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  • Title: Performance characteristics of the Access Inhibin A assay.
    Author: Rawlins ML, La'ulu SL, Erickson JA, Roberts WL.
    Journal: Clin Chim Acta; 2008 Nov; 397(1-2):32-5. PubMed ID: 18691567.
    Abstract:
    BACKGROUND: Second trimester maternal screening using AFP, uE3, hCG, and inhibin A has shown a detection rate for Down's syndrome of 81% with a 5% false positive rate. Inhibin A may also have utility as a serum tumor marker in postmenopausal women with ovarian cancer and men with testicular stromal tumors. METHODS: The Beckman Coulter Access Inhibin A assay was evaluated for limit of blank, dilution linearity, imprecision, interferences, reference intervals, and comparison to an inhibin A ELISA. RESULTS: The limit of blank was 0.1 ng/l. The assay was linear from 0.2 to 1347 ng/l. Total inter-assay CVs were <5% for control levels ranging from 24.6 ng/l to 811 ng/l. Interference studies showed recoveries of inhibin A within 10% of expected values at interferent concentrations of 10 g/l hemoglobin and 22 g/l triglycerides. No significant interference was observed at a bilirubin concentration of 400 mg/l. The 97.5th percentile upper reference limits were 6.8 ng/l for postmenopausal women and 3.0 ng/l for men. The Access assay compared to an ACTIVE ELISA showed a slope of 0.88, an intercept of -3.7 ng/l, S(y/x)=40 ng/l, and r=0.98. CONCLUSIONS: The analytical performance of the Access inhibin A assay is acceptable for routine laboratory testing.
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