title: Evaluation of the BiliChek being used on hyperbilirubinemic newborns undergoing home phototherapy.
abstract: BACKGROUND
  Newborns are often screened prior to discharge for hyperbilirubinemia. Transcutaneous bilirubin analyzers, such as the BiliChek, are promoted as screening tools, but it is unclear whether they also function well as monitoring devices. Newborns on home phototherapy require frequent determinations of serum bilirubin levels to monitor therapy effects. A transcutaneous bilirubin analyzer would be helpful to limit blood draws and enhance staff efficiency. We evaluated the accuracy of the BiliChek analyzer in this setting.
  
  
  OBJECTIVE
  Is the BiliChek sufficiently accurate to monitor the effectiveness of home phototherapy and establish when to terminate therapy?
  
  
  METHODS
  Paired serum bilirubin results and results from the BiliChek were obtained from newborns on home phototherapy during daily home health care visits.
  
  
  RESULTS
  The BiliChek demonstrates a negative bias (mean bias, -1.71 mg/dL; 95% confidence interval, -1.89 to -1.52 mg/dL) compared with serum bilirubin values. This bias worsens as the serum bilirubin level rises. If a value of 14 mg/dL or less obtained using the BiliChek had been used as the cutoff for termination of phototherapy, 45% of newborns would have had therapy terminated prematurely. If, knowing the negative bias of the BiliChek, the cutoff for termination of therapy was set at less than or equal to 11 mg/dL, then 29% of newborns would have had therapy terminated prematurely.
  
  
  CONCLUSIONS
  The values obtained using the BiliChek, compared to serum bilirubin values, have a negative bias that worsens at the higher bilirubin levels expected in newborns at home on phototherapy. The BiliChek does not provide sufficient accuracy to be utilized to monitor newborns on home phototherapy or to ascertain when to discontinue such therapy.
authors.affiliation: Department of Pathology, Children's Hospital, 8200 Dodge St, Omaha, NE 68114, USA. creyes@chsomaha.org
authors.forename: Christine A
authors.initials: CA
authors.lastname: Reyes
authors.forename: Donald R
authors.initials: DR
authors.lastname: Stednitz
authors.forename: Carol
authors.initials: C
authors.lastname: Hahn
authors.forename: Kelly D
authors.initials: KD
authors.lastname: Mutchie
authors.forename: Steven R
authors.initials: SR
authors.lastname: McCullough
authors.forename: Kent
authors.initials: K
authors.lastname: Kronberg
mesh_terms: D001663:Bilirubin / Q000097:blood*; D006699:Home Care Services; D006801:Humans; D051556:Hyperbilirubinemia, Neonatal / Q000097:blood / Q000175:diagnosis* / Q000628:therapy*; D007231:Infant, Newborn; D015997:Neonatal Screening / Q000295:instrumentation* / Q000379:methods*; D010789:Phototherapy; D011237:Predictive Value of Tests; D015203:Reproducibility of Results
chemical_list: D001663:Bilirubin