Tesis

Evaluasi PRÜFEN® GB101 sebagai tes cepat molekuler dalam deteksi kepekaan Mycobacterium tuberculosis terhadap rifampisin dan isoniazid pada spesimen sputum = Evaluation of PRÜFEN® Gb101 as a molecular rapid uji in the detection of sensitivity of Mycobacterium tuberculosis to rifampisin and isoniazid in sputum specimen.

Pendahuluan: Upaya pengendalian Infeksi Mycobacterium tuberculosis (Mtb) di Indonesia dengan mempercepat usaha penyediaan layanan diagnosis multidrug resistance (MDR) menjadi tantangan dalam pencapaian salah satunya penggunaan metode diagnostik cepat dengan sensitifitas dan spesifitas yang tinggi seperti pemeriksaan tes cepat molekuler. Saat ini, kit deteksi PRÜFEN® GB101 sedang dikembangkan untuk mendeteksi mutasi gen Mtb terkait resistansi rifampisin dan isoniazid. Kit ini menunjukkan potensi dalam membedakan mutasi pada gen rpoB serta pada regio promotor katG, ahpC dan InhA. Metode: Penelitian potong lintang, penelitian dilakukan dari mei 2023 hingga September 2023. Hasil uji kepekaan PRÜFEN® GB101 dibandingkan dengan kultur media cair BACTEC MGIT 960® menggunakan sampel sputum. Hasil uji kepekaan dianalisis untuk mendapatkan sensitivitas, spesifisitas, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), negative likelihood ratio (NLR), serta akurasi. Hasil : Didapatkan 2 sampel yang benar resistan rifampisin dan 2 sampel yang benar resistan isoniazid dari 34 sampel yang di uji. Deteksi kepekaan rifampisin kit PRÜFEN® GB101 diperoleh sensitivitas 100% (95% CI, 15,8 – 100%), spesifisitas 93,75% (95% CI, 79,2 – 99,2%), PPV 50%, NPV 100%, PLR 16,13%, NLR 0, dan nilai akurasi diagnostik 94,12%. Hasil Deteksi kepekaan isoniazid kit PRÜFEN® GB101 diperoleh sensitivitas 100% (95% CI, 15,8 – 100%), spesifisitas 90,62% (95% CI, 74,98 – 98,02%), PPV 40%, NPV 100%, PLR 10,67%, NPV 0 dan nilai akurasi diagnostik 91,18%. Kesimpulan: PRÜFEN® GB101 menunjukkan potensi sebagai alat diagnostik untuk resistansi rifampisin dan INH dengan sensitivitas tinggi, tetapi spesifisitasnya lebih rendah, sehingga penggunaannya lebih tepat sebagai alat pelengkap, bukan pengganti Xpert MTB/Rif dalam program TB Nasional. Untuk bersaing dengan Xpert, PRÜFEN® GB101 perlu melalui validasi lebih lanjut pada populasi yang lebih luas dan memperbaiki spesifisitasnya.
Kata Kunci: Mycobacterium tuberculosis, Xpert MTB/Rif, PRÜFEN® GB101, Biakan Mtb, uji kepekaan Mtb, rifampisin, isoniazid.


Introduction: The control of Mycobacterium tuberculosis infection in Indonesia by accelerating efforts to provide multidrug resistance (MDR) diagnosis services is a challenge to achieve, one of which is the use of rapid diagnostic methods with high sensitivity and specificity such as molecular rapid test examinations. Currently, the PRÜFEN® GB101 detection kit is being developed to detect Mtb gene mutations associated with rifampicin and isoniazid resistance. The kit shows potential in distinguishing mutations in the rpoB gene as well as in the katG, ahpC and InhA promoter regions. Methods: A cross-sectional study was conducted from May 2023 to September 2023. PRÜFEN® GB101 sensitivity test results were compared with BACTEC MGIT 960® liquid media culture using sputum samples. Sensitivity test results were analyzed to obtain sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), negative likelihood ratio (NLRT) and accuracy. Results: There were 2 true rifampicin-resistant samples and 2 true isoniazidresistant samples out of 34 samples tested. Detection of rifampicin sensitivity kit PRÜFEN® GB101 obtained sensitivity 100% (95% CI, 15.8 - 100%), specificity 93.75% (95% CI, 79.2 - 99.2%), PPV 50%, NPV 100%, PLR 16.13%, NLR 0 and diagnostic accuracy value 94.12%. The results of isoniazid sensitivity detection kit PRÜFEN® GB101obtained a sensitivity of 100% (95% CI, 15.8 - 100%), specificity of 90.62% (95% CI, 74.98 - 98.02%), PPV 40%, NPV 100%, PLR 10.67%, NLR 0 and diagnostic accuracy value 91.18%. Conclusion: PRÜFEN® GB101 shows potential as a diagnostic tool for rifampisin and INH resistance with high sensitivity, but lower specificity, making its use more appropriate as a complementary tool, rather than a replacement for Xpert MTB/Rif in National TB programs. To compete with Xpert, PRÜFEN® GB101 needs to undergo further validation in a wider population and improve its specificity.
Keywords: Mycobacterium tuberculosis, Xpert MTB/Rif, PRÜFEN® GB101, Mtb culture, Mtb sensitivity test, rifampicin, isoniazid.