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Division 6 The procedures, sampling methods and criteria for the evaluation of the results of laboratory tests must be:

United Kingdom

Original text. Later amendments are not shown.

  1. (a)

    those set out in this diagnostic manual; or

  2. (b)

    those authorised by the competent authority provided that:

    1. (i)

      the sensitivity and specificity of the authorised laboratory tests have been demonstrated as being effective following a comparative test F1...; or

    2. (ii)

      where no such evaluation has been organised F2... for a specific type of laboratory test, the sensitivity and specificity of the authorised laboratory test have been validated by the national reference laboratory so that the laboratory test is fit for the purpose for which it is used; F3....

Annotations

Textual amendments

F1

Words in Annex Ch. 1 para. 6(b)(i) omitted (31.12.2020) by virtue of The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 10(6)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F2

Words in Annex Ch. 1 para. 6(b)(ii) omitted (31.12.2020) by virtue of The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 10(6)(b)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F3

Words in Annex Ch. 1 para. 6(b)(ii) omitted (31.12.2020) by virtue of The Exotic Disease (Amendment etc.) (EU Exit) Regulations 2018 (S.I. 2018/1410), regs. 1, 10(6)(b)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)