Division 3.1.8 F1

Sensitivity with true positives and sero-conversion samples shall be evaluated as follows:

1. 3.1.8.1.

   Diagnostic test sensitivity during sero-conversion has to represent the state of the art. Whether further testing of the same or additional sero-conversion panels is conducted by the F2approved body or by the manufacturer the results shall confirm the initial performance evaluation data (see Table 1). Sero-conversion panels should start with a negative bleed(s) and should have narrow bleeding intervals.

2. 3.1.8.2.

   For blood screening devices (with the exception of HBsAg and anti-HBc tests), all true positive samples shall be identified as positive by the device to be F3UK or CE marked, (Table 1). For HBsAg and anti-HBc tests the new device shall have an overall performance at least equivalent to that of the established device (see 3.1.4).

3. 3.1.8.3.

   Regarding HIV tests:

   • all sero-conversion HIV samples shall be identified as positive, and

   • at least 40 early sero-conversion HIV samples shall be tested. Results should conform to the state of the art.