DIAGNOSTIC TEST OF MOLECULAR RAPID TEST AGAINST REAL-TIME PCR ON DETECTING BCR-ABL CHRONIC MYELOID LEUKEMIA

Authors

  • Resta Ratna Juwita Pratama Poltekkes Kemenkes Bandung, Bandung, Indonesia
  • Betty Nurhayati Poltekkes Kemenkes Bandung, Bandung, Indonesia
  • Fusvita Merdekawati Poltekkes Kemenkes Bandung, Bandung, Indonesia
  • Eem Hayati Poltekkes Kemenkes Bandung, Bandung, Indonesia
  • Ernawati Ernawati Instalasi Laboratorium Klinik, RSUP Hasan Sadikin Bandung, Bandung, Indonesia

DOI:

https://doi.org/10.34011/juriskesbdg.v17i2.2865

Keywords:

chronic myeloid leukemia, TCM BCR-ABL, real time PCR BCR-ABL, uji diagnostik

Abstract

Chronic Myeloid Leukemia (CML) merupakan suatu kondisi yang ditandai oleh proliferasi abnormal sel hematopoietik yang dapat terjadi pada berbagai kelompok usia. Deteksi Breakpoint Cluster Region-Abelson (BCR-ABL) penting untuk mengidentifikasi keberadaan Kromosom Philadelphia (Ph 1 chr). Pemeriksaan Real-Time Polymerase Chain Reaction (Real-Time PCR) merupakan gold standar untuk deteksi BCR-ABL, namun memiliki keterbatasan seperti waktu pengerjaan lama dan biaya tinggi. Tes Cepat Molekuler (TCM) melalui platform GenXpert menawarkan alternatif yang lebih cepat dan praktis. Penelitian ini bertujuan mengevaluasi kinerja TCM BCR-ABL dibandingkan Real-Time PCR. Desain penelitian menggunakan pendekatan cross sectional dengan 54 sampel yang diperoleh melalui teknik consecutive sampling berdasarkan rumus Lemeshow. Hasil penelitian menunjukkan sensitivitas 91%, spesifisitas 90%, positive predictive value (PPV) 94%, dan negative predictive value (NPV) 86%. Uji Wilcoxon menunjukkan tidak ada perbedaan signifikan antara kedua metode (p=0,100). Berdasarkan hasil penelitian tersebut, TCM memiliki kinerja diagnostik yang mendekati Real-Time PCR dan berpotensi digunakan sebagai alternatif pemeriksaan cepat dan efisien pada deteksi CML.

Downloads

Download data is not yet available.

References

Suttorp M, Millot F, Sembill S, Deutsch H, Metzler M. Definition, epidemiology, pathophysiology, and essential criteria for diagnosis of pediatric chronic myeloid leukemia. Cancers (Basel). 2021;13(4):1-21. doi:10.3390/cancers13040798

El-Tanani M, Nsairat H, Matalka II, et al. The impact of the BCR-ABL oncogene in the pathology and treatment of chronic myeloid leukemia. Pathol Res Pract. 2024;254. doi:10.1016/j.prp.2024.155161

Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660

Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834

Smitalova D, Dvorakova D, Racil Z, Romzova M. Digital PCR can provide improved BCR-ABL1 detection in chronic myeloid leukemia patients in deep molecular response and sensitivity of standard quantitative methods using EAC assays. Pract Lab Med. 2021;25(January 2020):e00210. doi:10.1016/j.plabm.2021.e00210

Budiarto E. Metodologi Penelitian Kedokteran : Sebuah Pengantar. EGC; 2004.

Tumbelaka A. Telaah Kritis Makalah Uji Diagnostik. Sari Pediatr. 2016;4:98. doi:10.14238/sp4.2.2002.98-102

Azis SI, Tandarto M, Adilah I, et al. Nilai sensitivitas, spesifisitas, nilai duga positif (NDP) dan nilai duga negatif (NDN) tes diagnostik cepat antigen pada skrining pasien Corona Virus Disease-19 (COVID-19) di Poliklinik Fakultas Kedokteran Universitas Mulawarman, Samarinda. J Ked Mulawarman. 2022;9(1):14-23.

Permana GP, Rahayu IG, Kurniawan E, Rohayati. Analisis Unit Cost Pemeriksaan Breakpoint Cluster Region - Abelson (BCR-ABL) Dalam Peningkatan Pendapatan Rsup Dr. Hasan Sadikin Bandung. J Med Lab Sci. 2024;4(2). doi:10.36086/medlabscience.v4i2

Swift A, Heale R, Twycross A. What are sensitivity and specificity? Evid Based Nurs. 2020;23(1):2-5. doi:10.1136/ebnurs-2019-103225

Thermo Fisher Scientific. PCR Basic. Thermo Fisher Scientific Inc. 2016. https://www.thermofisher.com/id/en/home/life-science/cloning/cloning-learning-center/invitrogen-school-of-molecular-biology/pcr-education/pcr-reagents-enzymes/pcr-basics.html

Cepheid. Xpert ® BCR-ABL Ultra.; 2022. https://infomine.cepheid.com/sites/default/files/2023-04/Xpert BCR-ABL Ultra Assay-INDONESIAN Package Insert 302-0742-ID Rev. D.pdf

Aliviameita A; P. Buku Ajar Mata Kuliah Hematologi. Cetakan pe. (Sartika, Septi B; Multazam M., ed.). UMSIDA Press; 2019.

Press RD, Kamel-Reid S, Ang D. BCR-ABL1 RT-qPCR for monitoring the molecular response to tyrosine kinase inhibitors in chronic myeloid leukemia. J Mol Diagnostics. 2013;15(5):565-576. doi:10.1016/j.jmoldx.2013.04.007

Brown JT, Beldorth IJ, Laosinchai-Wolf W, et al. Analytical Validation of a Highly Sensitive, Multiplexed Chronic Myeloid Leukemia Monitoring System Targeting BCR-ABL1 RNA. J Mol Diagnostics. 2019;21(4):718-733. doi:10.1016/j.jmoldx.2019.03.002

Jobbagy Z, van Atta R, Murphy KM, Eshleman JR, Gocke CD. Evaluation of the Cepheid GeneXpert BCR-ABL assay. J Mol Diagnostics. 2007;9(2):220-227. doi:10.2353/jmoldx.2007.060112

More S, Chatterjee T, Agarwal C, Pujani M, Chandoke RK. Fully Automated GeneXpert BCR-ABL1 Assay versus Standard Nonautomated BCR-ABL1 Real-Time Reverse Transcription – Polymerase Chain Reaction Quantitation : A Study from Tertiary Care Institute in India. Published online 2024:1-5. doi:10.4103/jmau.jmau

Arora R, Press RD. Measurement of BCR-ABL1 transcripts on the International Scale in the United States: current status and best practices. Leuk Lymphoma. 2017;58(1):8-16. doi:10.1080/10428194.2016.1190974

Siswosudarmo R. Tes Diagnostik. J Metodol Penelit. 2017;12.

Downloads

Published

2025-10-08

How to Cite

Pratama, R. R. J., Nurhayati, B., Merdekawati, F., Hayati, E., & Ernawati, E. (2025). DIAGNOSTIC TEST OF MOLECULAR RAPID TEST AGAINST REAL-TIME PCR ON DETECTING BCR-ABL CHRONIC MYELOID LEUKEMIA. JURNAL RISET KESEHATAN POLTEKKES DEPKES BANDUNG, 17(2), 666–674. https://doi.org/10.34011/juriskesbdg.v17i2.2865

Most read articles by the same author(s)

1 2 > >>