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Home / The International Journal of Tuberculosis and Lung Disease, Volume 20, Number 4

Safety and efficacy of tuberculin skin testing with microneedle MicronJet600™ in healthy adults

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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 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.

CONCLUSION: The novel microneedle device used for TST in this study was effective, safe and less painful in healthy adult volunteers.

Keywords: Mantoux; TST; intradermal; microneedle device

Document Type: Research Article

Affiliations: 1: Clinical Vaccine Research Section, International Tuberculosis Research Center, Changwon, †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, 2: ‡Clinical Research Section, International Tuberculosis Research Center, Changwon, §Development and Delivery Unit, International Vaccine Institute, Seoul, 3: Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Institute of Chest Diseases, Yonsei University College of Medicine, Seoul, Republic of Korea 4: †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,

Publication date: 01 April 2016

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  • The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as COVID-19, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details.

    The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health. To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication. Read fast-track articles.

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