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1. Intended Use
The NADAL® COVID-19 Ag plus Test is a lateral flow chromato-
graphic immunoassay for the qualitative detection of SARS-
CoV-2 viral nucleoprotein antigens
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 plus Test is designed
for professional use only.
2. 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.
3. Test Principle
The NADAL® COVID-19 Ag plus Test is a lateral flow chromato-
graphic immunoassay for the qualitative detection of SARS-
CoV-2 viral nucleoprotein antigens
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.
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® COVID-19 Ag plus Test
in human nasal,
in human nasal,
(Ref. 243104N-20)
The formation of a coloured line in the control line region (C)
serves as a procedural control, indicating that the proper
volume of specimen has been added and membrane wicking
has occurred.
4. Reagents and Materials Supplied
• 20 NADAL® COVID-19 Ag plus 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, CE0197
Jiangsu Changfeng Medical Industry Co., Ltd
Touqiao Town, Guangling District, Yangzhou,
Jiangsu
225109
representative Llins Service & Consulting GmbH,
Obere
Seegasse
Germany)
b) 20 sterile swabs, CE0197
Jiangsu Rongye Technology Co., LTD, Touqiao
Town, Yangzhou City, Jiangsu Province, China
(authorised EU representative Riomavix S.L., Calle
de Almansa 55, 1D, Madrid 28039 Spain)
c) 20 sterile swabs, CE0197
CITOTEST LABWARE MANUFACTURING CO., LTD
No.48, Xinxiu Road, Haimen, Jiangsu province
(authorised EU representative WellKang Ltd,
Enterprise
Hub,
1 Beraghmore Rd., Derry, BT48 8SE, Northern
Ireland)
• 20 extraction tubes incl. dropper caps
• 20 buffer ampoules for single use (300 μL each)*
• 1 reagent holder
• 1 package insert
*Buffer containing the following preservative: ProClin™ 300:
<0.03%.
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 the exemption
threshold.
5. Additional Materials Required
• Timer
6. Storage & Stability
Test kits should be stored at 2-30°C until the indicated expiry
date. Test cassettes are stable until the expiry date printed on
the foil pouches. Test cassettes must remain in the sealed foil
pouches until use. Do not freeze the test kit. Do not use tests
beyond the expiry date indicated on the packaging. Care
should be taken to protect test kit components from
contamination. Do not use test kit components if there is
evidence of microbial contamination or precipitation.
Biological contamination of dispensing equipment, containers
or reagents can lead to inaccurate results.
7. Warnings and Precautions
• For professional in-vitro diagnostic use only.
China
(authorised
34/2,
69124
Heidelberg,
NW
Business
Complex,
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