Tesis

Evaluasi Akurasi FIND™ TB Tes Triase Berbasis Deteksi Antibodi Spesifik Terhadap Protein ESAT-6, CFP-10 dan Rv1681 Pada Pasien Terduga Tuberkulosis Paru: Pilot Study = Evaluation of FIND™ TB Triage Test Accuracy Based on Detection of Specific Antibodies to ESAT-6, CFP-10 and Rv1681 Proteins in Pulmonary Tuberculosis Suspected Patients: A Pilot Study.

Pendahuluan: Kesenjangan antara jumlah kasus yang dilaporkan dengan angka perkiraan insiden TB akibat terbatasnya akses terhadap layanan pemeriksaan menjadi tantangan dalam pencapaian target penanggulangan TB. Masalah lain adalah meningkatnya pembiayaan diagnosis TB dengan penggunaan Xpert MTB/RIF sebagai pemeriksaan rutin. Point-of-care triage test TB dianggap dapat meningkatkan kemudahan akses pemeriksaan serta efektivitas pembiayaan diagnosis TB. Tes serologi memiliki potensi sebagai point-of-care triage test TB. Studi ini bertujuan untuk mengevaluasi FIND™ TB, suatu tes triase TB yang mendeteksi antibodi spesifik terhadap protein ESAT-6, CFP-10 dan Rv1681. Metode: Pilot study uji diagnostik dilakukan untuk mengevaluasi akurasi FIND™ TB. Terhadap pasien terduga TB paru yang memenuhi kriteria inklusi dilakukan pemeriksaan darah kapiler dengan FIND™ TB dan sputum dengan Xpert MTB/RIF sebagai reference test. Hasil: M. tuberculosis terdeteksi pada 16 dari 48 subjek penelitian berdasarkan pemeriksaan Xpert MTB/RIF. Sensitivitas FIND™ TB adalah 37.50% (95% CI, 15.20% - 64.57%) dengan spesifisitas 34.38% (95% CI, 18.57% - 53.19%). Tiga dari 21 subjek kelompok false positive memiliki hasil radiografi toraks dengan kesan tuberkulosis paru, menunjukkan potensi FIND™ TB dalam skrining TB klinis. Kesimpulan: Kesesuaian akurasi FIND™ TB dengan kriteria yang direkomendasikan oleh WHO belum dapat ditentukan. Hasil pilot-study ini merekomendasikan pemeriksaan radiografi toraks sebagai tes pembanding dalam evaluasi akurasi FIND™ TB.
Kata kunci: tuberkulosis paru; triage test; antibodi; ESAT-6; CFP-10; Rv1681


Background: The gap between the number of reported cases and the estimated incidence of TB due to the lack of access to examination services is a challenge in achieving TB control targets. Another problem is the increasing cost of TB diagnosis with the use of Xpert MTB/RIF as a routine examination. A point-of-care TB triage test is considered to be able to increase the ease of examination access and the effectiveness of financing TB diagnosis. Serological tests have the potential as a point-of-care TB triage test. This study aimed to evaluate FIND™ TB, a TB triage test that detects specific antibodies to the ESAT-6, CFP-10, and Rv1681 proteins. Methods: A pilot study of diagnostic test was conducted to evaluate the accuracy of FIND™ TB. To pulmonary tuberculosis suspected patients who met the inclusion criteria, capillary blood tests were performed with FIND™ TB and sputum with Xpert MTB/RIF as a reference test. Results: M. tuberculosis was detected on 16 of the 48 study subjects based on Xpert MTB/RIF examination. The sensitivity of FIND™ TB was 37.50% (95% CI, 15.20% - 64.57%) with a specificity of 34.38% (95% CI, 18.57% - 53.19%). Three of the 21 subjects in the false positive group had chest X-ray examinations suggesting pulmonary tuberculosis, indicate the potential of FIND™ TB in clinical TB screening. Conclusion: The appropriateness of FIND™ TB accuracy with criteria recommended by WHO cannot be determined yet. A chest X-ray examination is recommended as a comparator test in evaluating the accuracy of FIND™ TB.
Keywords: pulmonary tuberculosis; triage test; antibody; ESAT-6; CFP-10; Rv1681.