nal von minden NADAL COVID-19 IgG Instructions D'utilisation page 8

ENGLISH
Note: The colour intensity in the test line region 'IgG' and
'IgM' may vary depending on the concentration of anti-SARS-
CoV-2 antibodies in the specimen. Therefore, any shade of
colour in the test line region 'IgG' or 'IgM' should be
considered positive. Note that this is a qualitative test only
and it cannot determine the analyte concentration in the
specimen.
Negative
The blue line in the control line
region 'C' turns red.No lines develop
in the test line region 'IgM' and 'IgG'.
Invalid
Results from any test where the blue
line in the control line region 'C'
remains completely or partially blue
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.
11. Quality Control
An internal procedural control is included in the test cassette:
The line turning from blue to red 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 IgG/IgM Test is for professional
in-vitro diagnostic use only. It should be used for the
qualitative detection of anti-SARS-CoV-2 antibodies in
human whole blood, serum or plasma specimens only.
Neither the quantitative value nor the rate of increase in
the concentration of anti-SARS-CoV-2 antibodies can be
determined with this qualitative test.
 The NADAL® COVID-19 IgG/IgM Test only detects the
presence of anti-SARS-CoV-2 antibodies in specimens and
should not be used as the sole criterion for a diagnosis of
COVID-19.
 As with all diagnostic tests, all results should be interpreted
in conjunction with other clinical information available to
the physician.
 At the beginning of the disease, the concentration of anti-
SARS-CoV-2 IgM may be below the detection limit of the
test.
 The continued presence or absence of antibodies cannot be
used to determine the success or failure of therapy.
 Results from immunosuppressed patients should be
interpreted with caution.
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
the
(Ref. 243003N-25)
 A positive test result can also occur in case of negative PCR
results because antibodies are still present in the blood
after the illness and can be detected.
 If the test result is negative and clinical symptoms persist,
additional testing using other clinical methods
recommended. A negative result does not at any time
preclude the possibility of a SARS-CoV-2 infection.
 A high-dose hook effect may occur where the colour
intensity of test lines decreases as the concentration of
anti-SARS-CoV-2 IgM/IgG increases. If a high-dose hook
effect is suspected, the dilution of specimens may increase
the colour intensity of test lines.
13. Expected Values
SARS-COV-2 infection is characterised by the presence of
detectable IgM 3-7 days after the onset of the first symptoms.
Later in the course of infection, IgG may also be detected.
Persistent IgG levels in specimens after SARS-COV-2 infections
may cause positive test results even if the pathogen can no
longer be detected by PCR.
14. Performance Characteristics
Clinical performance
Diagnostic sensitivity and specificity
The NADAL® COVID-19 IgG/IgM Test was evaluated using
clinical specimens from patients with symptoms of pneumonia
or respiratory infections in comparison with a PCR.
NADAL®
Positive
COVID-19
IgG/IgM Test
Negative
(IgM)
Total
Diagnostic sensitivity: 93.7% (86.0% - 97.3%)*
Diagnostic specificity: 99.1% (96.8% - 99.8%)*
Overall agreement: 97.7% (95.4% - 98.9%)*
*95% confidence interval
The NADAL® COVID-19 IgG/IgM Test was evaluated using
clinical specimens from convalescent patients in comparison
with a PCR.
NADAL®
Positive
COVID-19
IgG/IgM Test
Negative
(IgG)
Total
Diagnostic sensitivity: 98.8% (93.5% - 99.8%)*
Diagnostic specificity: 98.7% (96.2% - 99.5%)*
Overall agreement: 98.7% (96.7% - 99.5%)*
*95% confidence interval
Analytical performance
Detection limit
The detection limit of the NADAL® COVID-19 IgG/IgM Test is
3.4 ng/mL for anti-SARS-CoV-2 IgG and 210 ng/mL for anti-
SARS-CoV-2 IgM.
PCR
Positive Negative Total
74 2 76
5 225 230
79 227 306
PCR
Positive Negative Total
82 3 85
1 224 225
83 227 310
is
8