A technical and clinical evaluation of a new assay for inhibin A and its use in second trimester Down syndrome screening
-
Georgina Wilson
Abstract
Background:
The objective of the study was to compare a new AutoDELFIA® Inhibin A kit (B064-102) with the Access Inhibin A kit (A36097) using clinical specimens and to evaluate the AutoDELFIA® Inhibin A assay performance in screening for Down syndrome in the second trimester of pregnancy.
Methods:
Using clinical samples, we performed a method comparison between new and existing inhibin A kits and assessed AutoDELFIA® Inhibin A kit precision performance. Normal median values for the second trimester of pregnancy were also determined. Finally, we evaluated the screening performance of the AutoDELFIA® Inhibin A kit together with other second trimester biomarkers for the detection of Down syndrome.
Results:
The two methods showed a high degree of correlation (r=0.99, Pearson and Spearman correlation), and the average relative level difference between the methods at a concentration range of 41.7–1925 pg/mL was 19.6% [95% confidence interval (CI) from 17.6% to 21.5%]. The acceptable precision of the AutoDELFIA® Inhibin A kit was demonstrated: the within-lot CV% varied from 1.9% to 3.9%. The screening performance results show that AutoDELFIA® Inhibin A when added to a combination of other second trimester serum markers [human alpha foetoprotein (hAFP), free beta subunit of human chorionic gonadotropin (free hCGβ) and unconjugated estriol (uE3) or hAFP and free hCGβ] improves the detection rate of screening in both combinations.
Conclusions:
The performance of the AutoDELFIA® Inhibin A assay is highly acceptable for routine laboratory use for screening Down syndrome in the second trimester of pregnancy.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: The employers of KS and GW received research funding from PerkinElmer.
Employment or leadership: PL, TP and MS are employees of PerkinElmer, the producers of the assay under evaluation. KS is an advisor to ThermoFisher Scientific on matters of Prenatal Screening.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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Articles in the same Issue
- Frontmatter
- Editorials
- The Theranos phenomenon, scientific transparency and freedom of speech
- Holotranscobalamin: in the middle of difficultly lies opportunity
- Review
- Laboratory and clinical risk assessment to treat myelodysplatic syndromes
- Mini Review
- Quantitative nucleic acid amplification by digital PCR for clinical viral diagnostics
- Genetics and Molecular Diagnostics
- Hybrid minigene splicing assay verified the pathogenicity of a novel splice site variant in the dystrophin gene of a Chinese patient with typical Duchenne muscular dystrophy phenotype
- General Clinical Chemistry and Laboratory Medicine
- Prospective validation of an automated chemiluminescence-based assay of renin and aldosterone for the work-up of arterial hypertension
- Sex steroid hormone stability in serum tubes with and without separator gels
- Reduced absorption and enhanced synthesis of cholesterol in patients with cystic fibrosis: a preliminary study of plasma sterols
- An International Standard for holotranscobalamin (holoTC): international collaborative study to assign a holoTC value to the International Standard for vitamin B12 and serum folate
- A technical and clinical evaluation of a new assay for inhibin A and its use in second trimester Down syndrome screening
- Investigation on the ability of first trimester glycodelin and angiopoietin-2 to predict small-for-gestational age pregnancies at delivery
- Plasma total C-terminal agrin fragment (tCAF) as a marker for kidney function in patients with chronic kidney disease
- Hematology and Coagulation
- Thirty-minutes’ exposure to smartphone call triggers neutrophil activation in vitro
- Performance of the XN-2000 WPC channel-flagging to differentiate reactive and neoplastic leukocytosis
- Differences in lupus anticoagulant final conclusion through clotting time or Rosner index for mixing test interpretation
- Reference Values and Biological Variations
- Derivation of level-specific reference change values (RCV) from a health screening database and optimization of their thresholds based on clinical utility
- Cancer Diagnosis
- BRAF analysis before surgery for papillary thyroid carcinoma: correlation with clinicopathological features and prognosis in a single-institution prospective experience
- Letters to the Editor
- Significant increase of serum prostate-specific antigen after exercise
- Serum delipidation but not high-speed centrifugation is effective in clearing lipemia interference in serum lipase activity measurement
- A relationship between absolute monocyte count and C-reactive protein in patients with migraine undergoing no pharmacological therapy
- Validation of the “Vacutainer® urinalysis preservative plus urine tube” for the determination of albumin and protein
- Performance evaluation of a novel automated HIV Ag/Ab chemiluminescence immunoassay
- SLC26A4 genotypes associated with enlarged vestibular aqueduct malformation in south Italian children with sensorineural hearing loss
- Is cystatin C level altered in women with polycystic ovary syndrome?
- Venous thromboembolism in a patient with persistent inhibitor to coagulation factor V – a case report
- Free light chains nephelometric assay: human urine stability in different storage conditions
- Comparing the viscoelastomeric fibrin polymerization assays FIBTEM® (ROTEM) vs. Functional Fibrinogen® (TEG): or why is a higher threshold for fibrinogen substitution better than a lower one?
- Reply to: Comparing the visco-elastomeric fibrin polymerization assays FIBTEM® (ROTEM) vs. Functional Fibrinogen® (TEG): or why is a higher threshold for fibrinogen substitution better than a lower one? By Schöchl et al.
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