目的 建立脲原体/人型支原体培养及药物敏感检测试剂盒行业标准。方法 选择6个厂家生产的解脲脲原体及人型支原体检测试剂盒,按拟定的行业标准,对外观、培养基 pH、生长性能、药物敏感符合率、特异性、重复性和稳定性项目进行验证。结果 除2个厂家试剂盒的解脲脲原体对红霉素及加替沙星的药物敏感结果的一致性不满足批间重复性要求外,其他验证结果均能满足拟定行标中的要求,表明行业标准各指标具有一定的合理性,可操作性强。结论 根据验证情况,最终建立了脲原体/人型支原体培养及药物敏感检测试剂盒行业标准,这将有助于该类试剂盒质量标准的统一和提高,为其生产、检验、流通等领域的监管提供了依据。
Abstract
OBJECTIVE To validate the industry standard for Ureaplasma spp./ Mycoplasma hominis culture and antimicrobial susceptibility testing kit. METHODS The testing kits for Ureaplasma urealyticum and Mycoplasma hominis produced by six enterprises were used. The appearance, culture medium pH, growth performance, drug sensitivity compliance, specificity, repeatability and stability were verified in accordance with the proposed industry standard. RESULTS In addition to the consistency of sensitivity results of Ureaplasma urealyticum test kits produced by two enterprises to erythromycin and gatifloxacin, other validation results met the requirements of the proposed standard. It shows that the industry standard was reasonable and workable.CONCLUSION According to the validation, the industry standard for Ureaplasma spp./ Mycoplasma hominis culture and antimicrobial susceptibility testing kit is ultimately established. This will help to unify and improve the quality standard of this kind of kit, and provide the basis for the supervision of its production, inspection, circulation and other fields.
关键词
脲原体 /
解脲脲原体 /
微小脲原体 /
人型支原体 /
培养 /
抗微生物敏感 /
试剂盒 /
行业标准
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Key words
Ureaplasma spp /
Ureaplasma urealyticum /
Ureaplasma parvum /
Mycoplasma hominis /
culture /
antimicrobial susceptibility /
kit /
industry standard
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中图分类号:
R917
R944
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参考文献
[1] SHEPARD M C. The recovery of pleuropneumonia-like organisms form Negro men with and without nongonococcal urethritis . Am J Syph Gonorrhea Vener Dis, 1954, 38(2):113-124.
[2] GUPTA V, DHAWAN B, KHANNA N, et al. Detection and biovar discrimination of Ureaplasma urealyticum in Indian patients with genital tract infections. Diagn Micr Infect Dis, 2007, 60(1):95-97.
[3] KONG F, MA Z, JAMES G, et al. Molecular genotyping of human Ureaplasma species based on multiple-banded antigen (MBA) gene sequences . Int J Syst Evol Microbiol, 2000, 50(5):1921-1929.
[4] JIANG S P, ZHANG W, CHEN X, et al. Correlation of the amount of ureaplasma parvum with premature rupture of fetal membranes and neonatal pneumonia . Chin J Woman Child Health Res(中国妇幼健康研究), 2019, 30(11): 1417-1420.
[5] LI W P, ZHAO H Y, ZHAO Z, et al. Analysis of Ureaplasma urealyticum, Ureaplasma parvum and Chlamydia trachomatis infection in female patients with genitourinary tract infection . Chin J Dermatovenereol(中国皮肤性病学杂志), 2019, 33(8): 920-923.
[6] ZHOU X Q, ZHAO X L,HUANG L, et al. Correlation of small colonies and Ureaplasma urealyticum and its clinical significance . Chin J Human Sexual(中国性科学), 2016, 25(11): 82-84.
[7] HE H L. Analysis of the effect of Ureaplasma urealyticum infection on premature rupture of membranes and adverse pregnancy outcome in reproductive tract . Smart Healthcare(智慧健康), 2020, 6(5): 92-94.
[8] GUO J Y, HE X Q, LI J Z. Analysis on prevalence and drug resistance of Mycoplasma hominis and Ureaplasma urealyticum in pregnant women from 316th hospital of PLA from 2014 to 2018 . Drugs Clin(现代药物与临床), 2019, 34(10): 3169-3172.
[9] WU K J, LAI C S. Progress on the diagnosis of extra-genitourinary tract and extra-pulmonary infection of Mycoplasma hominis. Chin J Experimental Clin Infect Dis(中华实验和临床感染病杂志 电子版), 2019, 13(4):269-272.
[10] MU L Q, MENG H R, CHEN W, et al. A case report of mycoplasma hominis induced bacteremia . Chin J Clin Lab Sci(临床检验杂志), 2016, 34(11):880.
[11] YE G Y, JIANG Z, WANG M, et al. The resistance analysis of Ureaplasma urealyticum and Mycoplasma hominis in female reproductive tract specimens. Cell Biochem Biophys, 2014, 68(1):207-210.
[12] HE M, XIE Y, ZHANG R, et al. Prevalence and antimicrobial resistance of Mycoplasmas and Chlamydiae in patients with genital tract infections in Shanghai, China. J Infect Chemother, 2016, 20(8):548-552.
[13] GEORGE E K, FRANK D C. Susceptibilities of Mycoplasma hominis, M. pneumoniae, and Ureaplasma urealyticum to GAR-936, dalfopristin, dirithromycin, evernimicin, gatifloxacin, linezolid, moxifloxacin, quinupristin dalfopristin, and telithromycin compared to their susceptibilities to reference macrolides, tetracyclines, and quinolones. Antimicrob Agents Ch, 2001, 45 (9):2604-2608.
[14] WU Y H. Detection results and drug sensitivity analysis of Ureaplasma urealyticum and Mycoplasma hominis . Clin Lab J(Elec Ed)( 临床检验杂志 电子版), 2020, 9(1):18-19.
[15] SUN B, WEI H, NIE L. Analysis of drug susceptibility trend of Ureaplasma urealyticum in urogenital tract from 2012 to 2018 . Chin J Med Guide(中国医药导刊), 2020, 22(1):43-47.
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脚注
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基金
河南省科技攻关计划项目资助(182102310603)
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