Product Manual

As further verification of the PCR test results shown from the samples with discrepant results between
OSOM Utra Flu A&B and viral culture, available archived remnant samples from the clinical studies with
concordant results were also tested by PCR. The PCR was performed on 138 Flu A negative and 27 Flu
A positive samples with OSOM Ultra FLU A&B and culture, and 154 Flu B negative and 11 Flu B positive
samples with OSOM Ultra Flu A&B and Culture. The specificity for both Flu A and Flu B was 100%, while
the sensitivity for Flu A was 90% and the sensitivity for Flu B was 91.7%.
Archived Sample Test Results
Eighty (80) frozen archived samples originally obtained from influenza positive patients visiting Columbia
NY Presbyterian Hospital and confirmed as positive for either influenza A or Influenza B by viral culture
were tested wtih OSOM Ultra Flu A & B Test.
Aspirate Sample
REFERENCE (VIRUS CULTURE) RESULTS
OSOM
Ultra Flu A & B
Flu A
Positive
Flu A
Negative
Total Agreement
Flu A
Positive
50 0 50 100%
Flu A
Negative
0 30 30 100%
Total 50 30 80
REFERENCE (VIRUS CULTURE) RESULTS
OSOM
Ultra Flu A & B
Flu B
Positive
Flu B
Negative
Total Agreement
Flu B
Positive
30 0 30 100%
Flu B
Negative
0 50 50 100%
Total 30 50 80
Swab Sample
REFERENCE (VIRUS CULTURE) RESULTS
OSOM
Ultra Flu A & B
Flu A
Positive
Flu A
Negative
Total Agreement
Flu A
Positive
50 0 50 100%
Flu A
Negative
0 30 30 100%
Total 50 30 80
REFERENCE (VIRUS CULTURE) RESULTS
OSOM
Ultra Flu A & B
Flu B
Positive
Flu B
Negative
Total Agreement
Flu B
Positive
30 0 30 100%
Flu B
Negative
0 50 50 100%
Total 30 50 80
Reproducibility
The reproducibility study for OSOM Ultra Flu A & B Test was conducted at two physicians’ offices and one
laboratory using a panel of 90 coded specimens for each site. Testing was performed by two personnel
for five days at each site. The panel consists of coded samples of high negative, low positive and
moderate positive specimens for each of influenza A and B. For influenza A and B positive samples,
A/PR/8/34 (H1N1) and B/Maryland/1/59 were used. The low positive was the LOD level of each strain.
Each specimen level was tested in triplicate every day per operator. Each operator conducted the tests
The tables below present test results with archived samples.