Lamellar Body Count, Amniotic Fluid
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Predicting fetal lung maturity and assessing the risk of developing neonatal respiratory distress syndrome, when performed during 32 to 39 weeks gestation
Sysmex XE5000, Platelet Count by Impedance Method
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Lamellar Body Count, AF
Fetal Lung Maturity
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Amniotic fluid container
Submission Container/Tube: Plastic vial
Specimen Volume: 10 mL
Collection Instructions: Do not centrifuge.
Additional Information: Centrifuging the specimen may cause erroneous results.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Visible hemolysis, reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Amniotic Fld||Refrigerated (preferred)||28 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Fetal lung maturity testing is used to determine the risk for developing respiratory distress syndrome (RDS) in infants born prematurely (32-39 weeks). The risk for developing RDS is inversely related to gestational age and is the most common cause of respiratory failure in neonates. RDS is associated with preterm birth due to insufficient production of pulmonary surfactant. Pulmonary surfactant is synthesized by type II pneumocytes. Surfactant consists of 90% phospholipids (primarily phosphatidylcholine and phosphatidylglycerol) and 10% proteins (surfactant proteins [SP]-A, SP-B, SP-C). Surfactant is packaged into lamellar bodies and is excreted into the alveolar space where it unravels and forms a monolayer on alveolar surfaces. Lamellar bodies can also pass into the amniotic cavity and, hence, are found in amniotic fluid. The surfactant functions to reduce the surface tension in the alveoli, preventing atelectasis. When surfactant is deficient, the small alveoli collapse and the large alveoli become overinflated and stiff, which has been associated with increased risk of developing respiratory distress. The status of fetal lung maturity is reflected in the concentration of surfactant in the form of phospholipids (see also FLP/8929 Fetal Lung Profile, Amniotic Fluid) and lamellar bodies present in amniotic fluid. Lamellar bodies are similar in size to platelets and can be quantified on a hematology analyzer utilizing the platelet channel and used to estimate fetal lung maturity.
FLP/8929 Fetal Lung Profile, Amniotic Fluid and LBC/60450 Lamellar Body Count, Amniotic Fluid are individually orderable. A reflexive testing algorithm (LBCR/61179 Lamellar Body Count Reflex, Amniotic Fluid) is available to reflex indeterminate lamellar body count results for FLP/8929 Fetal Lung Profile, Amniotic Fluid (lecithin/sphingomyelin [L/S] ratio and phosphatidylglycerol [PG] testing).
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Cutoffs are based on consensus protocol (Neerhof M, Dohnal JC, Ashwood ER, et al: Lamellar body counts: a consensus on protocol. Obstet Gynecol 2001;97:318-320)
Amniotic fluid lamellar body count (LBC) >50,000/mcL is predictive of fetal lung maturity.
Amniotic fluid LBC <15,000/mcL is suggestive of fetal lung immaturity and increased risk of neonatal respiratory distress syndrome (RDS).
The main value of fetal lung maturity testing is predicting the absence of RDS. An immature test result for fetal lung maturity is less reliable in predicting the presence of RDS.(1)
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Surfactant secretion into the amniotic fluid is minimal prior to 32-weeks gestation.
Fetal lung maturity testing is not indicated beyond week 39.
Specimens should not be frozen or centrifuged. Freezing and centrifuging the amniotic fluid falsely decreases the lamellar body count. Amniotic specimens should be blood and meconium free.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Fetal Lung Maturity. ACOG Practice bulletin. Obstet Gynecol September 2008;112(3):717-726
2. Eby C, Lu J, Gronowski AM: Lamellar Body Counts Performed on Automated Hematology Analyzers to Assess Fetal Lung Maturity. Lab Med 2008;39(7):15
3. Haymond S, Luzzi V, Parvin C, Gronowski A: A Direct Comparison Between Lamellar Body Counts and Fluorescent Polarization Methods for Predicting Respiratory Distress Syndrome. Am J Clin Pathol 2006;126:894-899
4. Szallasi A, Gronowski A, Eby C: Lamellar Body Count in Amniotic Fluid: A Comparative Study of Four Different Hematology Analyzers. Clin Chem 2003;49(6):994-997
5. Grenache DG, Gronowski AM: Fetal lung maturity. Clin Biochem 2006;39:1-10
6. Neerhof M, Dohnal JC, Ashwood ER, et al: Lamellar body counts: a consensus on protocol. Obstet Gynecol 2001;97:318-320
Method Description Describes how the test is performed and provides a method-specific reference
The Sysmex Automated Hematology Analyzer XE-5000 measures platelet count by the impedance method to quantify lamellar body counts. (Automated Hematology Analyzer XE-5000 Instructions for Use [North American Edition], Code No. 461-2638-6, Date of Last Revision: December 2011)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Sunday; Continuously
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|LBCC||Lamellar Body Count||In Process|