International Union Against Tuberculosis and Lung Disease, Paris, France.
Int J Tuberc Lung Dis. 2011 Jan;15(1):116-24.
The network of supranational tuberculosis reference laboratories (SRLs).
To evaluate the annual SRL Rounds 6-14 of proficiency testing for first-line drug susceptibility testing (DST).
Panels consisted of 20-30 cultures (including 10 pairs of duplicate strains), aiming at 50% resistance prevalence with a variety of profiles. The 27 SRLs participating in at least one of these rounds were free to use their preferred DST method. A judicial gold standard of at least 80% concordant 'susceptible' or 'resistant' was used to determine sensitivity, specificity and efficiency; otherwise the strain was excluded.
Of 600 strains, 10% were excluded from evaluation. The average SRL sensitivity and specificity varied between rounds, without attaining significance or trends. Both sensitivity and specificity remained at >95% for isoniazid (INH), rifampicin (RMP) and streptomycin and at >80% for ethambutol. The 16 SRLs participating in all rounds performed consistently better.
The rounds succeeded in comparing the proficiency of laboratories, and should be further promoted for DST quality assessment. However, to function with greater precision and to ultimately improve the clinical relevance of DST, the INH and RMP judicial result gold standard also needs to take into account genotypic and treatment outcome information.
跨国结核病参考实验室网络。
评估第 6 至 14 轮一线药物敏感性检测（DST）的年度 SRL 能力验证。
面板由 20-30 个培养物组成（包括 10 对重复菌株），目标是耐药率为 50%，具有多种耐药模式。至少参加过一轮的 27 个 SRL 可自由选择其首选的 DST 方法。采用至少 80%一致性的“敏感”或“耐药”的司法金标准来确定敏感性、特异性和效率；否则将排除该菌株。
在 600 株菌株中，有 10%被排除在评估之外。各轮次的平均 SRL 敏感性和特异性存在差异，但无统计学意义或趋势。异烟肼（INH）、利福平（RMP）和链霉素的敏感性和特异性均保持在>95%，乙胺丁醇的敏感性和特异性均保持在>80%。所有轮次都参加的 16 个 SRL 表现一致较好。
这些轮次成功地比较了实验室的能力，应该进一步推广用于 DST 质量评估。然而，为了更精确地发挥作用，并最终提高 DST 的临床相关性，INH 和 RMP 的司法结果金标准还需要考虑基因型和治疗结果信息。
