Oxford Immunotec Presents Data on the Use of T-SPOT®.TB Test in Children over the Age of 2 to The Korean Society of Pediatric Infectious Diseases

대한소아감염학회, 소아 잠복결핵에 대한 “Pediatrics LTBI Advisory Board Meeting” 성료

대한소아감염학회에서는 결핵감염 이후에 취약한 5세미만 소아(평생 위험률 40~50%)에서의 환자 치료와 잠복결핵 검사의 최신 지견을 공유하는 자리 마련

지난 6월 3일 소아환자의 결핵 치료 및 잠복결핵 검사의 최신 지견을 공유하는 ‘Pediatrics LTBI Advisory board meeting’을 성황리에 개최했다고 밝혔다.

잠복결핵감염(latent tuberculosis infection, LTBI)은 결핵균이 체내에 존재하나 질병의 증거가 없는 경우로 투베르쿨린 검사(tuberculin skin test, TST)나 인터페론감마 분비검사(interferon-γ releasing assay,IGRA)와 같은 결핵균 감염검사에서 양성이지만 증상이 없는 상태이다.

최근에는 잠복결핵감염을 검사하는 방법으로 IGRA 검사가 많이 사용되고 있으나, 5세미만에서는 IGRA의 민감도가 TST에 비해 떨어지는 경우가 있어 사용이 권고되지 않았다. 그러나 최근(2020년 9월)에 옥스퍼드 이뮤노텍에서 공급하는 T-SPOT. TB검사가 IGRA 검사 중에서 유일하게 2세 이상에서 잠복결핵 검사를 할 수 있도록 FDA승인을 받으면서 소아 청소년과에서 잠복결핵 검사의 대안으로 떠오르고 있다.

본 ABM은 을지의대 은병욱 교수가 좌장을 맡은 가운데 씨젠의료재단 민도식원장과Oxford Immunotec Medical affair의 Dr. Ho와 함께 연자로 나섰다. 또한 패널 토의에는 10여명의 소아청소년과 교수가 참석하여 토론이 진행되었다.

좌장을 맡은 을지의대 은병욱 교수는 “소아에서 잠복결핵의 진료에 있어 검사의 한계 및 중요성을 되짚어 보고, 국내 결핵 진료 지침에 대해 논의할 수 있는 의미 있는 시간으로 준비되었다. 앞으로도 잠복결핵 검사에 한계가 있던 소아에서의 IGRA 검사의 다양한 임상적 자료를 바탕으로 국내 소아의 결핵 치료 방향에 길잡이가 될 수 있을 것”이라고 말했다.

옥스퍼드 이뮤노텍 이수종 한국지사장은 “IGRA 검사 중 유일하게 2세 이상에서 FDA승인을 받은 T-SPOT. TB를 통해 소아에서의 잠복결핵 검사의 획기적인 전기를 마련하게 된 것을 기쁘게 생각한다”며, 옥스퍼드 이뮤노텍은 앞으로도 국내 결핵 예방에 중요한 역할을 하도록 지속적으로 노력할 것“이라고 전했다.

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About the T-SPOT.TB Test
The T-SPOT.TB test is a single-visit blood test for TB screening and is one of only two recommended alternatives to the tuberculin skin test (TST) – otherwise known as purified protein derivative (PPD) test, or the Mantoux test. The T-SPOT.TB test is available in over 50 countries including Europe, China, Japan and the US, and is recognized by the WHO as one of the 100 essential diagnostic tests. The T-SPOT.TB test uses a standardized sample, reducing the influence of factors in the blood which may affect performance, and normalizing for cell number variation. The test has been shown to have a sensitivity of 98.8% and a specificity > 99% and is able to maintain performance even in samples otherwise difficult to test, such as samples from immunosuppressed patients. The T-SPOT.TB test does not cross-react with the BCG vaccine. Automation of the T-SPOT.TB test is possible using the T-Cell Select reagent kit. Automation solutions are available for low, medium and high throughput settings. The T-Cell Select reagent kit also enables samples to be stored at ambient temperature for up to 54 hours after blood is collected.

About Oxford Immunotec
Oxford Immunotec is a global, high-growth diagnostics company and part of the PerkinElmer group. We bring energy and invention to a world in need of diagnostic truth. We are uniquely placed as the only company in the world offering regulated ELISPOT assays for T cell measurement, with approval around the globe. Our leading product, the T-SPOT.TB test, is used for diagnosing infection with Tuberculosis, the world’s largest cause of death from infectious disease. Oxford Immunotec is an experienced manufacturer of IVD tests, operating under a fully audited Quality Management System, ensuring rigorous batch control. The company has manufactured in excess of 20 million clinical T cell tests for TB infection. The T-SPOT.TB test has been approved for sale in over 50 countries, including the United States (where it has received pre-market approval from the Food and Drug Administration), Europe (where it has obtained a CE mark), as well as Japan and China. The recently released T-SPOT®.COVID test is CE marked in Europe for clinical use to detect the T cell immune response to SARS-CoV-2 (www.tspotcovid.com). Oxford Immunotec is headquartered near Oxford, U.K. and in Marlborough, MA. Additional information can be found at www.oxfordimmunotec.com.

About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare. With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets. We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise. Our dedicated team of about 14,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally. The Company reported revenue of approximately $3.8 billion in 2020, serves customers in 190 countries, and is a component of the S&P 500 index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.

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For Media Inquiries:
Lee Sujong
Country Manager, South Korea
Oxford Immunotec
Mobile: +82.10.3572.8674
Email: slee@oxfordimmunotec.com

Evelyn Lee