA.
authors.forename: Harry
authors.initials: H
authors.lastname: Hannon
authors.affiliation: Newborn Screening and Molecular Biology Branch, CDC, Atlanta, GA 30341, USA. Electronic address: rvogt@cdc.gov.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Vogt
mesh_terms: D000465:Algorithms; D059788:Dried Blood Spot Testing / Q000295:instrumentation / Q000379:methods / Q000592:standards; D006801:Humans; D007231:Infant, Newborn; D059232:Laboratory Personnel; D015997:Neonatal Screening / Q000295:instrumentation / Q000379:methods / Q000592:standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
keywords: Automation; Dried blood spots; Evaluation; Newborn bloodspot screening; Specimen quality; Training
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