That report describes the use of whole blood instead of urine or serum for the qualitative detection of hCG in a patient with a ruptured ectopic pregnancy. This was what I call a VBI: a Very Bad Idea.
Basically, they pointed out that:
- Using whole blood instead of serum or urine was a modification of the intended use of an FDA-approved test and as such was against the law without appropriate validation experiments.
- The peer-reviewers and journal editors failed to recognize that their report was in conflict with federal and state regulations and the report's publication essentially recommends the promotion of an unauthorized practice with serious patient safety risks.
- Involving laboratory professionals to help identify solutions for clinical dilemmas involving laboratory tests is always a smart idea.
A rapid pregnancy test without using urine? Not so fast.
Source: The Pregnancy Lab
Image credits: David Grenache
Art and Science of Laboratory Medicine