The McKesson Consult Influenza A & B Tests are rapid qualitative tests that detect Influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens. Intended for professional and laboratory use only, these tests are for in vitro diagnostic use (Rx Only). They detect influenza type A and type B nucleoprotein antigens from patients exhibiting signs and symptoms of respiratory infection, aiding in the rapid differential diagnosis of influenza A and B viral infections.

Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infection and should not be the sole basis for treatment or other management decisions. Performance characteristics for influenza A and B were established during the 2007-2009 and 2014-2016 influenza seasons, covering influenza A/H1N1, A/H1N1 pandemic, A/H3N2, influenza B/Victoria lineage, and B/Yamagata lineage as predominant circulating viruses according to CDC reports. Performance characteristics may vary with emerging influenza viruses.

If infection with a novel influenza virus is suspected based on clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions and sent to state or local health departments for testing. Viral culture should not be attempted unless a BSL 3+ facility is available.

Materials:

Materials Provided:

Each McKesson Consult Influenza A&B Test kit contains enough reagents and materials for 25 tests. The following components are included in a kit.

• McKesson Consult Influenza A&B test devices (25): The test strip in each device contains mouse monoclonal antibodies to nucleoprotein (NP) of influenza A and influenza B. The device is individually pouched.
• Extraction Reagent in capsules (25): For use with swab samples, 300 µL of Phosphate buffer with detergents and preservative
• Sterile Swabs (25): For swab samples
• Positive Control Swab (1): Influenza A and B antigens (non-infective recombinant nucleoprotein)
• Negative Control Swab (1): Inactivated Group B Streptococcus antigen (noninfective)
• Package Insert /Instructions for use (1)
• Procedure Card (1)

Materials Required, But Not Provided:

For Aspirate Samples only

• Extraction Reagent in a bottle (5 mL): Phosphate buffer with detergents and 0.09% sodium azide
• Disposable Transfer Pipettes (50): Buffer and sample transfer
• Procedure card for aspirate samples

For All Sample types:

• Timer
• Latex gloves

Test Procedure:

Step 1:

• 1. Tear the tab off the Extraction Reagent Capsule and dispense entire contents into the Extraction Well.

Step 2:

• Insert the specimen swab in the Swab Stand.
• Spin swab 3 times to mix the specimen.
• Let stand 1 minute.
• Spin swab 3 times again

Step 3:

• Discard the swab. Raise the device upright and let stand 1-2 seconds.

Step 4:

• Gently tap the device to ensure the liquid flows into the hole.
• Then, lay the device back down.
• Set a timer for 15 minutes.

Step 5:

• Read test results at 10–15 minutes.
• Confirm negative results at 15 minutes.

Precautions:

• 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 available. 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 McKesson Consult Influenza 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.

• The product warranty is applicable as per the terms and conditions provided by the product manufacturer.

Please call us for specific details.

• No returns will be accepted after 30 days from the date of shipment.
• All returns are subject to a restocking fee as per manufacturers terms and conditions.
• All returns must have an RGA number (Returned Goods Authorization), unauthorized returns will not be accepted.
• We do not guarantee fulfillment of any desired purpose or product suitability to the user and this will not be considered as a valid reason for return.
• The products must be new, unused condition, not tampered with, in original packaging and returned at the customers expense in the original packaging.
• If your return is not due to any manufacturing defect then the original shipping cost will be deducted from the total refund.
• Hygiene, bath and toilet items cannot be returned once opened or used.
• Standard manufacturer terms and conditions apply for return policy of this product.

Please call us for specific details.