TY - JOUR
T1 - Safety and efficacy of tuberculin skin testing with microneedle MicronJet600E in healthy adults
AU - Lee, H. J.
AU - Choi, H. J.
AU - Kim, D. R.
AU - Lee, H.
AU - Jin, J. E.
AU - Kim, Y. R.
AU - Lee, M. S.
AU - Cho, S. N.
AU - Kang, Y. A.
N1 - Publisher Copyright:
© 2016 The Union.
PY - 2016/4/1
Y1 - 2016/4/1
N2 - SETTING: 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 MicronJet600TM microneedle, compared with conventional injection in terms of skin reactivity to the TST. DESIGN: A prospective, open-label clinical study was conducted. The TSTwas 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 cutoff 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. CONCLUS ION: The novel microneedle device used for TST in this study was effective, safe and less painful in healthy adult volunteers.
AB - SETTING: 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 MicronJet600TM microneedle, compared with conventional injection in terms of skin reactivity to the TST. DESIGN: A prospective, open-label clinical study was conducted. The TSTwas 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 cutoff 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. CONCLUS ION: The novel microneedle device used for TST in this study was effective, safe and less painful in healthy adult volunteers.
UR - http://www.scopus.com/inward/record.url?scp=84961744137&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84961744137&partnerID=8YFLogxK
U2 - 10.5588/ijtld.15.0678
DO - 10.5588/ijtld.15.0678
M3 - Article
C2 - 26970160
AN - SCOPUS:84961744137
SN - 1027-3719
VL - 20
SP - 500
EP - 504
JO - International Journal of Tuberculosis and Lung Disease
JF - International Journal of Tuberculosis and Lung Disease
IS - 4
ER -
