Tests Help Detect Birth Defects and Monitor Testicular Cancer

A chemiluminescent microparticle immunoassay (CMIA) helps in the quantitative determination of alpha-fetoprotein (AFP).

The test for AFP in human serum and plasma helps to monitor disease progression during the course of disease and the treatment of patients with nonseminomatous testicular cancer. Men with this type of testicular cancer, or so-called nonseminoma germ cell, have elevated AFP levels present in their bloodstreams. Blood tests to measure AFP can be used to evaluate responses to treatment. By monitoring disease progression and seeking treatment when necessary, testicular cancer can be highly treatable and usually curable cancer.

The AFP assay in human serum, plasma, and amniotic fluid in pregnant women during the 15–30 weeks gestation period aids in the detection of fetal open neural tube defects (NTD). Neural tube defects (NTDs) are serious fetal birth defects of the brain and spine that occur very early in development. When the neural tube, a structure that develops into the brain and spinal cord, fails to close properly, AFP is thought to leak directly from the fetus into the mother’s amniotic fluid, causing unexpectedly high levels of AFP in the mother’s blood. A blood test that measures AFP can help doctors determine if a woman is carrying a fetus affected with birth defects, such as anencephaly (the absence of a large part of the brain and the skull) and spina bifida (the incomplete closing of the backbone and spinal canal). Treatments for NTDs focus on closing the defect with surgery (including surgery before birth) and treating or addressing related symptoms such as excess fluid in the brain and bladder and bowel problems.

The Abbott (Abbott Park, IL, USA) ARCHITECT AFP assays run on the company's fully-automated ARCHITECT i2000, i2000SR, ci8200, and ci16200 analyzers. The tests are available in the United States, where it has received the US Food and Drug Administration (FDA; Silver Spring, MD, USA) approval. It is CE marked and available in Europe as well as in nonregulated countries.

"The ARCHITECT AFP assay is a valuable tool that will help physicians obtain reliable measurements of this protein for use in guiding critical patient treatment decisions," said Brian Blaser, executive vice president, Diagnostics Products, Abbott. "Abbott is pleased to offer this important assay to our customers to positively affect patient care."

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