TECHLAB, Inc., Blacksburg, VA, USA.
Wisconsin Diagnostic Laboratories, Medical College of Wisconsin, Milwaukee, WI, USA.
Eur J Clin Microbiol Infect Dis. 2019 Jun;38(6):1087-1093. doi: 10.1007/s10096-019-03499-x. Epub 2019 Feb 19.
Campylobacter diagnosis is hampered because many laboratories continue to use traditional stool culture, which is slow and suffers false-negative results. This large multi-site study used a composite reference method consisting of a new FDA-cleared immunoassay and four molecular techniques to compare to culture. Prospectively collected patient fecal specimens (1552) were first preliminarily categorized as positive or negative by traditional culture. All specimens were also tested by EIA, and any EIA-positive or culture-discrepant results were further characterized by 16S rRNA qPCR, eight species-specific PCR assays, bidirectional sequencing, and an FDA-cleared multiplex PCR panel. The five non-culture methods showed complete agreement on all positive and discrepant specimens which were then assigned as true-positive or true-negative specimens. Among 47 true-positive specimens, culture incorrectly identified 13 (28%) as negative, and 1 true-negative specimen as positive, for a sensitivity of 72.3%. Unexpectedly, among the true-positive specimens, 4 (8%) were the pathogenic species C. upsaliensis. Culture had a 30% false result rate compared to immunoassay and molecular methods. More accurate results lead to better diagnosis and treatment of suspected campylobacteriosis.
空肠弯曲菌的诊断受到阻碍,因为许多实验室仍在使用传统的粪便培养,这种方法缓慢且容易出现假阴性结果。这项大型多地点研究使用了一种组合参考方法,包括一种新的美国食品和药物管理局批准的免疫测定法和四种分子技术,以与培养法进行比较。前瞻性收集的患者粪便标本(1552 个)首先通过传统培养初步分类为阳性或阴性。所有标本均采用 EIA 进行检测,任何 EIA 阳性或培养结果不一致的标本均通过 16S rRNA qPCR、8 种种特异性 PCR 检测、双向测序和美国食品和药物管理局批准的多重 PCR 面板进行进一步鉴定。五种非培养方法在所有阳性和不一致的标本上完全一致,然后将其分配为真阳性或真阴性标本。在 47 个真阳性标本中,培养法错误地将 13 个(28%)鉴定为阴性,而将 1 个真阴性标本鉴定为阳性,灵敏度为 72.3%。出乎意料的是,在真阳性标本中,有 4 个(8%)是致病性物种 C. upsaliensis。与免疫测定法和分子方法相比,培养法的假阳性率为 30%。更准确的结果可导致对疑似弯曲菌病的更好诊断和治疗。