Test methods

 

 

The EURLP’s diagnostic activities are performed in accordance with ISO/IEC 17025:2017. The lack of international standards for the diagnosis of foodborne parasitic diseases is a major constraint in implementing a quality assurance system. To date, few diagnostic methods have been standardized at European or international level (ISO 18743:2015. Microbiology of the food chain — Detection of Trichinella larvae in meat by artificial digestion method; ISO18744:2016. Microbiology of the food chain — Detection and enumeration of Cryptosporidium and Giardia in fresh leafy green vegetables and berry fruits). Thus there is a need to validate both commercial kits and in-house developed tests. EURLP staff, on the basis of long-lasting scientific experience, developed new tests and reagents for detecting parasitic pathogens, and contributed to work up international guidelines.
EURLP developed and validated the following diagnostic methods:

Detection of anti-Trichinella antibodies in swine serum by indirect ELISA  (MI-01)

Identification of Trichinella muscle larvae at species level by Multiplex PCR  (MI-02)

Detection of anti-Trichinella antibodies in human serum by indirect ELISA (MI-03)

Identification at species level of parasites of the family Anisakidae by PCR/RFLP (MI-04)

Identification at species level of Cryptosporidium oocysts by PCR/RFLP (MI-06)

Detection of anti-Opisthorchis antibodies in human sera (MI-07)

Identification of Opisthorchis spp eggs by PCR (MI-08)

Identification at assemblage level of Giardia duodenalis cysts by PCR/RFLP (MI-09)

Identification of Anisakidae larvae at the species level by multiplex PCR (MI-10)

Identification of the assemblages A and B of Giardia duodenalis (MI-11)

Identification of Toxoplasma gondii DNA in food matrices (fresh or processed meat) by LAMP (MI-12)

Identification of Trichinella spp. proteins recognized by specific IgG in serum of infected pigs by western blotting  (MI-13)

Identification of Toxoplasma gondii DNA in leafy green vegetable by LAMP  (MI-14)

Identification of Echinococcus granulosus sensu lato complex at species/genotypes level by PCR/RFLP and multiplex PCR (MI-15)

 

The methods listed, together with the magnetic stirrer method for pooled sample digestion for the detection of Trichinella in fresh meat (Commission Regulation No 2015/1375, see Section “Documents – EU Regulations”), were accredited by ACCREDIA, the italian accreditation body, according to the ISO/IEC 17025:2017 international standard.
The accreditation is submitted to a convention and recognises the technical competence of the laboratory to perform specific analytical methods. Nevertheless, the accreditation body doesn’t assume any responsability related to the results of the assays.
All methods are available as part of the services that EURLP provides to NRLs and other public institutions.
Before sending the samples to be tested, please download the Test Request Form attached below and send it together with the samples.

Privacy and data treatment: Personal data are processed in compliance with the regulatory provisions referred to in EU Regulation 2016/679 and Privacy Code, as reported in Legislative Decree no. 101/2018. The data controller of personal data is the Istituto Superiore di Sanità with registered office in Viale Regina Elena n. 299 – 00161 Rome, in the person of its President. In addition, the ISS has appointed its own Data Protection Officer (D.P.O.), e-mail address: protezionedati@iss.it. Data are processed exclusively for carrying out the test activities, for this purpose adequate physical, technical and organizational security measures have been set up to prevent and avoid their destruction and/or loss of integrity, as well as their illicit or incorrect use. Data and samples are accessible only to personnel authorized to process personal data as part of the test activities, authorized person has their own credentials and their own operating station. The applicant has the rights referred to in art. 15 GDPR et seq., more precisely right of access, right of rectification, right of limitation of treatment, right to data portability, right of opposition, as well as the right to lodge a complaint with the Guarantor Authority (art. 77 GDPR and 141 Privacy Code, as reported by Legislative Decree 101/2018). The ISS, in its capacity as Data Controller, undertakes to keep the records of processing activities correctly pursuant to art. 30 GDPR.

Claim: The EURLP provides a form to report any Claim from the client both in Italian (Reclamo da cliente MO/MAQ/01.IT) and in English (Claim form MO/MAQ/01.EN), see attachments below.

On receiving a claim, the head of the unit evaluate its validity, discuss with the function/functions involved, establish the measures to adopt and define the communication to provide to the applicant . If the claim is addressed to the head of the Unit, indipendent personnel will be identified to evaluate the claim, to estabilish the measure to adopt and communicate to the applicant. Indipendent personnel will be identified within the Unit. The applicant will be informed on the measures adopted and the schedule. Feed-back information on the satisfaction will be asked to the applicant.

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