Proficiency testing for drug susceptibility testing of Mycobacterium tuberculosis complex using commercial broth microdilution plate in China in 2021
ABSTRACT: Objectives: The characteristic and performance of Broth microdilution (BMD) plates for drug susceptibility of Mycobacterium tuberculosis have not been systematically evaluated in China. This study was designed to review the key information and assess the performance of BMD plates by analy...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2024-03-01
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| Series: | Journal of Global Antimicrobial Resistance |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2213716523002072 |
| _version_ | 1827311821712785408 |
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| author | Hui Xia Yuanyuan Song Yang Zheng Yang Zhou Xichao Ou Shengfen Wang Bing Zhao Yanlin Zhao |
| author_facet | Hui Xia Yuanyuan Song Yang Zheng Yang Zhou Xichao Ou Shengfen Wang Bing Zhao Yanlin Zhao |
| author_sort | Hui Xia |
| collection | DOAJ |
| description | ABSTRACT: Objectives: The characteristic and performance of Broth microdilution (BMD) plates for drug susceptibility of Mycobacterium tuberculosis have not been systematically evaluated in China. This study was designed to review the key information and assess the performance of BMD plates by analysis of proficiency testing results. Methods: We retrospectively analysed the proficiency testing results of phenotypic drug susceptibility testing (PT-DST) of 45 laboratories using BMD plates in China in 2021. Critical information, such as drug layout, concentration range of each drug, plate storage conditions and duration, operating procedures, and interpretation criteria for binary results were compared. The performance was also analysed. Results: Eight types of BMD plates produced by four manufactures were reported. The drug layout, number of drugs on plates, and concentration range varied a lot between different plates. The total sensitivity and specificity of BMD plates for drug susceptibility of Mycobacterium tuberculosis to ten drugs (isoniazid (INH), rifampin (RIF), kanamycin (KAM), amikacin (AM), levofloxacin (LFX), moxifloxacin (MFX), bedaquiline (BDQ), linezolid (LZD), clofazimine (CFZ), and delamanid (DLM)) were 93.9% (95% CI 92.–94.9) and 99.1% (95% CI 98.8–99.3), respectively. The lowest sensitivity was 84.8% (95% CI 80.3–88.4) for LFX and 86.4% (95% CI 82.5–89.6) for MFX, or 87.5% (95% CI 84.2–90.2) for Y1 plate and 87.9% (95% CI 83.5–91.1) for T plate. The lowest specificity was 94.4% (95% CI 91.4–96.4) for DLM, or 97.9% (95% CI 96.8–98.7) for B3 plate. Conclusion: Commercial BMD plates in China showed varied drug layouts and operational procedures, indicating the urgency of standardization. The lower performance for some drugs showed the low quality of the plates utilized or lack of proficiency of lab staffs in operating and interpreting results. |
| first_indexed | 2024-03-08T09:30:17Z |
| format | Article |
| id | doaj.art-b8b539405961447aaa8d0e6bedb0d3bc |
| institution | Directory Open Access Journal |
| issn | 2213-7165 |
| language | English |
| last_indexed | 2024-04-24T20:26:11Z |
| publishDate | 2024-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Global Antimicrobial Resistance |
| spelling | doaj.art-b8b539405961447aaa8d0e6bedb0d3bc2024-03-22T05:39:22ZengElsevierJournal of Global Antimicrobial Resistance2213-71652024-03-0136230236Proficiency testing for drug susceptibility testing of Mycobacterium tuberculosis complex using commercial broth microdilution plate in China in 2021Hui Xia0Yuanyuan Song1Yang Zheng2Yang Zhou3Xichao Ou4Shengfen Wang5Bing Zhao6Yanlin Zhao7National Tuberculosis Reference Laboratory, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaNational Tuberculosis Reference Laboratory, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaNational Tuberculosis Reference Laboratory, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaNational Tuberculosis Reference Laboratory, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaNational Tuberculosis Reference Laboratory, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaNational Tuberculosis Reference Laboratory, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaCorresponding author.; National Tuberculosis Reference Laboratory, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaAlternative corresponding author.; National Tuberculosis Reference Laboratory, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, ChinaABSTRACT: Objectives: The characteristic and performance of Broth microdilution (BMD) plates for drug susceptibility of Mycobacterium tuberculosis have not been systematically evaluated in China. This study was designed to review the key information and assess the performance of BMD plates by analysis of proficiency testing results. Methods: We retrospectively analysed the proficiency testing results of phenotypic drug susceptibility testing (PT-DST) of 45 laboratories using BMD plates in China in 2021. Critical information, such as drug layout, concentration range of each drug, plate storage conditions and duration, operating procedures, and interpretation criteria for binary results were compared. The performance was also analysed. Results: Eight types of BMD plates produced by four manufactures were reported. The drug layout, number of drugs on plates, and concentration range varied a lot between different plates. The total sensitivity and specificity of BMD plates for drug susceptibility of Mycobacterium tuberculosis to ten drugs (isoniazid (INH), rifampin (RIF), kanamycin (KAM), amikacin (AM), levofloxacin (LFX), moxifloxacin (MFX), bedaquiline (BDQ), linezolid (LZD), clofazimine (CFZ), and delamanid (DLM)) were 93.9% (95% CI 92.–94.9) and 99.1% (95% CI 98.8–99.3), respectively. The lowest sensitivity was 84.8% (95% CI 80.3–88.4) for LFX and 86.4% (95% CI 82.5–89.6) for MFX, or 87.5% (95% CI 84.2–90.2) for Y1 plate and 87.9% (95% CI 83.5–91.1) for T plate. The lowest specificity was 94.4% (95% CI 91.4–96.4) for DLM, or 97.9% (95% CI 96.8–98.7) for B3 plate. Conclusion: Commercial BMD plates in China showed varied drug layouts and operational procedures, indicating the urgency of standardization. The lower performance for some drugs showed the low quality of the plates utilized or lack of proficiency of lab staffs in operating and interpreting results.http://www.sciencedirect.com/science/article/pii/S2213716523002072Mycobacterium tuberculosis complexDrug susceptibility testingMinimal inhibitory concentration |
| spellingShingle | Hui Xia Yuanyuan Song Yang Zheng Yang Zhou Xichao Ou Shengfen Wang Bing Zhao Yanlin Zhao Proficiency testing for drug susceptibility testing of Mycobacterium tuberculosis complex using commercial broth microdilution plate in China in 2021 Journal of Global Antimicrobial Resistance Mycobacterium tuberculosis complex Drug susceptibility testing Minimal inhibitory concentration |
| title | Proficiency testing for drug susceptibility testing of Mycobacterium tuberculosis complex using commercial broth microdilution plate in China in 2021 |
| title_full | Proficiency testing for drug susceptibility testing of Mycobacterium tuberculosis complex using commercial broth microdilution plate in China in 2021 |
| title_fullStr | Proficiency testing for drug susceptibility testing of Mycobacterium tuberculosis complex using commercial broth microdilution plate in China in 2021 |
| title_full_unstemmed | Proficiency testing for drug susceptibility testing of Mycobacterium tuberculosis complex using commercial broth microdilution plate in China in 2021 |
| title_short | Proficiency testing for drug susceptibility testing of Mycobacterium tuberculosis complex using commercial broth microdilution plate in China in 2021 |
| title_sort | proficiency testing for drug susceptibility testing of mycobacterium tuberculosis complex using commercial broth microdilution plate in china in 2021 |
| topic | Mycobacterium tuberculosis complex Drug susceptibility testing Minimal inhibitory concentration |
| url | http://www.sciencedirect.com/science/article/pii/S2213716523002072 |
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