Anti-Treponema pallidum IgG and IgM Antibody (to Syphilis) Detection
Date of reception of the dossier
04.11.2021
Notified Body number
2797
Internal PECP dossier #
In vitro diagnostic medical device
This test is intended for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum
IgG and IgM antibodies to syphilis in human serum, EDTA plasma or CPDA 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 and IgM antibodies to Treponema pallidum
P2
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
Blood and plasma donor screening
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.
Syphilis
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
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
Blood and plasma donors
P8
intended user
Professional Users – Blood donor centres
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.
Haemagglutination assay