This review presents the results of a study into the offering of rapid microbial detection assays to the Irish dairy industry. At the outset, a consultation process was undertaken whereby key stakeholders were asked to compile a list of the key microorganisms of interest to the sector. The resultant list comprises 19 organisms/groups of organisms divided into five categories: single pathogenic species (Cronobacter sakazakii, Escherichia coli and Listeria monocytogenes); genera containing pathogenic species (Bacillus, Clostridium, Listeria, Salmonella; Staphylococcus); broad taxonomic groupings (Coliforms, Enterobacteriaceae, fecal Streptococci, sulfite reducing bacteria/sulfite reducing Clostridia [SRBs/SRCs], yeasts and molds); organisms displaying certain growth preferences or resistance as regards temperature (endospores, psychrotrophs, thermodurics, thermophiles); indicators of quality (total plate count, Pseudomonas spp.). A survey of the rapid assays commercially available for the 19 organisms/groups of organisms was conducted. A wide disparity between the number of rapid tests available was found. Four categories were used to summarize the availability of rapid assays per organism/group of organisms: high coverage (> 15 assays available); medium coverage (5–15 assays available); low coverage (< 5 assays available); no coverage (0 assays available). Generally, species or genera containing pathogens, whose presence is regulated-for, tend to have a good selection of commercially available rapid assays for their detection, whereas groups composed of heterogenous or even undefined genera of mainly spoilage organisms tend to be “low coverage” or “no coverage.” Organisms/groups of organisms with “low coverage” by rapid assays include: Clostridium spp.; fecal Streptococci; and Pseudomonas spp. Those with “no coverage” by rapid assays include: endospores; psychrotrophs; SRB/SRCs; thermodurics; and thermophiles. An important question is: why have manufacturers of rapid microbiological assays failed to respond to the necessity for rapid methods for these organisms/groups of organisms? The review offers explanations, ranging from the technical difficulty involved in detecting as broad a group as the thermodurics, which covers the spores of multiple sporeforming genera as well at least six genera of mesophilic nonsporeformers, to the taxonomically controversial issue as to what constitutes a fecal Streptococcus or SRBs/SRCs. We review two problematic areas for assay developers: validation/certification and the nature of dairy food matrices. Development and implementation of rapid alternative test methods for the dairy industry is influenced by regulations relating to both the microbiological quality standards and the criteria alternative methods must meet to qualify as acceptable test methods. However, the gap between the certification of developer's test systems as valid alternative methods in only a handful of representative matrices, and the requirement of dairy industries to verify the performance of alternative test systems in an extensive and diverse range of dairy matrices needs to be bridged before alternative methods can be widely accepted and adopted in the dairy industry. This study concludes that many important dairy matrices have effectively been ignored by assay developers.

本综述介绍了一项向爱尔兰乳制品行业提供快速微生物检测方法的研究结果。一开始，进行了磋商过程，要求主要利益相关者编制一份对该部门感兴趣的关键微生物清单。将所得的列表包括19个有机体/微生物分为五类的组：单致病物种（坂崎肠杆菌，大肠杆菌和李斯特菌）; 含有致病菌的属（芽孢杆菌属、梭菌属、李斯特菌属、沙门氏菌属；葡萄球菌属); 广泛的分类群（大肠菌、肠杆菌科、粪便链球菌、亚硫酸盐还原菌/亚硫酸盐还原梭菌 [SRBs/SRCs]、酵母菌和霉菌）；在温度方面表现出某些生长偏好或抵抗力的生物体（内生孢子、嗜冷菌、耐热菌、嗜热菌）；质量指标（总菌落数、假单胞菌属）。对可用于 19 种生物体/生物体组的快速测定法进行了调查。发现可用的快速测试数量之间存在很大差异。四个类别用于总结每个生物体/生物体组的快速检测的可用性：高覆盖率（> 15 个可用检测）；中等覆盖率（可用 5-15 次检测）；低覆盖率（< 5 个可用检测）；无覆盖（0 可用检测）。一般来说，含有病原体的物种或属，其存在是受调控的，往往有很好的商业上可用的快速检测方法可供选择，而主要由腐败生物的异质或什至未定义属组成的组往往是“低覆盖率”或“无保障”。快速检测“低覆盖率”的生物体/生物群包括：梭菌属；粪便链球菌；和假单胞菌属。快速检测“无覆盖”的那些包括： 内生孢子；嗜冷菌；SRB/SRC；耐热性；和嗜热菌。一个重要的问题是：为什么快速微生物检测的制造商未能对针对这些生物体/生物群的快速方法的必要性做出回应？该评论提供了解释，从检测与耐热菌一样广泛的群体所涉及的技术困难，涵盖多种孢子形成属以及至少六个嗜温非孢子形成属的孢子，到分类学上有争议的关于什么构成粪便的问题链球菌或 SRB/SRC。我们为检测开发人员审查了两个有问题的领域：验证/认证和乳制品基质的性质。乳制品行业快速替代测试方法的开发和实施受到与微生物质量标准和替代方法必须满足的标准相关的法规的影响，这些标准才有资格成为可接受的测试方法。然而，需要弥合开发者测试系统在少数代表性基质中作为有效替代方法的认证与乳制品行业在广泛多样的乳制品基质中验证替代测试系统性能的要求之间的差距。在乳制品行业广泛接受和采用替代方法之前。