BACKGROUND: Specimens for the external quality assessment (EQA) need to be highly stable during the EQA process. Therefore, we evaluated the stability of pooled sera (PS) for tumor markers including alpha fetoprotein (AFP), carcinoembryonic antigen (CEA), carbohydrate antigen 125 (CA 125), and carbohydrate antigen 19-9 (CA 19-9). METHODS: PS with 2 different levels (high and low) of each of the 4 tumor markers were collected and stored at -20degrees C, 4degrees C, and room temperature (RT). The concentration of each tumor marker was then measured after storage under these different conditions at baseline and on days 1, 3, 7, 14, 30, 90, and 181. Internal quality control (QC) results during the evaluation period were also analyzed. RESULTS: Irrespective of storage conditions, coefficients of variation (CVs) of AFP and CA 125 levels in the PS during the evaluation period ranged from 3.3% to 7.5% in EQA assays and were similar to the CVs of QC assays. However, the levels of CEA detected in PS stored at -20degrees C, and 4degrees C, showed higher variability, with CVs ranging from 4.0% to 10.4%, and samples stored at RT showed especially high CVs, i.e., >8.3%. Samples for CA 19-9 testing stored at RT also showed lower stability than the QC samples as well as samples stored at -20degrees C, after 3 days. CONCLUSIONS: CEA and CA 19-9 levels in PS showed higher variability than AFP and CA 125, especially when stored at RT. These results indicate that all EQA specimens for tumor marker assays need to be tested as soon as possible and not stored at RT for longer than 3 days during the EQA process.
alpha-Fetoproteins ; Carcinoembryonic Antigen ; Quality Control ; Biomarkers, Tumor

BACKGROUND: Tumor markers are used for diagnosing cancers and monitoring responses to cancer therapy. In this study, we evaluated the performance of Lumipulse G1200 (Fujirebio, Japan), a fully automated serum analyzer, for immunoassays of tumor markers. METHODS: We determined the precision and linearity of assays performed using Lumipulse G1200 and the correlation between the results of this and other analyzers used for tumor markers according to the guidelines of the Clinical and Laboratory Standards Institute (CLSI). We used 9 tumor markers, namely, carcinoembryonic antigen, alpha-fetoprotein, cancer antigen 125, cancer antigen 15-3 (CA 15-3), cancer antigen 19-9, prostate specific antigen, protein induced by vitamin K absence or antagonist-II, and pepsinogens I and II. Further, we validated reference intervals using 20 serum samples of healthy individuals. RESULTS: Lumipulse G1200 yielded acceptable precision with total CV< or =5% and within-run CV< or =3% for all markers. Total CV for all markers was 2.4-3.7%, with the exception of CA 15-3 and pepsinogens I and II (CV, 4.0-5.0%). Linearity was observed for all markers over the entire analytical range. Results of Lumipulse G1200 were in good agreement with those of currently used analyzers with correlation coefficients>0.975 for all markers, except pepsinogen I (0.9569). The reference intervals provided by the manufacturer met the criteria mentioned in the CLSI guideline. CONCLUSIONS: Assays using Lumipulse G1200 had high precision, clinically acceptable linearity, and good correlation with the established assays. This indicates that Lumipulse G1200 can be potentially used in routine laboratories.
alpha-Fetoproteins ; Carcinoembryonic Antigen ; Immunoassay ; Pepsinogen A ; Pepsinogens ; Prostate-Specific Antigen ; Biomarkers, Tumor ; Vitamin K

BACKGROUND: Tumor markers are used for diagnosing cancers and monitoring responses to cancer therapy. In this study, we evaluated the performance of Lumipulse G1200 (Fujirebio, Japan), a fully automated serum analyzer, for immunoassays of tumor markers. METHODS: We determined the precision and linearity of assays performed using Lumipulse G1200 and the correlation between the results of this and other analyzers used for tumor markers according to the guidelines of the Clinical and Laboratory Standards Institute (CLSI). We used 9 tumor markers, namely, carcinoembryonic antigen, alpha-fetoprotein, cancer antigen 125, cancer antigen 15-3 (CA 15-3), cancer antigen 19-9, prostate specific antigen, protein induced by vitamin K absence or antagonist-II, and pepsinogens I and II. Further, we validated reference intervals using 20 serum samples of healthy individuals. RESULTS: Lumipulse G1200 yielded acceptable precision with total CV< or =5% and within-run CV< or =3% for all markers. Total CV for all markers was 2.4-3.7%, with the exception of CA 15-3 and pepsinogens I and II (CV, 4.0-5.0%). Linearity was observed for all markers over the entire analytical range. Results of Lumipulse G1200 were in good agreement with those of currently used analyzers with correlation coefficients>0.975 for all markers, except pepsinogen I (0.9569). The reference intervals provided by the manufacturer met the criteria mentioned in the CLSI guideline. CONCLUSIONS: Assays using Lumipulse G1200 had high precision, clinically acceptable linearity, and good correlation with the established assays. This indicates that Lumipulse G1200 can be potentially used in routine laboratories.
alpha-Fetoproteins ; Carcinoembryonic Antigen ; Immunoassay ; Pepsinogen A ; Pepsinogens ; Prostate-Specific Antigen ; Biomarkers, Tumor ; Vitamin K

In 2017, the tumor marker program of the Korean Association of External Quality Assessment Service was performed for tumor markers I and II. Tumor marker I comprised alpha-fetoprotein (AFP), carcinoembryonic antigen, protein induced by vitamin K absence-II, and prostate specific antigen (PSA), and tumor marker II comprised cancer antigen (CA) 125, CA 19-9, CA 15-3, CA 72-4, and beta-2-microglobulin. Two challenges were conducted with three pooled serum or control materials, except for the first tumor marker I challenge. In total, 648 institutions participated in tumor marker I and 380 in tumor marker II programs. The response rates were 92.9%–97.0%. The coefficients of variation (CVs) were different depending on tests and samples, and average CVs were 3.7%–16.8%. The average CV of CA 72-4 tests, whose number of participants was the smallest, was the lowest. The average CV of AFP tests, which included a sample with very high levels, was the highest.
alpha-Fetoproteins ; Biomarkers, Tumor* ; Carcinoembryonic Antigen ; Korea* ; Prostate-Specific Antigen ; Vitamin K

Two trials of external quality assessment were performed in 2015, with 13 test items grouped into four test categories. The first trial materials were sent on May 19, 2015 and the second trial was performed on November 9, 2015 with 13 items including tumor markers, thyroid hormones, cardiac marker troponin (troponin T or troponin I), and procalcitonin (PCT) as biomarkers by immunoassay methods. The bone marker, carboxy-terminal collagen crosslinks (CTX) was replaced by procalcitonin since 2014, because a limited number of institutions performed assays with CTX. External quality surveys of 13 immunoassay test items with 16 control materials were conducted, as scheduled. In total, 13 control materials were used, which consisted of six tumor markers, namely alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), carcinoma antigen (CA) 125, carbohydrate antigen (CA) 19-9, human chorionic gonadotrophin (HCG), and prostate specific antigen (PSA). In addition to tumor markers, 5 thyroid markers, namely thyroid hormone (T)3, T4, thyroid stimulating hormone (TSH), free T4, and thyroglobulin (TG) were included. Furthermore, troponin, as a cardiac marker, and procalcitonin, as a new biomarker, have been adopted since 2014. Five home-made pooled sera and 3 commercial control sera were used as survey materials. MAS Tri-point Liquimmune level 3 (Medical Analysis Systems Inc., USA) was used for thyroid hormones. Procalcitonin and troponin control materials were from Elecsys Precis Control Varia and Elecsys Precis Control Troponin (Roche, Germany), respectively. The number of laboratories participating in the external quality assessment for Immunoassay Subcommittee was 719 institutions in the first trial survey (response rate 98.7%) and 730 institutions in the second survey (94.9%). The test items most frequently used in immunoassays were TSH (93.2%, 93.1%), free T4 (90.3%, 90.2%), and AFP (89.4%, 89.0%), whereas recently adopted biomarkers were less frequently used: troponin I (36.6%, 37.1%), procalcitonin (24.1%, 26.7%), and thyroglobulin (10.3%, 10.7%). The quality of the laboratories participating in the survey seems to be continuously improving, according to their peer group results.
alpha-Fetoproteins ; Biomarkers ; Biomarkers, Tumor ; Carcinoembryonic Antigen ; Chorion ; Collagen ; Humans ; Immunoassay* ; Korea* ; Peer Group ; Prostate-Specific Antigen ; Thyroglobulin ; Thyroid Gland ; Thyroid Hormones ; Thyrotropin ; Troponin ; Troponin I

Abstract　　B cell maturation antigen (BCMA) is an ideal target for precise treatment due to its highly selective expression on malignant myeloma cells. This review summarizes briefly the advances in the latest research progress on biological activity of BCMA, its significance as a biomarker and immunotherapy direcited against BCMA, such as bispecific antibodies, antibody drug conjugates, chimeric antigen receptor T cell therapy against mature B cell antigens.
Antigens, Differentiation, B-Lymphocyte ; B-Cell Maturation Antigen ; B-Lymphocytes ; Humans ; Immunotherapy ; Multiple Myeloma ; therapy ; T-Lymphocytes

<b>OBJECTIVEb>To investigate the diagnostic role of STAT6 immunohistochemistry in solitary fibrous tumors (SFT)/meningeal hemangiopericytomas (HPC).

<b>METHODb>Evaluated the expression of STAT6, vimentin, CD34, EMA, PR, S-100, CD56, GFAP and Ki-67 in a cohort of 37 SFT/meningeal HPC, 30 meningiomas and 30 schwannomas by immunohistochemistry staining.

<b>RESULTSb>All SFT/meningeal HPC demonstrated nuclear positivity for STAT6, and the proportion of positive tumor cells ranged from 60% to 95%, with no significant difference cases.Vimentin was strongly positive in all cases. CD34, EMA and PR positivity was found in 32 cases, 1 case and 4 cases, respectively.S-100 protein, CD56 and GFAP were negative; Ki-67 labeling index was 1%-8%. However, the meningiomas and schwannomas were negative for STAT6.

<b>CONCLUSIONSb>STAT6 is a relatively specific biomarker for SFT/meningeal HPC, and may be used in the diagnosis and differential diagnosis of SFT/meningeal HPC, especially for the atypical cases, and allows the precise pathologic diagnosis of SFT/meningeal HPC.

Antigens, CD ; analysis ; Antigens, CD34 ; analysis ; Antigens, Differentiation, T-Lymphocyte ; analysis ; Biomarkers, Tumor ; analysis ; Diagnosis, Differential ; Glial Fibrillary Acidic Protein ; analysis ; Hemangiopericytoma ; chemistry ; diagnosis ; Humans ; Immunohistochemistry ; Ki-67 Antigen ; analysis ; Meningeal Neoplasms ; chemistry ; diagnosis ; Meningioma ; chemistry ; diagnosis ; Neurilemmoma ; chemistry ; diagnosis ; S100 Proteins ; analysis ; STAT6 Transcription Factor ; analysis ; Solitary Fibrous Tumors ; chemistry ; diagnosis ; Vimentin ; analysis

The purpose of this study was to investigate the relationship between serum tumor markers and dietary intakes in healthy adults to address a nutrition guide for cancer prevention. We analyzed tumor-related markers, carcinoembryonic antigen (CEA), alpha-fetoprotein (AFP), prostate-specific antigen (PSA), and cancer antigen 125 (CA125) in serum and daily food and nutrient intakes using a 24-hour recall method in 23 healthy men and 32 healthy women. The average age was 50.7 years for men and 48.9 years for women. There were no significant differences in biochemical tumor markers and food intake between the men and women except energy intake. A significantly positive correlation was found between serum AFP, a biochemical marker of liver cancer, and serum glutamic oxaloacetic transaminase (GOT) and/or glutamic pyruvate transaminase (GPT) in both men and women. CEA had a significant and negative correlation with energy intake for men and food intake in women. PSA, a biomarker of prostate cancer, was significantly and positively correlated with the intake of animal iron and cholesterol in men. CA125, a biomarker of gynecologic cancers, was significantly and positively correlated with meat intake in women. As this study revealed the significant relationship between biochemical tumor markers and dietary factors, further studies are needed to elucidate the underlying mechanism of this relationship.
Adult* ; alpha-Fetoproteins ; Animals ; Aspartate Aminotransferases ; Biomarkers ; Biomarkers, Tumor ; CA-125 Antigen ; Carcinoembryonic Antigen ; Cholesterol ; Diet ; Eating ; Energy Intake ; Female ; Humans ; Iron ; Liver Neoplasms ; Male ; Meat ; Methods ; Prostate-Specific Antigen ; Prostatic Neoplasms ; Pyruvic Acid

BACKGROUND: Aviators are tested for the antigens and antibodies of hepatitis viruses or tumor markers when they visit the Aerospace Medical Center (AMC) for regular checkups. Although various enzyme immunoassay (EIA) or chemiluminescence immunoassay (CLIA) are currently the standard quantitative methods and are widely used, the clinical laboratory of AMC is currently using the rapid qualitative immunochromatographic assays (ICA) for these tests due to the lack of necessary equipment and high cost. The aim of our study was to evaluate the rapid ICAs in comparison with standard methods. METHODS: With the cooperation of the Department of Laboratory Medicine in Seoul National University Bundang Hospital (SNUBH) where the standard methods (CLIA) had been used, serum specimens of SNUBH patients were collected and provided for AMC together with the results of six test items. The six items were HBsAg, anti-HBs, anti-HCV, alpha-fetoprotein (AFP), prostate-specific antigen (PSA), and carcinoembryonic antigen (CEA). The test results of these specimens by rapid ICAs were compared with those by the SNUBH methods. RESULTS: When the SNUBH methods were regarded as a standard, sensitivity/specificity of each rapid ICA was HBsAg 95.1%/100%, anti-HBs 90.6%/92.6%, anti-HCV 97.5%/ 100%, AFP 75%/100%, PSA 66%/100%, and CEA 47.7%/100%, respectively. CONCLUSION: The rapid ICA methods used at the AMC generally showed high specificity but low sensitivity which meant that the overall accuracy may be unsatisfactory. These ICAs were unsuitable for accurate confirmative diagnosis due to low negative predictive values. For several items whose sensitivities are particularly low, they could not be used as screening tests. If immunoassays are to be helpful for an accurate diagnosis, it is necessary to equip the AMC with an EIA or CLIA instrument.
alpha-Fetoproteins ; Antibodies ; Carcinoembryonic Antigen ; Hepatitis B Surface Antigens ; Hepatitis Viruses ; Humans ; Immunoassay ; Immunochromatography ; Immunoenzyme Techniques ; Luminescence ; Mass Screening ; Prostate-Specific Antigen ; Sensitivity and Specificity ; Biomarkers, Tumor

<b>OBJECTIVEb>To investigate the effect of SAHA on the maturation of human dendritic cells (DC) and to explore its underlying mechanism.

<b>METHODSb>Peripheral blood mononuclear cells (PBMNC) were isolated from human peripheral blood and cultured in RPMI 1640 medium with 100 ng/ml rhGM-CSF and 500 U/ml rhIL-4. In the LPS induced maturation process, dendritic cells treated with or without SAHA were used as test group, and dendritic cells treated without LPS or SAHA were used as control group. DC was observed under inverted microscope. Flow cytometer was used to detect the surface antigen molecules expressed by DC. The mixed lymphocyte culture (MLC) was used to observe the allogeneic lymphocyte stimulation. The NF-κB signaling pathway was detected by electrophoretic mobility shift assay (EMSA).

<b>RESULTSb>The SAHA could effectively suppress the maturation of DC induced by LPS, the DC treated with SAHA+LPS had immature morphological characteristics; the expression of CD80, CD83 and HLA-DR in SAHA+LPS group and control group were significantly down-regulated as compared with single LPS group (P<0.01); the ability of DC to stimulate the proliferation of allogeneic T lymphocytes in SAHA+LPS group and control group was significantly weaker than that in single LPS group (P<0.01); EMSA results showed that NF-κB activity decreased after SAHA and LPS treatment and was significantly lower than that of single LPS group.

<b>CONCLUSIONb>SAHA can effectively suppress DC maturation induced by LPS and also weaken the ability to stimulate allogeneic T lymphocyte. NF-κB signaling pathway is involved in regulating DC maturation.

Cell Differentiation ; Dendritic Cells ; Flow Cytometry ; HLA-DR Antigens ; Humans ; Lymphocyte Activation ; Lymphocyte Culture Test, Mixed ; NF-kappa B ; T-Lymphocytes