General AI Questions

  1. Where can I find a list of the FDA registered products?

    On Dianet:

    Sites: Germany

    left side: "QR"

    QR: "Registrations"

    click on "USA"

  2. Where can I find a list with sensitivities and specificities of the EliA products?

    On Dianet:

    Sites: Germany

    Autoimmunity: Our Products

    click on the first Excelspreadsheet under Overview List

  3. Which EliA tests are streptavidin-coated?

    In general we do not use streptavidin for developing our new tests. However, when the needed diagnostic performance is only achievable with this type of coating, we agree in using it.

    This was the case for the following EliA tests: 

    CTD Screen, SmDp, Fib, Pm-Scl, Mi-2, PCNA, RNA Pol III, Scl-70s, PR3s and MPOs.

                                                                                        

  4. Are there patients with anti-streptavidin antibodies in their sera? And regarding streptavidin-coated tests: do unspecific reactions between these antibodies and the streptavidin influence the test results?

    Yes there are patients with anti-streptavidin antibodies. And this also may be a reason for positive CTD-Screen test results but negative Symphony results.

    Several tests are streptavidin-coated (CTD Screen, SmDp, Fib, Pm-Scl, Mi-2, PCNA, RNA Pol III, Scl-70s, PR3s, MPOs). Because the dilutions for this tests are always more than 1:10 (which means also an increased dilution of the streptavidin antibodies) there is in general no great influence, merely a slight increase of the results can be an implication of streptavidin antibodies.

  5. Please explain the number printed on the DFU to me: what's the meaning of each digit in detail?

    Here you have an example: the number printed on the DFU of EliA TG for Phadia 250 and the corresponding explanation:

    250-5642 -01 / UK

    250: Phadia instrument

    5642: product

    01: version of DFU

    UK: country

     

As in all diagnostic testing, the diagnosis is made by the physican based on both test results and the patient history.