Cellestis Merespon Pedoman World Health Organization mengenai Penggunaan UjiDarah untuk Tuberkulosis Aktif

AsiaNet 45648

MELBOURNE, Australia, 25 Juli 2011 /PRNewswire-AsiaNet/ —

Uji Darah Tetap Penting untuk Penyakit Laten; Pedoman WHO Tidak Berlaku
untuk QuantiFERON-TB Gold (QFT), yang Digunakan untuk Uji pada TB Laten

Rekomendasi kebijakan baru yang dikeluarkan pada tanggal 20 Juli oleh
Organisasi Kesehatan Dunia – World Health Organization (WHO) memperingatkan
akan penggunaan uji serologis (darah) untuk mendiagnosa penyakit tuberkulosis
aktif (TB). Uji serologis mengukur antibodi terhadap TB di dalam serum dan
berbeda dengan QuantiFERON, yang mengukur respon sel darah putih terhadap
protein khusus TB.

Tuberkulosis aktif terjadi saat organisme TB mengatasi pertahanan dan
perkembangan imun tubuh yang menyebabkan gejala klinis. Menurut WHO, TB
merenggut satu nyawa setiap 17 detik di seluruh dunia.(1) Penderita penyakit
yang aktif sering mengeluarkan bakteri TB dan menulari orang lain. Orang yang
terinfeksi bakteri penyebab TB, tetapi tidak menunjukkan gejala apapun dan
tidak merasakan sakit yang terkait dengan penyakit ini, dikatakan telah terkena
infeksi TB laten (LTBI).(2) Penderita LTBI beresiko mengidap TB aktif, terutama
jika sistem imun mereka menurun.(2)

QFT bertujuan membantu diagnosis infeksi TB, baik aktif maupun laten, dan
tidak membedakan antara kedua kondisi tersebut. Cellestis Limited, produsen
QuantiFERON(R)-TB Gold(QFT) sadar bahwa laporan berita di beberapa media telah
menyebabkan kebingungan terkait dengan pengumuman WHO. Rilis Pers dari WHO
menjelaskan bahwa ini mengacu pada uji darah serologis (berdasarkan antibodi)
untuk TB aktif, dan tanggapan mereka tidak berlaku untuk Interferon-Gamma
Release Assays (IGRAs) untuk mendiagnosa TB laten. Ini telah dikonfirmasikan
oleh korespondensi langsung dari WHO untuk Cellestis.

“QuantiFERON-TB dikembangkan dalam merespon buruknya kualitas pengujian
sebelumnya seperti yang dimaksud oleh WHO. Kami sepenuhnya setuju dengan
tanggapan WHO terkait dengan uji serologis untuk TB aktif,” ujar Dr Jim Rothel,
Chief Scientific Officer Cellestis. “Harus diakui bahwa TB masih merupakan
salah satu penyakit mematikan di dunia. Kami yakin bahwa QFT mampu membantu
mengurangi beban perawatan penyakit TB di masa depan, dan secara potensial
membantu mengurangi biaya perawatan kesehatan terkait dengan TB serta
mengurangi resiko penyebaran penyakit.”

QFT dianggap baik oleh komunitas kesehatan masyarakat dan penyakit
menular, dan bukti kemanjuran klinis serta kegunaan dalam penatalaksanaan
tuberkulosis telah didukung selama bertahun-tahun pada lebih dari 600
penelitian yang dikaji oleh tim ahli yang dimuat dalam jurnal medis bergengsi
di seluruh dunia.(3,4,5,6)

Tentang QuantiFERON(R)-TB Gold (QFT)
QuantiFERON(R)-TB Gold (QFT) adalah uji darah secara menyeluruh yang
secara akurat mengidentifikasi penderita Mycobacterium tuberculosis, bakteri
penyebab Tuberkulosis (TB). Sebagai alternatif modern terhadap Tuberculin Skin
Test (TST) berumur 110 tahun, yang juga dikenal dengan Mantoux, QFT menawarkan
kekhususan tak tertandingi, sensitivitas tinggi dan kesederhanaan. QFT
memungkinkan terapi TB terfokus dengan memberi para dokter alat diagnostik TB
yang akurat, terpercaya dan nyaman. QFT tidak terpengaruh oleh vaksinasi BCG
sebelumnya dan banyak mikobakteria lingkungan lainnya. Tidak seperti TST,
pengujian ini hanya membutuhkan satu kali kunjungan pasien, merupakan uji
laboratorium terkontrol dan memberikan hasil reproduksi objektif yang tidak
terpengaruh oleh penafsiran subjektif.

QFT tersedia untuk penggunaan dalam seluruh pengaturan klinis di mana TST
biasanya digunakan. Contohnya antara lain pelacakan kontak, uji darah untuk
karyawan biasa, misalnya untuk pekerja perawatan kesehatan, serta program
skrining untuk para tahanan dan imigran. Penerapan QFT pada skrining pasien
imunosupresi sebelum inisiasi terapi anti-TNF-alpha dan pada penderita HIV,
kanker maupun transplantasi organ menawarkan keunggulan yang berbeda dengan
TST.

QFT dijual secara langsung di Amerika Serikat oleh Cellestis Inc. dan
melalui Quest Diagnostics, Inc., LabCorp serta laboratorium komersial lainnya.
Di Eropa, QFT dijual oleh Cellestis Gmbh (Jerman); dan Australia/ New Zealand
oleh Cellestis International Pty. Ltd (Australia). QFT juga tersedia melalui
Cellestis Commercial Partners di Jepang, Eropa, Timur Tengah, Afrika, Amerika
Selatan, dan Asia.

Tentang Cellestis Limited
Cellestis Limited, perusahaan bioteknologi Australia yang sudah terdaftar,
didirikan pada tahun 2000 di Melbourne, Australia, mengembangkan dan
memproduksi uji QuantiFERON-TB Gold (QFT), uji darah terobosan untuk mendeteksi
dan mengontrol tuberkulosis. Teknologi QuantiFERON adalah metode paten untuk
mendeteksi respon kekebalan dengan perantaraan sel (CMI) limfosit sel T dengan
menggunakan sampel darah secara keseluruhan. Dibandingkan dengan metode
pengukuran CMI yang sudah ada, teknologi unik ini memberikan akurasi dan
sensitivitas dengan penghematan utama dalam waktu operator, pekerja, dan
reagen. Dengan menggunakan teknologi paten QuantiFERON-nya, Cellestis
mengembangkan uji diagnosis yang mengukur fungsi imun untuk penyakit dengan
kebutuhan medis yang belum terpenuhi.

Cellestis bangga dapat mencari peluang guna meningkatkan upaya global
mengatasi TB. Cellestis adalah mitra industri FIND (Foundation for Innovative
New Diagnostics) dan Stop-TB Partnership.

Untuk informasi lebih lanjut, kunjungi http://www.cellestis.com dan
http://www.TackleTB.com.

REFERENSI
(1) World Health Organization. Tuberculosis. World Health Organization,
2011. Tersedia di: http://www.who.int/mediacentre/factsheets/fs104/en/.

(2) Centers for Disease Control and Prevention. The Difference Between
Latent TB Infection and Active TB Disease. Centers for Disease Control and
Prevention, 2011. Tersedia di:
http://www.cdc.gov/tb/publications/factsheets/general/LTBIandActiveTB.htm.

(3) Diel R, Loddenkemper R, Niemann S, Meywald-Walter K, Nienhaus A.
“Negative and positive predictive value of a whole-blood IGRA for developing
active TB — an update.” Am J Respir Crit Care Med (2008).

(4) Diel et al. “Evidence-based comparison of commercial interferon-gamma
release assays for detective active TB: a metaanalysis.” Chest (2010) 137: 952
— 968.

(5) Anderson P, Munk ME, Pollock JM, Doherty TM. “Specific immune-based
diagnosis of TB.” Lancet (2000) 356: 1099 — 1104.

(6) Higuchi K, Harada N, Mori T, Sekiya Y. “Use of QuantiFERON(R)-TB Gold
to investigate tuberculosis contacts in a high school.” Respirology (2007) 12:
88 — 92.

SUMBER: Cellestis Limited

KONTAK: Amy Losak dari Ketchum Public Relations, +1-646-935-3917,
amy.losak@ketchum.com


Cellestis Responds to World Health Organization Guidance on Use of Blood Tests for Active Tuberculosis
MELBOURNE, Australia, July 25, 2011 /PRNewswire-AsiaNet/ —

Blood Tests Still Necessary for Latent Disease; WHO Guidance is Not Applicable to QuantiFERON-TB Gold (QFT), Used to Test for Latent TB

A new policy recommendation released on 20 July by the World Health Organization (WHO) warns against the use of serological (blood) tests to diagnose active tuberculosis (TB). Serological tests measure antibodies to TB in serum and are different to QuantiFERON, which measures responses of white blood cells to TB specific proteins.

Active tuberculosis occurs when the TB organism has overcome the body’s immune defences and proliferates to cause clinical symptoms. According to WHO, TB takes one life every 17 seconds globally.(1) People with active disease often shed live TB bacteria and infect others. A person who is infected with the bacteria that causes TB, but who shows no symptoms and is not sick with the disease, is said to have latent TB infection (LTBI).(2) People with LTBI are at risk of developing active TB, particularly if their immune system becomes depressed.(2)

QFT is intended as an aid to the diagnosis of TB infection, both active and latent, and does not discriminate between the two conditions. Cellestis Limited, manufacturer of QuantiFERON(R)-TB Gold (QFT), has become aware that some media reports have caused confusion around the WHO announcement. The press release from WHO clearly notes that it refers to serological (antibody-based) blood tests for active TB, and their comments do not apply to Interferon-Gamma Release Assays (IGRAs) for diagnosing latent TB. This has been confirmed by direct correspondence by WHO to Cellestis.

“QuantiFERON-TB was developed in response to the poor quality of previous tests such as those referred by WHO. We thoroughly agree with the comments of WHO regarding serological tests for active TB,” said Dr Jim Rothel, Chief Scientific Officer of Cellestis. “It is imperative to recognize that TB is still one of the world’s deadliest diseases. We are confident that QFT has the ability to help reduce the future healthcare burden of TB, and potentially help to lower healthcare costs related to TB and reduce the risk of epidemics.”

QFT is well-regarded by the public health and infectious disease communities, and evidence of its clinical effectiveness and utility in tuberculosis management has been supported over the years in more than 600 peer-reviewed studies published in prestigious medical journals throughout the world.(3,4,5,6,)

About QuantiFERON(R)-TB Gold (QFT)
QuantiFERON(R)-TB Gold (QFT) is a whole blood test that accurately identifies people infected with Mycobacterium tuberculosis, the causative agent of Tuberculosis (TB). As a modern alternative to the 110 year old Tuberculin Skin Test (TST), also known as the Mantoux, QFT offers unmatched specificity, high sensitivity and simplicity. QFT enables focused TB therapy by providing clinicians with an accurate, reliable and convenient TB diagnostic tool. QFT is unaffected by previous BCG vaccination and most other environmental mycobacteria. Unlike the TST, it requires only one patient visit, is a controlled laboratory test and provides an objective, reproducible result that is unaffected by subjective interpretation.

QFT is available for use in all clinical settings in which TST is commonly used. Examples include contact tracing, regular employee testing, for example for health care workers, as well as screening programs for prisoners and immigrants. QFT’s application in the screening of immunosuppressed patients prior to anti-TNF-alpha therapy initiation and in patients with HIV, cancer or organ transplants offers distinct advantages over the TST.

QFT is sold directly in the U.S. by Cellestis Inc. and through Quest Diagnostics, Inc., LabCorp, and other commercial laboratories. In Europe QFT is provided by Cellestis GmbH (Germany); and in Australia/New Zealand by Cellestis International Pty. Ltd. (Australia). QFT is also available through Cellestis Commercial Partners in Japan, Europe, the Middle East, Africa, South America and Asia.

About Cellestis Limited
Cellestis Limited, a listed Australian biotechnology company founded in 2000 in Melbourne, Australia, develops and manufactures the QuantiFERON-TB Gold (QFT) test, a breakthrough blood test for the detection and control of tuberculosis. The QuantiFERON technology is a patented method for detecting cell mediated immune (CMI) responses of T-cell lymphocytes using whole blood samples. In comparison to existing methods of measuring CMI, this unique technology provides accuracy and sensitivity along with major savings in operator time, labor and reagents. Using its patented QuantiFERON technology, Cellestis develops diagnostics tests that measure immune function for diseases with an unmet medical need.

Cellestis is proud to be exploring opportunities to enhance the global effort to eliminate TB. Cellestis is an industry partner of FIND (the Foundation for Innovative New Diagnostics) and the Stop-TB Partnership.

For more information, please visit http://www.cellestis.com and http://www.TackleTB.com.

REFERENCES
(1) World Health Organization. Tuberculosis. World Health Organization, 2011. Available at: http://www.who.int/mediacentre/factsheets/fs104/en/.

(2) Centers for Disease Control and Prevention. The Difference Between Latent TB Infection and Active TB Disease. Centers for Disease Control and Prevention, 2011. Available at:
http://www.cdc.gov/tb/publications/factsheets/general/LTBIandActiveTB.htm.

(3) Diel R, Loddenkemper R, Niemann S, Meywald-Walter K, Nienhaus A. “Negative and positive predictive value of a whole-blood IGRA for developing active TB — an update.” Am J Respir Crit Care Med (2008).

(4) Diel et al. “Evidence-based comparison of commercial interferon-gamma release assays for detective active TB: a metaanalysis.” Chest (2010) 137: 952 — 968.

(5) Anderson P, Munk ME, Pollock JM, Doherty TM. “Specific immune-based diagnosis of TB.” Lancet (2000) 356: 1099 — 1104.

(6) Higuchi K, Harada N, Mori T, Sekiya Y. “Use of QuantiFERON(R)-TB Gold to investigate tuberculosis contacts in a high school.” Respirology (2007) 12: 88 — 92.

SOURCE: Cellestis Limited

CONTACT: Amy Losak of Ketchum Public Relations, +1-646-935-3917, amy.losak@ketchum.com