Performance Characteristics of Seven Automated CA 125 Assays

Mongia, Shella K.; Rawlins, Mindy L.; Owen, William E.; Roberts, William L.

doi:10.1309/nba3-12w0-lanr-xyh9

Cited by 24 publications

(17 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The results on the linearity and imprecision of the assays by DxI were highly acceptable and in accordance with previous reports 12,14-16,21-23. In addition, we compared the results from DxI for CEA, AFP, and CA 125 with those measured by Centaur, and for CA 15-3 and CA 19-9 with those measured by ECi, as our laboratory currently uses Centaur and ECi, which were intended to be replaced with DxI, for assaying these respective tumor markers.…”

Section: Discussionsupporting

confidence: 91%

“…The concordance between assay systems can vary according to the evaluated tumor markers and researchers 12,15,16,21,22. Therefore, even though the results, on average, agreed fairly well across the assays, when replacing tumor marker assays for clinical use, parallel tests by old and new methods are recommended to establish a new baseline in the management of patients.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of the UniCel™ DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers

Park

et al. 2012

Yonsei Med J

View full text Add to dashboard Cite

PurposeTumor marker concentrations in a given specimen measured by different analyzers vary according to assay methods, epitopes for antibodies used, and reagent specificities. Although great effort in quality assessment has been instituted, discrepancies among results from different analyzers are still present. We evaluated the assay performance of the UniCel™ DxI 800 automated analyzer in measuring the alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), carbohydrate antigen (CA) 125, CA 15-3 and CA 19-9 tumor markers.Materials and MethodsThe linearity and precision performance of the five tumor marker assays were evaluated, and concentrations of the respective markers as measured by DxI were compared to those measured by other conventional analyzers (ADVIA Centaur™ and Vitros™ ECi) using 200 specimens collected from 100 healthy persons and 100 patients with respective cancers.ResultsThe linear fits for all five tumor markers were statistically acceptable (F=4648 for AFP, F=15846 for CEA, F=6445 for CA 125, F=2285 for CA 15-3, F=7459 for CA 19-9; p<0.0001 for all). The imprecision of each tumor marker assay was less than 5% coefficient of variation, except for low and high concentrations of AFP. The results from UniCel™ DxI 800 were highly correlated with those from other analyzers.ConclusionOur results demonstrate that UniCel™ DxI 800 has good linearity and precision performance for the tumor markers assayed in this study. However, there were discrepancies between assaying methods. Efforts to standardize tumor marker assays should be undertaken, and the redetermination of cut-off levels is necessary when developing methods of analyzing tumor markers.

show abstract

Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Evaluation of the UniCel™ DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers

Park

et al. 2012

Yonsei Med J

View full text Add to dashboard Cite

show abstract

“…(39) A further limitation: ROCA screening, even in high-risk populations, requires screening many women to detect a few early-stage cases. In the combined studies, 3 early-stage invasive incident cases were detected that may have been clinically detected in late-stage without screening in 13,080 woman-years , i.e .…”

Section: Discussionmentioning

confidence: 99%

Early Detection of Ovarian Cancer using the Risk of Ovarian Cancer Algorithm with Frequent CA125 Testing in Women at Increased Familial Risk – Combined Results from Two Screening Trials

Skates

Greene

Buys

et al. 2017

Clinical Cancer Research

117

View full text Add to dashboard Cite

Purpose Women at familial/genetic ovarian cancer risk often undergo screening despite unproven efficacy. Research suggests each woman has her own CA125 baseline; significant increases above this level may identify cancers earlier than standard 6–12 monthly CA125>35U/mL. Experimental Design Data from prospective Cancer Genetics Network and Gynecologic Oncology Group trials, which screened 3,692 women (13,080 woman-screening years) with a strong breast/ovarian cancer family history or BRCA1/2 mutations, were combined to assess a novel screening strategy. Specifically, serum CA125 q3 months, evaluated using a risk of ovarian cancer algorithm (ROCA), detected significant increases above each subject’s baseline, which triggered transvaginal ultrasound. Specificity and PPV were compared with levels derived from general population screening (specificity 90%, PPV 10%), and stage-at-detection was compared with historical high-risk controls. Results Specificity for ultrasound referral was 92% vs. 90% (p=0.0001), and PPV was 4.6% vs. 10% (p>0.10). Eighteen of 19 malignant ovarian neoplasms (prevalent=4, incident=6, RRSO=9) were detected via screening or risk-reducing salpingo-oophorectomy (RRSO). Amongst incident cases (which best reflect long-term screening performance), 3/6 invasive cancers were early-stage (I/II) (50% versus 10% historical BRCA1 controls; p=0.016). Six of 9 RRSO-related cases were stage I. ROCA flagged 3/6 (50%) incident cases before CA125 exceeded 35U/mL. Eight of 9 stages 0/I/II ovarian cancer patients were alive at last follow-up (median 6 years). Conclusions For screened women at familial/genetic ovarian cancer risk, ROCA q3 months had better early-stage sensitivity at high specificity, and low yet possibly acceptable PPV compared with CA125>35 U/mL q6/q12 months, warranting further larger cohort evaluation.

show abstract

“…There were one gynecological oncologist and seven gynecologists with different, nononcologic subspecialties doing the cytoreductive surgery. The serum CA125 levels were obtained from the Clinical Chemistry Laboratory database and were measured with a commercially available automatic secondgeneration assay using two monoclonal antibodies (26) .…”

Section: Study Populationmentioning

confidence: 99%

Preoperative serum CA125 levels do not predict suboptimal cytoreductive surgery in epithelial ovarian cancer

Arits,

Stoot,

Botterweck

et al. 2008

Int J Gynecol Cancer

View full text Add to dashboard Cite

The objective is to assess the ability of preoperative serum CA125 levels to identify patients at high risk of suboptimal cytoreductive surgery for epithelial ovarian cancer (EOC). One hundred and thirty-two women diagnosed with EOC between 1998 and 2004, who had serum CA125 levels measured preoperatively and received primary cytoreductive surgery, were retrospectively evaluated. The value of CA125 and patient and disease characteristics to predict suboptimal cytoreduction were determined, and a prognostic scoring system, based on statistically significant variables, was created. Optimal cytoreduction was achieved in 42.7% of the women with FIGO stage III/IV EOC. The optimal cutoff point of preoperative CA125 to predict surgical outcome in this group was 330 U/mL (sensitivity 80.0%; specificity 41.5%). The area under the receiver-operating characteristic curve (AUC) for preoperative CA125 predicting suboptimal surgery in FIGO stage III/IV was 0.576 (P= 0.617). Preoperative radiologic amount of ascites and weight loss (ie, ≥10% in the last 6 months before diagnosis) were independent prognostic factors for suboptimal cytoreduction, showing an AUC of 0.76 (P< 0.001) in women with FIGO stage III/IV. A prognostic scoring system showed that the chance of suboptimal surgery was 84.6% in FIGO stage III/IV when both these factors are present preoperatively. The role of CA125 levels predicting suboptimal cytoreduction seems questionable. Instead, women with considerable weight loss and a gross amount of ascites have a higher risk of suboptimal cytoreduction. These patients may be candidates for neoadjuvant chemotherapy.

show abstract

Performance Characteristics of Seven Automated CA 125 Assays

Cited by 24 publications

References 15 publications

Evaluation of the UniCel™ DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers

Evaluation of the UniCel™ DxI 800 Immunoassay Analyzer in Measuring Five Tumor Markers

Early Detection of Ovarian Cancer using the Risk of Ovarian Cancer Algorithm with Frequent CA125 Testing in Women at Increased Familial Risk – Combined Results from Two Screening Trials

Preoperative serum CA125 levels do not predict suboptimal cytoreductive surgery in epithelial ovarian cancer

Contact Info

Product

Resources

About