Multicenter evaluation of the analytical and clinical performance of the Elecsys ® S100 immunoassay in patients with malignant melanoma

2005 ◽  
Vol 43 (5) ◽  
Author(s):  
Bettina Alber ◽  
Rüdiger Hein ◽  
Claus Garbe ◽  
Ulrich Caroli ◽  
Peter B. Luppa
Keyword(s):  
Malignant Melanoma ◽  
Multicenter Study ◽  
Clinical Performance

AbstractThe aim of this multicenter study was to evaluate the technical and clinical performance of the Elecsys

scholarly journals 1088. Ultrasensitive Detection of C. difficile Toxins in Stool Using Single Molecule Counting Technology: A Multicenter Study for Evaluation of Clinical Performance

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S325-S326 ◽  
Author(s):  
Stephen Young ◽  
Ray Mills ◽  
Christen Griego-Fullbright ◽  
Aaron Wagner ◽  
Emily Herding ◽  
...  
Keyword(s):  
Single Molecule ◽  
Multicenter Study ◽  
Clinical Performance ◽  
Turnaround Time ◽  
Neutralization Assay ◽  
Single Step ◽  
Reporting Structure ◽  
One Step ◽  
Automated Immunoassay ◽  
Higher Sensitivity

Abstract Background Commercially available tests for Clostridium difficile infection (CDI) make test selection by the laboratory difficult due to the following unsatisfactory characteristics: long turnaround time, poor sensitivity, and/or poor specificity. The Singulex Clarity® C. diff toxins A/B assay (in development) is a rapid and automated immunoassay for the detection of C. difficile toxins A and B in stool, with analytical limits of detection for toxins A and B at 2.0 and 0.7 pg/mL, respectively. In this multicenter study, the clinical performance of the Singulex Clarity C. diff toxins A/B assay was compared with standalone PCR, a multistep algorithm with enzyme immunoassay (EIA) and PCR, and cell cytotoxicity neutralization assay (CCNA). Methods Fresh samples from 267 subjects with suspected CDI were tested at two sites (Minneapolis Medical Research Foundation and TriCore Reference Laboratories) with the Singulex Clarity assay, PCR (Xpert®C. difficile), and EIA (C. Diff Quik Chek Complete®) for GDH and toxin testing. The performance of the assays and multistep algorithms were evaluated against CCNA (Microbiology Specialists, Inc.). Results The overall CDI prevalence was 15.7%. The Singulex Clarity C. diff toxins A/B assay had 90.5% sensitivity and 96.0% specificity, with a 98.2% negative predictive value when compared with CCNA, and the Clarity assay’s AuROC was 0.9534. PCR had 90.5% sensitivity and 91.1% specificity. Compared with CCNA, the toxin EIA had 47.6% sensitivity and 100% specificity. Testing with a multistep algorithm using EIA with discordant results reflexed to PCR resulted in 85.7% sensitivity and 94.7% specificity. Conclusion The ultrasensitive Singulex Clarity C. diff toxins A/B assay is equivalent to the sensitivity of PCR while providing higher specificity. Compared with a multistep algorithm, the Clarity assay provides higher sensitivity and specificity while providing faster time-to-result in a simpler-to-understand, one-step reporting structure, allowing for a standalone, single-step solution for detection of C. difficile toxins in patients with suspected CDI. Disclosures E. Friedland, Singulex, Inc.: Employee, Salary. A. Bartolome, Singulex, Inc.: Employee, Salary. A. Almazan, Singulex, Inc.: Employee, Salary. S. Tam, Singulex, Inc.: Employee, Salary. S. Biscocho, Singulex, Inc.: Employee, Salary. S. Abusali, Singulex, Inc.: Employee, Salary. J. Sandlund, Singulex, Inc.: Employee, Salary. J. Estis, Singulex, Inc.: Employee, Salary. J. Bishop, Singulex, Inc.: Employee, Salary.

P-17 A multicenter study of neoadjuvant biochemotherapy in patients with stage III malignant melanoma

2007 ◽  
Vol 17 (1) ◽  
pp. A24
Author(s):  
Karl Lewis ◽  
William A. Robinson ◽  
Martin McCarter ◽  
Nathan Pearlman ◽  
Steven O??Day ◽  
...  
Keyword(s):  
Malignant Melanoma ◽  
Multicenter Study ◽  
Stage Iii

The effect of [-2]proPSA and prostate health index (phi) on the accuracy of the prediction of initial and repeat prostate biopsies compared to tPSA and percent fPSA in young men (age 65 or younger).

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 171-171
Author(s):  
Martin Boegemann ◽  
Sébastien Vincendeau ◽  
Carsten Stephan ◽  
Alain Houlgatte ◽  
Laura-Maria Krabbe ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Clinical Performance ◽  
Univariate Analysis ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Young Men ◽  
Health Index ◽  
Serum Samples ◽  
Prostate Health Index ◽  
Prostate Health

171 Background: Prostate-specific antigen (tPSA) based screening reduces mortality. But recent recommendations do not endorse PSA-screening due to possible over-diagnosis and over-treatment and the resulting harm afflicted to patients. Screening studies showed the maximum benefit in young men age 65 or younger. tPSA and percent free PSA (%fPSA) lack specificity in the diagnosis of PCa. [-2]proPSA and the "prostate health index" (phi) improve this diagnostic specifity in a non-age adjusted population. Markers to diagnose clinicaly relevant cancers in young men are needed. Methods: The clinical performance of [-2]proPSA and phi were evaluated in a multicenter study. A total of 1,362 patients (769 age 65 or younger) scheduled for initial or repeated prostate biopsy (668 with, 694 without PCa, each 10 or more core biopsies) were recruited in four different sites based on PSA level 1.6 to 8.0 ng/mL WHO-calibrated (2-10 ng/mL classically calibrated). Serum samples taken prior to digital rectal examination (DRE) were measured for the concentration of tPSA, fPSA and [-2]proPSA with Beckman Coulter immunoassays on Access 2 or DxI800 instruments. Phi was calculated as: [-2]proPSA/fPSA x √tPSA. Results: In univariate analysis [-2]proPSA/fPSA (%[-2]proPSA) and phi were the best predictors of PCa detection in patients at initial biopsy (AUC: 0,72 and 0,73) and repeated biopsy (AUC: 0,74 and 0,74). Analysis of the data for men age 65 and younger (n=593) showed that %[-2]proPSA and phi significantly improved PCa dectection (AUC: 0,72 and 0,73) as compared with tPSA (AUC: 0,53) or %fPSA (AUC: 0,62). In the detection of significant PCa (based on PRIAS criteria) %[-2]proPSA and phi demonstrated the best performance in the whole cohort and in young men (65 and younger) years as well (AUC 0,68 and 0,73). Conclusions: This multicenter study showed that [-2]proPSA and phi have a superior clinical performance in detecting PCa in the PSA range of 2 to 10 ng/mL compared to tPSA and %fPSA at initial and repeat biopsies. This superiority is maintained for the detection of PCa in young men (age 65 or younger).

scholarly journals Multicenter Study of Clinical Performance of the 3M Rapid Detection RSV Test

2010 ◽  
Vol 48 (7) ◽  
pp. 2337-2343 ◽  
Author(s):  
C. C. Ginocchio ◽  
E. Swierkosz ◽  
A. J. McAdam ◽  
M. Marcon ◽  
G. A. Storch ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Rapid Detection ◽  
Clinical Performance

Treatment outcomes of sinonasal malignant melanoma: a Korean multicenter study

2015 ◽  
Vol 5 (10) ◽  
pp. 950-959 ◽  
Author(s):  
Tae-Bin Won ◽  
Kyu Young Choi ◽  
Chae-Seo Rhee ◽  
Hong-Ryul Jin ◽  
Jong Sook Yi ◽  
...  
Keyword(s):  
Malignant Melanoma ◽  
Treatment Outcomes ◽  
Multicenter Study ◽  
Sinonasal Malignant Melanoma

Use of [-2]proPSA and prostate health index (phi) to improve the diagnostic accuracy of prostate cancer compared to t-PSA and %f-PSA in young men (≤ 65 years old).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5074-5074
Author(s):  
Martin Boegemann ◽  
Sebastien Vincendeau ◽  
Carsten Stephan ◽  
Alain Houlgatte ◽  
Laura-Maria Krabbe ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Multicenter Study ◽  
Clinical Performance ◽  
Univariate Analysis ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Young Men ◽  
Health Index ◽  
Prostate Health Index ◽  
Prostate Health

5074 Background: Although prostate-specific antigen (tPSA) screening reduced prostate cancer (PCa) mortality recent recommendations do not endorse PSA-screening due to overdiagnosis and overtreatment and the resulting harm afflicted to patients. Screening studies showed the maximum benefit in young men < 65 years of age. tPSA and percent free PSA (%fPSA) lack specifity in the diagnosis of PCa. [-2]proPSA and the prostate health index (phi) improved this diagnostic specifity. Markers to diagnose clinicaly relevant cancers in young men are needed. Methods: The clinical performance of [-2]proPSA and phi was evaluated in a multicenter study. A total of 1362 patients scheduled for initial or repeated prostate biopsy (668 with, 694 without PCa, each ≥ 10 core biopsies) were recruited in 4 different sites based on PSA level 1.6 – 8.0 ng/mL WHO-calibrated (2-10 ng/mL classically calibrated). Serum samples taken prior to digital rectal examination (DRE) were measured for the concentration of tPSA, fPSA and [-2]proPSA with Beckman Coulter immunoassays on Access 2 or DxI800 instruments. Phi was calculated as [-2]proPSA/fPSA*√tPSA. Results: In univariate analysis [-2]proPSA/fPSA (%[-2]proPSA) and phi were the best predictors of PCa detection in patients at initial biopsy (AUC: 0,72 and 0,73) and repeated biopsy (AUC: 0,74 and 0,74). Analysis of the data for men ≤ 65 years of age (n=593) showed that %[-2]proPSA and phi significantly improved PCa dectection (AUC: 0,72 and 0,73) as compared with tPSA (AUC: 0,54) or %fPSA (AUC: 0,62). In the detection of significant PCa (based on PRIAS criteria) %[-2]proPSA and phi demonstrated the best performance in the whole cohort and in young men (≤ 65) years as well (AUC 0,68 and 0,73). Conclusions: This multicenter study showed that [-2]proPSA and phi have a superior clinical performance in detecting PCa in the PSA range of 2-10 ng/mL compared with tPSA and %fPSA at initial and repeated biopsies. This superiority is maintained for the detection of PCa in young men (≤ 65 years of age).

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