Hepatitis E virus IgG Detection
Date of reception of the dossier
08.02.2023
Notified Body number
0459
Internal PECP dossier #
In vitro diagnostic medical device
Essay using chemiluminescent immunoassay (CLIA) technology for the quantitative determination of IgG antibodies to hepatitis E virus (anti-HEV IgG) in human serum and plasma samples included specimens collected postmortem (non-heart beating).
It is intended as an aid in the diagnosis of HEV infection in individuals with or without symptoms of hepatitis and to evaluate the presence and the amount of anti-HEV IgG. It is also intended as a screening test for organ, tissue, and cells postmortem donors.
Intended purpose
P1
what is detected and/or measured
please specify the analyte(s) or marker(s), e.g. SARS-CoV-2 spike protein, Kel1 (K)
- Anti-HEV IgG
P2
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
- Aid in the diagnosis of HEV infection.
- Screening test for post- mortem organ, tissue and cells donors.
P3
the specific disorder, condition or risk factor of
interest that it is intended to detect, define or
differentiate e.g. hepatitis C infection, exposure to SARS-CoV-2, risk of HIV transmission in blood transfusion etc.
HEV infection
P4
whether it is automated or not
Automated assay
P5
whether it is qualitative, semi-quantitative or
quantitative
Qualitative assay
P6
type of specimen(s)
e.g. whole blood, serum, saliva etc
Serum and plasma samples, including specimens collected post-mortem (non-heart beating).
P7
where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range
Individuals with or without symptoms of hepatitis.
P8
intended user
For Laboratory Professional Use Only
Technology
T1
principle of the assay method or principles of operation of the instrument e.g. real-time PCR, qualitative PCR, digital PCR, sandwich immunoassay, competitive immunoassay, immunoturbidimetric assay etc.
Chemiluminescence immunoassay (CLIA).