Method comparison of tumor markers assessed by LOCI™- and ECLIA-based technologies

2017 ◽  
Vol 41 (1) ◽  
pp. 3-11
Author(s):  
Ramona C. Dolscheid-Pommerich ◽  
Sarah Dolscheid ◽  
Lars Eichhorn ◽  
Berndt Zur ◽  
Stefan Holdenrieder ◽  
...  

AbstractBackground:Since the introduction of luminescent oxygen channeling immunoassays (LOCI™)-based assays in the daily laboratory routine of tumor marker measurements, only a small number of method comparisons with established immunoassays have been published. We performed a method comparison between LOCI™-based tumor marker assays for Dimension™ VISTA and electrochemiluminiscent immunoassays (ECLIA) for Cobas™ e411, for α-fetoprotein (AFP), carcinoembryonic antigen (CEA), CA 125, CA 15-3, CA 19-9, prostate-specific antigen (PSA) and free PSA (fPSA).Methods:Tumor markers were assessed in 1088 sera from routine diagnostics on the Dimension™ VISTA 1500 and Cobas™ e411 analyzers.Results:Strong correlations were achieved for PSA (r=0.999), AFP (r=0.994) and CEA (r=0.993). Results were quite comparable as only minor slopes of 1.05 (PSA), 1.02 (AFP) and 0.94 (CEA), respectively, were found. However, correlations for CA 125 (r=0.976), CA 19-9 (r=0.960), fPSA (r=0.950) and CA 15-3 (r=0.940) were only moderate, and considerable slopes were observed for these markers with higher values for CA 19-9 (slope 1.50) and lower ones for CA 15-3 (0.76), fPSA (0.75) and CA 125 (0.64), for Dimension™ VISTA 1500.Conclusions:We found excellent correlations and comparable values for AFP, CEA and PSA, but only moderate correlations for fPSA, CA 125, CA 15-3 and CA 19-9. The slopes for CA 19-9, CA 15-3, fPSA and CA 125 have to be considered when analysis methods for tumor markers are changed.

2006 ◽  
Vol 13 (01) ◽  
pp. 1-10
Author(s):  
FAISAL BILAL LODHI ◽  
DR IFTIKHAR ◽  
MUHAMMAD ALI ◽  
Riaz Hussain

With the advent of new generations of chemotherapeutic agents andadvances in radiation therapy in the management of malignancies, an understanding of tumor markers is becomingincreasingly important. These soluble molecules in the blood are usually glycoproteins detected by monoclonalantibodies. Each tumor marker has a variable profile of usefulness for screening, determining diagnosis and prognosis,assessing response to therapy, and monitoring for cancer recurrence. Monoclonal antibodies are used to detect serumantigens associated with specific malignancies. These tumor markers are most useful for monitoring response totherapy and detecting early relapse. With the exception of Prostate-Specific Antigen (PSA), tumor markers do not havesufficient sensitivity or specificity for use in screening. Cancer Antigen (CA) 27.29 most frequently is used to followresponse to therapy in patients with metastatic breast cancer. Carcinoembryonic antigen is used to detect relapse ofcolorectal cancer, and CA 19-9 may be helpful in establishing the nature of pancreatic masses. CA 125 is useful forevaluating pelvic masses in postmenopausal women, monitoring response to therapy in women with ovarian cancer,and detecting recurrence of this malignancy. Alpha-fetoprotein (AFP), a marker for hepatocellular carcinoma,sometimes is used to screen highly selected populations and to assess hepatic masses in patients at particular riskfor developing hepatic malignancy. Testing for the beta subunit of human chorionic gonadotropin (b-hCG) is an integralpart of the diagnosis and management of gestational trophoblastic disease. Combined AFP and b-hCG testing is anessential adjunct in the evaluation and treatment of nonseminomatous germ cell tumors, and in monitoring theresponse to therapy. AFP and b-hCG also may be useful in evaluating potential origins of poorly differentiatedmetastatic cancer. PSA is used to screen for prostate cancer, detect recurrence of the malignancy, and evaluatespecific syndromes of adenocarcinoma of unknown primary. This review article describes the use of common tumormarkers in primary care practice. Particular emphasis is given to when these tests should be ordered and to commonfactors that influence the interpretation of tumor marker levels.


2005 ◽  
Vol 129 (3) ◽  
pp. 331-337
Author(s):  
William E. Schreiber ◽  
David B. Endres ◽  
Geraldine A. McDowell ◽  
Glenn E. Palomaki ◽  
Ronald J. Elin ◽  
...  

Abstract Context.—Most proficiency testing materials (PTM) contain an artificial matrix that may cause immunoassays to perform differently with this material than with clinical samples. We hypothesized that matrix effects would be reduced by using fresh frozen serum (FFS). Objective.—To compare the performance of an FFS pool to standard PTM for measurement of α-fetoprotein, carcinoembryonic antigen, human chorionic gonadotropin (hCG), and prostate-specific antigen (PSA). Design.—One FFS specimen and 4 different admixtures of PTM were distributed in the 2003 College of American Pathologists K/KN-A (for α-fetoprotein, carcinoembryonic antigen, hCG, and total and free PSA) and C-C (hCG only) Surveys. Participants.—The number of laboratories that participated in the surveys varied from a low of 288 (free PSA, K/KN-A Survey) to a high of 2659 (hCG, C-C Survey). Main Outcome Measures.—Method imprecision and method bias were compared between the FFS specimen and the standard PTM specimen with the closest value. Method imprecision was determined by calculating the coefficients of variation for each method and for all methods combined. Bias was defined as the proportional difference between peer-group mean and the median of all method means. Results.—The FFS specimen gave significantly higher imprecision than PTM for the analytes α-fetoprotein, carcinoembryonic antigen, total PSA, and free PSA. For hCG, no substantial imprecision differences were observed in both surveys. Bias was significantly greater for the α-fetoprotein, carcinoembryonic antigen, and total PSA assays and significantly lower for the hCG and free PSA assays when comparing the FFS with the PTM. Conclusions.—Fresh frozen serum did not provide consistently lower imprecision or bias than standard PTM in a survey of commonly ordered tumor markers.


2020 ◽  
Vol 35 (4) ◽  
pp. 35-43
Author(s):  
Jamil A. Al-Mughales ◽  
Mahmood Shaheen Alahwal

Objectives: This study assessed the level of appropriateness of tumor marker requests in a teaching hospital and estimated the financial cost associated with inappropriate use. Methods: A retrospective review of patients’ electronic records was conducted over a 3-year period (2015–2017) for tumor marker requests, including carcinoembryonic antigen, alpha-fetoprotein, cancer antigen (CA)15-3, CA125, CA19-9, and total and free prostate-specific antigen (PSA and fPSA), along with the associated clinical data that motivated the requests. Inappropriate use was defined as tumor marker requests without any relevant clinical picture. Costs due to inappropriate tumor marker requests were estimated based on the unit costs applied in the institution. Results: A total of 7128 patients had at least one tumor marker request between 2015 and 2017. The clinical picture that motivated tumor marker requests was absent in 71.5%, while 12.9% of the requests were associated with a malignancy. The most frequent prescribing pattern was total prostate-specific antigen alone (2128; 29.9%), followed by alpha-fetoprotein alone (1185; 16.6%), and carcinoembryonic antigen alone (506; 7.1%). Year-over-year analysis revealed an increasing tendency in requesting carcinoembryonic antigen and CA15-3. The rate of inappropriate use varied by tumor marker and ranged between 56.4% for fPSA and 86.8% for total prostate-specific antigen. The overall costs due to inappropriate tumor marker requests were estimated at $2,785,493 over the 3 years, representing an average of $0.93 million per year. Conclusion: Inappropriate use of tumor marker requests is a major issue regarding its high prevalence and the considerable associated costs. The role of laboratories in the management of tumor marker requests should be emphasized.


1999 ◽  
Vol 45 (10) ◽  
pp. 1695-1707 ◽  
Author(s):  
Jean-Michel Bidart ◽  
François Thuillier ◽  
Christine Augereau ◽  
Jacqueline Chalas ◽  
Alain Daver ◽  
...  

Abstract Only a few markers have been instrumental in the diagnosis of cancer. In contrast, tumor markers play a critical role in the monitoring of patients. The patient’s clinical status and response to treatment can be evaluated rapidly using the tumor marker half-life (t1/2) and the tumor marker doubling time (DT). This report reviews the interest of determining these kinetic parameters for prostate-specific antigen, human chorionic gonadotropin, α-fetoprotein, carcinoembryonic antigen, cancer antigen (CA) 125, and CA 15-3. A rise in tumor markers (DT) is a yardstick with which benign diseases can be distinguished from metastatic disease, and the DT can be used to assess the efficacy of treatments. A decline in the tumor marker concentration (t1/2) is a predictor of possible residual disease if the timing of blood sampling is soon after therapy. The discrepancies in results obtained by different groups may be attributable to the multiplicity of immunoassays, the intrinsic characteristics of each marker (e.g., antigen specificity, molecular heterogeneity, and associated forms), individual factors (e.g., nonspecific increases and renal and hepatic diseases) and methods used to calculate kinetics (e.g., exponential models and timing of blood sampling). This kinetic approach could be of interest to optimize patient management.


2003 ◽  
Vol 127 (3) ◽  
pp. 345-348 ◽  
Author(s):  
Alexander Kratz ◽  
Kent B. Lewandrowski ◽  
Arthur J. Siegel ◽  
Patrick M. Sluss ◽  
Kelly Y. Chun ◽  
...  

Abstract Context.—Prostate-specific antigen (PSA) is an important tumor marker for the most frequently diagnosed cancer in the United States. A major limitation of this marker is falsely elevated results in patients who are found not to have prostate cancer. The effects of vigorous physical exertion on PSA concentrations are controversial. Objective.—To determine the effects of marathon running on PSA levels. Design.—Measurement of total and free PSA levels in the sera of participants in a marathon before and within 4 and 24 hours after the race. Results.—None of the participants had elevated total PSA levels before the race. Although we found no statistically significant changes in average total or free PSA concentrations at either time point, after the marathon, 2 (11%) of 18 runners had total PSA concentrations outside the standard reference range. Changes in total PSA levels did not correlate with age or prerace PSA concentrations. Free PSA levels were not statistically significantly changed after the race and did not allow a reliable determination of exercise-induced PSA elevations. Conclusions.—Although it may not be necessary for men to abstain from exercise involving running before blood draws for PSA analysis, elevated PSA concentrations may be observed in some individuals after participation in a major sporting event. In these cases, repeat measurements should be considered at a time significantly removed from such exercise.


1995 ◽  
Vol 41 (9) ◽  
pp. 1273-1282 ◽  
Author(s):  
Z Chen ◽  
A Prestigiacomo ◽  
T A Stamey

Abstract We describe for the first time a protocol to purify to apparent homogeneity an in vitro-prepared complex of prostate-specific antigen (PSA) and alpha 1-antichymotrypsin (ACT) by using a combination of gel filtration and ion-exchange chromatography. The purity of the PSA-ACT complex was confirmed by gel electrophoresis and Western blot. The PSA-ACT complex was stable in the pH range 6.0 to 7.8; it was also stable in various matrices, temperatures, and high concentrations of salt. Purification of the PSA-ACT complex was highly reproducible. An absorptivity of 0.99 L x g-1 x cm-1 at 280 nm was assigned to the PSA-ACT complex, based on amino acid analysis. Because PSA and ACT bind in a 1:1 molar ratio, we determined the molecular mass of the PSA-ACT complex as the mass encoded by the cDNA of ACT (plus 26% carbohydrate) plus the molecular mass of PSA (28,430 Da), which totals 89,280 Da. Using this material, we made two common calibrators, one of 100% PSA-ACT complex and one of 90% PSA-ACT complex plus 10% free PSA by volume (90:10 calibrator). Substitution of these calibrators for the manufacturers' calibrators in nine commercial immunoassays substantially reduced differences between immunoassays, especially for serum PSA values between 4 and 10 micrograms/L. The 90:10 calibrator is recommended as a universal calibrator for international standardization of PSA immunoassays.


2012 ◽  
Vol 59 (3) ◽  
pp. 49-56
Author(s):  
Ivana Likic-Ladjevic ◽  
Milan Terzic ◽  
Nebojsa Ladjevic ◽  
Jelena Dotlic ◽  
Igor Pilic ◽  
...  

OBJECTIVE: The aim of the study was to examine several tumor markers and their correlation with pathohistological findings in patients with adnexal masses. METHODS: Study involved 139 patients, 84 of them with benign, 47 with malignant and 8 with borderline adnexal tumor. Levels of CA 125, CA 19-9, CEA and CA 15-3 were obtained preoperatively and assessed regarding the specific pathohistological diagnose and the patient?s age. Obtaining these results led us to divide the patient?s CA 125 levels with age and by doing that we have attained a new Tumor Marker Age score (TMA score). Results: Patients with malignant adnexal tumors had significantly higher levels of CEA (p<0.05), CA 125, CA 19-9 and CA 15-3 tumor markers (p<0.01), in comparison with patients with benign tumors. TMA score highly statistically correlate with the tumor type (benignant/malignant). CONCLUSIONS: With the increase of tumor marker levels and the patient?s age the malignant nature of adnexal tumors is more often. Results of our study highlight the importance of the use of combined tumor markers (at least CA-125 and CA 19-9) in women with adnexal masses. Those levels along with the patient?s age and new TMA score could preoperatively predict malignant nature of the tumor.


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