Trypanosoma cruzi Detection
Date of reception of the dossier
24.11.2021
Notified Body number
0123
Internal PECP dossier #
In vitro diagnostic medical device
This assay is intended to be used as an aid in the diagnosis of Trypanosoma cruzi infection and as a screening test to prevent transmission of T. cruzi to recipients of blood, blood components, cells, tissue and organs.
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 Trypanosoma cruzi
P2
function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc
- Aid in the diagnosis of T. cruzi infection
- As a screening test to prevent transmission of T. cruzi 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.
Chagas disease or American
Trypanosomiasis
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 T. cruzi 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