CLSI C58
Assessment of Fetal Lung Maturity by the Lamellar Body Count
CLSI C58 provides guidance on assessing fetal lung maturity (FLM) using the lamellar body count (LBC) in amniotic fluid. This guideline supports laboratory professionals and manufacturers in developing, verifying, and validating LBC as a test for FLM. The document outlines the role of lamellar bodies in pulmonary surfactant production, the use of automated cell counting technologies, and best practices for test standardization and clinical interpretation to aid in evaluating the risk of neonatal respiratory distress syndrome.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical 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.
This document is available in electronic format only.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
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.
This document is available in electronic format only.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.