nal von minden COVID-19 Ag Test Instructions D'utilisation page 10

ENGLISH
Performance Characteristics
Clinical performance (specimens extracted in buffer without
VTM)
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
NADAL®
Positive
COVID-19 Ag
Negative
Test
Total
Diagnostic sensitivity (C 20-37):
t
Overall agreement (C 20-37):
t
Diagnostic specificity:
*95% confidence interval
In order to show the strong dependence of the diagnostic
sensitivity on the viral load, the following table demonstrates
the sensitivity for different C
PCR:
C range
t
20 – 25
20 – 30
20 – 32
20 – 35
20 – 37
Please note that C values may vary between different PCR
t
systems at the same virus concentration.
Detection limit
The detection limit of the NADAL® COVID-19 Ag Test is
2 x 10 TCID /mL and was determined with a SARS-CoV-2
2.4
50
control with a known virus titre.
The detection limit of the NADAL® COVID-19 Ag Test
is 0.4 ng/mL for recombinant SARS-CoV-2 nucleoprotein.
Interfering substances
The following substances, normally present in respiratory
specimens or artificially introduced into the respiratory tract,
were evaluated at the concentrations listed below and
showed no interference with the NADAL® COVID-19 Ag Test.
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® COVID-19 Ag Test
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%)*
RT-PCR, C 20-37
t
Positive Negative
150 0
37 161
187 161
80.2% (73.9% - 85.3%)*
89.4% (85.7% - 92.2%)*
>99.9% (97.7% - 100%)*
value ranges of the reference
t
Sensitivity
97.12%
97.56%
96.21%
85.71%
80.21%
(Ref. 243103N-20)
Substance
3 OTC nasal sprays
3 OTC
mouthwashes
3 OTC sore throat
liquids
4-acetamido-
phenol
Acetylsalicylic acid
Total
Albuterol
120
164
Chlorpheniramine
284
Dexamethasone
Dextromethor-
phan
Diphenhydramine
Doxylamine
succinate
Total
Flunisolide
150
Cross-reactivity
198
Specimens spiked with the following pathogens were tested
348
using the NADAL® COVID-19 Ag Test:
HCoV-HKU1, HCoV-OC43, HCoV-NL63, HCoV-229E, measles
virus, Streptococcus
Bordetella parapertussis, influenza A (H1N1) pdm09, influenza
A (H3N2), influenza A (H5N1), influenza A (H7N9), influenza A
(H7N7), influenza B Victoria lineage, Influenza B Yamagata
lineage, Haemophilus
Mycobacterium tuberculosis, respiratory syncytial virus,
adenovirus, parainfluenza virus type 1, 2, 3, human
metapneumovirus, rhinovirus, coxsackievirus type A16,
norovirus, mumps virus, Legionella pneumophila, Mycoplasma
pneumoniae,
pyogenes, Streptococcus agalactiae, Streptococcus group C,
Staphylococcus aureus.
No cross-reactivity with the specimens was observed when
tested using the NADAL® COVID-19 Ag Test.
Precision
Repeatability and reproducibility
Precision was established by testing 10 replicates of negative,
low positive and high positive controls.
Reproducibility was established by testing triplicates of
negative, low and high positive controls. Testing was
performed by 3 operators using 3 independent NADAL®
COVID-19 Ag test lots at 3 different sites on 5 separate days.
The NADAL® COVID-19 Ag Test demonstrated acceptable
repeatability and reproducibility. The negative and positive
values were correctly identified >99% of the time.
References
1. Cui J, Li F, Shi ZL, Origin and evolution of pathogenic coronaviruses, Nat Rev
Microbiol 2019; 17:181-192.
2. Su S, Wong G, Shi W, et al, Epidemiology, genetic recombination, and pathogenesis
of coronaviruses, TrendsMicrobiol 2016;24:490-502.
3. Weiss SR, Leibowitz JL, Coronavirus pathogenesis, Adv Virus Res 2011; 81:85-164.
Concen-
Substance
tration
Guaiacol
10%
glyceryl ether
10% Mucin
10% Mupirocin
10 mg/mL Oxymetazoline
20 mg/mL Phenylephrine
Phenylpro-
20 mg/mL
panolamine
Relenza®
5 mg/mL
(zanamivir)
5 mg/mL Rimantadine
Tamiflu®
10 mg/mL
(oseltamivir)
5 mg/mL Tobramycin
1 mg/mL Triamcinolone
3 mg/mL
pneumoniae, Epstein-Barr
influenzae, Candida
Chlamydia pneumoniae,
Rev. 1, 2020-11-20 OM
Concen-
tration
20 mg/mL
1%
250 µg/mL
10 mg/mL
10 mg/mL
20 mg/mL
20 mg/mL
500 ng/mL
100 mg/mL
40 mg/mL
14 mg/mL
virus,
albicans,
Streptococcus
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