Anti-Epstein-Barr Virus Viral Cpasid Antigen IgG Antibodies Detection
Date of reception of the dossier
20.12.2021
Notified Body number
0123
Internal PECP dossier #
In vitro diagnostic medical device
Chemiluminescent microparticle immunoassay (CMIA) for the
qualitative detection of IgG antibodies to Epstein-Barr Virus
(EBV) Viral Capsid Antigen (VCA) in human serum and plasma.
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)
IgG antibodies to Epstein-Barr Virus
(EBV) Viral Capsid
Antigen (VCA)
P2
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
- aid in the diagnosis of infectious mononucleosis (IM)
- aid in determining the stage of EBV infection
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.
Infectious mononucleosis
P4
whether it is automated or not
Automated
P5
whether it is qualitative, semi-quantitative or
quantitative
Qualitative
P6
type of specimen(s)
e.g. whole blood, serum, saliva etc
Human Serum and Plasma
P7
where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range
- Individuals suspected to have acute mononucleosis
- Potential organ donors / organ recipients
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.
Chemiluminescent microparticle
immunoassay (CMIA) technology