Product Manual

REAGENTS AND MATERIALS PROVIDED
Each OSOM Ultra Flu A & B Test kit contains enough reagents and materials for 25 tests. The following
components are included in a kit.
• 25 OSOM Ultra Flu A & B Test devices: The test strip in each device contains mouse monoclonal
antibodies to nucleoprotein (NP) of influenza A and influenza B. The device is individually pouched.
• 25 Extraction Reagent in capsules: For use with swab samples, 300 μL of Phosphate buffer with
detergents and preservative.
• 25 Sterile Swabs: For swab samples
• 1 Positive Control Swab: Influenza A and B antigens (non-infective recombinant nucleoprotein)
• 1 Negative Control Swab: Inactivated Group B Streptococcus antigen (non-infective)
• 1 Package Insert /Instructions for use
• 1 Procedure Card
NOTE: Two extra test sticks and extraction reagents have been included in the kit for external
QC testing.
MATERIALS REQUIRED, BUT NOT PROVIDED
For Aspirate Samples only (available separately; Catalog No. : 1007)
• Extraction Reagent in a bottle (5 mL): Phosphate buffer with detergents and 0.09% sodium azide
• 50 Disposable Transfer Pipettes: Buffer and sample transfer
For All Sample types:
• Timer
• Latex gloves
PRECAUTIONS/WARNINGS
• For in vitro diagnostic use only.
• Do not use after the expiration date.
• Use only the swabs provided for collecting swab samples. Other swabs may not work properly.
• Two forms of Extraction Reagent are provided. Use Extraction Reagent in capsules to test swab
samples, and Extraction Reagent in a bottle to test nasopharyngeal wash/aspirate samples.
• Do not smoke, eat or drink in areas in which specimens or kit reagents are handled.
• Extraction Reagent is slightly caustic. Avoid contact with eyes, sensitive mucous membranes, cuts,
abrasions, etc. If the reagent comes in contact with skin or eyes, flush with a large volume of water.
• Wear disposable gloves while handling kit reagents or specimens and thoroughly wash hands
afterwards.
• All specimens should be handled as if they are capable of transmitting disease. Observe established
precautions against microbiological hazards throughout all procedures and follow the standard
procedures for proper disposal of specimens and test devices.
• The OSOM Ultra Flu A & B Test device should remain in its original sealed pouch until ready for use.
Do not use the test if the seal is broken or the pouch is damaged.
• 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 emerge, performance
characteristics may vary.
• If infection with a novel influenza A virus is suspected based on current clinical and
epidemiological screening criteria recommended by public health authorities, specimen should be
collected with appropriate infection control precautions for novel virulent influenza viruses and sent
to state or local health departments for testing. Viral culture should not be attempted in these cases
unless a BSL 3+ facility is available to receive and culture specimens.
STORAGE AND STABILITY
The OSOM Ultra Flu A & B Test may be stored at 2–30°C (35–86°F) in the original sealed pouch, away
from direct sunlight. Kit contents are stable until the expiration date printed on the pouch or box.
SPECIMEN COLLECTION AND PREPARATION
• Inadequate or inappropriate specimen collection, storage, and transport are likely to yield false
negative test results. Training in specimen collection is highly recommended because of the
importance of specimen quality.
• To collect nasopharyngeal or nasal swab specimens, the swab provided in the OSOM Ultra Flu A & B
Test kit should only be used.
• Using 2.5 mL of sterile saline solution is recommended to collect wash/aspirate specimens. Use fresh
samples for best performance. Freshly collected specimens should be tested immediately.
• Use fresh samples if necessary, aspirate specimens may be stored for up to 8 hrs at room temperature
or up to 24 hrs at 2–8°C, and swab samples for up to 4 hrs at room temperature or up to 8 hrs at 2–8°C.
Aspirate samples can be frozen for up to 7 days.