Product Manual

The performance of OSOM Ultra Flu A&B was evaluated with nasal and nasopharyngeal swab samples
obtained from patients infected with the 2009 H1N1 influenza virus consisting of sixty six (66) frozen
clinical Nasal and Nasopharyngeal samples that had previously tested positive for 2009 H1N1 by
FDA-cleared CDC RT-PCR test. The OSOM Ultra Flu A&B test detected 71% (47/66) of the CDC RT-PCR
test positive specimens. The detection rate was 91% with the higher tittered specimens and 38% with the
lower titered specimens.
Analytical Specificity
Cross-reactivity
The potential cross-reactivity of the non-influenza respiratory pathogens and other microorganisms with
which the majority of the population may be infected was tested using the OSOM Ultra Flu A & B Test at
medically relevant levels, 10
6
cfu/mL for bacteria and 10
5
pfu/mL for non-flu viruses. None of the
organisms or viruses listed in the table below gave a positive result with OSOM Ultra Flu A & B Test at the
tested concentration.
Viruses Tested
Adenovirus*
Human coronavirus**
Cytomegalovirus**
Enterovirus**
Epstein Barr Virus**
Human parainfluenza; Type 1, 2 and 3*
Measles**
Human metapneumovirus**
Mumps virus**
Respiratory syncytial virus; Type B*
Rhinovirus; Type 1A**
* In the study the virus was confirmed using FDA approved immuno-fluorecence assay
**In the study the virus was confirmed using commercially available PCR (not approved by FDA).
Bacteria Tested
Bordetella pertussis
Chlamydia pneumoniae
Corynebacterium sp.
Escherichia coli
Hemophilus influenzae
Lactobacillus sp.
Legionella spp
Moraxella catarrhalis
Mycobacterium tuberculosis avirulent
Mycoplasma pneumoniae
*Clinical isolate cultured and titered. Culture confirmed positive for 2009 H1N1 Influenza A strain using
proFLU Influenza A Subtyping.
**Although this test has been shown to detect these viral strains cultured from positive human respiratory
specimens, the performance characteristics of this device with clinical specimens that are positive for
these viruses have not been established.
Influenza
Type
Viral Strain EID
50
/ML
A A/Anhui/1/2013 (H7N9)** 7.94 x 10
6
A A/Vietnam/1194/2004(H5N1)** 1.6 x 10
6
A A/Anhui/01/2005 (H5N1)** 1.6 x 10
7