Safety and efficacy of tuberculin skin testing with microneedle MicronJet600E in healthy adults

H. J. Lee, H. J. Choi, D. R. Kim, H. Lee, J. E. Jin, Y. R. Kim, M. S. Lee, Sangnae Cho, youngae kang

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)500-504
Number of pages5
JournalInternational Journal of Tuberculosis and Lung Disease
Volume20
Issue number4
DOIs
Publication statusPublished - 2016 Apr 1

Fingerprint

Tuberculin Test
Tuberculin
Skin Tests
Safety
Skin
Needles
Intradermal Injections
Equipment and Supplies
Injections
Syringes
Pain Measurement
Visual Analog Scale
Healthy Volunteers
Pain

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine
  • Infectious Diseases

Cite this

Lee, H. J. ; Choi, H. J. ; Kim, D. R. ; Lee, H. ; Jin, J. E. ; Kim, Y. R. ; Lee, M. S. ; Cho, Sangnae ; kang, youngae. / Safety and efficacy of tuberculin skin testing with microneedle MicronJet600E in healthy adults. In: International Journal of Tuberculosis and Lung Disease. 2016 ; Vol. 20, No. 4. pp. 500-504.
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abstract = "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.",
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Safety and efficacy of tuberculin skin testing with microneedle MicronJet600E in healthy adults. / Lee, H. J.; Choi, H. J.; Kim, D. R.; Lee, H.; Jin, J. E.; Kim, Y. R.; Lee, M. S.; Cho, Sangnae; kang, youngae.

In: International Journal of Tuberculosis and Lung Disease, Vol. 20, No. 4, 01.04.2016, p. 500-504.

Research output: Contribution to journalArticle

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AU - Choi, H. J.

AU - Kim, D. R.

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AU - Jin, J. E.

AU - Kim, Y. R.

AU - Lee, M. S.

AU - Cho, Sangnae

AU - kang, youngae

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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.

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