CLSI C58

Assessment of Fetal Lung Maturity by the Lamellar Body Count, 1st Edition

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 test.

This document is available in electronic format only.

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Chairholder: David G. Grenache, PhD, DABCC, FACB

Date of Publication: November 21, 2011

Order Code PDF: CLSI C58AE
ISBN Number: 1-56238-771-5

Order Code Print: print not available

Edition: First

Pages: 32

CLSI C58 Additional Details

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This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of July 2020. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI C58 Abstract

Clinical and Laboratory Standards Institute document C58-A—Assessment of Fetal Lung Maturity by the Lamellar Body Count; Approved Guideline provides guidance to laboratory professionals and manufacturers involved in the development of devices and materials related to the enumeration of lamellar bodies in amniotic fluid as a test of fetal lung maturity (FLM). Physicians use FLM tests to weigh the potential risks to a newborn of developing respiratory distress syndrome caused by a deficiency of pulmonary surfactant. Pulmonary surfactant decreases the surface tension of the hydrated inner layer of alveoli and prevents their collapse during exhalation. Pulmonary surfactant is packaged into lamellar bodies that are secreted from pneumocytes. The enumeration of lamellar bodies in amniotic fluid can be used as a test of FLM. This document provides guidelines for the use of automated cell counting to perform the lamellar body count test and describes methods to assist in test verification and validation.