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)

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

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