Reliability of the MODS assay decentralisation process in three health regions in Peru.

Reliability of the MODS assay decentralisation process in three health regions in Peru.
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发表时间：
2011-02
期刊：
The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease
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通讯作者：
A. Mendoza;Edith Castillo;N. Gamarra;T. Huamán;M. Perea;Y. Monroi;R. Salazar;J. Coronel;M. Acurio;G. Obregon;M. Roper;C. Bonilla;Luis Asencios;D. Moore;D. Moore
A. Mendoza;Edith Castillo;N. Gamarra;T. Huamán;M. Perea;Y. Monroi;R. Salazar;J. Coronel;M. Acurio;G. Obregon;M. Roper;C. Bonilla;Luis Asencios;D. Moore;D. Moore
中科院分区：
其他
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作者：
A. Mendoza;Edith Castillo;N. Gamarra;T. Huamán;M. Perea;Y. Monroi;R. Salazar;J. Coronel;M. Acurio;G. Obregon;M. Roper;C. Bonilla;Luis Asencios;D. Moore;D. Moore

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目的为使异烟肼（INH）和利福平（RMP）药敏试验（DST）更接近患者，我们在秘鲁设计了显微镜观察药敏试验（MODS）的分散化流程，并评价其可靠性。方法：经过2周的培训，实验室工作人员在3个区域实验室处理了≥ 120份连续痰液样本。在专家实验室中与MODS测试平行处理样品。由国家卫生研究所（INS）根据预先确定的标准对盲态配对结果进行独立分析：培养一致性、针对INH和RMP的DST和耐多药结核病（MDR-TB）诊断≥ 95%、McNemar P > 0.05、kappa指数（κ）≥ 0.75和污染1- 4%。计算MDR-TB的敏感性和特异性。结果：卡劳（126份样本，79.4%涂片阳性）、利马苏尔（n = 130，84%）和阿雷基帕（n = 126，80%）的认证过程分别耗时94、97和173天。所有区域实验室的预定标准均高于预期值。区域实验室检测耐多药结核病的灵敏度和特异性均大于95%，但利马南部的灵敏度为91.7%。污染为1.0- 2.3%。平均延迟至阳性MODS结果为9.9-12.9天。结论MODS的技术转移可靠、有效、快速，使INS能够快速地对区域实验室进行认证。
OBJECTIVE To deliver rapid isoniazid (INH) and rifampicin (RMP) drug susceptibility testing (DST) close to the patient, we designed a decentralisation process for the microscopic observation drug susceptibility (MODS) assay in Peru and evaluated its reliability. METHODS After 2 weeks of training, laboratory staff processed ≥ 120 consecutive sputum samples each in three regional laboratories. Samples were processed in parallel with MODS testing at an expert laboratory. Blinded paired results were independently analysed by the Instituto Nacional de Salud (INS) according to pre-determined criteria: concordance for culture, DST against INH and RMP and diagnosis of multidrug-resistant tuberculosis (MDR-TB) ≥ 95%, McNemar's P > 0.05, kappa index (κ) ≥ 0.75 and contamination 1-4%. Sensitivity and specificity for MDR-TB were calculated. RESULTS The accreditation process for Callao (126 samples, 79.4% smear-positive), Lima Sur (n = 130, 84%) and Arequipa (n = 126, 80%) took respectively 94, 97 and 173 days. Pre-determined criteria in all regional laboratories were above expected values. The sensitivity and specificity for detecting MDR-TB in regional laboratories were >95%, except for sensitivity in Lima Sur, which was 91.7%. Contamination was 1.0-2.3%. Mean delay to positive MODS results was 9.9-12.9 days. CONCLUSION Technology transfer of MODS was reliable, effective and fast, enabling the INS to accredit regional laboratories swiftly.