Analytical and clinical evaluation of an electrochemiluminescence immunoassay for the determination of CA 125

Abstract The CA 125 II assay on the Elecsys® 2010 analyzer was evaluated in an international multicenter trial. Imprecision studies yielded within-run CVs of 0.8–3.3% and between-day CVs of 2.4–10.9%; CVs for total imprecision in the manufacturer’s laboratory were 2.4–7.8%. The linear range of the assay extended to at least 4500 kilounits/L (three decades). Interference from triglycerides (10.3 mmol/L), bilirubin (850 μmol/L), hemoglobin (1.1 mmol/L), anticoagulants (plasma), and several widely used drugs was undetectable. Method comparisons with five other CA 125 II assays showed good correlation but differences in standardization. A 95th percentile cutoff value of 35 kilounits/L was calculated from values measured in 593 apparently healthy (pre- and postmenopausal) women. In 95% of patients with benign gynecological diseases CA 125 was ≤190 kilounits/L; 63% of patients with newly diagnosed ovarian carcinoma had values >190 kilounits/L. A comparison of CA 125 values obtained with the Elecsys test and with other common CA 125 tests in monitored patients being treated for ovarian cancer showed identical patterns. In conclusion, the Elecsys CA 125 II assay is linear over a broad range, yields precise and accurate results, is free from interferences, and compares well with other assays.

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Comparison of serum CYFRA 21-1 and ROMA in distinguishing ovarian cancer from benign pelvic masses.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e15565 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e15565-e15565

Author(s):

Zhong-Qian Li ◽

Robert J Smalley ◽

Curtis L Glover ◽

Savitha Raju ◽

Katherine Falcone ◽

...

Keyword(s):

Ovarian Cancer ◽

Cohort Study ◽

Single Point ◽

Pelvic Mass ◽

Cancer Biomarker ◽

Ca 125 ◽

Serum Samples ◽

Gynecological Diseases ◽

Benign Gynecological Diseases ◽

Female Subjects

e15565 Background: CYFRA 21-1 is a known lung cancer biomarker. In subjects with ovarian cancer (OC) versus those with benign gynecological diseases, serum CYFRA 21-1 was reported sensitivities (SN) of 44% and 41% at specificity (SP) of 95% for OC detection using an ELISA assay by Hasholzner U (1994) and Tempfer C (1998), respectively. Nolen B (2010) reported a SN of 84.1% and 85.8% and a SP of 85% and 79.3% with a combination of CYFRA 21-1, CA 125 and HE4 using a multiplex bead-based immunoassay in a training and validation set, respectively. We carried out a cohort study to evaluate the serum CYFRA 21-1 as an ovarian cancer biomarker and compared it with ROMA (Risk of Ovarian Malignancy Algorithm), an FDA-cleared ovarian cancer algorithm. Methods: ARCHITECT CYFRA 21-1 assay was used to measure the levels of serum CYFRA 21-1. Single point serum samples from 170 female subjects with a pelvic mass were randomly selected from an archive cohort of female subjects. Among the 170 subjects, 47 had OC (42 with epithelial OC and 5 with low malignant potential tumor) and 123 with benign gynecological diseases. ROMA values were obtained with HE4 EIA and ARCHITECT CA 125 II. Results: For ARCHITECT CYFRA 21-1, the ROC-AUC, cut-off, SN, SP, PPV and NPV were 86%, 1.8 ng/mL, 70.2% (95% CI: 55.1% to 82.7%), 95.1% (95% CI: 89.7% to 98.2%), 84.6% and 89.3%, repectively. For ROMA algorithm, the ROC-AUC, cut-off, SN, SP, PPV and NPV were 92%, 2.44, 89.4% (95% CI: 76.9% to 96.5%), 84.6% (95% CI: 76.9% to 90.4%), 68.9% and 95.4%, repectively. Chi-square test showed an SN for ROMA was significantly higher than that of ARCHITECT CYFRA 21-1 (p < 0.05), and SP for ARCHITECT CYFRA 21-1 was significantly higher than that of ROMA (p < 0.01). Conclusions: In distinguishing OC from benign gynecological diseases, ROMA algorithm appears to be more sensitive than serum ARCHITECT CYFRA 21-1 (p < 0.05), and serum ARCHITECT CYFRA 21-1 appears to be more specific than (p < 0.01) in this cohort study.

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Faculty Opinions recommendation of A multicenter trial of 6-mercaptopurine and prednisone in children with newly diagnosed Crohn's disease.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718140557.793485246 ◽

2013 ◽

Author(s):

Richard Pollok

Keyword(s):

Crohn’S Disease ◽

Crohn's Disease ◽

Multicenter Trial ◽

Newly Diagnosed

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Determination of Similarity Cutoff Value for the Classification of Macrobenthic Communities in the Korean Coast

Ocean Science Journal ◽

10.1007/s12601-021-00020-4 ◽

2021 ◽

Author(s):

Jae-Won Yoo ◽

Chae-Lin Lee ◽

Sungtae Kim ◽

Su-Young Jeong ◽

Chang-Gun Lee ◽

...

Keyword(s):

Cutoff Value ◽

Macrobenthic Communities

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Determination of the optimal cutoff values and validity of the Purdue Pegboard Test

British Journal of Occupational Therapy ◽

10.1177/03080226211008046 ◽

2021 ◽

pp. 030802262110080

Author(s):

Ilkem Ceren Sigirtmac ◽

Cigdem Oksuz

Keyword(s):

Construct Validity ◽

Hand Function ◽

Area Under The Curve ◽

Hand Injury ◽

Cutoff Value ◽

Cutoff Values ◽

Hand Dexterity ◽

Valid Instrument ◽

Healthy Participants

Introduction The Purdue Pegboard Test (PPT) is crucial for assessing fine dexterity of patients with hand injury. Determining the PPT cutoff value is needed to distinguish patients with impaired hand dexterity from those with unimpaired hand dexterity. The aim of this article is to examine the construct validity of PPT and to determine its cutoff values for patients with hand injuries. Method The PPT and Disabilities of Arm Shoulder and Hand Questionnaire Turkish version (DASH-T) were used to measure hand dexterity. To examine construct validity, we measured the correlation between PPT and DASH-T. The cutoff values were determined using the receiver operating characteristic (ROC) curve generated with sensitivity and 1-specificity. We recruited 101 patients with hand injury and 162 healthy participants. Results Correlation between all subtests of PPT and DASH-T were weak ( r = −0.282; −0.473: p<0.05). The cutoff value for the assembly subtest of PPT was 24.5. The range of area under the curve (AUC) values for PPT subtests was good to excellent (AUC: 0.82–0.92). Conclusion The current study demonstrates that PPT is a valid instrument for measuring hand dexterity in patients with hand injury. Results also suggest that PPT distinguished the patients with impaired hand function from those with unimpaired hand dexterity.

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