BioSign® Flu A + B

Product catalog summary

Overview: The document describes the BioSign® Flu A + B test, a rapid in vitro qualitative test for detecting influenza type A and B antigens from nasal and nasopharyngeal swabs, as well as nasal aspirate/wash specimens.

Specifications: The test kit includes 25 tests per kit (REF #BSP-510-25) and uses CPT codes 87084QW for Influenza A and 87084QW-59 for Influenza B, with a reimbursement of $15.392 each. It is important to check state-specific reimbursement rates.

Procedure for Swab Specimens: The procedure involves filling the extraction well with reagent, inserting the collection swab, incubating for 1 minute, and then flipping the device to allow liquid flow. Results are read in 10 to 15 minutes.

Clinical Performance: The test shows a positive agreement of 89.2% for Influenza A and 86.4% for Influenza B, with a negative agreement of 99.4% and 99.0% respectively, compared to PCR results.

Test Results: The test differentiates between Influenza A and B, with lines indicating positive results for each type. Invalid results require a repeat test with a new sample and device.

Design Features: The test includes an innovative flip design with onboard sample extraction, pre-measured developer solution capsules for accuracy, and flocked nasal swabs for improved patient comfort and specimen collection.

Additional Information: Nasal aspirate specimens are not CLIA waived. For complete details, refer to the package insert. Contact information and further resources are available at www.germainelabs.com.

Catalog excerpts

An in vitro rapid qualitative test that detects inﬂuenza type A and type B antigens directly from nasal swab, nasopharyngeal swab and nasal aspirate/wash specimens* SIMPLE PROCEDURE1 FOR SWAB SPECIMENS Diﬀerentiates between Inﬂuenza A and B EXTRACT Fill extraction well with reagent. INCUBATE Insert collection swab and incubate for 1 minute. FLIP Tip device for 1-2 seconds allowing liquid to ﬂow. READ RESULTS IN 10 TO 15 MINUTES. POSITIVE AND NEGATIVE CONTROL SWABS READING RESULTS 1 VALID TEST RESULTS NEGATIVE INNOVATIVE FLIP DESIGN WITH ONBOARD SAMPLE EXTRACTION PRE-MEASURED DEVELOPER SOLUTION CAPSULE for increased accuracy and ease of use FLOCKED NASAL SWABS for improved patient comfort and superior specimen collection INVALID TEST RESULTS A LINE: Inﬂuenza type A B LINE: Inﬂuenza type B A & B LINE: Inﬂuenza type A & B Repeat with new sample and device. PROVEN CLINICAL PERFORMANCE (BioSign® Flu A & B vs, PCR) POSITIVE % AGREEMENT NEGATIVE % AGREEMENT THE TESTS YOU WANT. THE ACCURACY YOU NEED! ©2019 Germaine Laboratories, Inc., CSM 0800-31 , Rev. 01-19 * CPT reimbursements vary, check your state for current amounts 1 See Package Insert for complete details. Check with each state for exact reimbursement. • Nasal Aspirate Specim

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