Document ID: chunk:federal_register_of_legislation:F2021C01065:clause:1_14:p1
Version: federal_register_of_legislation:F2021C01065
Segment Type: clause
Provision Reference: sch 1 cl 14 (pt 1/3)
Character Range: 17483–20361

14  Blood, stool and other samples—testing

General testing requirements
 (1) Samples taken in accordance with section 13, other than stool samples taken in accordance with subsection 13(6), must be tested as soon as practicable after collection in accordance with this section, and within the claimed sample stability timeframe specified by the manufacturer of the IVD medical device or in-house IVD medical device to be used for the testing.
 (2) Samples that are tested for infectious diseases must be tested using IVD medical devices or in-house IVD medical devices that:
 (a) use the most appropriate methodology available for testing the samples in relation to the target organisms; and
 (b) where testing is conducted in Australia—are either included in the Register or exempt from the requirement to be included in the Register, or the subject of an approval or authority under the Act; and
 (c) where testing is conducted outside Australia:
 (i) are approved by a relevant regulatory authority in the country in which the testing is conducted; and
 (ii) are used in a facility that has been approved for such testing by a relevant regulatory authority in the country in which the testing is conducted; and
 (iii) are considered acceptable by the Therapeutic Goods Administration.
 (3) Where testing is conducted by a laboratory that is not under the direct control of the manufacturer of the FMT products:
 (a) the testing must be conducted under a contract between the manufacturer and the laboratory; and
 (b) the contract mentioned in paragraph (a) must clearly set out the responsibilities of the manufacturer and the laboratory, and include arrangements to ensure information relating to matters in this section and any other relevant details relating to the IVD medical devices or in-house IVD medical devices used for such testing can be obtained from the laboratory.

Blood sample testing
 (4) The following tests must be conducted in relation to blood samples taken in accordance with subsection 13(1) or paragraph 13(3)(a):
 (a) C-reactive protein (CRP), full blood count (FBC) and liver function tests (LFTs); and
 (b) serology testing for antibodies to HIV-1 / HIV-2, HBV, HCV, HTLV-1 / HTLV-2, Strongyloides stercoralis, and syphilis (Treponema pallidum); and
 (c) HAV testing (unless RNA testing is conducted on the stool samples); and
 (d) nucleic acid amplification testing for HIV-1, HBV and HCV.
 (5) The following tests must be conducted in relation to the blood samples taken in accordance with subsection 13(3)(b):
 (a) C-reactive protein (CRP), full blood count (FBC) and liver function tests (LFTs); and
 (b) serology testing for antibodies to HIV-1 / HIV-2, HBV, HCV, HTLV-1 / HTLV-2, Strongyloides stercoralis, and syphilis (Treponema pallidum); and
 (c) HAV testing (unless RNA testing is conducted on the stool samples).

Stool sample testing