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New Product Lookup Web Application [05 October 2018]

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Special Testing General Database

Original Post August 25, 2016 [Updated December 28, 2018]: ICCBBA recognizes the growing need for facilities to be able to differentiate their blood component units that have been tested for the Zika virus and found to be non-reactive. A number of facilities have requested guidance recently for the coding and labeling of such units. As a result, ICCBBA has issued new codes that can be encoded into the ISBT 128 Special Testing General Data Structure. This is the same data structure that is commonly used for bar coding the anti-CMV negative test result found in the lower right quadrant of the ISBT 128 blood label.

The Special Testing General Data Structure is intended to indicate special characteristics of a product such as whether it has been phenotyped, the presence of antibodies, CMV antibody status, Hemoglobin S status, etc. Therefore it is fitting to use this data structure to encode Zika negative test results. The codes were added to version 5.3.0 of the Special Testing General Database to represent scenarios anticipated to be commonly used:

  • Test for Zika virus negative
  • CMV seronegative; Test for Zika virus negative

While the testing methodology for the Zika virus may be in an investigational status in some countries, this may not be the case in other countries. The transition from an “investigational” status to an “approved” status may also occur at different times. Since the ISBT 128 Standard is an international standard, it is important to note that details of the test methodology and status are not being encoded into these new codes for Zika. Such details may be included in accompanying documentation. In general, the codes found in the Special Testing Database that are related to additional screening/testing do not include testing methodology or status unless otherwise stated in their definition.

Those who choose to use the new Special Testing General codes would need to understand that the verbiage encoded in the Special Testing General Database may not necessarily match the verbiage that is printed on the label. The label text is nationally-defined. For example, the code N0008 is defined in the Special Testing General Database as “CMV seronegative”; however, national requirements could define the label text for this as “Negative for antibodies to CMV” or “Anti-CMV Neg.” Users should verify the approved label verbiage with their Competent Authority for indicating the negative Zika test result on the label.

The bar coding of Special Testing: General information is optional. Users who choose to bar code the Zika negative test result would need to download the Special Testing General Database from the ICCBBA website. The Database is available to ICCBBA-licensed users at www.iccbba.org/tech-library/iccbba-documents/databases-and-reference-tables/special-testing-general-database. Proper log-in is required to access the download. Any questions regarding the use of the ISBT 128 codes and data structures can be sent to iccbba@iccbba.org.