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 in the US for the Zika virus is in an investigational status, this may not be the case in other regions of the world, and 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 choosing to use the new codes would need to understand that the verbiage in the Special Testing General Database does not necessarily match the verbiage that is printed on the label. The label text is nationally defined. For example, a commonly used code in the US is N0008 (defined in the Database as “CMV seronegative”); the nationally defined label text for this in the US is “Negative for antibodies to CMV” or “Anti-CMV Neg.” Users should verify the approved label verbiage with their regulator(s) for indicating the negative Zika test result on the label.
Users choosing to optionally 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 here. 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 email@example.com.