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Test ID: FLP
Fetal Lung Profile, Amniotic Fluid

Secondary ID A test code used for billing and in test definitions created prior to November 2011

8929

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

Determining the ability of fetal lungs to produce sufficient quantities of pulmonary surfactant

 

Predicting the likelihood of the development of respiratory distress syndrome if the fetus were delivered

Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test

Method Name A short description of the method used to perform the test

Thin-Layer Chromatography (TLC) with Quantitation by Densitometry
Includes lecithin/sphingomyelin (L/S) ratio, and phosphatidylglycerol (PG), semiquantitative on amniotic fluid.

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Fetal Lung Profile, AF

Aliases Lists additional common names for a test, as an aid in searching

Amniotic Fluid-L/S (Lecithin/Sphingomyelin) Ratio
Fetal Lung Maturity Profile
L/S (Lecithin/Sphingomyelin)
L/S + PG Profile
Lecithin-Sphingomyelin (L/S) Ratio
LS Ratio (Lecithin/Sphingomyelin)
Lung Maturity Profile
PG (Phosphatidylglycerol)
Phosphatidyl Glycerol, Amniotic Fluid
Phospholipid Profile, Amniotic Fluid

Specimen Type Describes the specimen type needed for testing

Amniotic Fld

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.

Container/Tube: Amniotic fluid container

Specimen Volume: 10 mL

Collection Instructions:

1. Centrifuge at 1,000 rpm or 200 x G for 10 minutes, separate supernatant, and send both supernatant and sediment in separate plastic vials.

2. Label specimens sediment and supernatant.

Additional Information: Include estimate of duration of pregnancy (in weeks).

Forms:

1.     1. New York Clients-Informed consent is required. Please document on the request form or electronic order that a copy is on file. An Informed Consent for Genetic Testing (Supply T576) is available in Special Instructions.

2.     2. If not ordering electronically, submit a Biochemical Genetics Request Form (Supply T439) with the specimen.

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.

3 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

Mild OK; Gross OK

Lipemia

NA

Icterus

NA

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
Amniotic FldFrozen (preferred)14 days
 Ambient 72 hours
 Refrigerated 72 hours

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Respiratory distress syndrome is a common complication of prematurity occuring in infants whose lungs lack the surfactant necessary for healthy lung inflation and air exchange. Surfactant is not produced in sufficient quantity until relatively late in gestation. It is primarily made up of phospholipids such as lecithin and phosphatidylglycerol, which can be detected in amniotic fluid and used as markers for fetal lung maturity. Both the lecithin/sphingomyelin (L/S) ratio and phosphatidylglycerol (PG) concentration increase with gestational age and correlate with lung maturity. Testing both the L/S ratio and the presence or absence of PG provides a better assessment of neonatal risk than the use of either test alone.

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.

Lecithin/

Sphingomyelin

Ratio

 

 

Phosphatidylglycerol

 

 

Interpretation

<2.5

Absent

Immature

> or =2.5

Absent

Indeterminate

<2.5

Trace

Indeterminate

> or =2.5

Trace

Mature

Any ratio

Present

Mature

All results will be called back.

Interpretation Provides information to assist in interpretation of the test results

L/S ratio <2.5 and PG absent: immature

L/S ratio > or =2.5 and PG absent: indeterminate

L/S ratio <2.5 and PG trace: indeterminate

L/S ratio > or =2.5 and PG trace: mature

PG present: mature

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

No significant cautionary statements

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Ashwood ER, Knight GJ: Clinical Chemistry of Pregnancy. In Tietz Textbook of Clinical Chemistry and Molecular Diagnosis, 4th Edition, Edited by Carl A Burtis, Edward R Ashwood, and David E Bruns, St Louis, MO, Elsevier Saunders, 2006, pp 2188-2192

2. Kulovich MV, Hallman MB, Gluck L: The lung profile. I. Normal     pregnancy. Am J Obstet Gynecol 1979;135:57-63

3. Hill LM, Ellefson R: Variable interference of meconium in the determination of phosphatidylglycerol. Am J Obstet Gynecol 1983;147:339-340

4. Ragozzino MW, Hill LM, Breckle R, et al: The relationship of placental grade by ultrasound to markers of fetal lung maturity. Radiology 1983;148:805-807

Method Description Describes how the test is performed and provides a method-specific reference

This test uses a 1-dimensional, thin-layer chromatography (TLC) technique for separating the phospholipids in amniotic fluid. The first step in the process involves extraction of the lipids present in the amniotic fluid using a chloroform/methanol mixture. The extracted specimen is streaked onto a TLC plate and placed in tank 1 for prechromatography, a step that removes a component that otherwise comigrates with PG. Lipids are then separated using tank 2. The separated lipids are made visible with dilute cupric acetate and charring. L to S is determined using a scanning densitometer. The relative intensities of L and S are expressed as a ratio, and PG is reported from a visual observation of the plate and reported as present, absent, or trace. (Unpublished Mayo method)

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 Friday; 2 p.m.

Saturday and Sunday; 11 a.m.

Weekdays: Sample delivery time is 7:00 a.m. to 4:30 p.m.

Set-up time up to 2:00 p.m.

Saturday: Sample delivery time is 7:00 a.m. to 3:00 p.m.

Set-up time is up to 11:00 a.m.

Sunday: Sample delivery time is 8:00 a.m.-1:00 p.m.

Set-up time is up to 11:00 a.m. (On call only)

Holidays: Closed

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

2 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks

Performing Laboratory Location The location of the laboratory that performs the test

Rochester

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.

83661-Fetal lung maturity assessment; L/S ratio

84081-PG

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 IDReporting NameLOINC Code
8929Fetal Lung Profile, AF47226-6
2405L/S Ratio14976-5
2407Phospglycerol2785-4
2408Result47226-6