Performa Rapid Diagnostik Tes Hepatitis B dengan ELISA sebagai Gold Standar

Authors

  • I Gusti Ayu Sri Andayani Program Studi Magister Manajemen Sumberdaya Peternakan, Fakultas Peternakan, Universitas Mataram, Jalan Majapahit Nomor 62, Mataram, Nusa Tenggara Barat 83115
  • Mohammad Rizki Fakultas Kedokteran, Universitas Mataram, Jalan Majapahit Nomor 62, Mataram, Nusa Tenggara Barat 83125
  • Made Sriasih Program Studi Magister Manajemen Sumberdaya Peternakan, Fakultas Peternakan, Universitas Mataram, Jalan Majapahit Nomor 62, Mataram, Nusa Tenggara Barat 83115
  • Ika Nurfitria Tauhida Laboratorium Riset Rumah Sakit Universitas Mataram, Jalan Majapahit Nomor 62, Mataram, Nusa Tenggara Barat 83114

DOI:

https://doi.org/10.33394/bioscientist.v11i2.9035

Keywords:

RDT, ELISA, Sensitivity, Specificity.

Abstract

The ELISA (Enzyme Linked Immunoassay) method has high sensitivity and specificity, qualitatively and quantitatively detecting Hepatitis B Surface Antigen (HBsAg) levels, but the process is long, expensive and requires special expertise, compared to the Rapid Diagnostic Test (RDT) as a rapid test which is more practical and cheaper. The aim of this study was to compare the sensitivity and specificity of the Entebe Rapid Test Diagnostic (ERTD) produced by PT. Hepatika Mataram, with ELISA as the gold standard in detecting HBsAg. The requirement for interpreting sensitivity and specificity results according to World Health Organization (WHO) standards is a minimum of 95%. Testing with a negative panel of 00 samples and a positive panel of 1 samples from Papua in 012 at -80℃ storage. Testing in April 023 at the Molecular Diagnostics and Research Laboratory, Mataram University Hospital. Statistical analysis using MedCal software. ERD HBsAg produced by PT. Hepatika Mataram has a sensitivity of 95.45%, specificity of 99.50%, positive predictive value of 93.59%, negative predictive value of 99.65%, and accuracy of 99.21%.

References

Ahmad, N., & Kusnanto, H. (2017). Prevalensi Infeksi Virus Hepatitis B pada Bayi dan Anak yang Dilahirkan Ibu dengan HBsAg Positif. Berita Kedokteran Masyarakat, 33(11), 515-520. https://doi.org/10.22146/bkm.26310

Asaduzzaman, M., Milon, A. S., Juliana, F. M., Islam, M. J., & Kabir, M. S. (2018). Comparison Between Rapid ICT and ELISA Tests for the Detection of HBsAg; and Screening of Hepatitis B Infection in Apparently Healthy Bangladeshi Outbound Staff. The International Journal of Engineering and Science, 7(9), 34-39. https://doi.org/10.9790/1813-0709033439

Aydin, S. (2015). A Short History, Principles, and Types of ELISA, and Our Laboratory Experience with Peptide/Protein Analyses Using ELISA. Peptides, 72(1), 4-15. https://doi.org/10.1016/j.peptides.2015.04.012

Chauhan, A., Mittu, B., & Chauhan, P. (2015). Analytical Method Development and Validation: A Concise Review. Journal of Analytical & Bioanalytical Techniques, 6(1), 1-5. https://doi.org/10.4172/2155- 9872.1000233

Hadi, M. I., & Alamudi, M. Y. (2017). Hepatitis B Surface Antibody (HBsAb) Screening with Rapid Test among Teenagers in Surabaya. Journal of Health Science and Prevention, 1(2), 93-96. https://doi.org/10.29080/jhsp.v1i2.100

Kalma. (2016). Uji Validitas Reagen SD Bioline HBsAg untuk Deteksi HBsAg dalam Serum dengan ELISA sebagai Standar Baku. Media Analis Kesehatan, 7(1), 41-47.

Kementerian Kesehatan. (2023). Prilaku Beresiko Merupakan Penularan Hepatitis Lebih dari 35 Ribu Bayi. Jakarta: Kementerian Kesehatan Republik Indonesia.

Kiely, P., Hoad, V. C., & Wood, E. M. (2018). False Positive Viral Marker Results in Blood Donors and Their Unintended Consequences. Vox Sanguinis : The International Journal of Tranfusion Medicine, 113(6), 530-539. https://doi.org/10.1111/vox.12675

Kuswiyanto. (2015). Bakteriologi 1: Buku Ajar Analis Kesehatan. Makassar: CV. EGC.

Masriadi, H. (2017). Epidemiologi Penyakit Menular. Jakarta: PT. Rajagrafindo Persada.

Putra, A. P., Kartika, A. I., & Anggraini, H. (2019). Uji Sensitifitas dan Spesifisitas Strip Tes terhadap ELISA untuk Deteksi HBsAg. Jurnal Labora Medika, 3(2), 50-53. https://doi.org/10.26714/jlabmed.3.2.2019.50-53

Santosa, B. (2020). Buku Ajar: Teknik Elisa Metode Elisa untuk Pengukuran Protein Metallothionein pada Daun Padi Ir Bagendit. Semarang: Unimus Press.

Shenge, J. A., & Osiowy, C. (2021). Rapid Diagnostics for Hepatitis B and C Viruses in Low-and Middle-Income Countries. Frontiers in Virology, 1(1), 1-12. https://doi.org/10.3389/fviro.2021.742722

Taffon, S., Genovese, D., Blasi, M., Pierotti, P., Esposti, A. D., Catone, S., Candido, A., Dettori, S., Tosti, M. E., Argentini, C., Mazzotta, F., & Rapicetta, M. (2014). HBV Whole-Genome Mutation Profile in HIV-1/HBV Coinfected Patients in a Long-Term Follow-up Study. Infection, 42(4), 675-687. https://doi.org/10.1007/s15010-014-0616-2

Wijayanti, I. B. (2016). Efektivitas HBsAg Rapid Screening Test untuk Deteksi Dini Hepatitis B. Jurnal Kesehatan Kusuma Husada, 7(1), 9-34.

Zulfian., Setiawati, O. R., & Sapitia, A. (2019). Hubungan Tingkat Pengetahuan Ibu Hamil dengan Kejadian Hepatitis B di Puskesmas Beringin Kecamatan Lubai Kota Palembang. Jurnal Ilmu Kedokteran dan Kesehatan, 5(3), 24-231. https://doi.org/10.33024/.v5i3.965

Downloads

Published

2023-12-30

How to Cite

Andayani, I. G. A. S., Rizki, M., Sriasih, M., & Tauhida, I. N. (2023). Performa Rapid Diagnostik Tes Hepatitis B dengan ELISA sebagai Gold Standar. Bioscientist : Jurnal Ilmiah Biologi, 11(2), 1263–1271. https://doi.org/10.33394/bioscientist.v11i2.9035

Issue

Section

Articles