TY - JOUR
T1 - Performance characteristics of the Access® Inhibin A assay
AU - Rawlins, Mindy L.
AU - La'ulu, Sonia L.
AU - Erickson, J. Alan
AU - Roberts, William L.
N1 - Generated from Scopus record by KAUST IRTS on 2023-09-20
PY - 2008/11/1
Y1 - 2008/11/1
N2 - 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, Sy/x = 40 ng/l, and r = 0.98. Conclusions: The analytical performance of the Access inhibin A assay is acceptable for routine laboratory testing. © 2008 Elsevier B.V. All rights reserved.
AB - 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, Sy/x = 40 ng/l, and r = 0.98. Conclusions: The analytical performance of the Access inhibin A assay is acceptable for routine laboratory testing. © 2008 Elsevier B.V. All rights reserved.
UR - https://linkinghub.elsevier.com/retrieve/pii/S0009898108003628
UR - http://www.scopus.com/inward/record.url?scp=51249103182&partnerID=8YFLogxK
U2 - 10.1016/j.cca.2008.07.013
DO - 10.1016/j.cca.2008.07.013
M3 - Article
SN - 0009-8981
VL - 397
SP - 32
EP - 35
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
IS - 1-2
ER -
