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Comparison Study Between Local TSH IRMA Kit (CRRT) and Imported TSH IRMA Kit (Riakey, Korea) Mondrida, Gina; Triningsih, Triningsih; Purwanti, Kristina Dwi; Sutari, Sutari; Setyowati, Sri; Yulianti S, V.; Lestari, Wening; Ariyanto, Agus; Widayati, Puji
JKPK (Jurnal Kimia dan Pendidikan Kimia) Vol 4, No 2 (2019): JKPK ( Jurnal Kimia dan Pendidikan Kimia)
Publisher : Program Studi Pendidikan Kimia FKIP Universitas Sebelas Maret

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (826.081 KB) | DOI: 10.20961/jkpk.v4i2.29756

Abstract

Thyroid Stimulating Hormone (TSH) is one of hormones that our body need for growth of brains, bones and other tissues and regulate the metabolism in the body. Normal range of TSH for adult is from 0.3 to 5.5 µIU/ml, whereas for baby ranged from 3 to 18 µIU/ml. An Immunoradiometricassay (IRMA) is one of immunoassay technique using radionuclide as the tracer to detect low quantity of analyte. This technique is suitable for determine TSH levels in human blood serum which has complex matrix and various concentration. The Center for Radioisotope and Radiopharmaceutical Technology (CRRT)-BATAN has developed a reagent of TSH IRMA kit. The aim of this research is to compare between local TSH IRMA kit (CRRT-BATAN) and imported TSH IRMA kit (Riakey, Korea) toward 110 adult samples obtained from PTKMR - BATAN. The results showed 97 samples as true negative, 5 samples as true positive, 1 sample as false negative and 7 samples false positive. The comparison study gave diagnostic sensitivity as much as 83.33 %, diagnostic spesificity as much as 93.27 % and accuracy as much as 92.72 %.
PENGARUH WAKTU DAN SUHU INKUBASI PADA OPTIMASI ASSAY KIT RIA MIKROALBUMINARIA Susilo, Veronika Yulianti; Mondrida, Gina; Setiyowati, Sri; Sutari, .; Lestari, Wening
Jurnal Radioisotop dan Radiofarmaka Vol 8 (2005): JURNAL PRR 2005
Publisher : Jurnal Radioisotop dan Radiofarmaka

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Abstract

Penentuan kadar albumin dalam jumlah mikro dalam urin pasien sangat penting dilakukan untuk deteksi dini mikroalbumin sebelum menjadinephropathy(gagal ginjal). Penentuan kadar mikroalbumin tersebut menggunakan teknik radioimmunoassay(RIA) dengan kit RIA Mikroalbuminuria. Kit RIA yang baru harus memberikan kinerja assayyang baik, maka setelah diproduksi komponen kit RIA Mikroalbuminuria yang memenuhi syarat perlu dilakukan rancangan assayyang tepat agar diperoleh kondisi assayyang optimum. Telah dilakukan optimasi rancangan assaykit RIA Mikroalbuminuria untuk memperoleh waktu dan suhu inkubasi yang terbaik, yaitu variasi waktu inkubasi 1 jam, 3 jam, 5 jam dan 18 jam dan suhu inkubasi 4°C, 25°C dan 37°C. Protokolassayyang optimum dicapai dengan inkubasi selama 3 jam pada 37°C, yang menghasilkan % ikatan maksimum sebesar 52% dan ikatan non spesifik (NSB) cukup rendah 0,15%. Kit RIA Mikroalbuminuria ini stabil memenuhi syarat %B/T dan %NSB dan dapat dipertahankan selama 8 minggu. Kata kunci: Optimasi, Radioimmunoassay, Mikroalbuminuria Determination of albumin content at micro quantity in a patient urine is very important for an early detection of microalbuminuria before a nephropathy (kidney failure) state to occure. Determination of albumin content in a patient urine is by radioimmunoassay technique using microalbuminuria RIA kit. In a production of a new. icroalbuminuria RIA Kit, a good assay performance should be quaranteed, therefore after RIA reagent that fulfil the required quality were obtained, an optimum assay condition should be esigned. Optimization for assay design of microalbuminuria RIA kit have been carried out in order to obtained the best incubation time and temperature. Incubation time and temperature investigated were 1 hour, 3 hour, 5 hour and 18 hour and 4°C, 25°C dan 37°C respectively. The optimum assay protocol was achieved by 3 hour incubation at 37°C, resulting a high maximum binding of 52% and very low non spesific binding (NSB) of 0,15% respectively. The microalbuminuria RIA kit was stable and comply the required %B/T and %NSB up to 8 weeks. Keywords: Optimize, Radioimmunoassay, Microalbuminuria.
Immunoradiometricassay (IRMA) CA 15.3 untuk Deteksi Kanker Payudara Widayati, Puji; Lestari, Wening; Susilo, Veronika Yulianti
Jurnal Radioisotop dan Radiofarmaka Vol 17, No 1 (2014): Jurnal PTRR 2014
Publisher : Jurnal Radioisotop dan Radiofarmaka

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Abstract

Kanker payudara merupakan salah satu masalah kesehatan karena angka morbiditas dan mortalitas yang cukup tinggi. Tingginya angka mortalitas dikarenakan terapi yang ada sekarang ini belum memberikan hasil yang memuaskan. Tingginya tingkat stadium pasien kanker payudara di Indonesia disebabkan tingkat kesadaran masyarakat yang rendah, pada hal kanker payudara adalah salah satu jenis kanker yang dapat dideteksi dini, salah satu caranya dengan menggunakan kit IRMA CA 15.3. Carbohydrate Antigen 15.3 (CA 15.3) adalah sejenis gabungan glikoprotein heterogene yang dapat bereaksi dengan monoklonal antibodi anti CA 15.3. Senyawa CA 15.3 digunakan sebagai tumor marker dan penentuan kadarnya dapat dilakukan dengan teknik Immunoradiometricassay (IRMA). Pusat Radiosotop dan Radiofarmaka (PRR)-BATAN telah mengembangkan kit IRMA CA 15.3 dan sebelum digunakan secara klinis kit tersebut harus divalidasi. Penelitian ini bertujuan untuk melakukan validasi kit IRMA CA-125 produksi PRR yang meliputi penentuan batas deteksi, kepekaan (sensitivitas), ketelitian (presisi) dan parameter assay (Non Spesific Binding, NSB dan Maximum Binding, MB) sehingga dapat digunakan untuk menentukan kadar CA 15.3 pada pasien kanker payudara di rumah sakit. Telah dilakukan validasi kit IRMA CA 15.3 yang menghasilkan batas deteksi 0,84 mIU/mL dengan ketelitian intra assay memberikan koefisien variasi (%CV) untuk QCL (8,94%) dan QC H (7,99%) sedangkan ketelitian inter assay untuk QC L (11,94%) dan QC H(12,38%). Kit IRMA CA 15,3 ini mempunyai karakter yang baik sesuai dengan %NSB dan B/T yang ditunjukkannya (1,05 untuk %NSB dan 16,30% untuk B/T).ABSTRACTCANCER DETECTION. Breast cancer is one health problem because the rate of morbidity and mortalityare quite high. The high mortality rate due to the existing therapy to breast cancer patients did not givesatisfactory results. The high stage breast cancer patients in Indonesia due to the low level of public awareness, whereas breast cancer is one type of cancer that can be early detected, using CA 153 IRMA kit. The Carbohydrate antigen 15.3 (CA-153) is a kind of combination of heterogene glycoprotein which canreact with the monoclonal anti CA 153 antibody. The CA 153 compound can be used as tumor marker and the concentration can be detennined using IRMA technique. The Center for Radiosotope and Radiohannaceuticals (CRR)-BA TAN has developed a CA 153 IRMA kit to fullfil domestic demand. The aim of the study is to validate the CA-125 IRMA kit produced by CRR including detennination of sensitivity, accuracy, precision and the assay parameters (Non-specific binding, NSB and Maximum Binding, MB) of the kit in order to be used to detennine concentration ofCA 153 of patients in the hospital. IRMA kit validation has been carried out resulting detection limit for CA 15.3 at 0.8130 IV I mL withprecision CY for intra-assay QC L (8,94%CY) and QC H(7.99%CY) while the inter-assay precision for QC L (l1,94%CY) and QC H. (l2,38%CY). This CA 153 IRMA kit also has a good character showing 1,05% NSB and 16,30%BIT.Keywords: Radiometricassay, tumour marker, CA 1531
PRODUKSI KIT IMMUNORADIOMETRICASSA Y (IRMA) CA-125 UNTUK DETEKSI DINI KANKER OV ARIUM Widayati, Puji; Ariyanto, Agus; Lestari, Wening
Jurnal Radioisotop dan Radiofarmaka Vol 14, No 1 (2011): Jurnal PRR 2011
Publisher : Jurnal Radioisotop dan Radiofarmaka

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Abstract

ABSTRAKPRODUKSI KIT IMMUNORADIOMETRICASSAY (IRMA) CA-125 UNTUK DETEKSI DINIKANKER OV ARIUM.Kanker ovarium merupakan kanker terbanyak sesudah kanker leher rahim, namuntingkat kematiannya lebih besar dari pada kanker leher rahim. Penderita yang datang ke dokter (75%) pada umumnya telah mengidap kanker pada stadium lanjut (III-IV) sehingga pasien tidak dapat lagi tertolong. Kanker akan lebih mudah disembuhkan bila diketahui pada tahap awal pertumbuhan (terdeteksi dini). Carbohydrate Antigen-125 (CA-125) adalah glikoprotein antigenik yang dilepaskan ke darah penderita kanker ovarium, dengan kadar sangat rendah pada awalnya dan meningkat sesuai dengan keganasan kanker, sehingga deteksi kanker ovarium dapat dilakukan dengan mengukur kadar rendah senyawa CA-125 di dalam darah. Metode yang sesuai adalah immunoradiometricassay (IRMA). Pusat Radioisotop dan Radiofarmaka(PRR) telah mengembangkan metode ini sejak 2003, diawali dengan pembuatan komponen kit IRMA CA125, meliputi perunut CA-125 bertanda 1251,larutan standar CA-125, dan tabung bersalut antibodi monoklonal (coated tube), kemudianoptimasi assay kit IRMA CA-125 yang menghasilkan nilai Bff = 19,05% dan NSB = 0,53%, dengan daerah kerja 0-200 mIU/mL. Selanjutnya validasi metode menggunakansampel kadar tinggi (QCH) dan kadar rendah (QCL), menunjukkan nilai %CV intra assay (n=15) sebesar 9.9 % (QCL) dan 2.97 % (QCH) serta %CV inter assay (n=7) berturut-turut 13.1% (QCL) dan 4.9% (QCH), yang memenuhi syarat, memenuhi syarat Protocol IAEA Kata kunci: Kanker ovarium, Immunoradiometricassay(IRMA), CA-125, optimasi, validasiABSTRACTPRODUCTION OF IMMUNORADIOMETRICASSAY (IRMA) CA-125 FOR EARLYDETECTION OF OVARIAN CANCER. Ovarian cancer is the second highest incidence after cervix cancer, but has higher fatality level than cervix cancer. Generally, patient is known suffering ovarian cancer in very late stadium, III or IV, which almost incurable. Cancer would be easier cured if detected early. Carbohydrate Antigen-125 (CA-125) is an antigenic glycoprotein presence in blood of ovarian cancer patient, in a very low concentration initially and will increase proportionally with the level of malignancy,therefore, early detection of ovarian cancer can be carried out by measurement of low level CA-125 in the blood. The most suitable method is immunoradiometricassay (IRMA). Our laboratory has developed CA-125 IRMA kit since 2003, started from preparation of CA-125 IRMA kit components, consists of 125I_CA_125 tracer, CA-125 standard, and monoclonal antibody-coated tubes, followed by assay optimization of IRMA CA-125 kit, which produced BIT value of 19,05%, NSB value of 0,53% and working area of 0 to 200 mIU/mL. Furthermore, method validation of IRMA CA-125 kit using high and low concentration quality control (QCH and QCd, showed an intra assay (n= 15) CV value of 9.9% for QCL and 2.97% for QCH, while inter assay (n=7) CV value of 13.1% and 4.9% for QCL and QCH respectively. The results comply with theIAEA protocol requirement.Keyword :
VALIDASI KIT RADIOIMMUNOASSAY AFLATOKSIN 81 Widayati, Puji; Ariyanto, Agus; Triningsih, Triningsih; Susilo, Veronika Yulianti; Lestari, Wening
Jurnal Radioisotop dan Radiofarmaka Vol 18, No 1 (2015): JURNAL PTRR 2015
Publisher : Jurnal Radioisotop dan Radiofarmaka

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Abstract

Aflatoksin merupakan senyawa mikotoksin yang bersifat sangat toksik sehingga dapat menjadi penyebab terjadinya kanker pada manusia. Aflatoksin berpotensi karsinogenik, mutagenik, teratogenik, dan bersifat imunosupresif oleh karena itu kandungan aflatoksin B1 dalam bahan dan prod uk pangan harus dibatasi. Salah satu teknik penentuan kadar aflatoksin B1 adalah radioimmunoassay (RIA) yang didasarkan pada reaksi immunologi antara antigen dan antibodi yang spesifik hanya untuk antigen tertentu saja, serta menggunakan antigen yang ditandai zat radioaktif sebagai peru nut. Pusat Teknologi Radioisotop danRadiofarmaka BATAN telah berhasil mengembangkan kit RIA Aflatoksin B1 yang dapat digunakan untuk penentuan kandungan Aflatoksin B1dalam bahan dan produk pangan. Sebelum digunakan di lapangan kit aflatoksin B1 harus divalidasi meliputi penentuan batas deteksi, kepekaan (sensitivitas), ketelitian (presisi) dan parameter assay (Non Spesific Binding, NSB dan Maximum Binding, MB) sehingga dapat digunakan untuk menentukan kadar aflatoksin B1• Penelitian ini bertujuan untuk menentukan batas deteksi, ketelitian intra assay dan inter assay serta parameter assay. Telah dilakukan validasi kit RIA aflatoksin yang menghasilkan batas deteksi 0,35 ng/mL dengan ketelitian intra assay memberikan koefisien variasi (%CV) QC 9,80% sedangkan ketelitian inter assay untuk QC 12,39%. Kit RIA aflatoksin B1 ini disimpulkan memberikan unjuk kerja yang baik karena menghasilkan %NSB sebesar 6,6 dan B/T sebesar 47,18. Aflatoxins are mycotoxins compounds that are highly toxic and carcinogenic. Aflatoxins are potentially carcinogenic, mutagenic, teratogenic, and immunosuppressive so that the content of aflatoxin B1 in food products should be limited. One technique of determining the level of aflatoxin B1 is a radioimmunoassay (RIA) which is based on immunological reactions between antigens and antibodies, and using radioactive substances as a tracer. Center for Radioisotopes and Radiopharmaceuticals Technology (PTRR) has successfully developed Aflatoxin B1 RIA kit that can be used to determine the aflatoxin B1 in food products. Aflatoxin B1 RIA kit must be validated, which includes determining the limits of detection, sensitivity, accuracy (precision) and assay parameters (Non Specific Binding, NSB and Maximum Binding, MB) that can be used to determine the level of aflatoxin B1. This study aims to determine the limit of detection, accuracy intra-assay and inter-assay and assay parameters. The Aflatoxin B1 RIA kit validation results in the detection limit of 0.35 ng / mL with coefficient of variation (% CV) QC 9.80%, while the inter-assay precision for QC 12.39%. RIA Kit Aflatoxin B1 is inferred provide good performance because it produces 6.6% for NSBand 47.18 for B/T.  
Optimasi Sintesa Nanokoloid Human Serum Albumin sebagai Agen Limfoskintigrafi Menggunakan Central Composite Design-Response Surface Methodology Lestari, Wening; Setiyowati, Sri; Triningsih, Triningsih; Asyikin, Khoirunnisa Fauziah; Suharmadi, Suharmadi; Mujamilah, Mujamilah; Sulungbudi, Grace Tjungirai; Juliyanto, Sumandi
Jurnal Kefarmasian Indonesia VOLUME 12, NOMOR 1, FEBRUARI 2022
Publisher : Pusat Penelitian dan Pengembangan Biomedis dan Teknologi Dasar Kesehatan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.22435/jki.v11i1.5071

Abstract

The prevalence of cancer in Indonesia is increasing and various cancer treatments still have shortcomings, cancer recurrence still occurs. Lymphoscintigraphy is a method for detecting disorders of the lymphatic system, which are closely related to cancer cells. Human serum albumin nanocolloid as a lymphoscintigraphic agent consists of particles measuring