nal von minden NADAL COVID-19 IgG Instructions D'utilisation page 6

ENGLISH
1. Intended Use
The NADAL® COVID-19 IgG/IgM Test is a lateral flow
chromatographic immunoassay for the qualitative detection of
anti-SARS-CoV-2 IgG and IgM in human whole blood, serum or
plasma specimens of symptomatic patients (see section 12
'Limitations'). Note that in the early stages of infection (3 to 7
days after the onset of symptoms) anti-SARS-CoV-2 IgG and
IgM may be below the detection limit of the test. This test is
intended for use as an aid in the diagnosis of SARS-CoV-2
infections. The test procedure is not automated and requires
no special training or qualification. The NADAL® COVID-19
IgG/IgM 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.
This new virus was unknown before the disease outbreak in
Wuhan, China, in December 2019. 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 diarrhea. 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 IgG/IgM Test is a lateral flow
chromatographic immunoassay for the qualitative detection of
anti-SARS-CoV-2 IgG and IgM in human whole blood, serum or
plasma specimens.
Anti-human IgM are pre-coated onto the test line region 'IgM'
and anti-human IgG are pre-coated onto the test line region
'IgG' of the membrane. During testing, the specimen reacts
with SARS-CoV-2 antigens which are conjugated to coloured
particles. The mixture then migrates along the membrane
chromatographically by capillary action and reacts with the
anti-human IgM and anti-human IgG in the test line region
'IgM' and 'IgG' of the membrane. The presence of a red line in
the test line region 'IgM' and/or 'IgG' indicates a positive
result. The absence of a red line in the test line region 'IgM'
and/or 'IgG'indicates a negative result.
The colour change from a blue line to a red one 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.
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® COVID-19 IgG/IgM Test
(Ref. 243003N-25)
4. Reagents and Materials Supplied
 25 NADAL® COVID-19 IgG/IgM Test cassettes*
 25 disposable pipettes (5 μL)
 1 buffer (3 mL)
 1 package insert
*containing the preservative sodium azide: <0.02%
(7.5 ng/test)
No hazard labelling is required according to Regulation (EC) Nº
1272/2008 CLP, Concentrations are below exemption
threshold.
5. Additional Materials Required
 Specimen collection containers (appropriate for specimen
material to be tested)
 Centrifuge (for serum or plasma specimens only)
 Alcohol pads
 Lancets (for fingerstick whole blood specimens only)
 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.
 Carefully read through the test procedure prior to testing.
 Do not use the test beyond the expiration date indicated on
the packaging.
 Do not use test kit components if the primary packaging is
damaged.
 Tests are for single use only.
 Do not add specimens to the reaction area (result area).
 In order to avoid contamination, do not touch the reaction
area (result area).
 Avoid cross-contamination of specimens by using a new
specimen collection container for each specimen obtained.
 Do not substitute or mix components from different test
kits.
 Do not use the buffer if it is discoloured or turbid.
Discolouration or turbidity may be a sign of microbial
contamination.
 Do not eat, drink or smoke in the area where specimens
and test kits are handled.
 Wear protective clothing such as laboratory coats,
disposable gloves and eye protection when specimens are
being assayed.
 Handle all specimens as if they contain infectious agents,
Observe established precautions for microbiological risks
throughout all procedures and standard guidelines for the
appropriate disposal of specimens.
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