Stability of Lyophilized Homemade Control Serum After Reconstitution on SGOT and SGPT Levels Stored in Freezer at Temperature (-2° to -4°C) and -20°C for 8 Weeks
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Abstract
Improving health laboratory services is closely related to strengthening the quality of health laboratories. Serum control is part of the quality assurance of health laboratories. Lyophilized homemade serum is a type of homemade control serum. This research aims to determine the stability of lyophilized homemade control serum against Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) levels. This research used an experimental method with pooled sera as research material stored at -2°C to -4°C and -20°C for 8 weeks. Pooled sera were obtained from respondents who had no history of disease, were free from HIV, AIDS, and HBsAg. The research was conducted at the Reference Laboratory and Clinical Chemistry Laboratory Politeknik Kesehatan (Poltekkes) Kementerian Kesehatan, Surabaya. The results of the study were data analysis using linear regression test. The SGOT parameter at freezer temperature (-2 to -4°C) showed that the storage time had an effect of 90.97% with an error component of 9.03%. At freezer temperature (-20°C), the result of storage time has an effect of 78.71% with an error component of 21.29%. In the SGPT parameter with freezer temperature (-2 to -4°C), the result of storage time has an effect of 96.71% with an error component of 3.29%. At freezer temperature (-20°C), the result of storage time has an effect of 91.47% with an error component of 8.53%. The results of the SGOT and SGPT examinations did not exceed the limits of ±2SD and ±3SD The CV on the SGOT and SGPT examinations also did not exceed the CCV limits, which is to be stable.
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Copyright (c) 2023 Kadek Profit Hartani, Anik Handayati
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References
Hedayati M, Razavi SA, Boroomand S, Kheradmand Kia S. The impact of pre-analytical variations on biochemical analytes stability: A systematic review. Journal of Clinical Laboratory Analysis. John Wiley and Sons Inc; 2020; 34. DOI: 10.1002/jcla.23551 DOI: https://doi.org/10.1002/jcla.23551
Carey RB, Bhattacharyya S, Kehl SC, Matukas LM, Pentella MA, Salfinger M, Schuetz AN. Practical guidance for clinical microbiology laboratories: implementing a quality management system in the medical microbiology laboratory. Clinical microbiology reviews. 2018; 31(3), e00062-17. DOI: https://doi.org/10.1128/CMR.00062-17 DOI: https://doi.org/10.1128/CMR.00062-17
Kaur V, Kare PK, Madaan H. Quality Control in a Clinical Laboratory In book: Advances in Biochemistry & Applications in Medicine. 1st ed. Vol. 4. USA: Open Access eBooks; 2018; 1–9.
Broadhurst D, Goodacre R, Reinke SN, Kuligowski J, Wilson ID, Lewis MR, Dunn WB. Guidelines and considerations for the use of system suitability and quality control samples in mass spectrometry assays applied in untargeted clinical metabolomic studies. Metabolomics. 2018; 14: 1-17. DOI: https://doi.org/10.1007/s11306-018-1367-3 DOI: https://doi.org/10.1007/s11306-018-1367-3
Oosterhuis WP, Bayat H, Armbruster D, Coskun A, Freeman KP, Kallner A, Theodorsson E. The use of error and uncertainty methods in the medical laboratory. Clinical Chemistry and Laboratory Medicine (CCLM). 2018; 56(2): 209-219. DOI: https://doi.org/10.1515/cclm-2017-0341 DOI: https://doi.org/10.1515/cclm-2017-0341
Salma FD, Rahayu IG, Kurnaeni N, Rinaldi SF. Cost-Effectiveness Analysis ( Cea ) Commercial Control Material And Patient Pool Serum. J Health Res. 2017;(11):298–3. DOI:10.34011/juriskesbdg.v11i1.797 DOI: https://doi.org/10.34011/juriskesbdg.v11i1.797
Lee A, Kim HJ. Production and Performance Evaluation of External Quality Assessment Materials for Human Epididymis Protein 4 Assay. Journal of Laboratory Medicine and Quality Assurance. 2019; 41(3): 153-160. DOI: https://doi.org/10.15263/jlmqa.2019.41.3.153 DOI: https://doi.org/10.15263/jlmqa.2019.41.3.153
Danilenko U, Vesper HW, Myers GL, Clapshaw PA, Camara JE, Miller WG. An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials. Clinical Chemistry and Laboratory Medicine (CCLM). 2020; 58(3): 368-374. DOI: https://doi.org/10.1515/cclm-2019-0732 DOI: https://doi.org/10.1515/cclm-2019-0732
Lestari WS, Karwiti W, Latifah A, Listiani Y, Harianja SH. Sera Pooled Stability as a SGPT Control Material With Storage Time and Temperature Variation. J Med Lab Sci. 2022;2(1):33–9. DOI: 10.36086/medlabscience.v2i1 DOI: https://doi.org/10.36086/medlabscience.v2i1.1255
Handayati A. Design of Home Made Lyophilized Serum as a Control Material for Internal and External Quality Control in Clinical Laboratories. Health Notions' 2022; 6(12): 502-507. DOI: https://doi.org/10.33846/hn61203
Wu AH, Christenson RH, Greene DN, Jaffe AS, Kavsak PA, Ordonez-Llanos J, Apple FS. Clinical laboratory practice recommendations for the use of cardiac troponin in acute coronary syndrome: expert opinion from the Academy of the American Association for Clinical Chemistry and the Task Force on Clinical Applications of Cardiac Bio-Markers of the International Federation of Clinical Chemistry and Laboratory Medicine. Clinical Chemistry. 2018; 64(4): 645-655. DOI: https://doi.org/10.1373/clinchem.2017.277186 DOI: https://doi.org/10.1373/clinchem.2017.277186
West T, Kirmess KM, Meyer MR, Holubasch MS, Knapik SS, Hu Y, Yarasheski KE. A blood-based diagnostic test incorporating plasma Aβ42/40 ratio, ApoE proteotype, and age accurately identifies brain amyloid status: findings from a multi cohort validity analysis. Molecular neurodegeneration. 2021; 16(1): 1-12. DOI: https://doi.org/10.1186/s13024-021-00451-6 DOI: https://doi.org/10.1186/s13024-021-00451-6
Tambse V. Study of the Stability of various Biochemical Analytes in Pooled Sera preserved at 4-8oC. Asian Journal of Biomedical and Pharmaceutical Sciences. 2015;05(48): 38–9. DOI: 10.15272/ajbps.v5i48.722 DOI: https://doi.org/10.15272/ajbps.v5i48.722
Prasad P, Kumar R, Kumar S. Effect of Storage on the Stability of Enzyme Activities in Pooled Serum. Int J Res Rev. 2019;6(7):121–6.
https://www.ijrrjournal.com/IJRR_Vol.6_Issue.7_July2019/IJRR0017.pdf. DOI: 10.52403/ijrr DOI: https://doi.org/10.52403/ijrr
Gómez-Rioja R, Segovia Amaro M, Diaz-Garzón J, Bauçà JM, Martinez Espartosa D, Fernández-Calle P. Analytical Quality Commission of the Spanish Society of Laboratory Medicine (SEQCML). A protocol for testing the stability of biochemical analytes. Technical document. Clinical Chemistry and Laboratory Medicine (CCLM). 2019; 57(12): 1829-1836. DOI: https://doi.org/10.1515/cclm-2019-0586 DOI: https://doi.org/10.1515/cclm-2019-0586
Kulkarni S, Pierre SA, Kaliaperumal R. Efficacy of Pooled Serum Internal Quality Control in Comparison with Commercial Internal Quality Control in Clinical Biochemistry Laboratory. J Lab Physicians. 2020;12(3): 191–5. DOI: 10.1055/s-0040-1721151 DOI: https://doi.org/10.1055/s-0040-1721151
Alegre E, Varo N, Fernández-Calle P, Calleja S, González Á. Impact of ultra-low temperature long-term storage on the preanalytical variability of twenty-one common biochemical analytes. Clinical Chemistry and Laboratory Medicine (CCLM). 2022; 60(7): 1003-1010. DOI: https://doi.org/10.1515/cclm-2022-0063 DOI: https://doi.org/10.1515/cclm-2022-0063
Dupuy AM, Cristol JP, Vincent B, Bargnoux AS, Mendes M, Philibert P, Badiou S. Stability of routine biochemical analytes in whole blood and plasma/serum: focus on potassium stability from lithium heparin. Clinical Chemistry and Laboratory Medicine (CCLM). 2018; 56(3): 413-421. DOI: https://doi.org/10.1515/cclm-2017-0292 DOI: https://doi.org/10.1515/cclm-2017-0292
Warsyidah AA. Stability Test of Working Reagent Storage After Mixing at Room Temperature Against Blood Urea Examination. Media Laboran. 2016;6:1–4. https://uit.e-journal.id/MedLAb/article/view/299
Pawlik-Sobecka L, Sołkiewicz K, Kokot I, Kiraga A, Płaczkowska S, Schlichtinger AM, Kratz EM. The influence of serum sample storage conditions on selected laboratory parameters related to oxidative stress: a preliminary study. Diagnostics. 2020; 10(1): 51. DOI: https://doi.org/10.3390/diagnostics10010051 DOI: https://doi.org/10.3390/diagnostics10010051
Maulidiyanti ETS The Effect of Storage Time on Pooled Sera in Freezers on the Quality of Clinical Chemical Examination. J Med Lab Sci. 2021;4(2):78–82. DOI: 10.21070/medicra.v4i2.1613 DOI: https://doi.org/10.21070/medicra.v4i2.1613