nal von minden COVID-19 Ag Test Instructions D'utilisation page 7

ENGLISH
Intended Use
The NADAL® COVID-19 Ag Test is a lateral flow chromato-
graphic immunoassay for the qualitative detection of SARS-
CoV-2 viral nucleoprotein antigens in human nasopharyngeal
or oropharyngeal specimens (see section 12 'Limitations'). This
test is intended for use as an aid in the diagnosis of infections
with SARS-CoV-2. Note that the concentration of viral
nucleoprotein antigens may vary in the course of the disease
and might fall below the detection limit of the test. Possible
infectiousness of test subjects cannot be ruled out based on
negative test results. The test procedure is not automated and
requires no special training or qualification. The NADAL®
COVID-19 Ag Test is designed for professional use only.
Introduction and Clinical Significance
COVID-19 (Corona Virus Disease) is the infectious disease
caused by the recently discovered coronavirus SARS-CoV-2.
The most common symptoms of COVID-19 are fever, dry
cough, fatigue, sputum production, shortness of breath, sore
throat and headache. Some patients may have myalgia, chills,
nausea, nasal congestion and diarrhoea. These symptoms
begin gradually and are mild in most of the cases. Some
people become infected but do not develop any symptoms
and do not feel unwell. Most people (about 80%) recover from
the disease without special treatment. Approximately one in
six people who get infected with COVID-19 becomes seriously
ill and develops difficulty breathing. Elderly people, and those
with pre-existing conditions, such as high blood pressure,
heart problems or diabetes, are more likely to develop serious
illness. So far, about 2% of infected people have died.
COVID-19 is transmitted via respiratory droplets that are
exhaled by infected people via coughing, sneezing or talking.
These droplets can be inhaled or ingested directly by other
people or can contaminate surfaces, which can then be
infectious for several days. Most estimates of the incubation
period for COVID-19 range from 1 to 14 days, during which
people might already be infectious without showing disease
symptoms.
Test Principle
The NADAL® COVID-19 Ag Test is a lateral flow chromato-
graphic immunoassay for the qualitative detection of SARS-
CoV-2 viral nucleoprotein antigens in human nasopharyngeal
or oropharyngeal specimens.
Anti-SARS-CoV-2 antibodies are immobilised in the test line
region (T) of the membrane. A specimen is added to an
extraction tube containing buffer in order to release SARS-
CoV-2 antigens. During the test, extracted antigens bind to
anti-SARS-CoV-2 antibodies conjugated to coloured particles
and precoated onto the sample pad of the test cassette. The
mixture then migrates along the membrane chromato-
graphically by capillary action and interacts with the reagents
on the membrane. The complexes are then captured by anti-
SARS-CoV-2 antibodies in the test line region (T). Excess
coloured particles are captured in the control line region (C).
The presence of a coloured line in the test line region (T)
indicates a positive result. The absence of a coloured line in
the test line region (T) indicates a negative result.
The formation of a coloured line in the control line region (C)
serves as a procedural control, indicating that the proper
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® COVID-19 Ag Test
(Ref. 243103N-20)
volume of specimen has been added and membrane wicking
has occurred.
Reagents and Materials Supplied
 20 NADAL® COVID-19 Ag test cassettes*
 Additional material provided according to 93/42/EEC:
Due to possible supply shortages of COVID-19 related
accessory medical products, the swab manufacturer might
change. Therefore, the supplied swabs are from one of the
manufacturers listed below.
a) 20 sterile swabs, CE0086
Puritan Medical Products Company LLC
31 School Street
Guilford, Maine 04443-0149 USA (authorised EU
representative EMERGO EUROPE, The Hague, The
Netherlands)
b) 20 sterile swabs, CE0197
Jiangsu Changfeng Medical Industry Co., Ltd
Touqiao Town, Guangling District, Yangzhou,
Jiangsu 225109
representative Llins Service & Consulting GmbH,
Obere Seegasse
Germany)
c) 20 sterile swabs, CE0197
CITOTEST LABWARE MANUFACTURING CO., LTD
No.48, Xinxiu Road, Haimen, Jiangsu province
(authorised EU representative WellKang Ltd,
16 Castle St, Dover, CT16 1PW, UK)
d) 20 sterile swabs, Copan Floqswabs; CE0123
Copan Italia S.p.A.,
Via Perotti 10, 25125 Brescia, Italy
e) 20 sterile swabs, CE0123
Zhejiang Gongdong Medical Technology Co., Ltd
No.10 Beiyuan Ave., Huangyan, 318020 Taizhou,
Zhejiang, People's Republic of China (authorised
EU representative Shanghai International Holding
Corp. GmbH (Europe), Eiffestraße 80, 20537
Hamburg, Germany)
 20 extraction tubes incl. dropper caps
 Buffer (Due to possible supply shortages of COVID-19
related accessory medical products, buffer is supplied either
in 2 bottles (7 mL each) or 1 bottle (10 mL). Both options
are sufficient for 20 determinations.)**
 1 reagent holder
 1 package insert
*containing the preservative sodium azide: <0.1%
**Buffer containing the following preservatives: sodium
azide: <0.1 mg/mL
The detergents contained in the buffer lyse and neutralise
the virus.
No hazard labelling is required according to Regulation (EC) Nº
1272/2008 CLP. Concentrations are below exemption
threshold.
Additional Materials Required
 Timer
China (authorised
34/2, 69124 Heidelberg,
EU
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