3d03 BioGX

NEW FLU FAQ

Why did you introduce a new Flu?

As a company committed to continuous improvement, we continually review our products to ensure their performance meets our high standards. We always challenge ourselves to have the highest quality tests in the market and are committed to improving any tests for which improvement is a possibility.

What do we tell current users of your old Flu?

Currents users should know BioGX continues improving our products and as a result we are introducing an enhanced Flu test with additional targets and specimen types.

What targets does the new Flu assay identify?

The BioGX Flu A, Flu B, RSV A/B - OSR for BD MAXTM detects the presence of RNA from Influenza A, Influenza B, RSV A and RSV B.

Is the new Flu qualitative or quantitative?

The BioGX Flu A, Flu B, RSV A/B - OSR for BD MAX is for qualitative detection of RNA.

When can we start ordering?

Ordering may begin immediately.

What is the product number?

The product number for the BioGX Flu A, Flu B, RSV A/B - OSR for BD MAXTM is 400-056-C-MAX.

What is the difference between this and your old version?

The difference between our new Flu test and our previous one is we added an additional set of primers and probes for better coverage, expanded the specimen types and enhanced the sensitivity of the assay. Refer to the Instructions For Use (IFU) Manual for more details.

What is the difference between this and competitive tests on the BD MAX?

Specimen Type, Targets, and Performance. Other tests performed on the BD MAXTM system are limited to one specimen type. This limitation does not apply to our test. We are proud to introduce a test that provides clinicians multiple options with regards to specimen types. Additionally, our new Flu test provides more targets than our test currently run on the BD MAXTM.

Did you test it against QCMD?

Yes. Please refer to the IFU Manual for results.

What are the specimen types for this test?

  • Nasal wash collection
  • Nasopharyngeal swab collection
  • Copan Universal Transport Media (UTM®)
  • BD Universal Viral Transport (UVT)
  • Copan ESwab™
  • Pharyngeal swab collection
  • Copan Universal Transport Media (UTM®)
  • BD Universal Viral Transport (UVT)

Does this test use the same extraction kit and UDP as the old test?

The assay uses the BD MAX™ ExK™ TNA-3 extraction strip and the accompanying BioGX UDP file. The extraction kit is the same as the old version of the test but the UDP is new. Users should ensure they are using the new UDP.

Will you provide free kits to give to customers?

No. We have priced the test very competitively and customers will easily recognize the value of this enhanced Flu test.

Will you swap out old Flu tests for the new Flu?

No. We will not swap out our old Flu tests for our new tests. There is tremendous value in the customer switching over without BioGX or the distributor absorbing the costs of taking back old, unusable test kits.

Will customers using your old Flu have to revalidate in order to use the new Flu?

As CE-IVD marked, BioGX has validated the test thoroughly. However, customers can choose to conduct their own validation or concordance study comparing the older version of the test. There is tremendous value in customers switching to the new Flu test as soon as possible.

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