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Interfering substances
Solutions of the following potentially interfering substances
were tested in 3 test series (without anti-SARS-CoV-2
antibodies, spiked with anti-SARS-CoV-2 IgM and spiked with
anti-SARS-CoV-2 IgG) and showed no interference with the
NADAL® COVID-19 IgG/IgM Test at the concentrations listed
below.
Acetylsalicylic acid
Albumin
Amoxicillin
Ascorbic acid
Bilirubin
Caffeine
EDTA
Ethanol
Ethambutol
Fluconazole
Haemoglobin
Heparin
Ibuprofen
Isoniazid
Loratadin
Nadolol
Naproxen
Paroxetine
Potassium oxalate
Quinine
Rifampicin
Sodium citrate
Triglycerides
Cross-reactivity
ANA, anti-HSV-1 IgM, HAMA, anti-chikungunya virus, anti-HSV-
2 IgM, anti-HBsAg, anti-Chlamydia trachomatis, anti-rubella
virus IgM, Lyme
borreliosis, anti-CMV IgM, syphilis,
P. falciparum, anti-dengue virus, tuberculosis, P. vivax, anti-
HAV IgM, yellow fever, RF (high titre), anti-HCV, anti-Zika
virus, toxoplasmosis, anti-HEV IgM, Chagas disease, typhoid
fever, anti-HIV and anti-EBV IgG positive specimens were
tested using the NADAL® COVID-19 IgG/IgM Test. No cross-
reactivity with the specimens was observed when tested using
the NADAL® COVID-19 IgG/IgM Test.
Precision
Repeatability
Repeatability was established by testing 10 replicates of
negative, anti-SARS-CoV-2 IgM strong and weak positive as
well as anti-SARS-CoV-2 IgG strong and weak positive plasma
specimens.
Reproducibility
Reproducibility was established by testing 3 replicates of
negative, anti-SARS-CoV-2 IgM strong and weak positive as
well as anti-SARS-CoV-2 IgG strong and weak positive plasma
specimens with each of 3 independent lots of the NADAL®
COVID-19 IgG/IgM Test.
The NADAL® COVID-19 IgG/IgM Test demonstrated acceptable
repeatability and reproducibility. The negative and positive
values were correctly identified >99% of the time.
15. References
1. World Health Organization (WHO), WHO Statement Regarding Cluster of
Pneumonia Cases in Wuhan, China, Beijing: WHO; 9 Jan 2020,
2. World Health Organization (WHO), Report of the WHO-China Joint Mission on
Coronavirus Disease 2019 (COVID-19), WHO; 28 Feb 2020
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
3.62 mmol/L
50,000 mg/L
206 µmol/L
342 µmol/L
50 mg/L
308 µmol/L
3.4 µmol/L
86.8 mmol/L
58.7 µmol/L
245 µmol/L
200,000 mg/L
3000 U/L
2425 µmol/L
292 µmol/L
0.78 µmol/L
3.88 µmol/L
2170 µmol/L
3.04 µmol/L
2 mg/mL
148 µmol/L
78.1 µmol/L
5 mg/mL
5000 mg/L
(Ref. 243003N-25)
3. Weiss SR, Leibowitz JL, Coronavirus pathogenesis, Adv Virus Res 2011;81:85-164,
4. Cui J, Li F, Shi ZL, Origin and evolution of pathogenic coronaviruses, Nat Rev
Microbiol 2019; 17:181-192,
5. Su S, Wong G, Shi W, et al, Epidemiology, genetic recombination, and pathogenesis
of coronaviruses, TrendsMicrobiol 2016;24:490-502,
Rev. 0, 2020-03-18 OM
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