The Prenatal Screening Laboratory (PSL) started operations at the Foundation for Blood Research (FBR) in March, 1979, and offers state-of-the-art testing for identifying pregnancies at increased risk for open neural tube defects (spina bifida/anencephaly), Down syndrome (trisomy 21) or trisomy 18. Currently, maternal serum screening services are provided to over 75% of the pregnancies in Maine each year. These services also extend into New Hampshire and elsewhere in the United States.

PSL complies with the recommendations of professional organizations in offering laboratory services as part of a comprehensive screening program. The FBR's experienced laboratory personnel communicate positive test results directly to the physician, to provide assistance in coordinating follow-up and diagnostic studies, and to serve as an educational resource for physicians and patients.

FBR is in a position to deal with complex clinical situations because of in-depth understanding of the limitations and assumptions underlying screening. FBR personnel have authored numerous publications that have set the standard for prenatal screening as currently practiced.

  FBR identified and published the association between maternal weight and AFP levels¹.

  FBR published one of the first studies linking vaginal bleeding and elevated MSAFP to poor pregnancy outcome².

  FBR pioneered and published the protocols now used for triple testing in the United States³.

  FBR organized and published the first prospective study of the efficacy of multiple marker screening, with colleagues in New England⁴.

  FBR prospectively established the performance of multiple marker screening in women over 35, with colleagues in California⁵.

  FBR developed and published the protocols now used for screening for trisomy 18 in the United States⁶.

  FBR studied and published the effect of cigarette smoking on multiple marker analytes⁷.

The first quality assurance program for alpha-fetoprotein (AFP) screening, now shared by the College of American Pathologists (CAP), was developed and maintained originally by our laboratory. The PSL also continues to be a leader in the biochemical analysis of amniotic fluid to confirm the presence of an open fetal defect and manages a quality assurance program for amniotic fluid acetylcholinesterase. Research efforts are ongoing to develop more sophisticated tests for identifying high risk pregnancies.

The PSL also conducts research concerning cotinine in serum, urine, and saliva. Cotinine, the major metabolite of nicotine, provides an objective measure of the actual amount of inhaled tobacco smoke and is the most reliable biochemical measure for confirmation of smoking status. Cotinine levels show better correlation with adverse health effects of smoking than number of cigarettes smoked. The PSL assay is also sufficiently sensitive to measure the levels of cotinine found in the urine of individuals exposed to other people's tobacco smoke (second-hand smoke).

Beginning in early 1994, the PSL began offering analysis of serum and plasma samples for the presence of antiphospholipid antibodies and/or lupus-like anticoagulant. This testing can be helpful for some women who have experienced recurrent pregnancy loss, and also for patients with autoimmune disorders (such as lupus), or with a history of thrombosis.

References

¹Haddow JE, Knight G, Kloza E, Smith D: Relation between maternal weight and serum alpha-fetoprotein concentration during the second trimester. Clin Chem, 27:133-134, 1981.

²Haddow JE, Knight GJ, Kloza EM, Palomaki GE: Alpha-fetoprotein, vaginal bleeding, and pregnancy risk. Br J Obstet Gynaecol, 93:589-593, 1986.

³Wald NJ, Cuckle HS, Densem J, Nanchahal K, Royston P, Chard T, Haddow JE, Knight GJ, Palomaki GE, Canick J: Maternal serum screening for Down's syndrome in early pregnancy. BMJ, 297:883-887, 1988.

⁴Haddow JE, Palomaki GE, Knight GJ, Williams J, Pulkkinen A, Canick JA, Saller DN, Bowers GB: Prenatal screening for Down's syndrome with use of maternal serum markers. N Engl J Med, 327:588-593, 1992.

⁵Haddow JE, Palomaki GE, Knight GJ, Cunningham CG, Lustig LS, Boyd P: Reducing the need for amniocentesis in women age 35 years and older with serum markers for screening. N Engl J Med, 330:1114-1118, 1994.

⁶Palomaki GE, Haddow JE, Knight GJ, Wald NJ, Kennard A, Canick JA, Saller DN, Blitzer MG, Dickerman LH, Fisher R, Hansmann M, Luthy DA, Summers AM, Wyatt P: Risk-based prenatal screening for trisomy 18 using alpha-fetoprotein, unconjugated aestriol and human chorionic gonadotropin. Prenat Diagn, 15:713-723, 1995.

⁷Palomaki GE, Knight GJ, Haddow JE, Canick JA, Wald NJ, Kennard A: Cigarette smoking and levels of maternal serum alpha-fetoprotein, unconjugated estriol, and human chorionic gonadotropin: Impact on Down syndrome screening. Obstet Gynecol, 81:675-678, 1993.

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