ERP Micro December 2019

GENE-UP ® Listeria spp. 2 (LIS 2)

050567 - 02 - 2018-12 - en

• Visually inspect vials before testing. Do not use vials with evidence of damage, leakage, or deterioration. • Do not mix reagents (or disposables) from different lots. • Powder ‑ free latex or nitrile gloves are recommended for all PCR steps. • Spills should be wiped thoroughly after treatment with bleach or a nucleic acid degradation solution. See the GENE ‑ UP ® instrument User Manual for information on cleaning spills on or in the instrument. Do not autoclave solutions containing bleach. • The equipment and accessories should be regularly cleaned and decontaminated. • NEVER remove the caps from the lysis tubes. • Do not try to remove the strip tube caps once they have been sealed to the PCR strip tubes. • Listeria is a Gram ‑ positive, non ‑ spore ‑ forming, aerobic bacillus organism. 7,8 Care must be taken when handling samples that may contain Listeria spp. Strict compliance with BSL ‑ 2 practices, containment equipment, and facilities are recommended for all activities utilizing known or potentially infectious clinical materials or cultures. 7 While BSL ‑ 2 containment is suitable for all other Listeria , BSL ‑ 3 practices and equipment are recommended for activities likely to produce significant aerosols or for activities involving production quantities of this particular organism. Laboratory personnel must be adequately trained to handle pathogens before being permitted to analyze samples for Listeria spp. Follow appropriate safety guidelines when handling potentially contaminated samples. Waste should be disposed of in compliance with local and national legislation. Listeriosis can be life ‑ threatening to certain vulnerable groups, such as pregnant women and those with compromised immune systems, and can sometimes be life ‑ threatening to healthy individuals. Pregnant women and immune ‑ compromised individuals should take special care when handling samples that are potentially contaminated with Listeria . STORAGE AND STABILITY • Store the GENE ‑ UP ® Listeria spp. 2 kit at +02°C/+25°C. • Do not freeze. • Do not use the reagents beyond the expiration date printed on the kit box and/or label. • Carefully reseal the pouch after use to maintain stability of the strips and return the complete kit to +02°C/+25°C. • Keep away from light. • After opening the kit, check that the pouches are correctly sealed and undamaged. If not, do not use them. • If stored according to the recommended conditions (pouch closed with the desiccant), all components are stable until the expiration date indicated on the label. • Only remove the required number of tubes from the pouch. • The content of the pouch is stable for 2 months after opening if the pouch is correctly sealed and stored according to the recommended conditions. • After the lysed sample is added, the PCR mix is stable for 2 hours at +15°C/+25°C. SAMPLE PREPARATION The following protocols are recommended. 1. Allow the enrichment broths to reach +15°C/+25°C before use. Note: Frozen samples must be thawed before use. 9 2. In a blender bag plus filter, aseptically place the following: Method certified NF VALIDATION BIO XX/XX-XX/XX Matrix Protocol

◦ 25 g of sample. ◦ 225 mL of LTP broth. ◦ Mix using a paddle blender. ◦ Incubate at +37°C ± 1°C for 22 ‑ 28 hours (18 ‑ 24 hours for environmental samples). Note: For environmental surface samples, add enough LPT broth to cover the sampling tool (for example 10 mL for a swab, 100 mL for a sponge, 225 mL for cloth).

Standard procedure for all human food products and production environmental samples (excluding primary production samples)

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