nal von minden NADAL Instrucciones De Uso página 9

ENGLISH
cassette with the patient or control
identification.
8. Place the test cassette on a clean and
level surface.
9. Attach a dropper cap to the extraction
tube, invert the tube and transfer 3
drops (approximately 60 μL) of the
extracted solution to the specimen
well (S) of the test cassette.
10. Start the timer.
11. Wait for the coloured line(s) to appear.
Read the test result after 15 minutes.
Do not interpret the result after more
than 20 minutes.
10. 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 the
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.
11. 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.
12. Limitations
• The NADAL® COVID-19 Ag plus 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 nasal, nasopharyngeal or oropharyngeal
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
(Ref. 243104N-20)
specimens only. Neither the quantitative value nor the rate
of increase/decrease in the concentration of SARS-CoV-2
viral nucleoprotein antigens can be determined with this
qualitative test.
• The NADAL® COVID-19 Ag plus 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 plus 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.
• Positive and negative predictive values are highly dependent
on prevalence. The local prevalence should be taken into
consideration when interpreting diagnostic test results.
• Positive results do not preclude co-infections with other
pathogens (e.g. influenza virus A/B).
• The test does not differentiate between SARS-CoV and
SARS-CoV-2.
13. 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 nasal,
nasopharyngeal or 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.
14. Performance Characteristics
Clinical performance
Diagnostic sensitivity and specificity
The NADAL® COVID-19 Ag plus Test was evaluated with clinical
nasal swab specimens whose status was confirmed using RT-
PCR.
The results are presented in the following tables.
NADAL®
Positive
COVID-19 Ag
Negative
plus Test
Total
Diagnostic sensitivity:
other clinical methods
RT-PCR
Positive Negative Total
167 0 167
5 431 436
172 431 603
97.09% (93.38% - 98.75%)*
is
9