title: Measurement of Hymenoptera venom specific IgE by the IMMULITE 3gAllergy in subjects with negative or positive results by ImmunoCAP.
abstract: BACKGROUND
  Patients may receive negative results from a specific IgE (sIgE) test such as the ImmunoCAP (CAP) despite a documented history of systemic reaction to a Hymenoptera sting. Thus, further testing may be required using another serological method or venom skin prick tests to confirm allergy diagnosis and correct species.
  
  
  OBJECTIVE
  To evaluate the sensitivity and the specificity of CAP and IMMULITE 3gAllergy (IMMULITE) for detecting sIgE to Paper wasp (WA) and Yellow Jacket (YJ) venoms using patient clinical history as the comparator.
  
  
  METHODS
  Sera from 70 participants with a history of systemic reactions (SR) to WA and/or YJ stings were tested using CAP and IMMULITE. Fifty participants from this group had negative results on CAP. To assess specificity, sera from 71 participants who had never experienced either a WA or YJ sting were tested using CAP and IMMULITE. Fifty participants from this group tested positive using CAP.
  
  
  RESULTS
  In participants with a history of systemic reaction to a Hymenoptera sting, yet who tested negative for WA and/or YJ sIgE according to CAP, the positivity rate according to IMMULITE was 20-42% using 0.10 IU(A)/mL as the limit of detection (LoD), per the manufacturer's specification. When the LoD for CAP (0.35 IU(A)/mL) was applied to the IMMULITE results, positivity according to IMMULITE was 14-26%. Overall, sensitivity, specificity, and agreement with SR were greater for IMMULITE than for CAP. For YJ: sensitivity (IMMULITE:CAP), 42.8%:28.5%; specificity, 53.5%:39.4%; agreement, 48.2%:34%. For WA, sensitivity (IMMULITE:CAP), 58.6%:28.5%; specificity, 49.3%:47.8%; agreement, 43.9%:38.3%.
  
  
  CONCLUSIONS
  The IMMULITE performed well for detecting sIgE to Hymenoptera venom.
authors.affiliation: Department of Pulmonary Medicine and Clinical Immunology, Dokkyo University School of Medicine, Tochigi 321-0293, Japan.
authors.forename: Mineaki
authors.initials: M
authors.lastname: Watanabe
authors.forename: Hirokuni
authors.initials: H
authors.lastname: Hirata
authors.forename: Masafumi
authors.initials: M
authors.lastname: Arima
authors.forename: Yumeko
authors.initials: Y
authors.lastname: Hayashi
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Chibana
authors.forename: Naruo
authors.initials: N
authors.lastname: Yoshida
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Ikeno
authors.forename: Yasutsugu
authors.initials: Y
authors.lastname: Fukushima
authors.forename: Reiko
authors.initials: R
authors.lastname: Komura
authors.forename: Kazumi
authors.initials: K
authors.lastname: Okazaki
authors.forename: Kumiya
authors.initials: K
authors.lastname: Sugiyama
authors.forename: Takeshi
authors.initials: T
authors.lastname: Fukuda