scope:

This document provides guidelines for the use of automated cell counting to enumerate lamellar bodies in amniotic fluid. It describes the different counting technologies used in automated cell counters as well as methods laboratorians can use to verify/validate the lamellar body count (LBC) test.

The intended users of this guideline are laboratory directors, medical technologists, laboratory supervisors, and pathologists, as well as in vitro diagnostic manufacturers involved in the development of devices and materials related to LBC testing.

This guideline does not provide guidance on how to establish the clinical utility of the LBC for fetal lung maturity (FLM).