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All Journal Media Penelitian dan Pengembangan Kesehatan Medical Journal of Indonesia Medica Hospitalia
Vivi Lisdawati
RSPI Sulianti Saroso, Kemenkes RI
Decision Sciences, Operations Research & Management Dentistry Health Professions Medicine & Pharmacology Nursing Public Health

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Peran Standar Operasional Prosedur Penanganan Spesimen untuk Implementasi Keselamatan Biologik (Biosafety) di Laboratorium Klinik Mandiri Hasugian, Armedy Ronny; Lisdawati, Vivi
Media Penelitian dan Pengembangan Kesehatan Vol 26, No 1 Mar (2016)
Publisher : Badan Penelitian dan Pengembangan Kesehatan

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (384.868 KB)

Abstract

AbstrakStandar Operasional Prosedur (SOP) merupakan acuan laboratorium dalam berkegiatan dan harusmemenuhi kriteria Good Laboratory Practice (GLP) serta peraturan perundang-undangan yangberlaku. SOP berkaitan dengan penilaian risiko keselamatan biologik (biosafety), terutama terkaittindakan pencegahan (safety precaution) di laboratorium. Tulisan ini bertujuan untuk mengidentifikasikepemilikan/ada tidaknya SOP dan evaluasi terhadap SOP yang dimiliki di Laboratorium Klinik Mandiri(LKM) di Indonesia dikaitkan dengan implementasi keselamatan biologik (biosafety), yang dalam tulisanini dihubungkan dengan kejadian dan komplikasi saat pengambilan darah. Desain penelitian mengikutiRiset Fasilitas Kesehatan (Rifaskes) 2011 yaitu potong lintang. Metodologi dengan cara mendatangisecara langsung setiap LKM sesuai kriteria inklusi, melakukan wawancara menggunakan kuisionerterstruktur, observasi dan pencatatan data sekunder yang diperlukan. Variabel SOP yang dianalisisberjumlah 15 buah sesuai pertanyaan pada Rifaskes 2011. Total 782 LKM direkrut pada Rifaskes 2011.Sejumlah 695 LKM dianalisis untuk kepemilikan/ada tidaknya SOP dan 504 LKM untuk evaluasi SOP.Hasil menunjukkan hanya 49,3% LKM memiliki SOP dan 51,8%-nya yang melakukan evaluasi SOP.LKM yang memiliki dan mengevaluasi ≥ 75% SOP lebih banyak ditemukan di Pulau Jawa dan Sumatera.Kejadian tertusuk benda tajam, terkena limbah infeksius, dan tertumpah limbah lebih sering terjadi padakelompok kepemilikan/ada tidaknya SOP dan evaluasi SOP < 75%. Komplikasi hematoma, pingsandan perdarahan lebih banyak dilaporkan oleh kelompok kepemilikan/ada tidaknya SOP dan evaluasiSOP ≥ 75%. Analisis multivariat menunjukkan kepemilikan/ada tidaknya SOP dan evaluasi SOP ≥ 75%berhubungan dengan perlindungan dari komplikasi perdarahan di laboratorium. Kesimpulan dari studiini bahwa < 75% LKM di Indonesia yang memiliki SOP dan evaluasi SOP, sehingga perlu ditingkatkanuntuk dapat menerapkan prinsip keselamatan biologik secara luas.Kata Kunci: biosafety, Riset Fasilitas Kesehatan (Rifaskes), laboratorium, Standar Operasional Prosedur AbstractStandard Operating Procedure (SOP) is a reference laboratory guideline in daily laboratory activity andmust meet criteria one Good Laboratory Practice (GLP) as well as the laws and regulation. SOPs is alsorelated to risk assessment of biological safety (biosafety), mainly related to preventive measures (safetyprecaution) in the laboratory. This paper aims to identify the ownership/presence or absence of SOP andevaluation of the SOP owned in the private clinical laboratory (PCL) in Indonesia associated with theimplementation of the safety of biologics (biosafety), which in this paper is associated with the incidenceand complications when taking blood.The study design followed the Research Health Facility (Rifaskes)2011 which was a cross sectional. The methodology by approaching directly each PCL which fits theinclusion criteria, and conduct interviews using structured questionnaire, observation and recording ofsecondary data is required. In total, 15 SOP variables were analyzed according to Rifaskes questionin 2011. Total 782 PCL were recruited in 2011 Rifaskes, only 695 of PCL were analyzed for ownership/presence of absence SOP and 504 PCLs for evaluation of SOP. The analysis showed that only 49.3%PCL have SOP and 51.8% of them are evaluating the SOP. The PCLs have and evaluate the SOP ≥ 75%more common in Java and Sumatera. The punctured needle accident, spilled chemicals and infectedmaterials infectious were recorded frequently in the group ownership/presence or absence of SOPand evaluation of SOP < 75%. Complications hematoma, unconscious, and bleeding more reported by the group ownership/presence or absence of SOP and evaluation of SOP ≥ 75%. The analysis ofmultivariate show ownership/presence or absence SOP and evaluation of SOP ≥ 75% protection fromcomplications related to bleeding in the laboratory. The conclusion of the study is the ownership SOPand evaluation SOP on PCL in Indonesia < 75%, so it needs to be improved to be able to apply theprinciples of biological safety at large.Keywords: biosafety, Research Health Facilities (Rifaskes), laboratory, Standard Operating Procedure
Evaluating the use of loop-mediated isothermal amplification (LAMP) method for detection of Mycobacterium tuberculosis in Indonesian clinical isolates Lisdawati, Vivi; Oshibe, Tomohiro; Tsuji, Hidetaka; Sudiro, Tjahjani M.; Adianti, Myrna; Sukarso, Triyani; Arief, Holy; Hotta, Hak; Sudarmono, Pratiwi
Medical Journal of Indonesia Vol 21, No 4 (2012): November
Publisher : Faculty of Medicine Universitas Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (526.167 KB) | DOI: 10.13181/mji.v21i4.502

Abstract

Background: Loop-mediated isothermal amplification (LAMP) is a method already claimed as a simple technique to amplify DNA/ RNA using four to six primers as “a set” from conserved sequence of target gene. In this study we optimize the use of LAMP for detection of Mycobacterium tuberculosis in clinical isolates from Indonesia.Methods: Procedures to perform LAMP were optimized, then the method was applied to 122 archieved samples of DNA’s Mtb from clinical TB patients with Acid Fast Bacilli (AFB) smears positive. The samples were obtained in 2008 from 13 provinces in Indonesia for genotyping study, which then become collections of Center for Biomedical and Basic Technology of Health (CBBTH), NIHRD Indonesia. The optimization tests include sensitivity and specificity tests of several sets primers, which were evaluated using 10-fold serially diluted DNA of Mtb H37Rv and 12 species of Mycobacteria. Three equipments consisted of LAMP turbidimeter, heating block and water bath were compared for its ability in DNA amplification. Detection of M. tuberculosis from clinical isolates used set primers specific for gyrB gene, amplicon was detected with UV fluorescence system.Results: The results showed that the highest sensitivity was obtained using the set primers specific for 16S rRNA and gyrB which could detect 10.0 fg to 1.0 pg genomic DNA of Mtb H37Rv. The set primers specific for gyrB gene was the most specific primers. Application of LAMP using gyrB set primers on Indonesian clinical isolates showed 94.2% (114/121) positivity rate.Conclusion: LAMP method is potentially used in TB diagnosis in Indonesia. (Med J Indones. 2012;21:188-95)Keywords: Loop-mediated isothermal amplification, rim gene, 16S rRNA gene, gyrB gene, Mycobacterium tuberculosis
Effect of Fixed‐Dose Combinations Antituberculosis and Separate Formulations on Clinical Symptoms, Weight Gain, Adverse Effect and Plasma Concentration in Tuberculosis and HIV Coinfection Cases Sundari, Titi; Mariana, Nina; Permatasari, Debby Intan; Rusli, Adria; Sitompul, Pompini Agustina; Rosamarlina, Rosamarlina; Widiantari, Aninda Dinar; Maemun, Siti; Lisdawati, Vivi
Medica Hospitalia : Journal of Clinical Medicine Vol. 10 No. 2 (2023): Med Hosp
Publisher : RSUP Dr. Kariadi

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.36408/mhjcm.v10i2.867

Abstract

BACKGROUND: Fixed Dose Combination (FDC) was aimed to simplify TB therapy and facilitate physician and patient compliance. OBJECTIVE: We aimed to evaluate the effect of FDC antituberculosis and separate formulations (SF) on clinical symptoms, weight gain, adverse effect and plasma concentration in TB/HIV cases during the intensive phase. METHOD: Prospective cohort study was conducted in public hospital, Jakarta. We recruited TB-HIV patients in May 2018-May 2019. Patients (over than 18 years old) diagnosed with TB-HIV who consumed either FDC or SF and had not received antiretroviral. A total of 36 subjects were included in this study, 20 subjects in FDC group and 16 subjects in SF group. RESULT:  There was not significant different between FDC and SF groups with an improvement of clinical symptoms (P = 0.70) and weight gain (P = 1.00). Gastrointestinal syndrome was 75% in FDC group; 62.5 % in SF group. Mean (±SD) of rifampicin, isoniazid, pyrazinamide plasma concentration after 2 weeks therapy in FDC group were 5.49 mg/L (±3.40 mg/L), 1.35 mg/L (±1.20 mg/L), 19.87 mg/L (±17.00 mg/L), respectively. Mean (±SD) of rifampicin, isoniazid, pyrazinamide plasma concentration in SF group were 6.42 mg/L (±4.80mg/L), 0.87 mg/L (±0.70 mg/L), 5.03 mg/L (±7.60 mg/L), respectively. CONCLUSION: There was not significant different between FDC and SF groups on improvement of clinical symptoms and weight gain in intensive phase of therapy, the highest of adverse effects was gastrointestinal syndrome, and all subjects had normal reference ranges of rifampicin concentrations, and isoniazid and pyrazinamide below the normal range.
Co-Authors Adria Rusli, Adria Armedy Ronny Hasugian HAK HOTTA Hidetaka Tsuji Holy Arief L.Broto S Kardono Maemun, Siti Myrna Adianti Nina Mariana, Nina Permatasari, Debby Intan Pratiwi Pujilestari Sudarmono rosamarlina, rosamarlina Sitompul, Pompini Agustina Sumali Wiryowidagdo Titi Sundari Tjahjani M. Sudiro Tomohiro Oshibe Triyani Sukarso Widiantari, Aninda Dinar