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Published on: June 14, 2018
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
Summary
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.
- 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.
