Method Validation for Potency test of human Tetanus Immunoglobulin by commercial test kit
Keywords:
tetanus immunoglobulin, ELISA test kit, potencyAbstract
Tetanus is an infectious disease in neuromuscular diseases group caused by Clostridium tetani. Tetanus can be prevented by vaccination. If any patient has no immunity against tetanus, antibiotics and tetanus antiserum or human tetanus immunoglobulin are required for treatment. Therefore, the quality of the product is an important factor for effective treatment. The standard method for potency testing of human tetanus immunoglobulin is in vivo method which is high variation and costly. For this reason, the current European Pharmacopoeia has adopted Enzyme-linked Immunosorbent Assay as an alternative standard method. In this study, the commercial ELISA test kit for tetanus immunoglobulin in specimen was used. The results showed that the precision, accuracy, linearity and system suitability meet the validation criteria. The LOQ was 0.00208 IU/ml; and the absorbance after the reaction stopped could be measured up to 2.30 hours. In conclusion, the potency testing of human tetanus immunoglobulin by the commercial ELISA test kit is suitable to adopt as a national standard method.
References
สำนักระบาดวิทยา กรมควบคุมโรค. โรคบาดทะยัก. [ออนไลน์]. 2548. [เข้าถึงเมื่อ 4 พฤษภาคม 2559]; [3 หน้า]. เข้าถึงได้จาก: https://www.boe.moph.go.th/fact/Tetanus.htm
Gross S, Janssen SWJ, de Vries B, Terao E, Daas A, Buchheit KH. Collaborative study for the validation of alternative in vitro potency assays for human tetanus immunoglobulins. Biologicals 2010; 38(4): 501–10.
Aybay C, Karakus R, GÜndoğdu AG. Development of a diagnostic and screening Elisa system for measuring tetanus antitoxoid levels. Turk J Med Sci 2003; 33(5): 289-94.
Animal Ethics Infolink. Three Rs. [online]. 2015. [cited 2016 May 4]. Available from: https://www.animalethics.org.au/three-rs
European Pharmacopoeia. Human tetanus immunoglobulin. 8th ed. Strasbourg: Council of Europe; 2014. p. 2432-4.
Perry AL, Hayes AJ, Cox HA, Alcock F, Parker AR. Comparison of five commercial anti-tetanus toxoid immunoglobulin G enzyme-linked immunosorbent assays. Clin Vaccine Immunol 2009; 16(12): 1837-9.
van Hoeven KH, Dale C, Foster P, Body B. Comparison of three enzyme-linked immunosorbent assays for detection of immunoglobulin G antibodies to tetanus toxoid with reference standards and the impact on clinical practice. Clin Vaccine Immunol 2008; 15(12): 1751-4.
Tetanus ELISA IgG Testkit: EC 124.00 REV 18. Rüsselsheim: Sekisul Virotech GmbH [online]. 2014. [cited 2016 May 4]; [10 screens]. Available from: https://www.sekisuidiagnostics.com/writable/product_documents/files/tetanus_elisa_igg_ec124.00_gb.pdf
National Institute for Biological Standards and Control. WHO international standard 1st international standard for tetanus immunoglobulin, human.: TE-3 Version 8.0. Hertfordshire: NIBSC; 2013.
National Institute of Infectious Diseases. Biostatistics program 2006: how to use the statistical quality control program [CD-ROM]. Tokyo: Ministry of Health, Labour and Welfare; 2006.
Tierney R, Stickings P, Hockley J, Rigsby P, Iwaki M, Sesardic D. Collaborative study for the calibration of a replacement International Standard for Tetanus Toxoid Adsorbed. Biologicals 2011; 39(6): 404-16.
European Medicines Agency. Guideline on bioanalytical method validation. EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2. [online]. 2015. [cited 2016 May 4]; [23 screens]. Available from: https://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
