BD Veritor System Handbuch Seite 90

Analytical Studies
Analytical Sensitivity (Limit of Detection)
The limit of detection (LOD) for the BD Veritor System for Rapid Detection of RSV test was established for the following RSV
strains. The LOD for each strain represents the lowest concentration producing a positivity rate of ≥95% based on testing
60 to 80 replicates.
RSV Viral Strain
VR-26 (Long subgroup A)
VR-955 (9320 subgroup B)
VR-1540 (A-2)
VR-1580 (Washington subgroup B)
VR-1400 (Wild Type subgroup B)
TCID /mL = 50% Tissue Culture Infectious Dose
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Analytical Specificity (Cross Reactivity)
The BD Veritor System for Rapid Detection of RSV test was evaluated with bacteria and yeast at a target concentration
of approximately 5 x 10
6
10 4 TCID /mL or greater. Of the microorganisms tested, none showed cross-reactivity in the RSV test.
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Bacteroides fragilis
Bordetella pertussis
Candida albicans
Chlamydia pneumoniae
Corynebacterium diphtherium
Escherichia coli
Fusobacterium nucleatum
Haemophilus influenzae
Haemophilus parainfluenzae
Kingella kingae
Klebsiella pneumoniae
Lactobacillus sp.
Legionella sp.
Moraxella catarrhalis
Mycobacterium tuberculosis
Mycoplasma pneumoniae
Neisseria gonorrhoeae
Neisseria meningitidis
CFU/mL (CFU – Colony Forming Units). The viruses were evaluated at concentrations of
Neisseria mucosa
Neisseria sp. (Neisseria perflaus)
Neisseria subflava
Peptostreptococcus anaerobius
Porphyromonas asaccharolyticus
Prevotella oralis
Propionibacterium acnes
Proteus mirabilis
Pseudomonas aeruginosa
Serratia marcescens
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus mutans
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus sp. Group C
Streptococcus sp. Group G
Streptococcus salivarius
Calculated LOD No. Positive /
(TCID /mL)
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1.43 x 10 5
3.98 x 10 4
1.94 x 10 3
1.08 x 10 4
2.96 x 10
3
12
% Positive
Total
57/60 95.0
57/60 95.0
59/60 98.3
58/60 96.7
76/80 95.0
Veillonella parvula
Adenovirus, Type 1
Adenovirus, Type 7
Cytomegalovirus
Enterovirus
HSV Type 1
Human Coronavirus OC43
Human metapneumovirus (hMPV-27 A2)
Human Parainfluenza
Influenza A/California/7/2009 H1N1
Influenza A/Brisbane/10/2007 H3N2
Influenza A/Victoria/3/75 H3N2
Influenza B/Brisbane/60/2008
Influenza B/Florida/4/2006
Influenza B/Lee/40
Measles virus
Mumps virus
Rhinovirus