NAL NADAL Influenza A Test Instructions D'utilisation page 6

ENGLISH
1. Intended Use
The NADAL® Influenza A/B Test is a lateral flow chromato-
graphic immunoassay for the qualitative detection of influenza
virus type A and B antigens (nucleoproteins) in the nasal
swabs, pharyngeal swabs or nasal/nasopharyngeal aspirates of
symptomatic patients. This test is intended for use as an aid in
the rapid, differential diagnosis of influenza virus A and B
infections and is designed for professional use only.
2. Introduction and Clinical Significance
Influenza is a highly contagious viral infection of the upper
respiratory tract which is characterised by antigen variability,
seasonality and the impact on the general population. Of the
two main types (A and B) of influenza viruses, influenza A
subtypes are differentiated by the antigen variability of
surface glycoproteins (haemagglutinin and neuraminidase).
The influenza A virus is the most prevalent and is associated
with the most serious epidemics. Influenza can cause severe
complications such as bronchitis or pneumonia, particularly in
children, the elderly or in those with chronic respiratory
disease. However, it most commonly occurs as a mild viral
infection transmitted by respiratory secretions through
sneezing or coughing. There are many other viral infections
that can mimic influenza symptoms, making laboratory tests
necessary to distinguish it from other acute respiratory
infections.
With a sensitivity and specificity of almost 100%, RT-PCR is the
gold standard of laboratory diagnostics. However, as a
laboratory method, it does not allow immediate diagnosis and
requires qualified personnel and expensive laboratory
equipment. Antiviral influenza drugs, which have been
available since the late 1990s, are most effective if
administered early after the onset of the illness (within 48
hours). Rapid tests for the detection of influenza antigens can
therefore enable that a successful antiviral therapy is carried
out in good time, thereby improving patient healthcare and
reducing health costs.
3. Test Principle
The NADAL® Influenza A/B Test is a lateral flow chromato-
graphic immunoassay for the qualitative detection of influenza
virus type A and B antigens (nucleoproteins) in nasal swabs,
pharyngeal swabs or nasal/nasopharyngeal aspirates.
Antibodies specific to influenza virus type A and B nucleo-
proteins are pre-coated onto the test line region (A) and (B) of
the membrane. During testing, the extracted specimen reacts
with the antibodies to influenza virus type A and B antigens
which are conjugated to coloured particles. The mixture then
migrates along the membrane chromatographically by
capillary action and reacts with the antibodies to influenza
virus type A and B antigens in the test line region (A) and (B) of
the membrane. The presence of a coloured line in the test line
region (A) and/or (B) indicates a positive result. The absence
of a coloured line in the test line region (A) and/or (B)
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
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® Influenza A/B Test
(Ref. 241015N-10)
4. Reagents and Materials Supplied
 10 NADAL® Influenza A/B test strips
 10 sterile swabs CE 0197
Miraclean Technology Co., Ltd.
No. 18, Rongshuxia Industrial Zone
Tongle Community, Longgang District Shenzhen
518116 Guangdong,
representative Wellkang Ltd, Suite B, 29 Harley
Street, London W1G 9QR, UK)
 10 extraction tubes
 2 control swabs: 1 Influenza A+/B- Control Swab (non-viable
Influenza A, 0.02% NaN
(non-viable Influenza B, 0.02% NaN
 1 reagent holder
 1 buffer (8 mL)
 1 package insert
5. Additional Materials Required
 Timer
 Aspiration device with catheter and mucus trap (for
aspirates)
6. Storage & Stability
Test kits should be stored at 2-30°C until the expiry date. Test
strips are stable until the expiry date printed on the sealed foil
pouches. Test strips must remain in the sealed foil pouches
until use. Do not freeze tests. Do not use tests beyond the
expiry date indicated on the packaging.
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 the test if the foil pouch is damaged.
 Do not reuse tests.
 The test strip should remain in the sealed foil pouch until
use.
 Do not dip the test strip beyond the maximum immersion
mark.
 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
extraction tube for each specimen obtained.
Handling area
Control line (C)
Reaction area
Test line (B)
Test line (A)
Maximum immersion mark
Immersion area
China (authorised
); 1 Influenza A-/B+ Control Swab
3
)
3
EU
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