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Updated: Jul 6, 2026

Development and Validation of an Ultrasensitive Single Molecule Array Digital Enzyme-linked Immunosorbent Assay for Human Interferon-α
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Inhibin A measurement using an automated assay platform.

G M Lambert-Messerlian1, G E Palomaki, J A Canick

  • 1Department of Pathology and Laboratory Medicine, Divisions of Prenatal & Special Testing and Medical Screening, Women and Infants Hospital and the Alpert Medical School of Brown University, Providence, Rhode Island 02903, USA. gmesserl@wihri.org

Prenatal Diagnosis
|April 9, 2008
PubMed
Summary
This summary is machine-generated.

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A new automated assay for measuring inhibin A in maternal serum shows high correlation with the manual method, enabling comparable Down syndrome screening performance.

Area of Science:

  • Biochemistry
  • Clinical Chemistry
  • Reproductive Medicine

Background:

  • Maternal serum inhibin A measurement is crucial for second-trimester Down syndrome screening.
  • Currently, only a manual enzyme-linked immunosorbent assay (ELISA) from Diagnostic Systems Laboratories (DSL) is available.
  • A new automated assay from Beckman Coulter (Access) has been developed.

Purpose of the Study:

  • To compare the performance of the new automated Access inhibin A assay with the existing manual DSL assay.
  • To evaluate the accuracy and reliability of the Access assay for Down syndrome screening.

Main Methods:

  • Residual serum samples from 570 women were analyzed using both DSL and Access assays.
  • The Access assay's sensitivity, linearity, and reproducibility were assessed.

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  • Method comparison and correlation analysis were performed, including testing samples from pregnancies with confirmed Down syndrome.

    • Main Results:

    • The Access assay demonstrated high reproducibility (coefficients of variation <10%) and sensitivity (<1 pg/mL).
    • Inhibin A values from the Access assay strongly correlated with the DSL assay (r=0.961).
    • Access assay values were consistently 23% lower than DSL values, but median values and distribution (log standard deviations) were comparable, fitting expected gestational norms.

    Conclusions:

    • The automated Access inhibin A assay is a reliable alternative to the manual DSL assay.
    • With appropriate median calculations, the Access assay is expected to provide comparable Down syndrome screening performance.
    • This automated assay offers potential for improved efficiency in prenatal screening.