# Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (notified under document number C(2002) 1344) (Text with EEA relevance) (2002/364/EC), Division 3.1.8

Extent: E+W+S+N.I.

Sensitivity with true positives and sero-conversion samples shall be evaluated as follows:
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 approved 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.
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 UK 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).
3.1.8.3.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.

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Source: https://www.legislation.gov.uk/eudn/2002/364/annex/division/3/division/3.1/division/1/division/3.1.8 (the official version)
Page: https://openlegislation.uk/eu-decision-2002-364/annex/division-3/division-3.1/division-1/division-3.1.8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.