Évaluation analytique multicentrique du bilan thyroïdien proposé par Ortho-Clinical Diagnostics sur le système Vitros ECi

1998 ◽  
Vol 13 (6) ◽  
pp. 377-387
Author(s):  
P Carayon ◽  
P Douet ◽  
A Gruson ◽  
J.P. Klein ◽  
P.J. Lejeune ◽  
...  
Keyword(s):  
Clinical Diagnostics ◽  
Ortho Clinical Diagnostics

Analytical assessment of ortho clinical diagnostics high-sensitivity cardiac troponin I assay

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Peter A. Kavsak ◽  
Tara Edge ◽  
Chantele Roy ◽  
Paul Malinowski ◽  
Karen Bamford ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
Clinical Performance ◽  
Characteristic Curve ◽  
Area Under The Curve ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Clinical Diagnostics ◽  
Ortho Clinical Diagnostics

AbstractObjectivesTo analytically evaluate Ortho Clinical Diagnostics VITROS high-sensitivity cardiac troponin I (hs-cTnI) assay in specific matrices with comparison to other hs-cTn assays.MethodsThe limit of detection (LoD), imprecision, interference and stability testing for both serum and lithium heparin (Li-Hep) plasma for the VITROS hs-cTnI assay was determined. We performed Passing-Bablok regression analyses between sample types for the VITROS hs-cTnI assay and compared them to the Abbott ARCHITECT, Beckman Access and the Siemens ADVIA Centaur hs-cTnI assays. We also performed Receiver-operating characteristic curve analyses with the area under the curve (AUC) determined in an emergency department (ED)-study population (n=131) for myocardial infarction (MI).ResultsThe VITROS hs-cTnI LoD was 0.73 ng/L (serum) and 1.4 ng/L (Li-Hep). Stability up to five freeze-thaws was observed for the Ortho hs-cTnI assay, with the analyte stability at room temperature in serum superior to Li-Hep with gross hemolysis also affecting Li-Hep plasma hs-cTnI results. Comparison of Li-Hep to serum concentrations (n=202), yielded proportionally lower concentrations in plasma with the VITROS hs-cTnI assay (slope=0.85; 95% confidence interval [CI]:0.83–0.88). In serum, the VITROS hs-cTnI concentrations were proportionally lower compared to other hs-cTnI assays, with similar slopes observed between assays in samples frozen <−70 °C for 17 years (ED-study) or in 2020. In the ED-study, the VITROS hs-cTnI assay had an AUC of 0.974 (95%CI:0.929–0.994) for MI, similar to the AUCs of other hs-cTn assays.ConclusionsLack of standardization of hs-cTnI assays across manufacturers is evident. The VITROS hs-cTnI assay yields lower concentrations compared to other hs-cTnI assays. Important differences exist between Li-Hep plasma and serum, with evidence of stability and excellent clinical performance comparable to other hs-cTn assays.

scholarly journals Selecting COVID-19 Convalescent Plasma for Neutralizing Antibody Potency Using a High-capacity SARS-CoV-2 Antibody Assay

2020 ◽  
Author(s):  
Erin Goodhue Meyer ◽  
Graham Simmons ◽  
Eduard Grebe ◽  
Michael Gannett ◽  
Sergej Franz ◽  
...  
Keyword(s):  
Predictive Value ◽  
Neutralizing Antibodies ◽  
High Capacity ◽  
Neutralizing Antibody ◽  
Clinical Diagnostics ◽  
Characteristic Analysis ◽  
Assay Methods ◽  
Ortho Clinical Diagnostics ◽  
The Cost ◽  
Selection Of

BACKGROUND: Efficacy of COVID-19 convalescent plasma (CCP) to treat COVID-19 is hypothesized to be associated with the concentration of neutralizing antibodies (nAb) to SARS-CoV-2. High capacity serologic assays detecting binding antibodies (bAb) have been developed, nAb assays are not adaptable to high-throughput testing. We sought to determine the effectiveness of using surrogate bAb signal-to-cutoff ratios (S/CO) in predicting nAb titers using a pseudovirus reporter viral particle neutralization (RVPN) assay. METHODS: CCP donor serum collected by 3 US blood collectors was tested with a bAb assay (Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 Total, CoV2T) and a nAb RVPN assay. CoV2T prediction effectiveness at S/CO thresholds was evaluated for RVPN nAb NT50 titers using receiver operating characteristic analysis. RESULTS: 753 CCPs were tested with median CoV2T S/CO of 71.2 and median NT50 of 527.5. Proportions of CCP donors with NT50 over various target nAb titers were 86% ≥1:80, 76% ≥1:160, and 62%≥1:320. Increasing CoV2Ts reduced the sensitivity to predict NT50 titers, while specificity to identify those below thresholds increased. As the targeted NT50 increased, the positive predictive value fell with reciprocal increase in negative predictive value. S/CO thresholds were thus less able to predict target NT50 titers. CONCLUSION: Selection of a clinically effective nAb titer will impact availability of CCP. Product release with CoV2T assay S/CO thresholds must balance the risk of releasing products below target nAb titers with the cost of false negatives. A two-step testing scheme may be optimal, with nAb testing on CoV2T samples with S/COs below thresholds.

scholarly journals Routine free thyroxine reference intervals are suboptimal for monitoring children on thyroxine replacement therapy and target intervals need to be assay-specific

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Elizabeth Wheeler ◽  
Kay Weng Choy ◽  
Lit Kim Chin ◽  
Nilika Wijeratne ◽  
Alan McNeil ◽  
...  
Keyword(s):  
Thyroid Function ◽  
Reference Intervals ◽  
Clinical Diagnostics ◽  
Free Thyroxine ◽  
Thyroid Function Tests ◽  
Free Triiodothyronine ◽  
Central Hypothyroidism ◽  
Thyroxine Replacement ◽  
Ortho Clinical Diagnostics ◽  
Serum Tsh

AbstractCentral hypothyroidism is a condition where there is (qualitatively or quantitatively) TSH deficiency, leading to reduced thyroid hormone production. In such patients, serum TSH does not accurately reflect the adequacy of thyroxine replacement, as the log-linear relationship between thyrotropin (TSH) and free thyroxine (FT4) is lost. We aimed to prospectively determine the optimal physiological FT4 treatment range for children treated for primary hypothyroidism, based on their serum TSH concentrations. This information could be used to guide optimal therapy for all children on thyroxine replacement, including those with central hypothyroidism. In total, sixty children (median age: 11 years, range: 11 months to 18 years) were recruited over 21 months. They were prescribed a stable dose of thyroxine for at least 6–8 weeks prior to a thyroid function test that consisted of serum TSH, FT4 and free triiodothyronine (FT3) measurements. The serum sample for the thyroid function tests was collected before ingestion of the daily dose, i.e. the trough concentration, and measured using Beckman Coulter UniCel DxI 800 instrument, Siemens Advia Centaur, Roche Cobas, Abbott Architect, Ortho Clinical Diagnostics Vitros 5600 (Ortho-Clinical Diagnostics, Raritan, NJ) platforms. The FT4 and FT3 reference intervals showed significant inter-method difference. The lower limit of the FT4 reference intervals were generally shifted mildly higher when the TSH concentration of the children were restricted from 0.5–5.0 mIU/L to 0.5–2.5 mIU/L. By contrast, the upper limit of the FT3 and FT4 reference intervals were relatively stable for the different TSH concentrations. Assay-specific target ranges for optimal thyroxine therapy are required until FT4 assay standardisation is realised.

scholarly journals Disagreement between Cardiac Troponin Tests Yielding a Higher Incidence of Myocardial Injury in the Emergency Setting

2021 ◽  
Vol 8 (3) ◽  
pp. 31
Author(s):  
Peter A. Kavsak ◽  
Shawn E. Mondoux ◽  
Janet Martin ◽  
Mark K. Hewitt ◽  
Lorna Clark ◽  
...  
Keyword(s):  
Cardiac Troponin ◽  
Myocardial Injury ◽  
Ethylenediaminetetraacetic Acid ◽  
High Sensitivity ◽  
Clinical Diagnostics ◽  
Emergency Setting ◽  
Analytical Sensitivity ◽  
Edta Plasma ◽  
Ortho Clinical Diagnostics

Differences in patient classification of myocardial injury between high-sensitivity cardiac troponin (hs-cTn) assays have largely been attributed to assay design and analytical sensitivity aspects. Our objective was to compare Ortho Clinical Diagnostics’ (OCD) hs-cTnI assay to OCD’s contemporary/conventional assay (cTnI ES) and another hs-cTnI assay (Abbott hs-cTnI) in samples obtained from different emergency departments (EDs). Two different sample types were evaluated (lithium heparin and ethylenediaminetetraacetic acid (EDTA) plasma) in a non-selected ED population (study 1, n = 469 samples) and in patients for which ED physicians ordered cardiac troponin testing (study 2, n = 1147 samples), from five different EDs. The incidence of injury in study 1 was higher with the OCD hs-cTnI assay (30.9%; 95% CI: 26.9 to 35.2) compared to that of the Abbott hs-cTnI (17.3%; 95% CI: 14.1 to 21.0) and the OCD cTnI ES (15.4%; 95% CI: 12.4 to 18.9) assays, with repeat testing identifying 4.8% (95% CI: 3.0 to 7.5) of the OCD hs-cTnI results with poor reproducibility. In study 2, 4.6% (95% CI: 3.5 to 6.0) of the results were not reported for the OCD hs-cTnI assay (i.e., poor reproducibility) with 12.7% (95%CI: 8.7 to 17.8) of the OCD hs-cTnI results positive for injury being negative for injury with the Abbott hs-cTnI assay. In summary, the OCD hs-cTnI assay yields higher rates of biochemical injury with a higher rate of poor reproducible results in different ED populations.

scholarly journals PREVALENCE OF IRREGULAR RED CELLANTIBODIES IN HEALTHY BLOOD DONORS ATTENDING A TERTIARY CARE HOSPITAL IN SOUTH INDIA

2020 ◽  
pp. 50-51
Author(s):  
Keerthi C ◽  
Arun Rajendran ◽  
Suresh Babu B ◽  
Praveen D ◽  
Sandhya G ◽  
...  
Keyword(s):  
Blood Donors ◽  
Tertiary Care ◽  
Clinical Diagnostics ◽  
Blood Group System ◽  
Care Hospital ◽  
Screening And Identification ◽  
Compatible Blood ◽  
Ortho Clinical Diagnostics ◽  
Low Ionic Strength ◽  
Lewis Blood Group System

Introduction: Red cell antibodies that are found normally in human serum are considered naturally occurring and those are anti A and anti B. All other antibodies directed against RBC antigens are considered “unexpected or irregular". Aim: This study is aimed to evaluate the prevalence of the anti-red blood cell antibodies among healthy blood donors. Material and Methods: Antibody screening and identification was done using commercially available 3 cell and 11 cell reagent cells (0.8% Surgiscreen, Ortho Clinical Diagnostics Limited, USA and Low ionic Strength Saline Ortho Bliss with AHG Cassettes) in antihuman globulin phase. Results: A total of 36,684 donors were screened for the presence of irregular erythrocyte antibodies. Among these donors, twenty donors showed presence of alloantibodies in their serum (0.054%). Most frequent alloantibodies identified were from Lewis blood group system. The results showed statistically a higher prevalence of RBC alloantibodies in males than in females. Conclusion: Screening for presence of alloantibodies in donor blood is important to provide compatible blood products and to avoid transfusion reactions.

scholarly journals Declining antibody levels to Trypanosoma cruzi correlate with polymerase chain reaction positivity and electrocardiographic changes in a retrospective cohort of untreated Brazilian blood donors

2020 ◽  
Vol 14 (10) ◽  
pp. e0008787
Author(s):  
Lewis F. Buss ◽  
Léa Campos de Oliveira- da Silva ◽  
Carlos H. V. Moreira ◽  
Erika R. Manuli ◽  
Flavia C. Sales ◽  
...  
Keyword(s):  
Trypanosoma Cruzi ◽  
Retrospective Cohort ◽  
Blood Donors ◽  
Parasite Clearance ◽  
Clinical Diagnostics ◽  
Electrocardiographic Changes ◽  
Antibody Decline ◽  
Ortho Clinical Diagnostics ◽  
Antibody Levels

Background Although infection with Trypanosoma cruzi is thought to be lifelong, less than half of those infected develop cardiomyopathy, suggesting greater parasite control or even clearance. Antibody levels appear to correlate with T. cruzi (antigen) load. We test the association between a downwards antibody trajectory, PCR positivity and ECG alterations in untreated individuals with Chagas disease. Methodology/Principal findings This is a retrospective cohort of T. cruzi seropositive blood donors. Paired blood samples (index donation and follow-up) were tested using the VITROS Immunodiagnostic Products Anti-T.cruzi (Chagas) assay (Ortho Clinical Diagnostics, Raritan NJ) and PCR performed on the follow-up sample. A 12-lead resting ECG was performed. Significant antibody decline was defined as a reduction of > 1 signal-to-cutoff (S/CO) unit on the VITROS assay. Follow-up S/CO of < 4 was defined as borderline/low. 276 untreated seropositive blood donors were included. The median (IQR) follow-up was 12.7 years (8.5–16.9). 56 (22.1%) subjects had a significant antibody decline and 35 (12.7%) had a low/borderline follow-up result. PCR positivity was lower in the falling (26.8% vs 52.8%, p = 0.001) and low/borderline (17.1% vs 51.9%, p < 0.001) antibody groups, as was the rate of ECG abnormalities. Falling and low/borderline antibody groups were predominantly composed of individuals with negative PCR and normal ECG findings: 64% and 71%, respectively. Conclusions/Significance Low and falling antibody levels define a phenotype of possible spontaneous parasite clearance.

scholarly journals Ανίχνευση αντιερυθροκυτταρικών αντισωμάτων στην κύηση

2013 ◽  
Author(s):  
Λεοντίνη Φουντουλάκη-Παπαρίζου
Keyword(s):  
Clinical Diagnostics ◽  
Chi Square ◽  
Exact Test ◽  
Fisher's Exact Test ◽  
Fisher’S Exact Test ◽  
Ortho Clinical Diagnostics

Εισαγωγή: Η συχνότητα ανάπτυξης αντιερυθροκυτταρικών αντισωμάτων στις έγκυες στην Ελλάδα δεν είναι γνωστή.Σκοπός Της Μελέτης: H εκτίμηση της συχνότητας και της ειδικότητας των αλλοαντισωμάτων κατά την κύηση στην Ελλάδα και η μελέτη των παραγόντων που σχετίζονται με την εμφάνισή τους.Υλικό Και Μέθοδος: Μελετήθηκαν 4638 έγκυες γυναίκες μεταξύ Ιανουάριου 2006 και Ιούνιου 2011 σε δύο Τριτοβάθμια Νοσοκομεία της Αττικής. Έγινε καταγραφή των δημογραφικών στοιχείων και του ιστορικού των εγκύων. Προσδιορίστηκαν η ΑΒΟ ομάδα αίματος, το σύστημα Rhesus D, C c E e και το Kell ενώ η ανίχνευση των αλλοαντισωμάτων (έμμεση δοκιμασία Coombs) έγινε με πλήρως αυτοματοποιημένη μέθοδο (INNOVA Ortho Clinical Diagnostics). Η ταυτοποίηση των αλλοαντισωμάτων έγινε με panel ερυθροκυττάρων γνωστής αντιγονικής σύνθεσης των εταιρειών Ortho Clinical Diagnostics και Diamed. Η στατιστική ανάλυση (chi-square και Fisher's exact test) έγινε με τη χρήση του προγράμματος Prism 2.Αποτελέσματα: Από τις 4368 έγκυες που μελετήθηκαν, 3292 (75,37%) ήταν ελληνίδες και 1076 (24,63%) αλλοδαπές. Ανιχνευτήκαν 41 αλλοαντισώματα σε 39 αλλοανοσοποιημένες εγκυμονούσες (0,89%). Η συχνότητα αλλοανοσοποίησης ήταν 0,66% (22/3292) στις ελληνίδες και 1,76% (17/1076) στις αλλοαδαπές (p=0,01).Το συχνότερο κλινικά σημαντικό αλλοαντίσωμα ήταν το anti-D, n=8 (0,18%). Το anti-D ήταν σημαντικά συχνότερο στις Rh-D(-) αλλοδαπές 6/104 (5,76%) συγκριτικά με τις Rh-D(-) ελληνίδες 2/353 (0,56%), (p=0,002).Η συχνότητα των αλλοαντισώματων πέραν του anti-D κατανεμήθηκε ως εξής anti-C (0,02%), anti-c (0,05%), anti-E (0,14%) anti-Ce (0,02%), anti-K (0,11%), anti-Jka (0,02%), anti-Jkb (0,02%), anti-Lea (0,09%), anti-M (0,07%). Σε μια έγκυο ανιχνεύθηκαν πολλαπλά αλλοαντισώματα: anti-D+C+Jkb.Η συχνότητα ανάπτυξης ερυθροκυτταρικών αντισωμάτων ήταν σημαντικά μεγαλύτερη στις πολύτοκες σε σχέση με τις πρωτοτόκες (p=0,0088) καθώς και σε αυτές με ιστορικό μετάγγισης (p<0,0001).Συμπεράσματα: Η συχνότητα ανίχνευσης ερυθροκυτταρικών αντισωμάτων στην κύηση στην Ελλάδα είναι: 0,89%.Το anti-RhD είναι το συχνότερο αντίσωμα. Υπάρχει ετερογένεια στην αντιμετώπιση και παρακολούθηση των εγκύων και διαφαίνεται επιτακτική η ανάγκη σύνταξης και εφαρμογής εθνικών κατευθυντήριων οδηγιών για την πρόληψη της αιμολυτικής νόσου του νεογνού.

scholarly journals Performance Evaluation: Four Chemiluminescent SARS-Cov-2 Immunoassays and Rapid-Card Test in Mild Disease and Seroprevalence of SARS CoV-2 in Frontline Healthcare Workers

2021 ◽  
pp. 9-22
Author(s):  
Rasika Setia ◽  
Mitu Dogra ◽  
Anil Handoo ◽  
Gokhula Prasath Thangavel ◽  
Ramesh Yadav ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
Modern Medicine ◽  
Clinical Diagnostics ◽  
Clinical Samples ◽  
New Delhi ◽  
Mild Disease ◽  
Increased Risk ◽  
Sample Testing ◽  
And Performance ◽  
Ortho Clinical Diagnostics

Introduction: The COVID-19 pandemic raised a host of challenges to modern medicine. Key amongst these were in diagnostics, as most SARS-CoV-2 assays had been rapidly developed and released under emergency-use authorization with limited validation on clinical samples and secondly, an increased risk of COVID-19 infection to healthcare workers (HCW). There are limited inter-assay comparisons to detect SARS-CoV-2 antibodies in cases with milder symptoms of COVID-19, necessary to evaluate whether assays can detect SARS-CoV-2 antibodies in patients with mild infection.  Aim: Therefore this study aimed to evaluate the performance of four chemiluminescence immunoassays and a rapid immunochromatographic assay in 100 rRT-PCR diagnosed-recovered frontline HCW with milder COVID-19 disease and secondly to evaluate the seroprevalence of SARS-CoV-2 infection in the asymptomatic frontline HCW at a multispeciality hospital in Delhi, India. Study Design: Serum and plasma samples were obtained from 100 rRT-PCR diagnosed-recovered frontline HCWs with mild disease working across the hospital, and performance of four common chemiluminescence immunoassays evaluated. Also samples of 505 asymptomatic, frontline HCWs working in hospital, who had not developed or shown any symptoms of COVID-19 infection to date was collected and the seroprevalence of infection was evaluated. Place and Duration of the Study: A study was conducted at BLK Superspeciality Hospital, New Delhi from September to October 2020. Methods: Four chemiluminescence immunoassays [Abbott SARS-CoV-2 IgG (Nucleocapsid), Roche Elecsys® Anti-SARS-CoV-2 Total (Nucleocapsid), Ortho-Clinical Diagnostics: VITROS Anti-SARS-CoV-2 IgG (Spike) and Anti-SARS-CoV-2 Total (Spike)] and a rapid assay [Medsource Ozone Biomedicals] were evaluated in 100 rRT-PCR diagnosed-recovered frontline HCW with mild disease. Also, seroprevalence was studied in 505 asymptomatic, frontline HCW.  Results: At manufacturers' thresholds, overall sensitivity for Abbott was 71%, Roche 96%, Ortho (both total and IgG(S) 99% and rapid card 56%. Seroprevalence in asymptomatic frontline HCW was found to be 17.6%, with positivity being higher in the HCW group not facing patients directly compared to direct patient caregivers (P = 0.0034). Conclusion: Assay performance depends on assay design (total IgM & IgG antibodies versus IgG alone), choice of antigen, and time of sample testing from the onset of disease. In our study, Ortho Vitros total-Ab; IgG (Spike), and Roche Elecsys total-Ab (Nucleocapsid) assays were found to have optimal sensitivity. A seroprevalence study in the frontline HCWs at our institute showed that seroprevalence was higher (17.6%) in HCWs in comparison to the community.

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