ISO 15216-2:2019 食物連鎖の微生物学—リアルタイムRT-PCRを使用したA型肝炎ウイルスとノロウイルスの水平測定法—パート2：検出方法 | ページ 6

3.1

foodstuff

substance used or prepared for use as food

Note 1 to entry: For the purposes of this document, this definition includes bottled water.

3.2

surface

surface of food, food preparation surface or food contact surface

3.3

soft fruit

small edible stoneless fruit

3.4

leaf, stem and bulb vegetables

leaves, stems and bulbs of plants, eaten as a vegetable

3.5

hepatitis A virus

HAV

member of the Picornaviridae family responsible for infectious hepatitis

Note 1 to entry: Genetically, HAV can be subdivided into six genotypes on the basis of the VP1/2A region (genotypes 1, 2 and 3 have been found in humans, while genotypes 4, 5, and 6 are of simian origin). There is only one serotype.

Note 2 to entry: Transmission occurs via the faecal-oral route by person-to-person contact, through the consumption of contaminated foodstuffs (3.1) , contact with contaminated water or surfaces (3.2) , or contact with contaminated fomites. HAV is classified as a group 2 biological agent by the European Union and as a risk group 2 human aetiological agent by the United States National Institutes of Health.

3.6

norovirus

member of the Caliciviridae family responsible for sporadic cases and outbreaks of acute gastroenteritis

Note 1 to entry: Genetically, norovirus can be subdivided into seven separate genogroups. Three of these genogroups, GI, GII and GIV have been implicated in human gastrointestinal disease. GI and GII are responsible for the vast majority of clinical cases.

Note 2 to entry: Transmission occurs via the faecal-oral route by person-to-person contact, through the consumption of contaminated foodstuffs (3.1) , through contact with contaminated water or surfaces (3.2) , or contact with contaminated fomites. GI and GII noroviruses are classified as group 2 biological agents by the European Union and as risk group 2 human aetiological agents by the United States National Institutes of Health.

3.7

detection of HAV

detection of HAV (3.5) RNA in a predetermined mass or volume of foodstuff (3.1) , or on the area of a surface (3.2)

3.8

detection of norovirus

detection of norovirus (3.6) RNA in a predetermined mass or volume of foodstuff (3.1) , or on the area of a surface (3.2)

3.9

process control virus

virus added to the sample portion at the earliest opportunity prior to virus extraction to control for extraction efficiency

3.10

process control virus RNA

RNA extracted from the process control virus (3.9) in order to produce standard curve data for the estimation of extraction efficiency

3.11

negative RNA extraction control

control free of target RNA carried through all steps of the RNA extraction and detection procedure to monitor any contamination events

3.12

negative process control

target pathogen-free sample of the food matrix, or target pathogen-free non-matrix sample, that is run through all stages of the analytical process

3.13

hydrolysis probe

fluorescent probe coupled with a fluorescent reporter molecule and a quencher molecule, which are sterically separated by the 5′-3′-exonuclease activity of the enzyme during the amplification process

3.14

negative real-time RT-PCR control

aliquot of highly pure water used in a real-time RT-PCR reaction to assess contamination in the real-time RT-PCR reagents

3.15

external control RNA

EC RNA

reference RNA that can be used to assess inhibition of amplification for the real-time RT-PCR assay of relevance by being added in a defined amount to an aliquot of sample RNA in a separate reaction

3.16

C_q value

quantification cycle, which is the cycle at which the target is quantified in a given real-time RT-PCR reaction

Note 1 to entry: This corresponds to the cycle at which reaction fluorescence rises above a threshold level.