ANALISIS SITUASI HAK KEKAYAAN INTELEKTUAL BIDANG KESEHATAN DI INDONESIA

The information about intellectual property rights (IPR) related to health products in Indonesia is limited. This manuscript aims to describes the situation of health innovative researches including their products (patented and copyrights) in the last 5 years (2009-2013). This is a cross-sectional exploratory qualitative research, followed by the identifi cation of data and information related to health IPR documents retrospectively from 2009 till 2013. In-depth interviews conducted on IPR managers in 5 (fi ve) government research institutions, Indonesia Institute of Science, Agency for the Assessment and Application of Technology and 7 (seven) universities in Java island. The results showed that the IPR policy is strong, because it is written in the Act, majority of institutions state that IPR is their main indicators, however, the priority of health innovative researches is low. Generally, patented products were not planned to be patented from the beginning. Not all institutions have IPR management structured and incubation unit for development and “scaling up” of  researches results, so that, patented health products were potentially not to be commercialised. This shows that there is still a gap between policy and its implementation in terms of research innovation. Governments should actively promote and utilize the patented health products of Indonesia. Abstrak Informasi tentang Hak Kekayaan Intelektual (HKI) di Indonesia yang terkait dengan produk kesehatan masih sangat kurang. Tulisan ini bertujuan memaparkan situasi penelitian inovatif dan produk hasil penelitian kesehatan terkait HKI (paten dan hak cipta) dalam 5 tahun terakhir (2009-2013). Studi ini merupakan penelitian kualitatif eksplorasi potong lintang disertai identifi kasi data dan informasi pada dokumen HKI bidang kesehatan secara retrospektif dari tahun 2009 sd 2013. Wawancara mendalam dilakukan terhadap pengelola HKI di 5 (lima) lembaga litbang kementerian, Lembaga Ilmiah Pengetahuan Indonesia, Badan Pengkajian dan Penerapan Teknologi dan 7 (tujuh) universitas di pulau Jawa. Hasil penelitian menunjukkan bahwa dasar kebijakan HKI Indonesia telah kuat karena sudah dituangkan kedalam Undangundang, hampir semua institusi yang disurvei menjadikan HKI sebagai indikator utama, hanya penelitian yang berorientasi HKI kesehatan masih kurang diprioritaskan. Pada umumnya hasil penelitian yang dipatenkan tidak direncanakan sejakawal. Belum semua institusi memiliki unit pengelola HKI secara terstruktur dan unit inkubasi untuk pengembangan dan scaling up hasil penelitian agar dimanfaatkan masyarakat luas sehingga produk paten kesehatan berpotensi menjadi yang tidak bisa dikomersialisasikan. Hal ini menunjukkan bahwa terdapat gap antara kebijakan dan implementasinya dalam hal penelitian inovasi. Pemerintah perlu secara aktif membantu mempromosikan dan memanfaatkan hasil produk kesehatan yang telah memperoleh HKI. &nbsp

PEMANFAATAN ANTIBODI DALAM DIAGNOSIS DEMAM BERDARAH DENGUE

The Use of Antibody For Dengue Hemorrhagic Fever Diagnosis.Dengue Hemorrhagic Fever (DHF) is caused by a virus belongs to Flavivirus group; the diseaseis transmitted by mosquito bites (Ae. aegyti and Ae. albopictus). There are four dengue virus serotypes (Dengue-1, Dengue-2, dengue-3 and Dengue-4), these all 4 serotypes were found in Indonesia. The majority of the mortality cases were due to the serious manifestation of the infections, such as DHF and Dengue Shock Syndrome (DSS). In general, the case fatality rates (CFR) of the disease are about 5 % for DHF and 40% for DSS. ln Indonesia 2006, even though the morbidity was increased, but the CFR was decreased. However, the CFR is still higher than the national control program target which is < 1%. The symptom of illnesses are very non specific as flu-like mild undifferentiated fever, it was hard to differentiate the fever of dengue from others. Diagnosis of dengue virus infection on the basis of clinical syndromes is not reliable, and the diagnosis should be confirmed by laboratory studies. Laboratory diagnosis of dengue virus infection can be made by the detection of specific virus, virus isolation and identification, or anti virus antibody detection. Virus isolation and identification was more proper for virology study, molecular epidemiology study or for pathogenesis study than for diagnosis. The HI test even though this test was sensitive, but time consuming need more than 24 hours to performed. ELISA test was sensitive and specific for IgM and IgG identification, but need special place (serology laboratory) and reagent to performed. Rapid Diagnostic test based on IgM or IgG identification, the test was practiced no need special equipment or place to performed, with good sensitivity and specivicity. The recent advance for dengue diagnosis is NSI detection, the glyco protein produce by infected cells from day 1 to 9 after the onset of fever.Keywords: Dengue Hemorrhagic Fever, diagnosis, antibod

GAMBARAN KESEPAKATAN HASIL DIAGNOSIS MALARIA MIKROSKOPIS DI KABUPATEN PURWOREJO, JAWA TENGAH

GAMBARAN KESEPAKATAN HASIL DIAGNOSIS MALARIA MIKROSKOPIS DI KABUPATEN PURWOREJO, JAWA TENGA

EFEKTIVITAS DIAGNOSIS MIKROSKOPIS MALARIA DI TIGA PUSKESMAS DI KABUPATEN PURWOREJO, JAWA TENGAH

Prinsip pengobatan yang dipakai sebagai acuan unit-unit kesehatan masyarakat adalah: penyembuhan penderita malaria secara cepat, mengurangi/membasmi parasitemia, mencegah komplikasi dan kematian, mengobati rekrudensi/relaps, mencegah kekambuhan kembali, mengurangi penularan. Pengobatan malaria yang dilakukan di P. Jawa dan P.Bali atas dasar hasil diagnosis mikroskopis, yaitu ditemukannya Plasmodium di dalam darah penderita (standar diagnosis laboratoriitm). Sesudah pengobatan, sediaan darah penderita diperiksa secara berkala. Kebijakan ini memerlukan konfirmasi hasil pemeriksaan mikroskopis yang akurat. Tujuan dari penelitian ini adalah menilai efektijitas mikroskopis sebagai perangkat diagnosis malaria di puskesmas. Penelitian ini dilakukan di 3 Puskesmas di wilayah Kabupaten Purworejo, Propinsi Jawa Tengah ; yaitu: Puskesmas Begelen II, Puskesmas Bener dan Puskesmas Kemiri I. Desain penelitian adalah kros seksional (cross sectional study) dengan sampel penelitian sebanyak 186 subyek penelitian. Pengukuran dilakukan dengan menghitung reliabilitas antar dan inter petugas mikroskopis (observer), validitas hasil boca, penghitungan biaya dan pengukuran waktu diagnosis, sebagai baku emas (metode standar) adalah mikroskopis Pusat (Sub Dit Malaria, P2MPL, DepKes). Reliabilitas dan validitas diagnosis mikroskopis untuk malaria vivax di Puskesmas Bener dan Kemiri I menunjukkan hasil kurang baik, sensitivitas dan spesivisitas sebesar 53,7%  (CI = 95%; 0,5414 - 0,5325) dan 98,4% (CI=95%; 0,9851 - 0,9828) dan 52,7%  (CI = 95%; 0,531-1 - 0,5225) dan 98,4% (CI =95%; 0,9851 - 0,9828). Untuk diagnosis malariafalsiparum Puskesmas Kemiri I menunjukkan hasil yang kurang baik, sensitifitas dan spesivisitas sebesar 71,7 (CI = 95%; 0,7209 - 0,713) dan 95% (CI=95%; 0,9519 - 0,948). Biaya pemeriksaan per sampel untuk melakukan diagnosis malaria adalah Rp 863.190,06, biaya tersebut adalah apabila pelatihan mikroskopis hanya 1 (satu) kali

"DENGUE IgG/IgM ANTIBODI RAPID TEST" (IR-113c) SEBAGAI PERANGKAT DIAGNOSTIK CEPAT DEMAM BERDARAH DENGUE

Dengue Haemorraghic Fever (DBD) remains one of the main major health problem. The morbidity rate increases from year to year, especially in the urban area like Jakarta. It is caused by flaviviridae virus, and transmitted through mosquitoes biting (Aedes aegypti or Aedes albopictus). Although the morbidity from 1990 to 2006 was high (total cases showed 22.807 in 1990, and 111.730 in 2006), the case fatality rate (CFR) were gradually decrease (CFR showed 3,60% in 1990 and 1,41% in 2006). The problem is in the early clinical manifestation of dengue virus infection causes a broad spectrum of illnesses, may as an asymptomatic infection, a like undifferentiated fever, a common influenza, a chikungunya, or as a typhoid fever. Prompt and accurate diagnosis is needed, to saving the lives of DBD patients. In order to get prompt and accurate diagnosis for dengue virus infection, we validated a Dengue IgG/IgM Antibody Rapid Test/IR-113c) (produced by Oncoprobe), using 61 sera taken from dengue infected patients from Jakarta, Semarang andMedan. All sera were paired or taken from acute and convalescence phases of infection. RDT result were compare to HI (Haemaglutination Inhibition) Test as a gold standard, ELISA test was also be done to measure the titers oflgM and IgG. It was found that this device showed 76,9% (76,8-77) sensitivity (Se), 77,7% (77,6-77,8) specivicity (Sp), 77,05% (76,95-77,15) accuracy, 95,2% (95,45-95,25) and 36,8% (36,68-36,92) positive predictive value (ppv) and negative predictive value (npv), all those result were statistically valid (x'=10,7, p = 0,001). The convalescence sera showed 98,1% (98,07-98,13) sensitivity (Se), 77,7% (77,6-77,8) specivicity (sp), 95,1% (95,05-95,15) accuracy, 96,2% (96,16-96,24) and 87,5% (87,42-87,58) positive predictive value (ppv) and negative predictive value (npv), all those result were statistically valid (x2 = 38,74, p = 0,000). Dengue IgG/IgM Antibody Rapid Test/IR-113c has an adequate sensitivity and accuracy however it is less specific. This device showed higher validity for convalence sera