Dual Analyte Immunoassay—a New Approach to Neural Tube Defect and Down's Syndrome Screening

Author(s):  
J N Macri ◽  
K Spencer ◽  
R Anderson

A microtiter plate based Dual Analyte enzymeimmunoassay method for the simultaneous measurement of α-fetoprotein (AFP) and Free-β human chorionic gonadotrophin (hCG) was evaluated. This rapid assay, which has application in both Neural Tube Defect screening and Down's screening, shows good precision with between assay coefficients of variation between 5 and 7·5% for AFP and 3·7 to 5·8% for Free-β(hCG). Correlation with single analyte procedures is good, with correlation coefficients being greater than 0·91 in both cases. Clinical discrimination in detecting both types of abnormalities is not compromised by this new simultaneous Dual Analyte assay. We conclude that the Dual Analyte approach, which combines analytes achieving the highest known detection efficiency, will bring about improvements in the efficiency of screening, reduce costs and improve report turnaround, all leading to better quality of patient care.

Diagnostics ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. 2400
Author(s):  
Yu Jeong Choi ◽  
Juhye Roh ◽  
Sinyoung Kim ◽  
Kyung-A Lee ◽  
Younhee Park

Numerous immunoassays have been developed to measure the levels of chromogranin A (CgA), a useful biomarker for diagnosing and monitoring generally heterogeneous neuroendocrine tumors (NETs). Here, we evaluated the imprecision and linearity of three such assays: KRYPTOR (ThermoFisher Scientific), NEOLISA (EuroDiagnostica), and CgA-RIA (CisBio), using 123 samples for each assay. The correlation coefficients between the assays were 0.932 (CgA-RIA versus NEOLISA), 0.956 (KRYPTOR versus CgA-RIA), and 0.873 (NEOLISA versus KRYPTOR). KRYPTOR showed good precision, with percent coefficients of variation less than 5% for low and high concentration quality controls. Linearity was maintained over a wide concentration range. Comparison of CgA levels from three disease entities (NETs, non-NET pancreatic tumors, and prostate cancer) and healthy controls showed that patients with NETs had significantly higher CgA levels (n = 57, mean: 1.82 ± 0.43 log ng/mL) than healthy individuals (n = 20, mean: 1.51 ± 0.23 log ng/mL; p = 0.018). No other significant differences between groups were observed. All three immunoassays showed strong correlations in measured CgA levels. Because KRYPTOR operation uses a fully automated random-access system and requires shorter incubation times and smaller sample volumes, the KRYPTOR assay may improve laboratory workflow while maintaining satisfactory analytical performance.


2021 ◽  
Author(s):  
Yu Jeong CHOI ◽  
Juhye Roh ◽  
Sinyoung Kim ◽  
Kyung-A Lee ◽  
Younhee Park

Abstract Background: Numerous immunoassays have been developed to measure the levels of chromogranin A (CgA), a useful biomarker for diagnosing and monitoring generally heterogeneous neuroendocrine tumors (NETs). Here, we evaluated the imprecision and linearity of three such assays: KRYPTOR (ThermoFisher Scientific), NEOLISA (EuroDiagnostica), and CgA-RIA (CisBio) using 123 samples for each assay.Results: The correlation coefficients between the assays were 0.932 (CgA-RIA versus NEOLISA), 0.956 (KRYPTOR versus CgA-RIA), and 0.873 (NEOLISA versus KRYPTOR). KRYPTOR showed good precision, with percent coefficients of variation less than 5% for low and high concentration quality controls. Linearity was maintained over a wide concentration range. Comparison of CgA levels from three disease entities (NETs, non-NET pancreatic tumors, and prostate cancer) and healthy controls showed that patients with NETs had significantly higher CgA levels (n = 57, mean: 1.82 ± 0.43 log ng/mL) than healthy individuals (n = 20, mean: 1.51 ± 0.23 log ng/mL; P = 0.018). No other significant differences between groups were observed.Conclusion: All three immunoassays showed strong correlations in measured CgA levels. Because KRYPTOR operation uses a fully automated random-access system and requires shorter incubation times and smaller sample volumes, the KRYPTOR assay may improve laboratory workflow while maintaining satisfactory analytical performance.


Author(s):  
K Spencer ◽  
J N Macri ◽  
R W Anderson ◽  
D A Aitken ◽  
E Berry ◽  
...  

We report a multicentre clinical field trial of a novel dual analyte enzyme immunoassay method for the simultaneous measurement of alpha-fetoprotein (AFP) and free β-human choriogonadotropin (hCG) in the same microtitre well. The assay was shown to have good technical performance in the hands of all trial centres, with between assay coefficients of variation better than 10% for both analytes across the whole of the assay ranges. The method compared well with single analyte measuring procedures and produced acceptable performance as judged by external quality assurance criteria. Recovery of added analyte and analyte dilution curves also showed acceptable performance. In clinical evaluation of a large set of neural tube defect cases, good clinical discrimination from unaffected cases was observed using APP. With over 150 Down's syndrome cases, the combination of AFP and free (3 hCG confirmed the high detection rates achievable using this marker combination, with detection rates in excess of 70% in early gestation. We conclude that the combination of clinically superior markers coupled with technologically innovative assay design will lead to more efficient Down's screening programmes.


Neurosurgery ◽  
2019 ◽  
Vol 85 (3) ◽  
pp. E409-E411 ◽  
Author(s):  
David F Bauer ◽  
Alexandra D Beier ◽  
Dimitrios C Nikas ◽  
Nadege Assassi ◽  
Jeffrey Blount ◽  
...  

Abstract BACKGROUND Myelomeningocele (MM) is an open neural tube defect treated by pediatric neurosurgeons with prenatal or postnatal closure. OBJECTIVE The objective of this systematic review was to answer the question: What is the evidence for the effectiveness of prenatal vs postnatal closure of MM regarding short and long-term ambulatory status? Treatment recommendations were provided based on the available evidence. METHODS The National Library of Medicine PubMed database and Embase were queried using MeSH headings and keywords relevant to ambulatory status after prenatal or postnatal closure of MM. Abstracts were reviewed to identify which studies met the inclusion criteria. An evidence table was assembled summarizing the studies and the quality of evidence (Classes I-III). Based on the quality of the literature, a recommendation was rendered (Level I, II, or III). RESULTS One randomized controlled trial (Class II) and 3 retrospective cohort studies (Class III) were included as evidence. Initial ambulatory status depended on anatomic level of the neural tube defect. In the short term, prenatal closure may improve ambulatory status compared to postnatal closure. Spinal cord tethering or dermoid inclusion cyst has been associated with neurologic deterioration in infants closed in utero and after birth. Ambulation may cease in both groups over time. No long-term studies evaluated whether there is a difference in the ability to ambulate upon reaching adulthood. CONCLUSION Prenatal closure of MM may improve ambulatory status in the short term (Level II). Spinal cord tethering in both groups caused deterioration in the ability to walk. Evaluation and treatment of spinal cord tethering may help maintain ambulatory status (Level III). No studies evaluate whether prenatal or postnatal repair provides improved ability to ambulate upon reaching adulthood. The full guideline can be found at https://www.cns.org/guidelines/guidelines-spina-bifida-chapter-3.


2009 ◽  
Vol 39 (6) ◽  
pp. 20
Author(s):  
ELIZABETH MECHCATIE

2013 ◽  
Vol 11 (1) ◽  
pp. 8-13
Author(s):  
V. Behar ◽  
V. Bogdanova

Abstract In this paper the use of a set of nonlinear edge-preserving filters is proposed as a pre-processing stage with the purpose to improve the quality of hyperspectral images before object detection. The capability of each nonlinear filter to improve images, corrupted by spatially and spectrally correlated Gaussian noise, is evaluated in terms of the average Improvement factor in the Peak Signal to Noise Ratio (IPSNR), estimated at the filter output. The simulation results demonstrate that this pre-processing procedure is efficient only in case the spatial and spectral correlation coefficients of noise do not exceed the value of 0.6


Author(s):  
B. C. King ◽  
J. Hagan ◽  
R. Corroenne ◽  
A. A. Shamshirsaz ◽  
J. Espinoza ◽  
...  

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Hua-hong Wu ◽  
Feng-qi Wu ◽  
Yang Li ◽  
Jian-ming Lai ◽  
Gai-xiu Su ◽  
...  

Abstract Background Juvenile idiopathic arthritis (JIA) may seriously affects patients’ quality of life (QoL), but it was rarely focused and studied in China, so we explore JIA children’s QoL using Chinese version of the PedsQL4.0 Generic Core and PedsQL3.0 Rheumatology Module scale, and analyzed the psychometric properties of these two Scales among Chinese JIA children. Methods We recruited 180 JIA patients from Children's Hospital Affiliated to Capital Institute of Pediatrics and Hebei Yanda Hospital from July 2018 to August 2019. The questionnaires include information related on JIA, PedsQL4.0 generic core and PedsQL3.0 Rheumatology Module scales. According to the disease type, onset age of and course of JIA, we divided them into different groups, then compared the QoL status among different groups. Moreover, we analyzed the reliability and validity of these two scales in these 180 JIA children. Results The mean score of PedsQL4.0 generic core scale on these 180 patients was 82.85 ± 14.82, for these in active period was 72.05 ± 15.29, in remission period was 89.77 ± 9.23; the QoL score of systemic, polyarticular and oligoarticular JIA patients were 77.05 ± 19.11, 84.33 ± 12.46 and 87.12 ± 10.23. The mean score of PedsQL3.0 Rheumatology Module scale on 180 patients was 91.22 ± 9.45, for these in active period was 84.70 ± 11.37, in remission period was 95.43 ± 4.48; the QoL score of systemic, polyarticular and oligoarticular JIA patients were 89.41 ± 11.54, 89.38 ± 10.08 and 93.71 ± 6.92. In the PedsQL 4.0 Generic Core scale, the α coefficients of total scale and almost every dimension are all greater than 0.8 except for the school activity dimension of 0.589; the correlation coefficients of 22 items’ scores (total 23 items) with the scores of dimensions they belong to are greater than 0.5 (maximum value is 0.864), and the other one is 0.406. In PedsQL3.0 Rheumatology Module scale, except for the treatment and worry dimensions of 0.652 and 0.635, the α coefficients of other dimensions and the total scale are all greater than 0.7; the correlation coefficients of all items’ score were greater than 0.5 (the maximum is 0.933, the minimum is 0.515). Conclusions The QoL of Chinese JIA children is worse than their healthy peers, these in active period and diagnosed as systemic type were undergoing worst quality of life. The reliability and validity of PedsQL 4.0 Generic Core and PedsQL3.0 Rheumatology Module scale in Chinese JIA children are satisfactory, and can be used in clinical and scientific researches.


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