NAL NADAL Covid-19 Ag Instrucciones De Uso página 10

ENGLISH
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 2.4 TCID /mL and was determined with a SARS-CoV-2
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.
Concen-
Substance
tration
3 OTC nasal sprays 10%
3 OTC
10%
mouthwashes
3 OTC sore throat
10%
liquids
4-acetamido-
10 mg/mL
phenol
Acetylsalicylic acid 20 mg/mL
Albuterol 20 mg/mL
Chlorpheniramine 5 mg/mL
Dexamethasone 5 mg/mL
Dextromethor-
10 mg/mL
phan
Diphenhydramine 5 mg/mL
Doxylamine
1 mg/mL
succinate
Flunisolide 3 mg/mL
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® COVID-19 Ag Test
RT-PCR, C 20-37
t
Positive Negative Total
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%
Concen-
Substance
tration
Guaiacol
20 mg/mL
glyceryl ether
Mucin 1%
Mupirocin 250 µg/mL
Oxymetazoline 10 mg/mL
Phenylephrine 10 mg/mL
Phenylpro-
20 mg/mL
panolamine
Relenza®
20 mg/mL
(zanamivir)
Rimantadine 500 ng/mL
Tamiflu®
100 mg/mL
(oseltamivir)
Tobramycin 40 mg/mL
Triamcinolone 14 mg/mL
(Ref. 243103N-20)
Cross-reactivity
Specimens spiked with the following pathogens were tested
using the NADAL® COVID-19 Ag Test:
150
HCoV-HKU1, HCoV-OC43, HCoV-NL63, HCoV-229E, measles
198
348 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. Coronavirus disease 2019 (COVID-19) in the EU/EEA and the UK – ninth update, 23
April 2020. Stockholm: ECDC; 2020.
2. Cui J, Li F, Shi ZL, Origin and evolution of pathogenic coronaviruses, Nat Rev
Microbiol 2019; 17:181-192.
3. He, X., Lau, E.H.Y., Wu, P. et al. Temporal dynamics in viral shedding and
transmissibility of COVID-19. Nat Med 26, 672–675 (2020).
4. Su S, Wong G, Shi W, et al, Epidemiology, genetic recombination, and pathogenesis
of coronaviruses, TrendsMicrobiol 2016;24:490-502.
5. Weiss SR, Leibowitz JL, Coronavirus pathogenesis, Adv Virus Res 2011; 81:85-164.
pneumoniae, Epstein-Barr
influenzae, Candida
Chlamydia pneumoniae,
Rev. 2, 2020-09-02 OM
virus,
albicans,
Streptococcus
10