Use of SuperScript IV in AML NPM1 MRD testing
Case reference FOI2026/00246
Received 20 January 2026
Published 18 March 2026
Request
Response
I am writing to make a request for information under the Freedom of Information Act 2000.
This request concerns the use of Invitrogen SuperScript IV Reverse Transcriptase, a molecular biology reagent manufactured by Thermo Fisher Scientific, within acute myeloid leukaemia (AML) NPM1 (nucleophosmin 1) minimal residual disease (MRD) molecular testing pathways.
Please provide the following information for the period 1 January 2018 to 31 December 2024.
1. Use of SuperScript IV
Please confirm whether your Trust, or any laboratory operated by or on behalf of your Trust, used (Invitrogen) SuperScript IV Reverse Transcriptase (Thermo Fisher Scientific) as part of any AML NPM1 MRD testing undertaken for clinical decision-making during the above period.
Please answer yes or no.
No. We have only ever used the Invitrogen Vilo Superscript kit which uses Superscript III.
2. If yes
If the answer to question 1 is yes, please provide:
a) The years during which SuperScript IV was used in AML NPM1 MRD testing;
b) Whether the relevant MRD assay was UKAS (United Kingdom Accreditation Service) accredited at the time of clinical use;
c) Whether SuperScript IV was treated as Research Use Only (RUO) or otherwise subject to any diagnostic limitation or manufacturer warning;
d) Whether any validation, governance approval, or risk assessment was undertaken specifically in relation to its use within AML NPM1 MRD testing (a high-level confirmation is sufficient).
3. Concerns or review
Please confirm whether your Trust (including any relevant laboratory, pathology directorate, or governance function) identified, received, or was notified of any concerns, reviews, or discussions (including by email, meeting note, or internal memorandum) relating to the suitability, reliability, or governance of SuperScript IV (Thermo Fisher Scientific) for use in AML NPM1 MRD testing during the same period.
If so, please provide the year or years in which such concerns arose and a high-level description of the action taken.
During an NHSE AML MRD subgroup meeting in September 2021, in which guidance was being developed on the standards to which AML MRD testing should be performed, it was stated that Superscript IV should not be used for samples for NPM1 testing as it had been identified to occasionally introduce small insertions into the cDNA during RT. This was included in AML MRD minimal technical standards.
This request does not seek personal data or information about individual patients or staff. Aggregate information and high-level confirmations are sufficient.
If any part of this request is considered likely to exceed the appropriate cost limit, please advise how it may be refined before refusal, in accordance with Freedom of Information Act guidance.
Documents
This is Oxford University Hospitals NHS Foundation Trust's response to a freedom of information (FOI) or environmental information regulations (EIR) request.
You can browse our other responses or make a new FOI request.