nal von minden NADAL Instrucciones De Uso página 10

ENGLISH
Diagnostic specificity:
Overall agreement:
*95% confidence interval
Detection limit
The 95% detection limit of the NADAL® COVID-19 Ag plus Test
is 75.5 TCID /mL and was determined via dilution of
50
inactivated SARS-CoV-2 virus.
Measuring range
No prozone effect was observed when testing inactivated
SARS-CoV-2 viruses with
1.51 x 10 TCID /mL.
6
50
Interfering substances
The following substances, normally present in respiratory
specimens or artificially introduced into the respiratory tract,
were evaluated at the concentrations listed below. All
substances were mixed with a 1/20000 SARS-CoV-2 virus
dilution (1.51 x 10 TCID
6
50
with the NADAL® COVID-19 Ag plus Test.
Substance
Zanamivir
Oseltamivir
Artemether/Lumefantrine
Doxycycline hyclate
Quinine
Lamivudine
Ribavirin
Daclatasvir
Mucin from bovine submaxillary glands, type
I-S
EDTA-anticoagulated human blood
Biotin
Neosynephrin® (phenylephrine)
Afrin® Nasal Spray (oxymetazoline)
Saline nasal spray
homeopathic Zicam® Allergy Relief Nasal Gel
Sodium cromoglycate
Olopatadine hydrochloride
Paracetamol
Acetylsalicylic acid
Ibuprofen
Mupirocin
Tobramycin
Erythromycin
Ciprofloxacin
Cross-reactivity
Specimens spiked with the following pathogens were tested
using the NADAL® COVID-19 Ag plus Test:
Pathogen
Influenza A H1N1 virus
Influenza A H3N2 virus
Influenza A H5N1 virus
Influenza A H7N9 virus
Influenza B
Adenovirus type 1
Adenovirus type 2
Adenovirus type 3
Adenovirus type 5
Adenovirus type 7
Adenovirus type 55
Respiratory syncytial virus type A/B
Human coronavirus 229E
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
>99.99% (99.12% - 100%)*
99.17% (98.07% - 99.65%)*
concentrations of
/mL) and showed no interference
Concentration
5 mg/mL
10 mg/mL
50 μM
70 μM
150 μM
1 mg/mL
1 mg/mL
1 mg/mL
100 μg/mL
5% (v/v)
100 μg/mL
10% (v/v)
10% (v/v)
10% (v/v)
5% (v/v)
20 mg/mL
10 mg/mL
199 μM
3.62 mM
2.425 mM
10 mg/mL
5 μg/mL
81.6 μM
30.2 μM
Concentration
5
6×10 TCID
5
9×10 TCID
4
8×10 TCID
4
9×10 TCID
5
3×10 TCID
5
3×10 TCID
5
2×10 TCID
6
1×10 TCID
5
4×10 TCID
6
1×10 TCID
5
4×10 TCID
5
3×10 TCID
4
3×10 TCID
(Ref. 243104N-20)
Human coronavirus OC43
Human coronavirus NL63
Human coronavirus HKU1
MERS-Coronavirus Florida/USA-2/Saudi
Parainfluenza virus type 1/2/3/4
Legionella pneumophila Bloomington-2
Legionella pneumophila 82A3105
Mycobacterium tuberculosis K
up to
Mycobacterium tuberculosis Erdman
Mycobacterium tuberculosis HN878
Mycobacterium tuberculosis CDC1551
Mycobacterium tuberculosis H37Rv
Streptococcus pneumoniae 475298
[Maryland (D1) 6B-17]
Streptococcus pneumoniae 178 [Poland
Streptococcus pneumoniae 262 [CIP
Streptococcus pneumoniae Slovakia 14-
Streptococcus pyogenes T1
Mycoplasma pneumoniae mutant 22
Mycoplasma pneumoniae FH strain of
Mycoplasma pneumoniae M129-B7
No cross-reactivity with the specimens was observed when
tested using the NADAL® COVID-19 Ag plus Test. SARS-CoV
positive specimens (Urbani strain, 1 x 10
reactivity with the NADAL® COVID-19 Ag plus Test.
Precision
Repeatability and reproducibility
Precision was established by testing 20 replicates of negative,
low positive, medium positive and high positive controls.
Repeatability was established within the reproducibility study.
Testing was performed by 5 operators using 3 independent
NADAL® COVID-19 Ag plus test lots at 2 different sites on 3
separate days.
The NADAL® COVID-19 Ag plus Test demonstrated acceptable
repeatability and reproducibility. The negative and positive
values were correctly identified >99% of the time.
15. 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.
/mL
50
/mL
50
/mL
50
/mL
50
/mL
50
/mL
50
/mL
50
/mL
50
/mL
50
/mL
50
/mL
50
/mL
50
/mL
50
Pathogen
Arabia.2014
Rhinovirus type A16
23F-16]
104340]
10 [29055]
Eaton Agent
Concentration
5
1×10 TCID /mL
50
4
1×10 TCID /mL
50
3
1×10 ng/mL
4
4×10 TCID /mL
50
5
1×10 TCID /mL
50
5
1×10 TCID /mL
50
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
5
1×10 cells/mL
PFU/mL) show cross-
6
Rev. 3, 2021-01-18 OM
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