REAGEN BUATAN SENDIRI SEBAGAI REAGEN ALTERNATIF UNTUK PEMERIKSAAN KADAR ALBUMIN

Fusvita Merdekawati

Abstract


The use of homemade reagents is a modification of the inspection method that has been validated, so that to be used it needs to be tested first for its quality in order to obtain a guarantee of quality against the results of a good examination The study aimed to determine the performance of homemade reagents compared to using a commercial reagent kit on albumin examination. The research method is descriptive with comparative studies where commercial reagent kits act as a comparison method and homemade reagents act as test methods. Both of these reagents are in the form of a solution. Homemade reagents are used for albumin examination in the validation test method which consists of test accuracy, precision, linearity, reportable range, limit detection, limit quantity, recovery, and interference. The data obtained is then processed using descriptive statistical tests, One Way Annova and Wesgard rules. Based on the results of testing, all parameters in the method validation were accepted, so there was no difference in performance between using homemade reagents and commercial reagent kits


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References


Infusino I, Panteghini M. Serum albumin: Accuracy and clinical use. Clin Chim Acta [Internet]. 2013;419:15–8. Available from: http://dx.doi.org/10.1016/j.cca.2013.01.005

Wardhan P. Clinical Pathology and Clinical Pathology and. Indones J. 2016;22(2).

Irsan Hasan TAI. Peran Albumin Dalam Penatalaksanaan Sirosis Hati. Csientific J Pharm Dev Med Appl. 2008;21(2):3–7.

Bishop ML, Fody EP, Schoeff LE. Clinical Chemistry Techniques, Principles, Correlations. Sixth edit. Wolters Kluwer; 2010.

Kementerian Kesehatan Republik Indonesia. Cara Penyelenggaraan Laboratorium Yang Baik. 2013;

Anggi L. Validasi Metode Bromocresol Green Untuk Pemeriksaan Albumin Menggunakan Reagen Buatan Sendiri. Bandung; 2016. 1–3 p.

Courses WO. Westgard QC Order Form.

CLSI EP 9. Method Comparison and Bias Estimation Using Patient Samples ; Approved Guideline — Second Edition Serving the World ’ s Medical Science Community Through Voluntary Consensus. Vol. 22.

Lumsden JH. Laboratory test method validation. Rev Méd Vét. 2000;151(7):623–30.

UNODC. Guidance for the Validation of Analytical Methodology and Calibration of Equipment used for Testing of Illicit Drugs in Seized Materials and Biological Specimens A. New York: UNITED NATIONS PUBLICATION; 2009.

Molinaro R, Ascp MT. Method Validation. In Atlanta: Profesional Practice ini Clinical Chemistry; 2013.

WHO. Guidelines On Validation – Appendix 4 Analytical Method Validation. 2016;(June):1–11.

Supriyanto R, Kimia J, Lampung U, Lampung B. Studi Analisis Spesiasi Ion Logan Cr(III) dan Cr(VI) Dengan Asam Tanat Dari Ekstrak Gambir Menggunakan Spektrometri UV-VIS. 2011;17(1):35–42.

Kusumawardhani N, Sulistyarti H, Veteran J. Penentuan Panjang Gelombang Maksimum Dan pH Optimum Dalam Pembuatan Tes Kit Sianida Berdasarkan Pembentukan Hidrindantin. 1(1):711–7.

Rives LH. Albumin BCG Method. France; 2011.

Harmita. Petunjuk Pelaksanaan Validasi. PETUNJUK Pelaks VALIDASI Metod DAN CARA PERHITUNGANNYA. 2004;I(3):117–35.

United Nations Office on Drugs and Crime. Guidance for the Validation of Analytical Methodology and Calibration of Equipment used for Testing of Illicit Drugs in Seized Materials and Biological Specimens. 2009. 67 p.

Westgard S, Qc W. Six Sigma Metric Analysis for Analytical Testing Processes. 2009;

Irish National Accreditation Board (INAB). Guide to Method Validation for Quantitative Analysis in Chemical Testing Laboratories. 2012;(3):36.

Coulter B. Albumin. 2009;1–2.

Muthalib MI binti A, A. Determination of Critical Micelle Concentration of Mixed Solution of Zwitterionic-Nonionic Surfactants. 2011;(Stf 3015).

Patent WO1982000056A1 - Improved albumin reagent - Google Patentsuche.

Friedecký B., Šprongl L. KJ. Validation and Verification of Analytical. Valid Verif Anal Methods Clin Lab. 2004;(November):1–15.

Sugio, S., Kashima, A., Mochizuki, S., Noda, M., Kobayashi K. RCSB PDB - 1AO6: Crystal Structure Of Human Serum Albumin Structure Summary Page [Internet]. 1999. Available from: http://www.rcsb.org/pdb/explore/explore.do?structureId=1AO6

Eurachem. The Fitness for Purpose of Analytical Methods [Internet]. Eurachem Guide, ISBN: 0-94948926-12-0. 1998. 1–61 p. Available from: http://www.eurachem.org/images/stories/Guides/pdf/valid.pdf

Validation M, Software V, Methods Q, Summary V, Methods Q, Summary V, et al. Standardized Protocol for Method Validation / Verification Standard Operating Procedure Quality Assurance Unit Laboratory Services Section - Austin Table of Contents I . Purpose II . Scope.

Klick RL. Decision making in the clinical laboratory: a quantitative and statistical approach for methods evaluation. 1997;(November):1–27.


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