Rapid Diagnosis Of Multidrug-Resistant Tuberculosis Impacts Expenditures Prior To Appropriate Treatment: A Performance And Diagnostic Cost Analysis

Abstract

Xuezheng Li,1,2 Yunfeng Deng,2 Junling Wang,2 Hui Jing,2 Wei Shu,3 Jingmin Qin,2 Yu Pang,4 Xin Ma1,2 1School of Public Health, Shandong University, Jinan, People’s Republic of China; 2Katharine Hsu International Research Center of Human Infectious Diseases, Shandong Provincial Chest Hospital, Shandong University, Jinan, People’s Republic of China; 3Clinical Center on TB Control, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, People’s Republic of China; 4National Clinical Laboratory on Tuberculosis, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, People’s Republic of ChinaCorrespondence: Yu PangNational Clinical Laboratory on Tuberculosis, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, No 9, Beiguan Street, Tongzhou District, Beijing 101149, People’s Republic of ChinaTel/Fax [phone]Email [email protected] MaSchool of Public Health, Shandong University, No. 44 Wenhuaxi Road, Lixia District, Jinan 250012, People’s Republic of ChinaTel [phone]Fax [phone]Email [email protected]: In this study, we aimed to describe the impact of the Genotype® MTBDRplus line probe assay (LPA) for multidrug-resistant tuberculosis (MDR-TB) on total costs in a high-burden setting in China. The second objective was to evaluate the performance of HAIN on smear-positive sputum and clinical isolates.Methods: All definitive TB inpatients at the Shandong Provincial Chest Hospital between May 2012 and May 2017 were included in the study. Two sputum specimens were collected from each patient to conduct smear microscopy, conventional drug susceptibility testing (DST), and the HAIN test. Laboratory and cost data were collected from the electronic medical record system.Results: A total of 1670 definitive TB patients were included in this study. Of these patients, 1307 (78.3%) had smear-positive/culture-positive tuberculosis, and the remaining 363 (21.7%) had smear-negative/culture-positive tuberculosis. The sensitivity and specificity of the HAIN test for RIF resistance was 94.8% (95% confidence interval [CI]: 91.9–97.6%) and 98.8% (95% CI: 98.3–99.4%), respectively. For INH resistance, the sensitivity and specificity was 89.5% (95% CI: 85.7–93.2%) and 95.6% (95% CI: 94.5–96.7%), respectively. The mean time for detection of MDR-TB in smear-negative cases was determined to be 32 days by the HAIN test, which was significantly shorter than that by conventional DST (56 days). Similarly, the mean time for detection of MDR-TB by the HAIN test was significantly shorter than that by conventional DST in smear-positive cases (3 versus 53 days). In addition, by utilizing the HAIN test, the total health care cost decreased by 71.0% for smear-positive cases and 25.9% for smear-negative cases.Conclusion: In conclusion, our data demonstrate that the HAIN test is an accurate rapid test for detecting both RIF and INH resistance in TB patients. The use of the HAIN test can decrease health care costs and reduce the detection time for MDR-TB patients in China, despite the increased costs for laboratory testing.Keywords: tuberculosis, HAIN, multidrug-resistance, performance, cost

Keywords

• tuberculosis
• hain
• multidrug-resistance
• performance
• cost