MSACL 2018 US Abstract

Topic: Small Molecules / Tox

Method Performance and Clinical Workflow Outcomes Associated with Meconium and Umbilical Cord Toxicology Testing

Steven Cotten (Presenter)
Ohio State University Wexner Medical Center

Bio: Dr. Steven Cotten is Director of Chemistry, Immunology, Toxicology and Point of Care at the Ohio State University Wexner Medical Center. Dr. Cotten received his PhD in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill. He completed his fellowship in Clinical Chemistry in the Department Pathology and Laboratory Medicine at UNC Chapel Hill. Dr. Cotten is a diplomate of the American Board of Clinical Chemistry. His research interests include toxicology, natural product chemistry, and operational efficiency metrics for clinical laboratories.

Authorship: Steven W. Cotten
Ohio State University

Short Abstract

Umbilical cord tissue testing for neonatal drug exposure enables proactive intervention to mitigate withdrawal symptoms and potential adverse effects in neonatal abstinence syndrome. Switching from meconium to UCT demonstrated reductions in collect to result time and positively impacted the nursing clinical workflow. Additionally the number of QNS specimens and missed collections was minimized compared to meconium. The clinical sensitivity and specificity evaluated through ICD9 and ICD10 codes showed mixed results for both specimen types. UCT showed increased clinical sensitivity and NPV for NAS relative to meconium. However, neither specimen showed a calculated sensitivity for NAS >80%.

Long Abstract

Introduction

Neonatal abstinence syndrome (NAS) is a rising concern with unknown long-term effects. It is apparent that higher cost of care, impact on the community and reduced quality of life are associated with similar etiologies (e.g., fetal alcohol syndrome). Detection of drug exposure in utero allows for earlier intervention to potentially reduce undesired outcomes. Umbilical cord tissue (UCT) has been documented as a readily accessible specimen for detection of drug exposure and has emerged as an alternative specimen to meconium.

Methods

A mass spectrometry method for toxicology analysis from umbilical cord tissue was developed. Extraction of target compounds was followed by analysis with a SCIEX 3200 Q-TRAP LC/MS/MS system. Quantitative matrix effects were estimated for both meconium and UCT specimens using spiking studies. The analytical and clinical impact of umbilical cord tissue relative to meconium was evaluated for assessment of in utero drug exposure. Quality metrics relating to turnaround-time and diagnosis of NAS were investigated after switching from meconium to UCT.

Results

Comparison of target compound detected between meconium and UTC was mixed. Negative agreement was >95% for all drug classes calculated but positive agreement varied from 40-100%. Processing efficiency (extraction recovery + matrix effects) was <40% for key opiate compounds in UTC. Outcome data using ICD9/10 codes showed umbilical cord tissue had a higher clinical sensitivity but lower specificity for prediction of NAS diagnosis versus meconium (79% vs 65% and 76% vs 85% respectively). Birth to result time decreased by the switching to UTC as well as the number of missed collections. The clinical sensitivity and negative predictive value for NAS increased with UCT; however both meconium and UTC samples were negative for opiates for a significant percentage of newborns with a diagnosis of NAS (35% and 21% respectively).

Conclusions & Discussion

Umbilical cord tissue testing for neonatal drug exposure enables proactive intervention to mitigate withdrawal symptoms and potential adverse effects in neonatal abstinence syndrome. Switching from meconium to UCT demonstrated reductions in collect to result time and positively impacted the nursing clinical workflow. Additionally the number of QNS specimens and missed collections was minimized compared to meconium. The clinical sensitivity and specificity evaluated through ICD9 and ICD10 codes showed mixed results for both specimen types. UCT showed increased clinical sensitivity and NPV for NAS relative to meconium. However, neither specimen showed a calculated sensitivity for NAS >80%. Testing algorithms that incorporate meconium or urine analysis should be considered for other clinical applications such as assessment of drug compliance during pregnancy or legal testing for social services for the highest clinical sensitivity due to varied disposition of drugs in UCT.


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