Anti-SARS-CoV-2 Antibody Detection

Date of reception of the dossier

19.10.2021

Notified Body number

0123

Internal PECP dossier #

In vitro diagnostic medical device

The device is a qualitative double-antigen sandwich assay for
the detection of Antibodies to SARS-CoV-2 in serum/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

Aid in the determination of the
immune reaction to SARS-CoV-2.

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.

Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2)

P4

whether it is automated or not

Fully automated

P5

whether it is qualitative, semi-quantitative or
quantitative

Qualitative.

P6

type of specimen(s)
e.g. whole blood, serum, saliva etc

Serum, venous plasma

P7

where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range

No specific testing population

P8

intended user

Professional Laboratory User

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.

Double-antigen sandwich assay
using electro-chemi-luminescence
detection method (ECLIA)

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