NAL NADAL Influenza A Test Instructions D'utilisation page 9

ENGLISH
Cross-reactivity
Specimens spiked with the following pathogens were tested
using the NADAL® Influenza A/B Test:
Viruses
Adenovirus, coxsackievirus, cytomegalovirus, parainfluenza
virus type 1, 2, 3, 4a, enterovirus, mumps virus, respiratory
syncytial virus, rhinovirus.
Bacteria
Bordetella pertussis, Haemophilus parainfluenzae, Staphylo-
coccus aureus, Streptocococcus
meningitides, Streptococcus sp. group A, B, C.
No cross-reactivity was observed with the aforementioned
pathogens when tested using the NADAL® Influenza A/B Test.
Analytical reactivity with human influenza strains
The human influenza strains listed below were serially diluted
to strong and weak positive concentrations. Swabs were
spiked with 10 μL of each dilution, tested in triplicates using
the NADAL® Influenza A/B Test and demonstrated a positive
reaction.
Influenza strains
Influenza virus type A
H1N1 A/NWS/33
H1N1 A/WS/33
H1N1 A/New Jersey/8/76
H1N1 A/Mal/302/54
H3N2 A/Aichi/2/68
H3N2 A/Hong Kong/8/68
H3N2 A/Port Chalmers/1/73
Precision
Repeatability and reproducibility
Precision was established by testing 5 replicates of negative,
influenza A as well as influenza B strong and weak positive
specimens. Repeatability
reproducibility study. Testing was performed using 3
independent NADAL® Influenza A/B test lots on 3 separate
days.
The NADAL® Influenza A/B Test demonstrated acceptable
repeatability and reproducibility. The negative and positive
values were correctly identified >99% of the time.
14. References
1. Murphy, B.R., and R.G. Webster, 1996, Orthomyxoviruses, pp.1397-1445. In: Fields,
Virology, 3rd edition, B.N. Fields, D.M. Knipe, P.M. Howley, et al. (eds.), Lippincott-
Raven, Philadelphia.
2. Biosafety in Microbiological and Biomedical Laboratories, 4th Edition. U.S.
Department of Health and Human Services, CDC, NIH, Washington, DC (1999).
3. CDC website: http://www.cdc.gov/flu/
4. Anne Moscona. Neuraminidase Inhibitors for Influenza, 2005. The New England
Journal of Medicine, 353 (13):1363-1373.
5. https://www.rki.de/DE/Content/Infekt/EpidBull/Merkblaetter/Ratgeber_Influenza
_saisonal.html
6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4848591/
nal von minden GmbH • Carl-Zeiss-Strasse 12 • 47445 Moers • Germany • info@nal-vonminden.com • www.nal-vonminden.com
NADAL® Influenza A/B Test
agalactiae, Neisseria
Influenza virus type B
B/Russia/69
B/Hong Kong/5/72
B/Lee/40
B/Brigit
B/B/R5
B/Wisconsin/1/2010 (Yamagata
lineage)
B/Florida/78/2015 (Victoria
lineage)
was established within
Rev. 0, 2019-07-26 OM/SDe
(Ref. 241015N-10)
the
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