Product Manual

External Quality Control
Good laboratory practice includes the use of external controls to ensure proper kit performance. It is
recommended that external control testing be performed with each new operator and before using a
new lot or shipment of OSOM Ultra Flu A & B kits to confirm the expected Q.C. results, using the external
controls provided in the kit. The frequency of additional Q.C. tests should be determined according to
your laboratory’s standard Q.C. procedures and local, State and Federal regulations or accreditation
requirements. Upon confirmation of the expected results, the kit is ready for use with patient specimens.
If external controls do not perform as expected, do not use the test results. Repeat the tests or contact
Sekisui Diagnostics Technical Service at 800-332-1042 (US Customer’s Only). The built-in reddish purple
Control line indicates only the integrity of the test device and proper fluid flow. The OSOM Ultra Flu A & B
kit contains two control swabs. Test the control swabs in the same manner as patient specimens. When
the positive control is tested, reddish purple lines appear at the C, A and B positions. When the negative
control is tested, a reddish purple line appears at the C position only. If the controls do not perform as
expected, do not report patient results.The use of positive and negative controls from other commercial
kits has not been established with OSOM Ultra Flu A & B Test.
EXPECTED VALUES
The prevalence of influenza varies every year and the rate of positives in influenza testing varies
depending on many factors, including the specimen collection method, the test method used,
the disease prevalence, and the geographic location. The prevalence observed with reference tests
(culture and PCR) during the 2007-2009 clinical study for OSOM Ultra Flu A & B was 27% for influenza A
and 11% for influenza B.
PERFORMANCE CHARACTERISTICS
Clinical Performance
A prospective clinical study was conducted from January 2007 to March 2008 and during March and
April 2009 to determine the performance of OSOM Ultra Flu A & B for aspirate, nasopharyngeal swab,
and nasal swab specimens.
The samples were collected at 5 sites in the USA from patients who visited physicians’ offices and clinics
with signs and symptoms of respiratory infection during the study period. All collected samples were
tested with OSOM Ultra Flu A & B, and were cultured. The culture was used as the reference method. The
total number of patients tested was 862, of which 30% were 5 and younger, 38% were 6-21 years old, and
the rest were older than 21. Forty eight (48) percent were male and 52% were female. In addition to the
prospective clinical study, eighty (80) positive influenza A or B frozen archived samples were tested with
OSOM Ultra Flu A & B.
The combined data from all sites of the prospective study are presented in the tables below.
The samples that produced discrepant results between OSOM Ultra Flu A & B and viral culture were
further analyzed with proFLU plus by Prodesse (real time RT-PCR, PCR hereafter). These results are
presented in the footnote below each table.
Nasopharyngeal Aspirate Sample
REFERENCE (VIRUS CULTURE) RESULTS
OSOM
Ultra Flu A & B
Flu A
Positive
Flu A
Negative
Total Performance
Flu A
Positive
41 30* 71
Sensitivity
95.3%
95% CI: 92.1-
98.5%
Flu A
Negative
2** 180 182
Specificity
85.7%
95% CI: 83.3-
88.1%
Total 43 210 253
REFERENCE (VIRUS CULTURE) RESULTS
OSOM
Ultra Flu A & B
Flu B
Positive
Flu B
Negative
Total Performance
Flu B
Positive
11 6* 17
Sensitivity
91.6%
95% CI: 83.6-
99.6%
Flu B
Negative
1** 235 236
Specificity
97. 5 %
95% CI: 96.5-
98.5%
Total 12 241 253
*Of 30 discrepant results, 22 were positive by both OSOM Ultra Flu A&B and PCR
**Of 2 discrepant results, 1 was negative by both OSOM Ultra Flu A&B and PCR
*Of 6 discrepant results, all 6 were positive by both OSOM Ultra Flu A&B and PCR
**The discrepant result was positive by PCR