Verifikasi Metode ELISA (Enzym Linked Immunosorbent Assay) Untuk Penentuan Kadar AMH (Anti Mullerian Hormone)
Verification of The ELISA Method (Enzym Linked Immunosorbent Assay) for Determination of AMH Levels (Anti Mullerian Hormone)
DOI:
https://doi.org/10.33084/jsm.v5i1.973Keywords:
verification, ELISA, AMH 4, Logistic ParameterAbstract
Validation is the process of confirming that the method used has capabilities that are consistent with what is needed while being used continuously. The AMH ELISA kit has carried out a method validation process before marketed and used in a laboratory to determine AMH levels. AMH is a specific biomarker used to diagnose PCOS patients. The laboratory can adopt a validated procedure but the laboratory still needs to confirm its ability to apply this method. Verification is the provision of objective evidence that the measured parameters meet the specified requirements. The purpose of this study was to find out how well verification of the ELISA AMH kit and comparing the calculation of 4 PL with linear regression. Based on the statistical test obtained p = 0.871 (p>0.05). It can be said that there was no significant difference between Optical Density days 1 and 7(p = 0.05). Linear regression equation (r) 0.9543 (p = 0.000; p <0.05) while in equation 4 PL (r) 1,000. The ELISA kit AMH method meets the verification requirements. The 4PL model calibration curve is more suitable to be used in the AMH ELISA kit than the linear regression model.
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References
Chauhan ashish, Bharti M & Priyanka. 2015.Analytical Method Development and Validation: A Concise Review. Journal of Analytical & Bioanalytical Techniques. (6)
1. pp 1-5. Doi: 10.4172/2155-9872.1000233
Aydin Suleyman. 2015.A Short History, Principles, and Types of ELISA, and our Laboratory Experience with Peptide/Protein Analyses Using ELISA. Peptides. (72). pp 4-15. Doi:10.1016/j.peptides.2015.04.012
Dewailly D, Claus Y.A, Adam B, Frank B, Nafi D, Renato F, Georg G, Tom W.K, Antonio L.M, Cornelius L, Helen M, Scott M.N, Jenny A.V, Hamish W and Richard A.A. 2014. The physiology and clinical utility ofanti-Mullerian hormone in women.Human Reproduction. (20) 3. pp 1-16. Doi: 10.1093/humupd/dmt062.
WHO. 2016. Guidelines On Validation Appendix 4 Analytical Method Validation Working
FDA. 2016. Guidelines for the Validation of Analytical Methods for the Detection of Microbial Pathogens in Foods and Feeds. pp 1-54
European Medicine Agency (EMEA). 2011. Guideline on Bioanalytical Method Validation.Commitee for Medicinal Products for Human Use. EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2
Azadeh M., Gorovits B., Kamerud J.,MacMannis S.,Safavi A.,Sailstad J.,and Sondag P. 2017. Calibration Curves in Quantitative Ligand Binding Assays: Recommendations and Best Practices for Preparation, Design, and Editing of Calibration Curves. The AAPS Journal. 20(1). pp 1-16. doi: 10.1208/s12248-017-0159-4.
Samuel M & Lawrence E.O. 2015. The Relevance And Significance Of Correlation In Social Science Research. International Journal of Sociology and Anthropology
Research. 3(1). pp 22-28. ISSN 2059-1209, ISSN 2059-1217
Schober P, Christa B & Lothar S. 2018. Correlation Coefficients: Appropriate Use and Interpretation. Correlation Coefcients in Medical Research. 126(5). pp. 1763-1768. doi:10.1213/ANE.0000000000002864.
Masdor N.A, Altintas Z &Tothill I.E. 2016. Sensitive Detection Of Campylobacter Jejuni using Nanoparticles Enhanced QCM Sensor. BiosensBioelectron: 78. pp 328–
36. doi: 10.1016/j.bios.2015.11.033
John W.A. F & Robert F.D. 2007. Appropriate Calibration Curve Fitting in Ligand Binding Assays. The AAPS Journal. 9(2). pp 260-267. doi: 10.1208/11psj0902029
Hyun W.S, Weng K.W &Yarong Y. 2018. VNM: An R Package for Finding Multiple ObjectiveOptimal Designs for the 4-Parameter LogisticModel. Journal of Statistical Software. 83(5). pp 1- 19. doi: 10.18637/jss.v083.i05
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