NAL NADAL Influenza A Test Instructions D'utilisation page 8

ENGLISH
Negative
A coloured line develops in the
control line region 'C'. No lines
develop in the test line region 'A'
and 'B'.
Invalid
The control line 'C' fails to appear.
Results from any test which has not
produced a control line at the
specified reading time must be
discarded. Please review
procedure and repeat the test with a
new test strip. If the problem
persists, discontinue using the test
kit immediately and contact your
distributor.
Insufficient specimen volume, incorrect operating procedure
or expired tests are the most likely reasons for the control line
failure.
11. Quality Control
An internal procedural control is included in the test strip:
A coloured line appearing in the control line region (C) is
considered an internal procedural control. It confirms
sufficient specimen volume, adequate membrane wicking and
correct procedural technique.
Good laboratory practice (GLP) recommends the use of
external control materials to ensure proper test kit
performance.
Influenza A+/B- and Influenza A-/B+ control swabs are
provided and should be tested with each test kit.
Procedure for external quality control testing:
Influenza A+/B- and Influenza A-/B+ control swabs should be
tested by following the instructions described in section 9
'Test Procedure'.
If the controls do not yield the expected results, do not use
the test kit and contact your distributor.
12. Limitations
 The NADAL® Influenza A/B Test is for professional in-vitro
diagnostic use only and should only be used for the
qualitative detection of influenza virus type A and B
antigens in nasal swabs, pharyngeal swabs or nasal/
nasopharyngeal aspirate
quantitative value nor the rate of increase in influenza virus
type A and B concentration can be determined with this
qualitative test.
 The NADAL® Influenza A/B Test only detects the presence of
viable and non-viable influenza virus type A and/or B strains
in specimens.
 As with all diagnostic tests, all results should be interpreted
in conjunction with other clinical information available to
the physician.
 A negative test result obtained using the NADAL® Influenza
A/B Test should be confirmed by culture. A negative test
result may be obtained if the concentration of influenza
virus type A and/or B in nasal swabs, pharyngeal swabs or
nasal/ nasopharyngeal aspirates is below the detection limit
of the test.
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® Influenza A/B Test
the
specimens. Neither the
(Ref. 241015N-10)
 Excess blood or mucus in nasal swabs, pharyngeal swabs or
nasal/nasopharyngeal aspirate specimens may interfere
with the test performance and yield a false positive result.
 The accuracy of the test depends on the quality of the
specimen. False negative results may occur due to improper
specimen collection or storage.
 The use of over-the-counter and prescription nasal sprays at
high concentrations can interfere with test results, leading
to either invalid or incorrect test results.
 A positive result for influenza virus type A and/or B does not
preclude an underlying co-infection with another pathogen;
therefore the possibility of an underlying bacterial infection
should be considered.
 The performance of the NADAL® Influenza A/B Test has not
been evaluated for monitoring antiviral treatment for
influenza.
13. Performance Characteristics
Sensitivity and specificity
The NADAL® Influenza A/B Test was evaluated using
specimens obtained from patients. RT-PCR was used as a
reference method. Specimens were considered positive or
negative if RT-PCR showed a corresponding result.
Influenza virus type A
RT-PCR
Posi-
68 14
tive
Nega-
10 242
tive
Total 78 256
Relative
87.2%
sensitivity
Relative
94.5%
specificity
Overall
92.8%
agreement
Interfering substances
100 µL of each one-percent solution of the substances listed
below were added to several swabs. Then 10 µL of a negative
control, 10 µL of a strong positive or of a weak positive
influenza A specimen, as well as 10 µL of a strong positive or
of a weak positive influenza B specimen were added
separately to these swabs. The swabs were evaluated using
the NADAL® Influenza A/B Test.
Mucosolvan® Ambroxol Hydrochloride Oral Solution, Nin Jiom
Pei Pa Koa (cough syrup), Flixonase
propionate), Dextromethorphan Hydrobromide Oral Solution,
Hyland's 4 Kids Cold'n Cough Liquid Safe Natural Relief,
Durham's Canker-Rid®,
mouthwash, haemoglobin,
ibuprofen.
None of the substances interfered with the assay at the
concentrations tested.
influenza virus type B
RT-PCR
82 49 7
252 4 274
334 53 281
92.5%
97.5%
96.7%
TM nasal spray (fluticasone
Listerine® mouthwash,
acetaminophen, Aspirin®,
56
278
334
Scope®
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