Ozongwu C, Personne Y, Platt G, Jeanes C, Aydin S, Kozato N, Gant V, O'Grady J, Enne V I
Centre for Clinical Microbiology, Division of Infection and Immunity, University College London, Royal Free Campus, Roland Hill Street, London, UK.
Norwich Medical School, University of East Anglia, Norwich, UK.
Biomol Detect Quantif. 2017 Jun 28;13:1-6. doi: 10.1016/j.bdq.2017.06.001. eCollection 2017 Sep.
O'Neill's recent Review on Antimicrobial Resistance expressed the view that by 2020 high-income countries should make it mandatory to support antimicrobial prescribing with rapid diagnostic evidence whenever possible.
Routine microbiology diagnosis of 95 respiratory specimens from patients with severe infection were compared with those generated by the Unyvero P55 test, which detects 20 pathogens and 19 antimicrobial resistance markers. Supplementary molecular testing for antimicrobial resistance genes, comprehensive culture methodology and 16S rRNA sequencing were performed.
Unyvero P55 produced 85 valid results, 67% of which were concordant with those from the routine laboratory. Unyvero P55 identified more potential pathogens per specimen than routine culture (1.34 vs. 0.47 per specimen). Independent verification using 16S rRNA sequencing and culture (n = 10) corroborated 58% of additional detections compared to routine microbiology. Overall the average sensitivity for organism detection by Unyvero P55 was 88.8% and specificity was 94.9%. While Unyvero P55 detected more antimicrobial resistance markers than routine culture, some instances of phenotypic resistance were missed.
The Unyvero P55 is a rapid pathogen detection test for lower respiratory specimens, which identifies a larger number of pathogens than routine microbiology. The clinical significance of these additional organisms is yet to be determined. Further studies are required to determine the effect of the test in practise on antimicrobial prescribing and patient outcomes.
奥尼尔最近关于抗微生物药物耐药性的综述认为，到2020年，高收入国家应尽可能强制要求在抗微生物药物处方时提供快速诊断证据支持。
将95例严重感染患者的呼吸道标本的常规微生物学诊断结果与Unyvero P55检测结果进行比较，Unyvero P55可检测20种病原体和19种抗微生物药物耐药性标志物。对抗微生物药物耐药基因进行了补充分子检测、采用了综合培养方法并进行了16S rRNA测序。
Unyvero P55产生了85个有效结果，其中67%与常规实验室结果一致。Unyvero P55每个标本鉴定出的潜在病原体比常规培养更多（每个标本分别为1.34种和0.47种）。与常规微生物学相比，使用16S rRNA测序和培养（n = 10）进行的独立验证证实了58%的额外检测结果。总体而言，Unyvero P55检测生物体的平均灵敏度为88.8%，特异性为94.9%。虽然Unyvero P55检测到的抗微生物药物耐药性标志物比常规培养更多，但仍有一些表型耐药情况未被检测到。
Unyvero P55是一种用于下呼吸道标本的快速病原体检测试验，它比常规微生物学鉴定出的病原体数量更多。这些额外生物体的临床意义尚待确定。需要进一步研究以确定该试验在实际应用中对抗微生物药物处方和患者预后的影响。
