FLU OIA is the first clinical test capable of scientifically confirming in 15 minutes that a person is infected with an influenza virus. It allows doctors to identify patients likely to benefit from neuraminidase inhibitor drugs, which are effective against all strains of flu if taken within 48 hours of the first symptoms. Used together with neuraminidase inhibitor drugs, FLU OIA will form the first line of defence against the next influenza pandemic when it strikes. Appropriate vaccine will not be available for about six months after the pandemic strain emerges, so FLU OIA will be of enormous significance to humanity in the battle against influenza. It will play a key role in disease management in that accurate diagnosis allows appropriate treatment and limitation of spread of the disease throughout the community.

FLU OIA was co-developed by Biota, the same Australian company that developed Relenza, the first neuraminidase inhibitor drug. The company is a world leader in anti-viral research. Both FLU OIA and neuraminidase drugs like Relenza have enormous scientific and social significance. Used together, they can identify, treat and help contain the spread of influenza, a disease capable of killing millions of people in a matter of months.

The FLU OIA - Influenza diagnostic test kit was developed jointly by Biota Holdings and the US company, Thermo Electron. It was launched in the USA in December 1998.

This kit was produced in the USA by Thermo Electron Corporation. In the USA it is manufactured and marketed by Thermo Electron. Biota holds the marketing and distribution rights outside the USA and its major distributors are Daiichi Pure Chemical Co., Ltd in Japan and Dade Behring in Australia.

The FLU OIA - Influenza diagnostic test kit was developed jointly by Biota Holdings and the US company, Thermo Electron. It was launched in the USA in December 1998.

Diagnostic test kit, 'FLU OIA', optical immunoassay for the detection of influenza A and B, paper / plastic / cardboard / liquid reagents / monoclonal antibodies / calf serum, developed and made by Biota, Melbourne, Victoria, Australia / Thermo Electron Corporation, Louisville, Colorado, United States of America, 2004

The FLU OIA is a kit containing immobilised antibodies that capture specific antigens (proteins) of the influenza virus. If the antigens are present a coloured reaction occurs. The kit is presented in a cardboard box with pictorial directions for use built into the sleeve of the box. The kit contains: Reagent 1 - Buffer solution containing surfactant and reducing agent; Reagent 2 - Buffer solution containing surfactant and stabilising proteins; Wash - Phosphate buffer solution containing surfactant; Substrate - Tetramethylbenzidine and hydrogen peroxide solution; Positive control - Formaldehyde-inactivated influenza A virus (AHong Kong/68 H3N2) suspension in a buffered protein solution; Negative control - Buffered saline solution; Test devices - Coated with a mixture of anti-influenza A and B antibodies (mouse); 30 plastic extraction tubes; 30 plastic transfer pipettes; 30 rayon-tipped swabs on plastic shafts; 1 clear plastic stand designed to hold reagents and extraction tubes during a test

Designed: Biota Holdings; Notting Hill, Victoria; 1998

Made: Thermo Electron Corporation; Ohio, USA; 2004

The top of the box is multicoloured and carries a picture of a woman grimacing as if she has the flu. The following words appear:
On the top: FLU OIA a BioStar product. biota Thermo ELECTRON CORPORATION
On side 1: FLU OIA Optical ImmunoAssay for the Detection of Influenza A and B. For In Vitro diagnostic use.
Point of Care & Rapid Diagnostics EC REP
331 South 104th Street Thermo Clinical Labsystems Oy
Louisville, CO 80027 USA Ratastie 2, PO Box 100, FIN-01621
303-530-3888 Vantaa, Finland
www.thermo.com/biostar +358-9-802766
IVD CE REF FLU30 biota Thermo ELECTRON CORPORATION

On side 2: All of the contents are listed along with information in 4 languages: French, German, Spanish and Italian

2005/162/1

1998

300 mm

225 mm

220 mm