Anti-Treponema pallidum Antibodies Detection
Date of reception of the dossier
30.11.2021
Notified Body number
0123
Internal PECP dossier #
In vitro diagnostic medical device
Chemiluminescent microparticle immunoassay (CMIA) used
for the qualitative detection of antibodies to Treponema pallidum in human serum and plasma, including specimens collected post-mortem (non-heart-beating) using propietary
instrumentation.
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)
Antibodies to Treponema pallidum
P2
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
- Aid in the diagnosis of Syphilis infection
- As a screening test to prevent transmission of Treponema pallidum to recipients of blood, blood components, cells, tissues, and organs
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
- Human Serum and Plasma
- Serum and Plasma specimens from Cadaveric (non-heart beating) donors
P7
where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range
- Volunteer blood donors of whole blood and blood components
- Organ donors when specimens are obtained while the donor’s heart is still beating
- Cadaveric (non-heart-beating) donors
- Individuals suspected to have syphilis infection
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