The following post was written several years ago. Although more recent developments have changed the field of clinical laboratory science since the original posting, the information contained was deemed to be of historical interest.
Abbott Laboratories recently announced that it was ending production of its widely used fetal lung maturity test, the TDx FLM II, due to the retirement of their TDx and TDxFLx instrument platforms. The impact of the loss of this test on the obstetrical and clinical laboratory communities remains uncertain but one thing is clear: laboratories that currently perform the TDx FLM II test need to prepare now. What are some options to consider?
Provide an Alternate Test
One obvious option is to provide an alternate test of fetal lung maturity but let’s review the choices. The lecithin/sphingomyelin (L/S) ratio was the first test of fetal lung maturity developed by Gluck and colleagues in 1971 (1) and, because it was first, everything that came after it was compared to it. In other words, it became the de facto gold standard test. Despite numerous studies suggesting otherwise (2), it is still considered to be the best fetal lung maturity test by many obstetricians. Indeed, a survey of obstetricians revealed that, in the absence of Abbott’s test, 68% would order the L/S ratio (3). However, only ~20% of laboratories that offer fetal lung maturity testing currently perform the L/S ratio so it has limited availability. Further, it's unlikely that laboratories that are not currently performing the L/S ratio will begin to offer it. This is because it’s a labor-intensive test that requires considerable technical expertise to perform and it has poor analytical precision.
A commercially available test for the rapid detection of phosphatidylglycerol (PG) is another option. It’s particularly attractive because it is simple to perform but has some drawbacks. The test result is somewhat subjective to interpretation and is qualitative (mature or immature) rather than quantitative. More importantly, PG is a late marker of lung maturity and is often undetectable until 35-36 weeks of gestation.
A third option is the lamellar body count (LBC). Because lamellar bodies are approximately the same size as blood platelets, they can be enumerated using an automated hematology cell counter. Outcome-based studies have demonstrated that the LBC performs at least as well as the TDx FLM II test (4, 5). However, unlike the L/S ratio and rapid detection of PG, it is a laboratory-developed test, which can make implementation more challenging.
Refer Specimens to Another Laboratory
Rather than replacing the TDx FLM II test with another test, a laboratory may opt to simply send all fetal lung maturity test requests to a laboratory that performs one. However, physicians typically demand and expect a relatively rapid turn-around-time for fetal lung maturity tests. Most desire results within 12 hours of sample collection (3), an expectation that may be difficult to meet by referring tests to another laboratory.
Stop Offering Fetal Lung Maturity Tests
Due to improvements in gestational age dating, maternal administration of corticosteroids that accelerate fetal lung maturity in at-risk pregnancies, and exogenous surfactant replacement therapies, the number of newborn deaths due to respiratory distress syndrome has declined considerably over the last 15 years. Most laboratories have noted a decline in the number of fetal lung maturity tests that they perform each year. This trend reflects their decreased use by obstetricians, many of whom indicate that the tests are no longer needed for patient care (3). Further, fetal lung maturity testing is predominantly performed in the United States. Clinical laboratory colleagues in the European Union tell us that they rarely, if ever, perform these tests and yet the rates of infant death due to respiratory distress are no worse than they are in the US. Has the time come to bid adieu to tests of fetal lung maturity?
- Gluck L, Kulovich MV, Borer RC, Brenner PH, Anderson GG, Spellacy WN. Diagnosis of respiratory distress by amniocentesis. Am J Obstet Gynecol 1971;109:440-5.
- Grenache DG, Gronowski AM. Fetal lung maturity. Clin Biochem 2006;39:1-10.
- Grenache DG, Wilson AR, Gross GA, Gronowski AM. Clinical and laboratory trends in fetal lung maturity testing. Clinica Chimica Acta 2010;411:1746-9.
- Ghidini A, Poggi SH, Spong CY, Goodwin KM, Vink J, Pezzullo JC. Role of lamellar body count for the prediction of neonatal respiratory distress syndrome in non-diabetic pregnant women. Arch Gynecol Obstet 2005;271:325-8.
- Haymond S, Luzzi VI, Parvin CA, Gronowski AM. A direct comparison between lamellar body counts and fluorescent polarization methods for predicting respiratory distress syndrome. Am J Clin Path 2006;126:894-9.
- Grenache DG, Wilson A, Gross G, Gronowski AM. Clinical and Laboratory Trends in Fetal Lung Maturity Testing Clin Chim Acta. 2010;411:1746-9
- Haymond S, Luzzi VI, Parvin CA, Gronowski AM. A direct comparison between Lamellar body counts and the fluorescent polarization methods for predicting respiratory distress syndrome. Am J Clin Path 2006;126:894-899
- Lockwood CM, Crompton JC, Riley JK, Landeros K, Dietzen DJ, Grenache DG, Gronowski AM. Validation of lamellar body counts (LBC) using three hematology analyzers. Am J Clin Path. 2010;134:420-8
- Pineda V, Gronowski AM. Biomarkers for fetal lung maturity. Biomarkers in Medicine 2010:4:In press
Szallasi A, Gronowski AM, Eby CS. Lamellar body count in amniotic fluid: a comparative study using four different hematology analyzers. Clin Chem 2003;49:994-997