Format of assessment of methodological quality adapted from QUADAS tool17
| Quality Indicator | Notes |
| 1. Was the spectrum of patients representative of the spectrum of patients who will receive the test in practice? | ‘Yes’ if the characteristics of the participants are well described and probably typical of patients with suspected sepsis. ‘No’ if the sample is unrepresentative of people with suspected sepsis. ‘Unclear’ if the source or characteristics of participants is not adequately described |
| 2. Were the selection criteria described? | 2a ‘Yes’ by international sepsis definitions,15 ‘No’ otherwise: 2b ‘Yes’ by some other specified sepsis definition ‘No’ otherwise or 2c ‘Unclear’ if insufficient information provided. |
| 3. Is the time period between reference standard and index test short enough to be reasonably sure the target condition did not change between the two tests | ‘Yes’ if reference and index tests performed on blood samples drawn at the same time. ‘No’ if tests were performed on blood samples taken at different times. ‘Unclear’ if insufficient information is provided |
| 4. Is partial verification avoided? | ‘Yes’ if all participants who received the index text also underwent the reference test. ‘No’ if not all the participants who received the index test also underwent the reference test. ‘Unclear’ if insufficient information is provided. If not all participants received the reference tests, how many did not (of the total)? |
| 5. Is differential verification avoided? | ‘Yes’ if the same reference test was used regardless of the index test results. ‘No’ if different reference tests are used depending on the results of the index test. ‘Unclear’ if insufficient information is provided.If any participants received a different reference test, what were the reasons stated for this, and how many participants were involved? |
| 6. Was the execution of the index test done in accordance with the CE-mark protocol? | ‘Yes’ as per CE-marked protocol described by manufacturer (Roche Diagnostics) from January 2006. ‘No’ if CE-mark protocol breached. ‘Unclear’ if insufficient information provided. (CE-marked protocol will be provided to the independent reviewers). |
| 7. Was the execution of the reference standard described in sufficient detail to permit its replication? | ‘Yes’ if clinical standard described and is consistent with published standard operating procedures.5 ‘No’ if reference standard falls short of standard operating procedures.5 ‘Unclear’ if insufficient information provided. Also comment on how culture contaminations were defined and reported? |
| 8. Are the reference standard test results blinded? | ‘Yes’ if the report stated that the person undertaking the reference test did not know the results of the index tests, or if the two tests were carried out in different places. ‘No’ if the report stated that the same person performed both tests, or that the results of the index tests were known to the person undertaking the reference tests. ‘Unclear’ if insufficient information provided. |
| 9. Are the index test results blinded? | ‘Yes’ if the report stated that the person undertaking the index test did not know the results of the reference tests, or if the two tests were carried out in different places. ‘No’ if the report stated that the same person performed both tests, or that the results of the index tests were known to the person undertaking the reference tests. 'Unclear' if insufficient information provided. |
| 10. Were uninterpretable results reported? | ‘Yes’ if the number of participants in the two-by-two table matches the number of participants recruited into the study, or if sufficient explanation is provided for any discrepancy. ‘No’ if the number of participants in the two-by-two table does not match the number of participants recruited into the study, and insufficient explanation is provided for any discrepancy. ‘Unclear’ if insufficient information is given to permit judgement. Report how many results were uninterpretable (of the total). |
| 11. Were any withdrawals explained? | ‘Yes’ if there are no participants excluded from the analysis, or if exclusions are adequately described. ‘No’ if there are participants excluded from the analysis and there is no explanation given. ‘Unclear’ if not enough information is given to assess whether any participants were excluded from the analysis. Report how many participants were excluded from the analysis, for reasons other than uninterpretable results. |