Product Manual

FOR LABORATORY AND PROFESSIONAL USE ONLY
INTENDED USE
OSOM Ultra Flu A & B Test is an in vitro rapid qualitative test that detects influenza type A and type B
nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal
aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection.
It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.
Negative test results are presumptive and it is recommended these results be confirmed by viral culture.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for
treatment or other management decisions. The test is intended for professional and laboratory use.
Performance characteristics for influenza were established during the 2007-2009 influenza seasons
when influenza A viruses A/New Caledonia/20/99(H1N1), A/Solomon Islands/3/2006(H1N1),
A/Brisbane/59/2007(H1N1), A/California/07/2009(H1N1), A/Wisconsin/67/2005(H3N2),
A/Brisbane/10/2007(H3N2) and influenza B viruses B/Ohio/01/2005, B/Florida/4/2006,
B/Brisbane/60/2008 were the predominant influenza viruses in circulation according to the
Flu Activity & Surveillance report by CDC. Performance characteristics may vary against other
emerging influenza viruses.
If infection with a novel Influenza virus is suspected based on current clinical and epidemiological
screening criteria recommended by public health authorities, specimens should be collected with
appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local
health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+
facility is available to receive and culture specimens.
SUMMARY AND EXPLANATION
Influenza is a highly contagious acute viral infection of the respiratory tract. It is a communicable disease
easily transmitted from person to person through aerosol droplets excreted when sneezing and coughing.
Common symptoms include high fever, chills, headache, cough, sore throat and malaise. The type A
influenza virus is more prevalent and is the primary pathogen associated with serious epidemics. The type
B virus causes a disease that is generally not as severe as that caused by the type A virus.
An accurate diagnosis of influenza based on clinical symptoms is difficult because the initial symptoms of
influenza are similar to those of numerous other illnesses. Therefore, it can be confirmed only by laboratory
diagnostic testing.
1
Early differential diagnosis of influenza type A or type B can allow for proper treatment
with appropriate antiviral therapy while reducing the incidence of inappropriate treatment with
antibiotics. Early diagnosis and treatment is of particular value in a clinical setting where accurate
diagnosis can assist the healthcare professional with management of influenza patients who are at risk
for complications.
2
OSOM Ultra Flu A & B is a rapid immunoassay to be used as an aid for the differential
diagnosis of influenza type A and type B.
PRINCIPLE OF PROCEDURE
OSOM Ultra Flu A & B utilizes the chemical extraction of viral antigens followed by solid-phase
immunoassay technology for the detection of extracted antigen, influenza A and/or B. In the test
procedure, a specimen is collected and placed for one minute into the Extraction Well of the test
device containing extraction solution, during which time antigen is extracted from disrupted virus
particles. The test device is then raised, tapped and laid back down onto a level surface to allow the
solution in the Extraction Well to migrate through the pads containing lyophilized detector antibodies
conjugated to gold dye and then through the test membrane. If influenza antigens are present in the
specimen, they will react with anti-influenza antibody coupled to gold dye particles, migrate through
the membrane as antigen-antibody-dye complexes, bind to the immobilized anti-influenza antibody
on the membrane, and generate a colored line in the Test line position (A and/or B). The rest of the
sample and unbound/bound dye complexes continue to migrate to the Control line position (C), where
antibody to the anti-influenza antibody is immobilized, and forms the Control line. Formation of the
Control line serves as an internal control to demonstrate that lyophilized antibodies in the dye pad have
been hydrated and that sufficient sample has been applied to allow for migration to the Test line and
beyond. If the Control line does not appear within the designated incubation time, the result is invalid
and the test should be repeated.
OSOM Ultra Flu A & B has two Test lines, one for influenza A and one for influenza B. The two Test lines
allow for the separate and differential identification of influenza A and/or B from the same specimen. If
either Test line appears in the test result window, together with the Control line, the test result is positive
for influenza.
®
CLIA Complexity: Moderate
Ultra FLU A&B Test
8. Let it stand for 1-2 seconds. Tap the device on a flat surface to ensure that the liquid flows into the hole.
7. Raise the test device upright (see picture).
9. Immediately after tapping,
slowly lay the device back down onto the flat surface.