MESOMARK TM : A Potential Test for Malignant Pleural Mesothelioma
|
|
- Bertram Quinn
- 8 years ago
- Views:
Transcription
1 Clinical Chemistry 53: (2007) Cancer Diagnostics MESOMARK TM : A Potential Test for Malignant Pleural Mesothelioma Heather L. Beyer, Ryan D. Geschwindt, Curtis L. Glover, Ly Tran, Ingegerd Hellstrom, Karl-Erik Hellstrom, M. Craig Miller, Thorsten Verch, W. Jeffrey Allard, * Harvey I. Pass, and Niranjan Y. Sardesai Background: Soluble mesothelin-related peptides (SMRP) have been reported to be potential biomarkers for malignant pleural mesothelioma (MPM). We report analytical and preliminary clinical studies of MESOMARK TM, a quantitative assay for SMRP. Methods: The MESOMARK assay is a 2-step immunoenzymatic assay in an ELISA format with a 6-point calibration curve (0 32 nmol/l). We assessed analytical imprecision, analyte stability, and analytical interferences. We measured SMRP by this assay in 409 apparently healthy individuals (reference interval study), 177 patients with nonmalignant conditions, and 500 cancer patients, including 88 with MPM. Results: The limit of detection was 0.16 nmol/l. At 2 19 nmol/l, intraassay imprecision (CV) was 1.1% 5.3%, and total imprecision was 4.0% 11.0%. The mean dilution recovery for 5 samples was 109% (range, 99% 113%). No interference was seen from added bilirubin (200 mg/l), hemoglobin (500 mg/l), triglycerides (30 g/l), chemotherapeutic agents, or other tested substances. Recombinant mesothelin was stable in serum upon freeze/thaw at 70 C and upon storage for at least 7 days at 2 8 C. The 99 th percentile of the reference group was 1.5 nmol/l [95% confidence interval (CI), nmol/l; n 409], and mean SMRP was significantly higher in sera from patients with MPM (7.5 nmol/l; 95% CI, nmol/l; n 88). SMRP was increased in 52% and 5% of MPM patients and asbestosexposed individuals, respectively. Concentrations in other nonmalignant and malignant conditions were similar to those in healthy controls. Research and Development Division, Fujirebio Diagnostics, Inc., Malvern, PA. * Address correspondence to this author at: Research and Development Division, Fujirebio Diagnostics, Inc., 201 Great Valley Pkwy., Malvern, PA Fax ; allardj@fdi.com. Received August 31, 2006; accepted December 22, Previously published online at DOI: /clinchem Conclusions: The MESOMARK assay is analytically robust and may be useful for the detection and management of mesothelioma American Association for Clinical Chemistry Malignant mesothelioma is a highly aggressive neoplasm with poor prognosis. Mesothelioma accounted for 1.5% of the total lung and bronchus malignancies in the US in 2003 (1, 2), and epidemiological studies have established exposure to asbestos fibers as the primary cause (3 5). Although malignant mesothelioma remains a relatively uncommon malignancy in the US, it continues to be an important cause of mortality in numerous areas worldwide, e.g., England, Wales, continental Europe, and Australia. Because the disease is asymptomatic in early stages and definitive diagnosis is difficult, detection typically occurs at a late stage, and recurrence rates, even in patients with surgically resected tumors, are very high. Treatment efficacy is routinely assessed by clinical symptoms and costly radiologic imaging techniques with limited sensitivity and specificity (6). Thus, there has been an increasing need for a simple diagnostic blood test for screening asbestos-exposed patients as well as for monitoring response to treatment. The MESOMARK assay measures soluble molecules that are related to the mesothelin/megakaryocyte potentiating factor (MPF) 1 family of proteins and recognized by the monoclonal antibody OV569 (7). Mesothelin and MPF are synthesized together as a 69-kDa precursor from which an N-terminal 31-kDa fragment is released as MPF, and mesothelin is the 40-kDa C-terminal membranebound fragment. Immunohistochemical studies revealed 1 Nonstandard abbreviations: MPF, megakaryocyte potentiating factor; SMRP, soluble mesothelin-related peptides; HAMA, human antimouse antibody; RF, rheumatoid factor; AUC, area under the curve; CI, confidence interval. 666
2 Clinical Chemistry 53, No. 4, tissue expression of mesothelin in a variety of tissues, most notably in mesothelioma, lung, ovarian, endometrial, and pancreatic tumors (8). At least 3 known variants of the mesothelin family have been reported in the literature (9, 10). Although early studies indicated that mesothelin was not soluble (11), recent work demonstrated variants 1 and 3 to be soluble, with variant 1 being the predominant form detected in serum (10, 12). Variant 3 contains a 3 frameshift leading to an extended C-terminus, and variant 2 contains a 24-bp insertion and can be detected only at the mrna level. Despite the expression of membrane-bound mesothelin in different tumors, these soluble mesothelin-related peptides (SMRP) have proven to be a promising cancer biomarker in the sera of patients with tumors of mesothelial origin (7, 10). We report here analytical validation studies of the MESOMARK assay, establishing assay performance and its potential utility in a clinical patient population. Materials and Methods mesomark assay The MESOMARK assay (Fujirebio Diagnostics, Inc.) uses antibody 4H3, which binds to mesothelin variants 1, 2, and 3, and antibody 569, which binds to variant 1 and 3 (12). We performed the assay according to the manufacturer s instructions. Briefly, patient serum samples were diluted 1:101 with the assay diluent provided and applied in duplicate to a microwell plate precoated with antibody 4H3. After incubation for 1 h at room temperature, plates were washed, and antibody OV569-HRP conjugate was added for 1 h. After a wash step, TMB substrate was added to the reaction wells for 15 min, and then 100 L of stop solution was added. The absorbance at 450 nm was used to quantify the SMRP concentrations by comparison with a 6-point calibration curve established by a 4-parameter logistic fit using Softmax Pro software (Molecular Devices). Unless otherwise noted, all studies were performed with representative reagent sets from 2 independent lots. Four operators were trained during a 5-day, 10-run training study before the start of analytical MESOMARK tests. primary antigen and assay standardization MESOMARK values are expressed as nmol/l and are related to a reference preparation maintained by Fujirebio Diagnostics, Inc. The reference preparation is a recombinant antigen (reactive with both OV569 and 4H3) produced with a stably transfected cell line, OV569-, immunoaffinity purified, and quantified by amino acid analysis. This cell line has been described in detail elsewhere (10). Antigen concentrations were measured in nanomoles per liter. Primary calibrators and controls were referenced to this preparation and ranged from 0 to 32 nmol/l to cover the majority of the expected range in patient populations. Subsequent lots of antigen (used to manufacture the reagent set calibrators and controls) were matched against the primary calibrators and controls based on absorbance measurement in the MESOMARK assay, allowing for traceability to the reference preparation. samples Serum samples for use in analytical studies were supplemented with recombinant OV569-reactive antigen, whereas serum samples for use in the clinical studies were not supplemented. The latter were collected from apparently healthy volunteers (n 409), as well as from patients with several malignant and nonmalignant conditions. Malignant conditions included mesothelioma (n 88), ovarian cancer (n 111), lung cancer (n 174), colon cancer (n 50), pancreatic cancer (n 52), and endometrial cancer (n 25). Nonmalignant conditions included hypertension (defined as a blood pressure 150/90 mmhg; n 100), exposure to asbestos (n 61), and endometriosis (n 16). Clinical samples were collected retrospectively based on reported diagnosis and blinded to the operator. Invalid results were addressed by retests of the sample in question. These samples were obtained from commercial sources (Biochemed) in 2004 except for samples from mesothelioma patients and asbestos-exposed individuals, which were kindly supplied by Dr. Harvey Pass (Karmanos Cancer Institute, Wayne State University, Detroit, MI). Patients with a histologically confirmed diagnosis of mesothelioma seen at the Karmanos Cancer Institute gave informed consent to have serum, plasma, and normal and tumor tissue samples taken on the day of operative intervention for their tumors. These cases were performed both at the Karmanos Cancer Institute and the National Cancer Institute in Bethesda, Maryland, between 1995 and All blood samples were drawn before anesthesia or before surgery in the clinic, when the patient was examined by the physician. The asbestos-exposed population consisted of patients seen at the Center for Environmental Medicine in Southfield, Michigan, who, after giving informed consent, donated urine and serum. These asbestos-exposed patients also filled out a demographics questionnaire and gave permission for analysis of their pulmonary function tests and radiographic images. All patients provided informed consent, and all procedures and protocols were approved by the institutional review board. analytical methods Analytical Sensitivity. Calibrator A (the assay diluent) was assayed in replicates of 25 for each reagent set lot, and the mean absorbance plus 2 SD was determined and compared with a calibration curve (prepared in duplicate). The detection limit (also called the limit of the blank) was calculated based on the linear segment connecting the A and B calibrators. Imprecision. Within-run and total imprecision values were evaluated according to NCCLS Protocol EP5-A (13). Two replicates each of 3 panels were assayed in 2 separate runs
3 668 Beyer et al.: MESOMARK Test for Malignant Pleural Mesothelioma on each of 20 days, at 2 separate clinical sites. The low-end imprecision was evaluated at a single clinical site by assaying low-end panels (40 runs in 20 days). Panels consisted of defibrinated human plasma supplemented with OV569-reactive antigen (range, nmol/l). Data from the study were analyzed with the Analyze-It software package (Analyze-it Software, Ltd.). Dilution Linearity. Dilution linearity was assessed with a single reagent set lot and modeled after the NCCLS protocol EP6-A (13). Five serum samples from apparently healthy individuals were supplemented with OV569- reactive antigen to 25 nmol/l, followed by dilutions ranging from 1:1.1 to 1:20. Expected and observed SMRP values were compared for each dilution. Recovery. To each of 5 sera we added OV569-reactive antigen at concentrations covering the range of the calibration curve. Using the same reagent set lot, we compared observed and expected sample values. Interference Studies. All interference studies were performed using 1 reagent set lot. Potentially interfering compounds were added at final concentrations 10-fold higher than the expected peak plasma concentrations (C max ) to aliquots of 5 independent serum samples containing OV569-reactive antigen, whereas control samples were treated with the appropriate vehicle solution. Chemotherapeutics included Gemzar (gemcitabine- HCl) and Alimta, both purchased from Eli Lilly and Company, and carboplatin and cisplatin (cis-diammineplatinum dichloride), both purchased from Sigma Chemical. Naturally occurring serum components included hemoglobin (5 g/l), triglycerides (Liposyn, Abbott Diagnostic Division; 30 g/l), bilirubin (Sigma; 200 mg/l), and added protein (1.5% bovine serum albumin and 0.5% bovine gamma globulin, Sigma). Human hemoglobin was isolated from whole blood cellular pellets that were lysed with an equivalent volume of water followed by centrifugation to remove cellular debris. To assess human antimouse antibody (HAMA) and rheumatoid factor (RF) interference, 1 serum specimen collected from an otherwise healthy volunteer, 10 specimens that were positive for HAMA, and 5 specimens that were positive for RF were supplemented with 3 different concentrations of OV569-reactive antigen. All samples were assayed, and the observed values of the supplemented samples were compared with the nonsupplemented samples. A potential prozone/hook effect was tested by adding high concentrations of recombinant antigen to 3 serum samples (5991, 7881, and nmol/l) followed by 2-fold serial dilutions to 1:1024. antigen stability studies Serum Processing. We tested 30 serum samples supplemented with 2 different concentrations of OV569-reactive antigen and 20 nonsupplemented samples on days 0, 3, and 7 (intermediate storage at 2 8 C). Values were compared over the time course. Two different collection procedures were also compared (red top tubes vs serum separator tubes; Becton Dickinson) Sample Freeze/Thaw. Aliquots from 12 of the above samples and 1 mesothelioma patient sample were subjected to 1 10 freeze/thaw cycles at 70 C, and SMRP values for the frozen/thawed samples were compared with the fresh sample values. Storage Temperature. Five serum separator tubes of blood were collected from each of 20 healthy volunteers. One tube of each set was processed on the day of collection, and the serum was stored at 70 C as the comparison (presumably stable) material. The remaining blood tubes were stored unprocessed at 2 8 C or at 37 C and processed on days 1, 2, 4, and 7 followed by storage at 70 C until further analysis. All samples were analyzed in 1 batch. statistical analyses of clinical samples Nonparametric ROC analyses were performed comparing the MESOMARK results in the mesothelioma patients to those of the healthy volunteers alone and to the benign and other nonmalignant conditions combined, and the areas under the curves (AUCs) were calculated. The 95% confidence interval (CI) was also determined for the AUCs. Equality of the median MESOMARK assay values in the healthy volunteers and the different stages and histological subtypes of the mesothelioma patients were compared using a nonparametric k-sample test and the 2 statistic. Results analytical studies Within-run imprecision (CV) of the MESOMARK assay ranged from 1.1% to 6.4% between the 2 clinical sites tested (total imprecision, 11.0%; see Table 1 in the Data Supplement that accompanies the online version of this article at and the limit of detection (limit of the blank) was 0.16 nmol/l for both lots tested (see Table 2 in the online Data Supplement). Dilution linearity was demonstrated across 1 27 nmol/l, and linear regression analysis resulted in the following: observed 0.99(expected) 0.77; R The total mean percent recovery of added antigen in serum samples (see Table 3 in the online Data Supplement) across all of the dilutions tested was 107%, and individual recoveries ranged from 94% to 127%. After addition of potential interferents, mean results were 96% 101% of expected (Table 1).
4 Clinical Chemistry 53, No. 4, Test condition Table 1. Interfering substances. a Test concentration Measured concentration as % of expected concentration (range) b Native serum components Bilirubin 200 mg/l 100 (96 102) Hemoglobin 500 g/l 100 (85 111) Total protein 120 g/l 99 (94 105) Triglycerides 30 g/l 101 (95 108) Chemotherapeutic agents Cisplatin 1.53 g/l 96 (85 110) Carboplatin 0.34 g/l 101 (93 107) Alimta 1.3 g/l 99 (89 106) Gemcitabine 300 mol/l 99 (92 108) Potentially interfering clinical condition HAMA c 1281 g/l 99 (86 112) RF d 288 kiu/l 105 ( ) a Different potential interfering substances that may be found in patient blood were added together with recombinant antigen into serum samples. b For native serum components and chemotherapeutic agents, value 100 measured value with test condition/measured value without test condition. For HAMA and RF samples, values 100 (measured value of sample with added HAMA or RF sample with added antigen) (measured original value of sample) / (measured value of normal serum with added antigen) (measured original value of normal serum). c Pool of 10 HAMA-positive samples. d Pool of 5 RF-positive samples. None of the 3 serum samples tested exhibited this effect (data not shown). Most importantly, the highest concentration of analyte tested for the prozone effect ( nmol/l) was 60-fold greater than the highest measured value in a mesothelioma patient sample (170 nmol/l) to date. clinical validation SMRP was higher in 88 mesothelioma patients than in other patient groups and controls, including 61 asbestosexposed individuals (Fig. 1). Median MESOMARK values in the preoperative samples from mesothelioma patients were significantly higher than values in samples from healthy individuals (Table 2; P values ). In MPM, results showed no clear relationship to stage of MPM or its histologic type (Tables 2 and 3). ROC curves (Fig. 2) comparing normal individuals with preoperative mesothelioma samples yielded an AUC of 87.4% (95% CI, 82.8% 92.0%), whereas a comparison of asbestos-exposed patients with preoperative mesothelioma samples yielded an AUC of 80.6% (95% CI, 73.7% 87.4%). An ROC curve comparing preoperative mesotheliomas vs all nonmesothelioma samples (healthy, benign, and other cancers) yielded an AUC of 81.0% (95% CI, 75.5% 86.5%; data not shown). As shown in Table 4, 99% of serum collected from apparently healthy individuals demonstrated SMRP values 1.5 nmol/l, whereas SMRP values were 1.5 nmol/l in 52% of mesothelioma patients. In other cancers (ovarian, pancreatic, colon, and endometrial), MESO- MARK values were increased in 10% of the samples tested. In 83% of samples from lung cancer patients and 95% of samples from asbestos-exposed individuals, SMRP was 1.5 nmol/l. Statistical performance of MESO- MARK at the chosen cutoff was determined in comparison with different patient groups (Table 4). Discussion Our analytical studies indicate that the MESOMARK assay is robust, with freedom from interference from a range of potential interferents; an analyte that is stable (e.g., with freeze/thaw cycles and processing); assay imprecision (total CV) 11%; detection limit (0.16 nmol/l) well below the upper limit of the reference antigen stability Freeze/thaw studies (12 samples) yielded mean values of 89% 98% of the fresh control samples ( 70 C sample) across 10 freeze/thaw cycles, with no trends observed (see Table 4 in the online Data Supplement). For samples stored at 2 8 C for up to 7 days, mean recoveries across all samples tested (n 51) were 94% and 92% on days 3 and 7 of testing, respectively (data not shown). Neither a storage temperature of 37 C nor hemolysis resulting from storing unprocessed blood samples over extended periods of time (at 2 8 C and 37 C) had a significant effect on measured SMRP. For the 10 samples in each set at 2 8 C (37 C), mean recoveries were as follows, as a percentage of the initial values: day 1, 99% (96%); day 2, 99% (87%); day 4, 101% (80%); day 7, 95% (103%). No trends were observed, and the variations in recoveries were within the imprecision profile for the assay. Fig. 1. MESOMARK values across a cross-section of samples. Samples from patients with different diagnosed cancers were tested for SMRP concentrations using the MESOMARK assay. Ca, cancer; Exp, exposure; Pre-op mesos, preoperative mesothelioma samples.
5 670 Beyer et al.: MESOMARK Test for Malignant Pleural Mesothelioma Table 2. SMRP concentrations in healthy controls and mesothelioma patients. a Diagnosis n MESOMARK, nmol/l Individuals with MESOMARK within indicated intervals, % Mean (SD) Median <1.5 nmol/l nmol/l nmol/l >10.0 nmol/l Healthy (0.4) Mesothelioma (21.9) Mesothelioma histology Epithelioid (15.6) Biphasic (2.7) Sarcomatoid (59.2) Mesothelioma stage Stage I (17.0) Stage II (35.9) Stage III/IV (14.3) a Samples from mesothelioma patients were collected before surgical intervention. interval; linearity to a concentration (27 mmol/l) nearly 20 times the upper limit of the reference interval; and essentially quantitative recovery of added analyte. The clinical findings in our study are similar to those reported by others using different assays (7, 14, 15).In our study, 83% of lung cancer patients and 95% of asbestosexposed individuals exhibited serum SMRP concentrations below the upper limit of the reference interval (defined as the 99th percentile value of a distribution of normal healthy individuals). In contrast, 52% of mesothelioma patients had SMRP values above the same cutpoint. For example, increased SMRP concentrations were reported in an Australian mesothelioma patient population, which included patients who had been occupationally exposed to asbestos (7). Interestingly, of 7 patients with increased SMRP values, 3 were later diagnosed with mesothelioma, and 1 was found to have lung cancer (7). Increased SMRP concentrations were found in sera from patients with mesothelioma of the epithelial subtype, but not in sera from patients with sarcomatoid mesothelioma in this study and in studies by other groups (7, 16). In Table 3. Demographic data for healthy controls and preoperative mesothelioma patients. Characteristic Healthy controls (n 409) Mesothelioma patients, preoperative samples (n 88) Sex Male, % 246 (60) 70 (80%) Female, % 163 (40%) 18 (20%) Age at diagnosis, years Mean (SD) 46 (12) 64 (10) Median Range 31 to to 84 Race Caucasian Black Smoking history, % Never (no) 251 (61) Past Current (yes) 108 (27) Unknown 50 (12) 88 (100) Stage, % I 14 (16) II 22 (25) III 49 (56) IV 3 (3) Histology, % Epithelioid 59 (67) Sarcomatoid 8 (9) Biphasic 21 (24) Fig. 2. ROC curve for healthy vs preoperative (pre-op) mesotheliomas. ROC curve for the ability of the MESOMARK assay to differentiate between healthy volunteers (n 409) and patients with mesothelioma (n 88). The table shows the threshold value required for the MESOMARK assay and the sensitivity (and the 95% CI for the sensitivity) at the 5 different specificity levels.
6 Clinical Chemistry 53, No. 4, Table 4. Concentrations and diagnostic accuracy of SMRP in subgroups of patients and controls. A. The percentage of study participants with MESOMARK values within the selected intervals are indicated. Percentage sums of the individual groups may not add up to 100% due to rounding influences. % Number of study participants <1.5 nmol/l nmol/l nmol/l >10.0 nmol/l Apparently healthy Females Males Malignant conditions Mesothelioma Ovarian cancer Lung cancer Colon cancer Pancreatic cancer Endometrial cancer Nonmalignant conditions Hypertension Asbestos-exposed individuals Endometriosis B. Diagnostic specificity of SMRP at the 99th percentile concentration in diverse patient populations. At this concentration, the sensitivity for the detection of mesothelioma was 57% (95% CI 46% 67%). Sample population % Specificity at a 1.5 nmol/l cut-off (95% CI) Mesothelioma vs normal/healthy 88/ ( ) Mesothelioma vs asbestos-exposed 88/ ( ) Mesothelioma vs tested cancers 88/ ( ) Mesothelioma vs lung cancer 88/ ( ) Mesothelioma vs nonmalignant 88/ ( ) addition, in longitudinal studies increased SMRP concentrations were detected months before detection of mesothelioma by conventional means (2 of 8 patients; unpublished data). Although these longitudinal studies included only a limited number of patients, our results might indicate the potential of SMRP as a marker for monitoring response to treatment. Such a biomarker would be beneficial because current imaging methods have limited sensitivity (6) and are costly. There were no reports of established biomarkers for mesothelioma published at the time of the study. Additional studies, however, are ongoing to compare SMRP with other serologic markers such as osteopontin, CYFRA21-1, or CA125. Preliminary data are presented elsewhere (17). In summary, serum concentrations of SMRP are higher in patients with mesothelioma than in healthy persons, and can be reliably measured by the MESOMARK assay. Data are remarkably consistent across different patient populations and different laboratories and indicate potentially important clinical utility of the SMRP assay in mesothelioma diagnostics. Limitations of SMRP include its increase in patients with renal failure, hypertension, and certain other tumors such as ovarian cancer. Although additional tests and demographic information may be needed to address some of these shortcomings, SMRP does have potential as a biomarker for detection of mesothelioma in a high-risk, asbestos-exposed population. Because mesothelioma is a rare disease, the use of SMRP as a screening assay may also require the addition of other markers to increase specificity, for example in an asbestos-exposed population. Candidate markers include osteopontin, which was recently reported to be increased in mesothelioma patients (18), the absence of increased carcinoembryonic antigen (6), or a combination with CYFRA21 1, which could aid in differential diagnosis (19). A marker panel requires further studies that are currently ongoing. Other studies are under way to confirm diagnostic accuracy as established in this preliminary study. References 1. Connelly RR, Spirtas R, Myers MH, Percy CL, Fraumeni JF Jr. Demographic patterns for mesothelioma in the United States. J Natl Cancer Inst 1987;78: Walker AM, Loughlin JE, Friedlander ER, Rothman KJ, Dreyer NA. Projections of asbestos-related disease J Occup Med 1983;25: Carbone M, Kratzke RA, Testa JR. The pathogenesis of mesothelioma. Semin Oncol 2002;29: Carbone M, Rdzanek MA. Pathogenesis of malignant mesothelioma. Clin Lung Cancer 2004;5(Suppl 2):S46 50.
7 672 Beyer et al.: MESOMARK Test for Malignant Pleural Mesothelioma 5. Craighead JE, Mossman BT. The pathogenesis of asbestosassociated diseases. N Engl J Med 1982;306: Sterman DH, Albelda SM. Advances in the diagnosis, evaluation, and management of malignant pleural mesothelioma. Respirology 2005;10: Robinson BW, Creaney J, Lake R, Nowak A, Musk AW, de Klerk N, et al. Mesothelin-family proteins and diagnosis of mesothelioma. Lancet 2003;362: Ordonez NG. Application of mesothelin immunostaining in tumor diagnosis. Am J Surg Pathol 2003;27: Muminova ZE, Strong TV, Shaw DR. Characterization of human mesothelin transcripts in ovarian and pancreatic cancer. BMC Cancer 2004;4: Scholler N, Fu N, Yang Y, Ye Z, Goodman GE, Hellstrom KE, et al. Soluble member(s) of the mesothelin/megakaryocyte potentiating factor family are detectable in sera from patients with ovarian carcinoma. Proc Natl Acad Sci U S A 1999;96: Chang K, Pastan I. Molecular cloning of mesothelin, a differentiation antigen present on mesothelium, mesotheliomas, and ovarian cancers. Proc Natl Acad Sci U S A 1996;93: Hellstrom I, Raycraft J, Kanan S, Sardesai NY, Verch T, Yang Y, et al. Mesothelin variant 1 is released from tumor cells as a diagnostic marker. Cancer Epidemiol Biomarkers Prev 2006;15: National Committee for Clinical Laboratory Standards. Evaluation of the linearity of quantitative measurement procedures: a statistical approach. NCCLS document EP6-A. Wayne, PA: NCCLS, Creaney J, Robinson BW. Detection of malignant mesothelioma in asbestos-exposed individuals: the potential role of soluble mesothelin-related protein. Hematol Oncol Clin North Am 2005;19: Hassan R, Remaley AT, Sampson ML, Zhang J, Cox DD, Pingpank J, et al. Detection and quantitation of serum mesothelin, a tumor marker for patients with mesothelioma and ovarian cancer. Clin Cancer Res 2006;12: Scherpereel A, Grigoriu B, Conti M, Gey T, Gregoire M, Copin MC, et al. Soluble mesothelin-related peptides in the diagnosis of malignant pleural mesothelioma. Am J Respir Crit Care Med 2006;173: Stieber P, Hatz R, Holdenrieder S, Hofmann K, Schalhorn A. Diagnostische relevanz der SMRP beim malignen mesotheliom. The XXXIII Meeting of the International Society of Oncodevelopmental Biology and Medicine. Rhodes, Greece. Tumour Biology 2006; 27(Suppl 1): Pass HI, Lott D, Lonardo F, Harbut M, Liu Z, Tang N, et al. Asbestos exposure, pleural mesothelioma, and serum osteopontin levels. N Engl J Med 2005;353: Paganuzzi M, Onetto M, Marroni P, Filiberti R, Tassara E, Parodi S, et al. Diagnostic value of CYFRA 21 1 tumor marker and CEA in pleural effusion due to mesothelioma. Chest 2001;119:
Interest in any of the products, request or order them at Bio-Connect Diagnostics.
MESOMARK, Brochure Interest in any of the products, request or order them at Bio-Connect Diagnostics. Bio-Connect Diagnostics B.V. T NL +31 () 3 T BE +3 () 5 1 53 Begonialaan 3a F NL +31 () 3 1 F BE +3
More informationMESOMARK : A Potential Test for Malignant Pleural Mesothelioma
MESOMARK : A Potential Test for Malignant Pleural Mesothelioma H. Beyer 1, R. Geschwindt 1, C. Glover 1, D. Wolaniuk 1, D. Kenney 1, T. Kettlety 1, K. Peterson 1, I. Hellstrom 2, H. Pass 3, N.Y. Sardesai
More informationNon-invasive diagnosis of pleural malignancies: The role of tumour markers
Lung Cancer (2008) 59, 350 354 available at www.sciencedirect.com journal homepage: www.elsevier.com/locate/lungcan Non-invasive diagnosis of pleural malignancies: The role of tumour markers Michel M.
More informationSoluble Mesothelin-Related Peptide Level Elevation in Mesothelioma Serum and Pleural Effusions
Soluble Mesothelin-Related Peptide Level Elevation in Mesothelioma Serum and Pleural Effusions Harvey I. Pass, MD, Anil Wali, PhD, Naimei Tang, PhD, Alla Ivanova, PhD, Sergey Ivanov, PhD, Michael Harbut,
More informationDOI: 10.1016/j.athoracsur.2007.07.042
Soluble Mesothelin-Related Peptide Level Elevation in Mesothelioma Serum and Pleural Effusions Harvey I. Pass, Anil Wali, Naimei Tang, Alla Ivanova, Sergey Ivanov, Michael Harbut, Michele Carbone and Jeffrey
More informationCombined CA125 and Mesothelin Levels for the Diagnosis of Malignant Mesothelioma*
CHEST Combined CA125 and Mesothelin Levels for the Diagnosis of Malignant Mesothelioma* Jenette Creaney, PhD; Ivonne van Bruggen, BSc; Michelle Hof, BSc; Amanda Segal, MBBS; Arthur W. Musk, MBBS, MD, FCCP;
More informationSummary of Safety and Probable Benefit
Summary of Safety and Probable Benefit I. GENERAL IN],ORMATION Device Generic name(s): Device Trade name(s): Applicant's name and address Enzyme-linked Immunosorbent Assay (ELISA) for the in vitro quantitative
More informationRisks of testing. Benefits of testing. What are the costs?
You are receiving this information because you have been diagnosed with malignant mesothelioma, a rare form of cancer, associated with exposure to asbestos. In this disease, cancer (malignant) cells are
More informationSerum mesothelin and megakaryocyte potentiating factor in pancreatic and biliary cancers
Clin Chem Lab Med 2011;50(4):xxx xxx 2011 by Walter de Gruyter Berlin Boston. DOI 10.1515/CCLM.2011.816 Serum mesothelin and megakaryocyte potentiating factor in pancreatic and biliary cancers Elad Sharon
More informationTitle: A prospective trial evaluating the role of mesothelin in undiagnosed pleural effusions. Authors
ERJ Express. Published on July 12, 2012 as doi: 10.1183/09031936.00148211 Title: A prospective trial evaluating the role of mesothelin in undiagnosed pleural effusions. Authors 1/. Clare E Hooper clarehooper@doctors.org.uk
More informationRetrospective analysis of large scale research screening of construction workers for the early diagnosis of mesothelioma
26 Retrospective analysis of large scale research screening of construction workers for the early diagnosis of mesothelioma TOMOKO HIROHASHI 1, KIYOKO IGARASHI 2, MASAAKI ABE 1, MASAHIRO MAEDA 3 and OKIO
More informationCancer Medicine. Newly established ELISA for N-ERC/mesothelin improves diagnostic accuracy in patients with suspected pleural mesothelioma
Cancer Medicine ORIGINAL RESEARCH Open Access Newly established ELISA for N-ERC/mesothelin improves diagnostic accuracy in patients with suspected pleural mesothelioma Tadashi Sato 1, Yohei Suzuki 1, Takanori
More informationRat Creatine Kinase MB isoenzyme,ck-mb ELISA Kit
Rat Creatine Kinase MB isoenzyme,ck-mb ELISA Kit Catalog No: E0479r 96 Tests Operating instructions www.eiaab.com FOR RESEARCH USE ONLY; NOT FOR THERAPEUTIC OR DIAGNOSTIC APPLICATIONS! PLEASE READ THROUGH
More informationUtility of Osteopontin and Serum Mesothelin in Malignant Pleural Mesothelioma Diagnosis and Prognosis Assessment
Imaging, Diagnosis, Prognosis Utility of Osteopontin and Serum Mesothelin in Malignant Pleural Mesothelioma Diagnosis and Prognosis Assessment Bogdan-Dragos Grigoriu, 1,6 Arnaud Scherpereel, 1,2 Patrick
More informationHuman Free Testosterone(F-TESTO) ELISA Kit
Human Free Testosterone(F-TESTO) ELISA Kit Catalog Number. MBS700040 For the quantitative determination of human free testosterone(f-testo) concentrations in serum, plasma. This package insert must be
More informationبسم هللا الرحمن الرحيم
بسم هللا الرحمن الرحيم Updates in Mesothelioma By Samieh Amer, MD Professor of Cardiothoracic Surgery Faculty of Medicine, Cairo University History Wagner and his colleagues (1960) 33 cases of mesothelioma
More informationA 70-year old Man with Pleural Effusion
Mesothelioma Diagnosis: Pitfalls and Latest Updates S Klebe and DW Henderson Recommendations Indisputable malignant cells on cytomorphological criteria which demonstrate a mesothelial phenotype, which
More informationThe diagnostic usefulness of tumour markers CEA and CA-125 in pleural effusion
Malaysian J Path01 2002; 24(1) : 53-58 The diagnostic usefulness of tumour markers CEA and CA-125 in pleural effusion Pavai STHANESHWAR MD, Sook-Fan YAP FRCPath, FRCPA and Gita JAYARAM MDPath, MRCPath
More informationPRINCIPLE. REF 442635 (200 tests/cartridge) REF 476836 (400 tests/cartridge) ANNUAL REVIEW Reviewed by: Date. Date INTENDED USE
SYNCHRON System(s) Chemistry Information Sheet Copyright 2010 Beckman Coulter, Inc. Creatine Kinase REF 442635 (200 tests/cartridge) REF 476836 (400 tests/cartridge) For In Vitro Diagnostic Use ANNUAL
More informationCarbohydrate antigen 19 9 (CA 19 9) (serum, plasma)
Carbohydrate antigen 19 9 (CA 19 9) (serum, plasma) 1 Name and description of analyte 1.1 Name of analyte Carbohydrate antigen 19 9 (CA 19 9) 1.2 Alternative names Cancer antigen 19 9, cancer antigen GI
More informationMALIGNANT MESOTHELIOMA UPDATE ON PATHOLOGY AND IMMUNOHISTOCHEMISTRY
MALIGNANT MESOTHELIOMA UPDATE ON PATHOLOGY AND IMMUNOHISTOCHEMISTRY Sisko Anttila, MD, PhD Jorvi Hospital Laboratory of Pathology Helsinki University Hospital Espoo, Finland 2nd Nordic Conference on Applied
More informationRESEARCH COMMUNICATION. HE4 and Mesothelin: Novel Biomarkers of Ovarian Carcinoma in Patients with Pelvic Masses
HE4 and Mesothelin: Novel Biomarkers of Ovarian Carcinoma RESEARCH COMMUNICATION HE4 and Mesothelin: Novel Biomarkers of Ovarian Carcinoma in Patients with Pelvic Masses Hala A Abdel-Azeez 1 *, Hany A
More informationClinical Significance of Serum Mesothelin in Patients with MesotheliomaandLungCancer
Imaging, Diagnosis, Prognosis Clinical Significance of Serum Mesothelin in Patients with MesotheliomaandLungCancer Alfonso Cristaudo, 1 Rudy Foddis, 1 AgneseVivaldi, 1 Giovanni Guglielmi, 1 Nicola Dipalma,
More informationUpdate on Mesothelioma
November 8, 2012 Update on Mesothelioma Intro incidence and nomenclature Update on Classification Diagnostic specimens Morphologic features Epithelioid Histology Biphasic Histology Immunohistochemical
More informationRat creatine kinase MM isoenzyme (CK-MM) ELISA Kit
Rat creatine kinase MM isoenzyme (CK-MM) ELISA Kit Catalog Number. CSB-E14405r For the quantitative determination of rat creatine kinase MM isoenzyme (CK-MM) concentrations in serum, plasma and tissue
More information510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number: K092353 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY B. Purpose for Submission: This is a new 510k application for a new indication for the MONOLISA Anti-HAV IgM EIA
More informationRat creatine kinase MM isoenzyme (CK-MM) ELISA Kit
Rat creatine kinase MM isoenzyme (CK-MM) ELISA Kit Catalog Number. CSB-E14405r For the quantitative determination of rat creatine kinase MM isoenzyme (CK-MM) concentrations in serum, plasma, tissue homogenates.
More informationAssay Qualification Template for Host Cell Protein ELISA
Assay Qualification Template for Host Cell Protein ELISA Introduction: With ever increasing importance being placed on host cell protein (HCP) removal during the purification process, it is critical to
More informationMesothelioma. Mesothelioma and Asbestos 11/21/2009
Mesothelioma Michele Carbone, M.D.,PH.D. Director Cancer Research Center of Hawaii Professor and Chairman, Dept. of Pathology J.A. Burns Medical School University of Hawaii Honolulu, HI 96813 Mesotheliomas
More informationInc. Wuhan. Quantity Pre-coated, ready to use 96-well strip plate 1 Plate sealer for 96 wells 4 Standard (liquid) 2
Uscn Life Science Inc. Wuhan Website: www.uscnk.com Phone: +86 27 84259552 Fax: +86 27 84259551 E-mail: uscnk@uscnk.com ELISA Kit for Human Prostaglandin E1(PG-E1) Instruction manual Cat. No.: E0904Hu
More informationBlood-Based Cancer Diagnostics
The Biotechnology Education Company Blood-Based Cancer Diagnostics EDVO-Kit 141 Store entire experiment at room temperature. EXPERIMENT OBJECTIVE: The objective of this experiment is to learn and understand
More informationL Lang-Lazdunski, A Bille, S Marshall, R Lal, D Landau, J Spicer
Pleurectomy/decortication, hyperthermic pleural lavage with povidone-iodine and systemic chemotherapy in malignant pleural mesothelioma. A 10-year experience. L Lang-Lazdunski, A Bille, S Marshall, R Lal,
More informationIgM ELISA. For the quantitative determination of IgM in human serum and plasma. For Research Use Only. Not For Use In Diagnostic Procedures.
IgM ELISA For the quantitative determination of IgM in human serum and plasma For Research Use Only. Not For Use In Diagnostic Procedures. Please read carefully due to Critical Changes, e.g., Calibrator
More informationEarly Detection Research Network: Validation Infrastructure. Jo Ann Rinaudo, Ph.D. Division of Cancer Prevention
Early Detection Research Network: Validation Infrastructure Jo Ann Rinaudo, Ph.D. Division of Cancer Prevention 15 October 2015 Mission The NCI Early Detection Research Network s (EDRN) mission is to implement
More informationFree Testosterone Cat# 2924Z
See external label 2 C-8 C Σ=96 tests Cat # 2924Z Free Testosterone Cat# 2924Z Direct immunoenzymatic determination of Free Testosterone in serum or plasma. For in vitro diagnostic use only INTENDED USE
More informationMouse Creatine Kinase MB isoenzyme (CKMB) ELISA
KAMIYA BIOMEDICAL COMPANY Mouse Creatine Kinase MB isoenzyme (CKMB) ELISA For the quantitative determination of mouse CKMB in serum, plasma, cell culture fluid and other biological fluids Cat. No. KT-57681
More informationAdvances in Treatment of Malignant Pleural Mesothelioma: A Reason for Hope
Advances in Treatment of Malignant Pleural Mesothelioma: A Reason for Hope Daniel H. Sterman, M.D. Associate Professor of Medicine and Surgery Co-Director, PENN Mesothelioma and Pleural Program University
More informationHow To Use An Osteopontin Prognostic Marker In A Cancer
Tropical Journal of Pharmaceutical Research December 2010; 9 (6): 605-613 Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, 300001 Nigeria. All rights reserved. Review Article
More informationCanine creatine kinase MB isoenzyme (CK-MB)ELISA Kit
Canine creatine kinase MB isoenzyme (CK-MB)ELISA Kit Catalog No. CSB-E15852c (96T) This immunoassay kit allows for the in vitro quantitative determination of canine CK-MB concentrations in serum and plasma.
More informationMouse krebs von den lungen 6 (KL-6) ELISA
KAMIYA BIOMEDICAL COMPANY Mouse krebs von den lungen 6 (KL-6) ELISA For the quantitative determination of mouse KL-6 in serum, plasma, cell culture supernatants, body fluid and tissue homogenate Cat. No.
More informationMALIGNANT MESOTHELIOMA UPDATE ON PATHOLOGY AND IMMUNOHISTOCHEMISTRY
MALIGNANT MESOTHELIOMA CLASSIFICATION MALIGNANT MESOTHELIOMA UPDATE ON PATHOLOGY AND IMMUNOHISTOCHEMISTRY Sisko Anttila, MD, PhD Jorvi Hospital Laboratory of Pathology Helsinki University Hospital Espoo,
More informationTOTAL PROTEIN FIBRINOGEN
UNIT: Proteins 16tproteins.wpd Task Determination of Total Protein, Albumin and Globulins Objectives Upon completion of this exercise, the student will be able to: 1. Explain the ratio of albumin and globulin
More informationIndividual patient data meta-analysis of continuous diagnostic markers
Individual patient data meta-analysis of continuous diagnostic markers J.B. Reitsma Julius Center for Health Sciences and Primary Care UMC Utrecht / www.juliuscenter.nl Outline IPD benefits Meta-analytical
More informationSamsung POINT OF CARE Systems - Cardiac/Acute Care Biomarkers LABGEO IB Clinical Chemistry Analytes LABGEO PT
Samsung POINT OF CARE Systems - Cardiac/Acute Care Biomarkers LABGEO IB Clinical Chemistry Analytes LABGEO PT Alexander Belenky, PhD Director -Product Development Samsung - Nexus-Dx Edward Brennan, PhD
More informationDetection and Quantitation of Serum Mesothelin, a Tumor Marker for Patients with Mesothelioma and Ovarian Cancer
Detection and Quantitation of Serum Mesothelin, a Tumor Marker for Patients with Mesothelioma and Ovarian Cancer Raffit Hassan, 1 Alan T. Remaley, 2 Maureen L. Sampson, 2 Jingli Zhang, 1 Derrick D. Cox,
More informationBeware that Low Urine Creatinine! by Vera F. Dolan MSPH FALU, Michael Fulks MD, Robert L. Stout PhD
1 Beware that Low Urine Creatinine! by Vera F. Dolan MSPH FALU, Michael Fulks MD, Robert L. Stout PhD Executive Summary: The presence of low urine creatinine at insurance testing is associated with increased
More informationApplication Sheet for Rivaroxaban (Xarelto ) Standard Range with. BIOPHEN Heparin LRT (#221011/221013) RUO
Instrument Adaptation The attached instrument adaptation has been prepared and validated by the reagent manufacturer, Hyphen-Biomed. Instrument Siemens BCS-XP Product BIOPHEN Heparin LRT Analyte Rivaroxaban
More informationRat Creatine Kinase MB Isoenzyme (CKMB) ELISA
Rat Creatine Kinase MB Isoenzyme (CKMB) ELISA For the quantitative determination of rat CKMB in serum, plasma, tissue homogenates and other biological fluids. Cat. No. KT-12247 For Research Use Only. Not
More informationBiomarkers for early detection of asbestosassociated
Biomarkers for early detection of asbestosassociated cancers ( study) G. Johnen, B. Pesch, D. Weber, K. Gawrych, S. Casjens, I. Raiko, O. Bryk, D. Taeger, S. Meier, P. Rozynek, T. Wiethege, G. Aguilar-Madrid,
More informationTargeting Specific Cell Signaling Pathways for the Treatment of Malignant Peritoneal Mesothelioma
The Use of Kinase Inhibitors: Translational Lab Results Targeting Specific Cell Signaling Pathways for the Treatment of Malignant Peritoneal Mesothelioma Sheelu Varghese, Ph.D. H. Richard Alexander, M.D.
More informationFor In Vitro Diagnostic Use
SYNCHRON System(s) Chemistry Information Sheet Creatine Kinase REF (200 tests/cartridge) 442635 REF (400 tests/cartridge) 476836 For In Vitro Diagnostic Use ANNUAL REVIEW Reviewed by: Reviewed by: Date
More informationMouse Insulin ELISA. For the quantitative determination of insulin in mouse serum and plasma
Mouse Insulin ELISA For the quantitative determination of insulin in mouse serum and plasma Please read carefully due to Critical Changes, e.g., Calculation of Results. For Research Use Only. Not For Use
More informationMouse IgM ELISA. Cat. No. KT-407 K-ASSAY. For the quantitative determination of IgM in mouse biological samples. For Research Use Only. 1 Rev.
K-ASSAY Mouse IgM ELISA For the quantitative determination of IgM in mouse biological samples Cat. No. KT-407 For Research Use Only. 1 Rev. 072309 K-ASSAY PRODUCT INFORMATION Mouse IgM ELISA Cat. No. KT-407
More information3 Summary of clinical applications and limitations of measurements
CA125 (serum) 1 Name and description of analyte 1.1 Name of analyte Cancer Antigen 125 (CA125) 1.2 Alternative names Mucin 16 1.3 NLMC code To follow 1.4 Description of analyte CA125 is an antigenic determinant
More informationRulex s Logic Learning Machines successfully meet biomedical challenges.
Rulex s Logic Learning Machines successfully meet biomedical challenges. Rulex is a predictive analytics platform able to manage and to analyze big amounts of heterogeneous data. With Rulex, it is possible,
More informationHuman Luteinizing Hormone (LH) Custom Kit
Human Luteinizing Hormone (LH) Custom Kit 18089-v2-2015Jan 1 MSD Toxicology Assays Human Luteinizing Hormone (LH) Custom Kit This package insert must be read in its entirety before using this product.
More information1.5 Function of analyte For albumin, see separate entry. The immunoglobulins are components of the humoral arm of the immune system.
Total protein (serum, plasma) 1 Name and description of analyte 1.1 Name of analyte Total protein 1.2 Alternative names None 1.3 NMLC code 1.4 Description of analyte This is a quantitative measurement
More information20 Diagnostic Cytopathology, Vol 36, No 1 ' 2007 WILEY-LISS, INC.
Utility of WT-1, p63, MOC31, Mesothelin, and Cytokeratin (K903 and CK5/6) Immunostains in Differentiating Adenocarcinoma, Squamous Cell Carcinoma, and Malignant Mesothelioma in Effusions Robert T. Pu,
More informationResearch Article Pleural Fluid Mesothelin as an Adjunct to the Diagnosis of Pleural Malignant Mesothelioma
Disease Markers, Article ID 43946, 0 pages http://dx.doi.org/0.55/4/43946 Research Article Pleural Fluid Mesothelin as an Adjunct to the Diagnosis of Pleural Malignant Mesothelioma Jenette Creaney,,2 Amanda
More informationPractical Effusion Cytology
Practical Effusion Cytology A Community Pathologist s Approach to Immunocytochemistry in Body Fluid Cytology Emily E. Volk, MD William Beaumont Hospital Troy, MI College of American Pathologists 2004.
More informationStandardization, Calibration and Quality Control
Standardization, Calibration and Quality Control Ian Storie Flow cytometry has become an essential tool in the research and clinical diagnostic laboratory. The range of available flow-based diagnostic
More informationMouse Keyhole Limpet Hemocyanin antibody(igm) ELISA Kit
Mouse Keyhole Limpet Hemocyanin antibody(igm) ELISA Kit Catalog No. MBS702810 (96 tests) This immunoassay kit allows for the in vitro semi-quantitative determination of mouse KLH(IgM)antibody concentrations
More informationCanine Creatine Kinase MM isoenzyme(ck-mm) ELISA. kit
BlueGene Biotech. Tel: 0086-21-61471242 Fax: 0086-21-61471242 ext 806 E-mail: sales@bluegene.cc tech@bluegene.cc www.elisakit.cc www.bluegene.cc Canine Creatine Kinase MM isoenzyme(ck-mm) ELISA kit 96
More informationValidation and Calibration. Definitions and Terminology
Validation and Calibration Definitions and Terminology ACCEPTANCE CRITERIA: The specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an
More informationCancer Antigen CA125 Human ELISA Kit
ab108653 Cancer Antigen CA125 Human ELISA Kit Instructions for Use For the quantitative measurement of Human Cancer Antigen CA125 concentrations in serum. This product is for research use only and is not
More informationBiochemistry Validation Form
Biochemistry Validation Form Method: Piccolo Xpress Chemistry 13 panel Manufacturer: Abaxis Cat no: 400-0029 CE marked: Yes: x No: Location of bench book: X:\Bio\Patricia\Piccollo Xpress evaluation (August
More information竞 争 性 分 析 Epitope Mapping 实 验 方 法
竞 争 性 分 析 Epitope Mapping 实 验 方 法 ABSTRACT The simplest way to determine whether two monoclonal antibodies bind to distinct sites on a protein antigen is to carry out a competition assay. The assay can
More informationHow To Test For Creatinine
Creatinine is measured amperometrically. Creatinine is hydrolyzed to creatine in a reaction catalyzed by the enzyme creatinine amidohydrolase. Creatine is then hydrolyzed to sarcosine in a reaction catalyzed
More informationDiagnostic Utility of Thoracoscopy & Mesothelin in Malignant Mesothelioma. Egypt ranaelhelbawy@yahoo.com
Diagnostic Utility of Thoracoscopy & Mesothelin in Malignant Mesothelioma Rana El-Helbawy 1 ; Nesreen El-Helbawy 2 ; Safaa Tayel 2 and Ehab Shaltot 3 1 Chest, 2 Medical Biochemistry and 3 Clinical Oncology
More informationSupplemental Material. Paradoxical association of enhanced cholesterol efflux with increased incident cardiovascular risks
Supplemental Material Paradoxical association of enhanced cholesterol efflux with increased incident cardiovascular risks Xin-Min Li, PhD 1, W. H. Wilson Tang, MD 1,2, Marian K. Mosior, PhD 3, Ying Huang,
More informationSurvey of Mesothelioma Associated with Asbestos Exposure in Japan
The research and development and the dissemination projects related to the 13 fields of occupational injuries and illnesses Survey of Mesothelioma Associated with Asbestos Exposure in Japan Clinical characteristics
More informationTumour Markers. What are Tumour Markers? How Are Tumour Markers Used?
Dr. Anthony C.H. YING What are? Tumour markers are substances that can be found in the body when cancer is present. They are usually found in the blood or urine. They can be products of cancer cells or
More informationOriginal Article Performance of osteopontin in the diagnosis of malignant pleural mesothelioma: a meta-analysis
Int J Clin Exp Med 2014;7(5):1289-1296 www.ijcem.com /ISSN:1940-5901/IJCEM0000365 Original Article Performance of osteopontin in the diagnosis of malignant pleural mesothelioma: a meta-analysis Hui Lin
More informationSummary of treatment benefits
Risk Management Plan PEMETREXED Powder for concentrate for Solution for infusion Pemetrexed is also indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non small cell
More informationThe kit is a sandwich enzyme immunoassay for in vitro quantitative measurement of PST in mouse tissue homogenates and other biological fluids.
FOR IN VITRO AND RESEARCH USE ONLY NOT FOR USE IN CLINICAL DIAGNOSTIC PROCEDURES SEB268Mu 96 Tests Enzyme-linked Immunosorbent Assay Kit For Phenol Sulfotransferase (PST) Organism Species: Mus musculus
More informationToxoplasma gondii IgM ELISA Kit Protocol
Toxoplasma gondii IgM ELISA Kit Protocol (Cat. No.:EK-310-87) 330 Beach Road, Burlingame CA Tel: 650-558-8898 Fax: 650-558-1686 E-Mail: info@phoenixpeptide.com www.phoenixpeptide.com Toxoplasma IgM ELISA
More informationChem 405 Biochemistry Lab I Experiment 2 Quantitation of an unknown protein solution.
Chem 405 Biochemistry Lab I Experiment 2 Quantitation of an unknown protein solution. Introduction: The determination of protein concentration is frequently required in biochemical work. Several methods
More informationGuidance for Industry and FDA Staff
Guidance for Industry and FDA Staff Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hscrp) and Cardiac C-Reactive Protein (ccrp) Assays Document issued
More informationNational Coverage Determination (NCD) for Tumor Antigen by Immunoassay - CA 125 (190.28)
National Coverage Determination (NCD) for Tumor Antigen by Immunoassay - CA 125 (190.28) Tracking Information Publication Number Manual Section Number 100-3 190.28 Manual Section Title Tumor Antigen by
More informationArticle in press - uncorrected proof
Clin Chem Lab Med 2010;48(2):271 278 2010 by Walter de Gruyter Berlin New York. DOI 10.1515/CCLM.2010.066 Soluble mesothelin related peptides (SMRP) and osteopontin as protein biomarkers for malignant
More informationEffects of Herceptin on circulating tumor cells in HER2 positive early breast cancer
Effects of Herceptin on circulating tumor cells in HER2 positive early breast cancer J.-L. Zhang, Q. Yao, J.-H. Chen,Y. Wang, H. Wang, Q. Fan, R. Ling, J. Yi and L. Wang Xijing Hospital Vascular Endocrine
More informationACTIVE-B12 EIA. the next level of B12 testing
ACTIVE-B12 EIA the next level of B12 testing Vitamin B12 an essential nutrient Vitamin B12 is an essential nutrient (can only be obtained from the diet) and is a vital component in many cellular functions
More informationMalondialdehyde (MDA) ELISA
Malondialdehyde (MDA) ELISA For the quantitative determination of MDA in serum, plasma and other biological fluids Cat. No. KT-21493 For Research Use Only. Not for use in diagnostic procedures. Page 1
More informationReagents Quantity Reagents Quantity. Pre-coated, ready to use 96-well strip plate 1 Plate sealer for 96 wells 4. Standard 2 Standard Diluent 1 20mL
FOR IN VITRO AND RESEARCH USE ONLY NOT FOR USE IN CLINICAL DIAGNOSTIC PROCEDURES SEA479Ra 96 Tests Enzyme-linked Immunosorbent Assay Kit For Creatine Kinase MB Isoenzyme (CKMB) Organism Species: Rattus
More informationSuperior TrueMAB TM monoclonal antibodies for the recognition of proteins native epitopes
Superior TrueMAB TM monoclonal antibodies for the recognition of proteins native epitopes Outlines Brief introduction of OriGene s mission on gene-centric product solution. TrueMAB monoclonal antibody
More informationPSA Testing 101. Stanley H. Weiss, MD. Professor, UMDNJ-New Jersey Medical School. Director & PI, Essex County Cancer Coalition. weiss@umdnj.
PSA Testing 101 Stanley H. Weiss, MD Professor, UMDNJ-New Jersey Medical School Director & PI, Essex County Cancer Coalition weiss@umdnj.edu September 23, 2010 Screening: 3 tests for PCa A good screening
More informationASBESTOS EXPOSURE AND SARCOMATOID MALIGNANT PLEURAL MESOTHELIOMA Gorantla Sambasivarao 1, Namballa Usharani 2, Tupakula Suresh Babu 3
ASBESTOS EXPOSURE AND SARCOMATOID MALIGNANT PLEURAL MESOTHELIOMA Gorantla Sambasivarao 1, Namballa Usharani 2, Tupakula Suresh Babu 3 HOW TO CITE THIS ARTICLE: Gorantla Sambasivarao, Namballa Usharani,
More informationPOLICY A. INDICATIONS
Alimta (pemetrexed) Line(s) of Business: HMO; PPO; QUEST Integration Akamai Advantage Original Effective Date: 09/01/2007 Current Effective Date: 10/01/2015 POLICY A. INDICATIONS The indications below
More informationQuickTiter Hepatitis B Surface Antigen (HBsAg) ELISA Kit
Product Manual QuickTiter Hepatitis B Surface Antigen (HBsAg) ELISA Kit Catalog Numbers VPK-5004 VPK-5004-5 96 assays 5 x 96 assays FOR RESEARCH USE ONLY Not for use in diagnostic procedures Introduction
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: Genscreen ULTRA HIV Ag-Ab Number: PQDx 0096-031-00. Abstract
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Genscreen ULTRA HIV Ag-Ab Number: PQDx 0096-031-00 Abstract Genscreen ULTRA HIV Ag-Ab with product codes 72386 and 72388, manufactured
More informationMouse glycated hemoglobin A1c(GHbA1c) ELISA Kit
Mouse glycated hemoglobin A1c(GHbA1c) ELISA Kit Catalog Number. CSB-E08141m For the quantitative determination of mouse glycated hemoglobin A1c(GHbA1c) concentrations in lysate for RBC. This package insert
More informationUnderstanding CA 125 Levels A GUIDE FOR OVARIAN CANCER PATIENTS. foundationforwomenscancer.org
Understanding CA 125 Levels A GUIDE FOR OVARIAN CANCER PATIENTS foundationforwomenscancer.org Contents Introduction...1 CA 125................................... 1 The CA 125 Test...2 The Use of the CA
More informationSoluble mesothelin-related peptides levels in patients with malignant mesothelioma
Disease Markers 32 (2012) 123 131 123 DOI 10.3233/DMA-2011-0866 IOS Press Soluble mesothelin-related peptides levels in patients with malignant mesothelioma Alenka Franko a, Vita Dolzan b, Viljem Kovac
More informationHigh Resolution Epitope Mapping of Human Autoimmune Sera against Antigens CENPA and KDM6B. PEPperPRINT GmbH Heidelberg, 06/2014
High Resolution Epitope Mapping of Human Autoimmune Sera against Antigens CENPA and KDM6B PEPperPRINT GmbH Heidelberg, 06/2014 Introduction This report describes the epitope mapping of autoimmune sera
More informationJOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR. 2nd Edition
JOINT COMMISSION INTERNATIONAL ACCREDITATION STANDARDS FOR CliniCAl laboratories 2nd Edition Effective 1 April 2010 International Patient Safety Goals (IPSG) Goals The following is a list of all goals.
More information510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: k103555 B. Purpose for Submission: New submission C. Measurand: Platelet aggregation D. Type of Test: Platelet aggregometer
More informationDIAPHRAGM. DIAgnostic and Prognostic biomarkers in the Rational Assessment of Mesothelioma
DIAPHRAGM DIAgnostic and Prognostic biomarkers in the Rational Assessment of Mesothelioma Kevin Blyth Consultant Respiratory Physician, Southern General Hospital NRS Research Fellow & Honorary Clinical
More informationThe Value of Thyroid Transcription Factor-1 in Cytologic Preparations as a Marker for Metastatic Adenocarcinoma of Lung Origin
Anatomic Pathology / TTF-1 IN CYTOLOGY OF BODY FLUIDS The Value of Thyroid Transcription Factor-1 in Cytologic Preparations as a Marker for Metastatic Adenocarcinoma of Lung Origin Jonathan L. Hecht, MD,
More informationCreatine Kinase Activity Assay Kit (Colorimetric)
ab155901 Creatine Kinase Activity Assay Kit (Colorimetric) Instructions for Use For the sensitive and accurate measurement of Creatine Kinase activity in various samples. This product is for research use
More informationImmunoglobulin E (IgE) concentrations in Human. Immunoglobulin E (IgE) Human ELISA Kit
ab108650 Immunoglobulin E (IgE) Human ELISA Kit Instructions for Use For the quantitative measurement of Immunoglobulin E (IgE) concentrations in Human serum. This product is for research use only and
More information