NAL NADAL Covid-19 Ag Instrucciones De Uso página 9

ENGLISH
10. Start the timer.
11. Wait for the coloured line(s) to
appear. Read the test result after
exactly 15 minutes. Do not interpret
the result after more than 15
minutes.
Result Interpretation
Positive:
Two coloured lines appear in the
result area. One line appears in the
control line region (C) and the other
line appears in the test line region
(T).
Note: The colour intensity in the test line region (T) may vary
depending on the concentration of SARS-CoV-2 viral
nucleoprotein antigens in the specimen. Any shade of colour
in the test line region (T) should be considered a positive
result. Note that this is a qualitative test only and it cannot
determine the analyte concentration in the specimen.
Negative:
Only one coloured line appears in
the control line region (C). No
coloured line appears in the test line
region (T).
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 cassette. 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 control line
failure.
Quality Control
An internal procedural control is included in the test cassette:
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.
Limitations
 The NADAL® COVID-19 Ag Test is for professional
in-vitro diagnostic use only. It should be used for the
qualitative detection of SARS-CoV-2 viral nucleoprotein
antigens in human nasopharyngeal and oropharyngeal
specimens only. Neither the quantitative value nor the rate
of increase/decrease in the concentration of SARS-CoV-2
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® COVID-19 Ag Test
the
(Ref. 243103N-20)
viral nucleoprotein antigens can be determined with this
qualitative test.
 The NADAL® COVID-19 Ag Test only detects the presence of
SARS-CoV-2 viral nucleoprotein antigens in specimens and
should not be used as the sole criterion for a diagnosis of
COVID-19.
 Both viable and non-viable SARS-CoV-2 viruses can be
detected using the NADAL® COVID-19 Ag Test.
 The sections 'Specimen Collection and Preparation' as well
as 'Test Procedure' must be followed closely while testing.
Failure to follow them may lead to inaccurate test results
because the antigen concentration in the swab is highly
dependent on the correct procedure.
 As with all diagnostic tests, all results should be interpreted
in conjunction with other clinical information available to
the physician.
 In the course of SARS-CoV-2 infection, the concentration of
viral nucleoprotein antigens may fall below the detection
limit of the test.
 If the test result is negative and clinical symptoms persist,
additional testing using
recommended. A negative result does not at any time
preclude the possibility of a SARS-CoV-2 infection and
should be confirmed via molecular assay.
Expected Values
SARS-CoV-2 viral particles are normally present in the
respiratory tracts of COVID-19 patients. A positive test result
can indicate an acute infection. Virus concentrations in
nasopharyngeal and oropharyngeal swab specimens may vary
in the course of the disease and might fall below the detection
limit of rapid tests, even though patients are still showing
symptoms. Conversely, the virus might continue be detectable
over long periods of time even in convalescent patients.
Possible infectiousness of test subjects cannot be ruled out
based on negative test results.
Performance Characteristics
Clinical performance
Diagnostic sensitivity and specificity
The NADAL® COVID-19 Ag Test was evaluated with clinical
specimens whose status was confirmed using RT-PCR
(C range positive: 20-37). The sensitivity was calculated for
t
the range from high to medium viral load (C
high to very low viral load (C
in the following tables.
NADAL®
Positive
COVID-19 Ag
Negative
Test
Total
Diagnostic sensitivity (C 20-30):
t
Overall agreement (C 20-30):
t
Diagnostic specificity:
*95% confidence interval
other clinical methods
20-30) and from
t
20-37). The results are presented
t
RT-PCR, C 20-30
t
Positive Negative
120 0
3 161
123 161
97.6% (93.1% - 99.2%)*
98.9% (96.9% - 99.6%)*
>99.9% (97.7% - 100%)*
is
Total
120
164
284
9