Stability Test of Pooled Sera Control Material Level in Clinical Chemistry Examination against Storage Time and Temperature

  • Heru Setiawan Poltekkes Kemenkes Jakarta III
  • Muhammad Yusuf Semendawai
  • Novian Febiyanto
Keywords: pooled sera

Abstract

In providing quality assurance for laboratory examinations, it is necessary to ensure quality by examining control materials. Pooled sera was chosen as a control material because the use of commercial control materials is relatively expensive and if the specimens examined are of human origin, it is better to use control materials of human origin as well. The use of pooled sera must be stable over a long period of time. The selection of HDL-Cholesterol and AST parameters is expected to be representative in metabolic and enzymatic examinations. The aim of the research was to determine the stability of pooled sera control materials level in clinical chemistry tests against storage time and temperature. This research is an experimental study, pooled sera were treated at storage time of 0, 1, 2, 3, 7, 14, 28, and 35 days and storage temperature (-5ºC and -20ºC) then HDL-Cholesterol and AST levels were measured repeatedly 3 times each. Data analysis used the repeated measure ANOVA test with 95% confidence level. The results showed that the test for the difference in average HDL-Cholesterol levels for each treatment had a value of p=0.002 < α=0.05, and the test for the difference in average AST levels for each treatment had a value of p=0.081 < α=0, 05. The conclusion of this study is that there is a significant difference between HDL-Cholesterol levels in each treatment (unstable) and there is no significant difference between AST levels in each treatment (stable).

References

1. Kepmenkes. Keputusan Menteri Kesehatan Republik Indonesia Nomor HK.01.07/MENKES/2011/2022 tentang Standar Akreditasi Laboratorium Kesehatan. Jakarta: Kementerian Kesehatan Republik Indonesia; 2022.
2. Praptomo AJ. Pengendalian Mutu Laboratorium Medis. Yogyakarta: Deepublish; 2018.
3. Permenkes. Peraturan Menteri Kesehatan Republik Indonesia Nomor 43 tahun 2013 tentang Cara Penyelenggaraan Laboratorium Klinik Yang Baik. Jakarta: Kementerian Kesehatan Republik Indonesia; 2013.
4. BSN. ISO 15189 tentang Laboratorium Medik-Persyaratan Mutu dan Kompetensi. Jakarta: BSN; 2012.
5. Devi A, Negi A. Pooled Sera as an Alternative to Commercial Internal Quality Control in Clinical Laboratories. J Clin DIAGNOSTIC Res [Internet]. 2023; Available from: https://www.jcdr.net//article_fulltext.asp?issn=0973-709x&year=2023&month=October&volume=17&issue=10&page=BC23-BC26&id=18567
6. 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 [Internet]. 2020 Dec 23;12(03):191–5. Available from: https://jlabphy.org/efficacy-of-pooled-serum-internal-quality-control-in-comparison-with-commercial-internal-quality-control-in-clinical-biochemistry-laboratory/
7. Muslim, Muhammad; kustiningsih, Yayuk; Yanuarti E. Pemanfaatan Pool Serum sebagai Bahan Kontrol Ketelitian Pemeriksaan Glukosa Darah. Med Lab Tchnology J. 2015;1(2):54–60.
8. Lestari, Wuni Sri; Karwiti, Witi; Latifah, Aminahtun; Listiani, Yenni; Harianja SH. Stabilitas Pooled Sera Sebagai Bahan Kontrol Pemeriksaan SGPT dengan Waktu Penyimpanan dan Variasi Suhu. J Med Lab Sci. 2022;2(1):33–9.
9. Wulandari S. Karya Tulis Ilmiah : Pengaruh Lama Penyimpanan Serum Kumpulan (Pooled Sera) Pada Freezer Dan Refrigerator Terhadap Kadar Kolesterol Dan Kadar Trigliserida. UNIVERSITAS MUHAMMADIYAH SURABAYA; 2014.
10. Jamtsho R. Stability of Lyophilized Human Serum for Use as Quality Control Material in Bhutan. Indian J Clin Biochem [Internet]. 2013 Oct 23;28(4):418–21. Available from: http://link.springer.com/10.1007/s12291-013-0328-x
11. Siregar, Maria Tuntun; Wulan, Wieke Sri; Setiawan, Doni; Nuryati A. Kendali Mutu. Kementerian Kesehatan Republik Indonesia; 2018.
Published
2024-12-05
How to Cite
Setiawan, H., Semendawai, M., & Febiyanto, N. (2024). Stability Test of Pooled Sera Control Material Level in Clinical Chemistry Examination against Storage Time and Temperature. Jurnal Fisioterapi Dan Kesehatan Indonesia, 4(02), 235-244. https://doi.org/10.59946/jfki.2024.356