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Clinical Chemistry 50: 182-189, 2004; 10.1373/clinchem.2003.023986
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(Clinical Chemistry. 2004;50:182-189.)
© 2004 American Association for Clinical Chemistry, Inc.

General Clinical Chemistry

Invasive Trophoblast Antigen (Hyperglycosylated Human Chorionic Gonadotropin) in Second-Trimester Maternal Urine as a Marker for Down Syndrome: Preliminary Results of an Observational Study on Fresh Samples

Glenn E. Palomaki1,a, George J. Knight1, Marie M. Roberson2, George C. Cunningham2, Jo Ellen Lee3, Charles M. Strom3 and Raj Pandian3

1 Foundation for Blood Research, PO Box 190, Scarborough, ME 04070-0190.
2 Genetics Disease Branch, State of California, 850 Marina Bay Pkwy., Room F175, Richmond, CA.
3 Quest Diagnostics Nichols Institute, 33608 Ortega Hwy., San Juan Capistrano, CA.

aAuthor for correspondence. Fax 207-885-0807; e-mail palomaki{at}fbr.org.

Background: Down syndrome screening is commonly performed in the US using maternal age and three or four second-trimester maternal serum markers that can identify up to 75% of affected pregnancies by offering diagnostic studies to 5% of women. Invasive trophoblast antigen [ITA; hyperglycosylated human chorionic gonadotropin (hCG)] is a promising marker that can be measured in urine or serum in the first or second trimester. We report preliminary results for urinary ITA in an ongoing observational study.

Methods: Women undergoing second-trimester amniocentesis for reasons not associated with biochemical testing provided consent and a urine (and possibly serum) sample that was tested within a few days. Demographic and pregnancy-related information was collected, along with karyotype. Screening performance was modeled for ITA alone and in combination with serum markers

Results: Twelve recruitment centers collected urine from 2055 women with singleton pregnancies between 15 and 20 weeks of gestation (2023 unaffected, 28 Down syndrome, and 4 pregnancies with other chromosome abnormalities). After correction for gestational age, urine concentration, and maternal race and weight, the ITA measurements were higher in women with a Down syndrome pregnancy (median ITA, 4.33 multiples of the median). At a 75% detection rate, the false-positive rate could be reduced by substituting ITA for hCG measurements (from 5.6% to 2.6% for the triple test) or by adding ITA measurements to existing combinations (from 3.3% to 2.0% for the quadruple test).

Conclusions: Our data provide preliminary confirmation of the potential usefulness of urinary ITA measurements in detecting Down syndrome in a setting that simulates routine usage.




The following articles in journals at HighWire Press have cited this article:


Home page
 Clin. Chem.Home page
G. E. Palomaki, G. J. Knight, L. M. Neveux, R. Pandian, and J. E. Haddow
Maternal Serum Invasive Trophoblast Antigen and First-Trimester Down Syndrome Screening
Clin. Chem., August 1, 2005; 51(8): 1499 - 1504.
[Abstract] [Full Text] [PDF]

Home page
 Clin. Chem.Home page
M. J.N. Weinans, U. Sancken, R. Pandian, J. M.W. van de Ouweland, H. W.A. de Bruijn, J. P. Holm, and A. Mantingh
Invasive Trophoblast Antigen (Hyperglycosylated Human Chorionic Gonadotropin) as a First-Trimester Serum Marker for Down Syndrome
Clin. Chem., July 1, 2005; 51(7): 1276 - 1279.
[Full Text] [PDF]

Home page
 Clin. Chem.Home page
G. E. Palomaki, L. M. Neveux, G. J. Knight, J. E. Haddow, and R. Pandian
Maternal Serum Invasive Trophoblast Antigen (Hyperglycosylated hCG) as a Screening Marker for Down Syndrome during the Second Trimester
Clin. Chem., October 1, 2004; 50(10): 1804 - 1808.
[Abstract] [Full Text] [PDF]


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