2. EVALUATION OF ACCURACY OF XPERT MTB/XDR TESTING REGARDING DETECTION FOR DRUG RESISTANCE OF ISONIAZID, FLUOROQUINOLONES, INJECTABLE DRUGS AT NATIONAL LUNG HOSPITAL

Dinh Thi Huong1, Doan Thu Ha1, Le Thi Nam1, Dinh Thi Phuong Thanh2
1 National Lung Hospital
2 University of Medicine and Pharmacy - Hanoi National University

Main Article Content

Abstract

Objective: To evaluate the accuracy of Xpert MTB/XDR regarding detection for drug resistance of INH, FLQ and injectable drugs.


Methods: 100 RR-TB patients were tested for drug resistance detection by Xpert MTB/XDR test, MTB firstline, secondline LPA test and phenotypic drug susceptibility testing, a cross-sectional study.


Results: The sensitivity of Xpert MTB/XDR testing regarding drug resistance detection was 98.85% for INH, 80% for FLQ, 83.33% for AMK, 100% for KAN and CAP. The specificity for all drugs resistance detection achieved 95%-100%. Positive Prediction Value (PPV) ranged among 94-100%, except KAN’s with 85.71% and CAP’s with 33.33%. Negative Prediction Value (NPV) for all drugs obtained 92%-100%. Concordance based on Cohen's kappa value between Xpert MTB/XDR and MTB firstline, secondline LPA ranged 0.9-1.0 regarding INH/ FLQ resistance detection, 0.6-0.7 for AMK, KAN and CAP resistance detection.


Conclusion: Xpert MTB/XDR testing had high sensitivity and specificity in INH, FLQ, and injectable drugs resistance detection as well as obtained high concordance when compared with MTB firstline, secondline LPA. Xpert MTB/XDR testing is considered as a rapid, simple molecular drug resistance test which would be an effective diagnosis tool for Vietnam National TB Control Program to improve the coverage of diagnostic tests for detection of drug resistance in the upcoming time.

Article Details

References

[1] Global tuberculosis report 2023. Geneva: World
Health Organization; 2023. Licence: CC BYNC-SA 3.0 IGO.
[2] Vietnam TB Profile Report, 2022, WHO.
[3] Technical manual for drug susceptibility testing
of medicines used in the treatment of tuberculosis.
Licence: CC BY-NC-SA 3.0 IGO.
[4] GLI Practical Guide to TB Laboratory Strengthening,
Geneva, World Health Organization, 2017.
[5] Cepheid. Xpert MTB/XDR [website]. 2021
(https://www.cepheid.com/en/tests/ Critical-
Infectious-Diseases/Xpert-MTB-XDR).
[6] WHO consolidated guidelines on tuberculosis.
Module 3: Diagnosis – rapid diagnostics for
tuberculosis detection, third edition. Geneva:
World Health Organization; 2024. Licence: CC
BY-NC-SA 3.0 IGO.
[7] Update on the use of nucleic acid amplification
tests to detect TB and drug-resistant TB: Rapid
communication. Geneva: World Health Organization;
2021 (https://www.who.int/publications/i/item/update-
on-the-use-of-nucleic-acid-amplification-tests-to-
detect-tb-and-drug-resistant-tbrapid-communication.
[8] Penn-Nicholson A, Georghiou SB, Ciobanu N
et al., Detection of isoniazid, fluoroquinolone,
ethionamide, amikacin, kanamycin, and capreomycin
resistance by the Xpert MTB/XDR assay: A cross-
sectional multicentre diagnostic accuracy study.
The Lancet Infectious Diseases. 2022;22(2):242-9.
[9] Cao Y, Parmar H, Gaur RL et al., Xpert MTB/
XDR: A 10-Color Reflex Assay Suitable for
Point-of-Care Settings To Detect Isoniazid,
Fluoroquinolone, and Second-Line-Injectable-Drug
Resistance Directly from Mycobacterium tuberculosis-
Positive Sputum. Journal of clinical microbiology. 2021;59(3).
[10] Syed RR, Catanzaro DG, Colman RE et al.,
Clinical Evaluation of the XDR-LFC Assay for
the Molecular Detection of Isoniazid, Rifampin,
Fluoroquinolone, Kanamycin, Capreomycin,
and Amikacin Drug Resistance in a Prospective Cohort.
Journal of clinical microbiology. 2023;61(3):e0147822.
[11] Katamba A, Ssengooba W, Sserubiri J et al.,
Evaluation of Xpert MTB/XDR test for susceptibility
testing of Mycobacterium tuberculosis
to first and second-line drugs in Uganda. PLOS
ONE. 2023;18(8):e0284545.
[12] Bộ Y tế, Hướng dẫn Chẩn đoán, điều trị và dự
phòng bệnh Lao, Quyết định 162/QĐ-BYT 2024, Bộ Y tế.
[13] Nguyen HB, Nguyen NV, Tran HT et al., Prevalence
of resistance to second-line tuberculosis drug among
multidrug-resistant tuberculosis patients in Viet Nam,
2011. Western Pacific surveillance and response journal :
WPSAR. 2016;7(2):35-40.