title: Safety and efficacy of tuberculin skin testing with microneedle MicronJet600™ in healthy adults.
abstract: METHODS
  Intradermal injection using a syringe and needle is generally accepted as the most accurate method for the tuberculin skin test (TST). However, the Mantoux technique using a conventional needle is often difficult to perform reliably, affecting testing results and safety.
  
  
  OBJECTIVE
  We evaluated the efficacy and safety of a novel intradermal injection device, the MicronJet600(TM) microneedle, compared with conventional injection in terms of skin reactivity to the TST.
  
  
  METHODS
  A prospective, open-label clinical study was conducted. The TST was administered by both methods in the same subject. For pain assessment, participants filled in a visual analogue scale (VAS) after each TST. Any side effects due to TST or injections were observed.
  
  
  RESULTS
  TST reaction rates (cut-off ⩾5 mm) from microneedles and needles were respectively 44.0% and 47.2%, with no significant difference between the two. Furthermore, agreement of positivity between the two methods was excellent with both 5 mm and 10 mm cut-off values. However, the level of pain experienced when microneedles were used for TST was significantly lower than with conventional needles. No adverse effects were attributed to the MicronJet device.
  
  
  CONCLUSIONS
  The novel microneedle device used for TST in this study was effective, safe and less painful in healthy adult volunteers.
authors.affiliation: Clinical Vaccine Research Section, International Tuberculosis Research Center, Changwon, Republic of Korea; Brain Korea 21 Plus Project for the Medical Sciences, Department of Microbiology and Institute for Immunology and Immunological Diseases, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: H-J
authors.initials: HJ
authors.lastname: Lee
authors.affiliation: Clinical Research Section, International Tuberculosis Research Center, Changwon, Republic of Korea; Development and Delivery Unit, International Vaccine Institute, Seoul, Republic of Korea.
authors.forename: H-J
authors.initials: HJ
authors.lastname: Choi
authors.affiliation: Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Institute of Chest Diseases, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: D-R
authors.initials: DR
authors.lastname: Kim
authors.affiliation: Brain Korea 21 Plus Project for the Medical Sciences, Department of Microbiology and Institute for Immunology and Immunological Diseases, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: H
authors.initials: H
authors.lastname: Lee
authors.affiliation: Brain Korea 21 Plus Project for the Medical Sciences, Department of Microbiology and Institute for Immunology and Immunological Diseases, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: J-E
authors.initials: JE
authors.lastname: Jin
authors.affiliation: Clinical Research Section, International Tuberculosis Research Center, Changwon, Republic of Korea; Development and Delivery Unit, International Vaccine Institute, Seoul, Republic of Korea.
authors.forename: Y-R
authors.initials: YR
authors.lastname: Kim
authors.affiliation: Clinical Research Section, International Tuberculosis Research Center, Changwon, Republic of Korea; Development and Delivery Unit, International Vaccine Institute, Seoul, Republic of Korea.
authors.forename: M-S
authors.initials: MS
authors.lastname: Lee
authors.affiliation: Brain Korea 21 Plus Project for the Medical Sciences, Department of Microbiology and Institute for Immunology and Immunological Diseases, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: S-N
authors.initials: SN
authors.lastname: Cho
authors.affiliation: Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Institute of Chest Diseases, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Y A
authors.initials: YA
authors.lastname: Kang
mesh_terms: D000328:Adult; D044466:Asian People; D015992:Body Mass Index; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007271:Injections, Intradermal / Q000009:adverse effects / Q000295:instrumentation; D008297:Male; D008875:Middle Aged; D009339:Needles; D010146:Pain / Q000175:diagnosis / Q000209:etiology; D011446:Prospective Studies; D056910:Republic of Korea; D013594:Syringes; D014373:Tuberculin / Q000008:administration & dosage / Q000276:immunology; D014374:Tuberculin Test / Q000009:adverse effects / Q000295:instrumentation*; D055815:Young Adult
chemical_list: D014373:Tuberculin