In case you haven't signed up for our mailing list (really - why not? go there and do it now!) - We are going deep on the FDA approved NephroCheck™, a new test for the early diagnosis of AKI. This is not industry sponsored BS, just honest, crowd-sourced, EBM.
For this #NephJC we have three topics we want to discuss:
*please preface your tweets with the topic: i.e. T0, T1 and so on*
Topic Zero: How are you currently diagnosing AKI?
- Is it all FENa and a microscope slide?
- What do you think of the KDIGO AKI stages?
- How do you use oliguria?
Topic 1: Evaluate their strategy for developing a novel test for AKI.
Three studies in 2 papers:
Discovery: the scientists tested 340 biomarkers and came up with a pair that performed best. N=522.
Sapphire: validated the biomarker from Discovery in a unique cohort. N=744.
Topaz: A separate study just to validate the results of Sapphire. N=420.
Is this a compelling story line? Is this a fair way to discover and validate a test? Do you agree with the conclusions?
Topic 2: Evaluating a test.
- On ROC the area under the curve was 0.82. Good enough?
- Two cutoffs are provided, one is sensitive (92%) and the other is specific (95%). How will you use that?
Topic 3: So what?
- How will having a 12 hour lead time change your management?
- Should we expect trials designed to change the course of AKI to use NephroCheck™?