Accreditation
ČIA Accreditation
The laboratory GENvia, s.r.o. has been included among the accredited laboratories since 26.1.2006, when it obtained the Certificate of Accreditation and was included in the National Registry of ČIA (Czech Institute for Accreditation) under the No. M 8006 (ČIA-registry).
The results issued by the laboratory GENvia, s.r.o. are labelled with the ČIA-mark and the laboratory number M8006, which demonstrate assurance of the highest quality of testing performed and the meeting of all requirements set in the international ISO norm No. 15 189 for clinical examinations.
List of methods accredited by ČIA, o.p.s. (Czech Institute for Accreditation):
Expertise 816 – Laboratory of Medical Genetics
- Examination of constitutional karyotype (Conventional cytogenetic analysis)
- Constitutional chromosome aberration testing (FISH)
- Examination of germline genome variants (PCR with fragmentation analysis)
- Examination of germline genome variants (QF PCR)
- Examination of germline genome variants (aCGH)
Germline genome variant testing (MLPA) - Germline genome variant screening (NGS-MPS)
- Germline genome variant testing (RT PCR)
- Examination of germline genome variants (Sanger sequencing)
Details on individual examinations can be found in the Laboratory section
SÚKL Certification
GENvia, s.r.o. ensures compliance with the requirements for diagnostic laboratories according to §19 (2) of Act 296/2008 Coll., as amended. The State Office for Drug Control (SÚKL) authorised the activity of the diagnostic laboratory on the basis of the decision No. sukls124246/2019 of 12 June 2019 and included the laboratory in the central register of holders of authorisation for activities in the field of human tissues and cells (SÚKL database).
Overview of methods certified by SÚKL (State Office for Drug Control):
- Cytogenetic karyotype determination from peripheral blood
- Examination of carriers of mutations for cystic fibrosis (CFTR gene)
- Examination of carriers of mutations for spinal muscular atrophy (SMN1 gene)
- Examination of carriers of mutations for hereditary hearing impairment (GJB2 gene)
Details on individual examinations can be found in the Laboratory section
The accreditation (ISO norm No. 15 189)
guarantees that the laboratory follows very strict quality requirements for examinations, including regular interlaboratory inspections, internal quality audits, calibration plan compliance, etc. The accreditation is granted entirely by ČIA, o.p.s. (Czech Institute for Accreditation).
The certification (§ 9 of the Act No. 296/2008 Coll.)
ensures compliance with legislative requirements for the diagnostic laboratory, i.e. following strict conditions for preservation and handling of samples, personal data protection, regular service inspections of equipment, etc. The approval is granted entirely by SÚKL, o.p.s. (State Office for Drug Control).