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

Abstract

BackgroundIn 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.MethodsAll 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.ResultsA 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.ConclusionIn 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.

Analysis of drug resistance and mutation profiles in Mycobacterium tuberculosis isolates in a surveillance site in Beijing, China

“…Despite the increased costs of laboratory testing, the use of the LPAs decreases the total health care costs for Chinese patients with MDR-TB. 23 More importantly, patients are not exposed to ineffective empirical therapy, which prevents disease progression and improves clinical outcomes for patients with MDR-TB. However, extremely few patients with MDR-TB were resistant to only RIF and INH resistance in our study.…”

Impact of molecular diagnostic tests on diagnostic and treatment delays in tuberculosis: a systematic review and meta-analysis

“…DR-TB care delays gradually improved to 28 days (IQR: 16–40) through the 3-year DR-TB care decentralization program, which included streamlining LPA testing in the clinical practice (years 2009–2011). Moreover, studies from settings with more established healthcare infrastructure (e.g., China and South Korea) also found that operational challenges diminished the potential benefit of rapid molecular testing in improving DR-TB care delays [ 41 – 43 ].…”

“…However, reduction of these delays were not solely due the implementation of the technology alone. In an earlier phases of LPA implementation in South Africa, use of LPA for DR-TB care were much restricted and centralized at higher levels of the health and laboratory system, and caused treatment initiation delays of more than Moreover, studies from settings with more established healthcare infrastructure (e.g., China and South Korea) also found that operational challenges diminished the potential benefit of rapid molecular testing in improving DR-TB care delays [41][42][43].…”

Cost analysis of GenoType® MTBDRplus and GenoType® MTBDRsl at the State Laboratory of São Paulo, Brazil

“…In a study conducted in a tertiary hospital in China, the costs were lower in the diagnosis of MDR-TB using GenoType ® owing to the reduction of the TAT for result release, but the authors did not include the costs of the multiple components 9 . In another study conducted in Russia 10 , the use of GenoType ® in routine DR-TB investigations, compared with the use of MGIT 960, was associated with a lower cost and greater success in the treatment of DR-TB.…”

“…The accuracy and cost of conventional and molecular methods for the diagnosis of MDR-TB have been described in several countries [8][9][10] , including Brazil [11][12][13] . However, data on the costs incurred with the use of molecular tests in Public Health Laboratories are scarce, and the information obtained can be used to optimize resource management health services in countries with a unified health system, such as Brazil, particularly with the recent incorporation of GenoType ® MTBDRplus and GenoType ® MTBDRsl 14 .…”