1 (US Patent No. US D560281 (S1); US D5601344 (S1); US ...

9. Failure to bring specimens and reagents to room temperature (20-25 C) before testing may decrease assay sensitivity.
10. Influenza virus antigens are relatively unstable. Care should be taken to store samples as indicated in this document.
11. Performance characteristics for influenza A were established when influenza A/H3 and A/H1 were the predominant
influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
12. If infection with a novel influenza A 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 public health departments for testing. Viral
culture should not be attempted in these cases unless a Biosafety Level 3+ facility is available to receive and
culture specimens. Some patient specimens contain infectious agents other than influenza virus; therefore all patient
specimens should be handled and disposed of as if they are biologically hazardous.
13. Meridian’s Flu/RSV Positive Control (sold as an adjunct reagent) contains inactivated influenza A, influenza B and RSV
viruses and should be handled as if it were potentially infectious. This reagent contains 0.094% sodium azide. Sodium
azide is a skin irritant. Avoid skin contact. Disposal of reagents containing sodium azide into drains consisting of lead
or copper plumbing can result in the formation of explosive metal oxides. Eliminate build-up of oxides by flushing
drains with large volumes of water during disposal.
14. Swab samples can be transported in 0.5 mL to 3.0 mL of an approved transport media. Stronger positive reactions
may be obtained if the transport media volume is 0.5 mL to 1.5 mL.
15. Sample Diluent must be added to the Conjugate Tube within one minute after removing the cap from the tube.
PROCEDURAL NOTES
The transfer pipette is diagrammed below:
The TRU FLU Test Strip and Conjugate Tube are diagrammed below.
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