Validation

Antigen Plus provides a template for validation of the software based on the NAACLS format on its website www.antigenplus.com. It is intended to be modified to meet the protocols and standards of the individual institution, but may be reliably used as is to validate the software. Antigen Plus provides technical support for this process.

The panels provided are electronically verified to match with the specification sheets provided by the supplier. The phenotypic information printed on a selected or results panel can be validated by assuring that its data exactly match the data from the suppliers. Part of a laboratory’s validation procedure should be to print several lot panels and have the responsible technologist compare them with the supplier’s data sheets.

Antigen Plus makes no decision or final recommendation on the meaning of test results or on patient care — this is the user’s responsibility. Antigen Plus uses the logic recommended by the American Association of Blood Banks to evaluate initial test results in the same way a technologist would do.