OBJECTIVE: To explore the application of blood screening method based on chemiluminescence immunoassay（CLIA）and to evaluate its officacy. METHODS: Screening HBsAg, anti-HCV, anti-HIV and TP was performed on 3,530 voluntary blood donors by ELISA and CLIA, and then all the specimens with ELISA and ELISA/CLIA were further confirmed by NAT; TP single and double positive specimens by ELISA or CLIA were further confirmed by TPPA. RESULTS: The results of CLIA method was well consistent with NAT results, displaying better repeatability and higher sensitivity than ELISA method. For CLIA/ELISA specimens there was a certain false-negative result obtained by ELISA method, especially for blood donors with low virus biter concentration or "window period". CONCLUSION ELISA and CLIA have complementary advantages in blood screening, which can improve the sensitivity of blood screening, reduce the missed detection and shorten detection time. The introduction of CLIA for blood screening is of great importance for ensuring the quality of blood and the safety of clinical transfusion.
Blood Donors ; Hepatitis B Surface Antigens ; Hepatitis B virus ; Luminescence ; Luminescent Measurements ; Mass Screening

OBJECTIVE: To evaluate the performance of the chemiluminescence immune assay (CLIA) and the electro-chemiluminescence immuneoassay(ECLIA) for Treponemapallidum antibody（anti-TP） screening in blood donors. METHODS: The sero-panel samples from NCCL were tested with ELISA, CLIA and ECLIA assays synchronously to evaluate their performances respectively. RESULTS: The sensitivity and the negative predictive value of the CLIA were 100%, which were the same as one kind of ELISA, and better than the other ELISA; The specificity of the CLIA was 88.46%, the accuracy rate was 97.02%, the positive predictive value was 96.13%, which were higher than both ELISA. Due to the significant interference of sample heat inactivation in ECLIA detection, the result can not demonstrate the true performance of ECLIA in this study. The preliminary result was as follows: the sensitivity was 98.93%, the negative predictive value was 96.75%, and the accuracy rate, specificity and positive predictive value of ECLIA were 97.02%, 91.54% and 97.10% respectively. CONCLUSION Compared with ELISA, the CLIA has higher sensitivity and specificity and can be used for Treponemal antibody screening in blood bank. Unfortunately, the data in this study cannot come to a conclusion for ECLIA and needs more testing.
Blood Donors ; Enzyme-Linked Immunosorbent Assay ; Humans ; Luminescence ; Luminescent Measurements ; Sensitivity and Specificity

No abstract available.
Adult ; Autoantibodies/*immunology ; Female ; Hashimoto Disease/*diagnosis ; Humans ; Luminescent Measurements ; Radioimmunoassay ; Republic of Korea ; Thyroid Function Tests ; Thyroxine/*blood/immunology ; Triiodothyronine/blood

OBJECTIVETo study the reference ranges of six sex hormones, i.e., luteinizing hormone, follicle-stimulating hormone, progesterone, prolactin, estradiol, and testosterone, for healthy children aged 0-18 years in Shenzhen, China.

METHODSStratified cluster sampling was performed to select 2 178 healthy children aged 0-18 years in the districts of Futian, Luohu, Nanshan, Bao'an, and Longgang in Shenzhen between September 2015 and September 2016. There were 1 219 boys and 959 girls, including 81 neonates, 335 infants, 346 young children, 469 preschool children, 419 school-aged children, and 528 adolescents. The American Beckman DXI800 chemiluminescence meter was used to measure the levels of luteinizing hormone, follicle-stimulating hormone, progesterone, prolactin, estradiol, and testosterone.

RESULTSThere were significant differences in the levels of luteinizing hormone, follicle-stimulating hormone, progesterone, prolactin, estradiol, and testosterone between different age groups (P<0.05). There were also significant differences in the levels of these sex hormones between boys and girls in the same age group (P<0.05). The reference ranges of six sex hormones were established for healthy children aged 0-18 years in Shenzhen based on the levels of these hormones in different age groups.

CONCLUSIONSThere are significant differences in sex hormones between different age groups or sex groups. The reference ranges of six sex hormones established for different sexes or ages have great significance in the diagnosis and treatment of endocrine diseases in children.

Adolescent ; Age Factors ; Child ; Child, Preschool ; Estradiol ; blood ; Female ; Follicle Stimulating Hormone ; blood ; Gonadal Steroid Hormones ; blood ; Humans ; Infant ; Infant, Newborn ; Luminescent Measurements ; Luteinizing Hormone ; blood ; Male ; Progesterone ; blood ; Reference Values ; Testosterone ; blood

BACKGROUND: Measurement of postoperative serum thyroglobulin (Tg) is important for detecting persistent or recurrent differentiated thyroid cancer. We evaluated the analytic performance of the DxI 800 assay (Beckman Coulter, USA) for serum Tg and anti-thyroglobulin antibodies (TgAbs) in comparison with that of the GAMMA-10 assay (Shinjin Medics Inc., Korea) for serum Tg and RIA-MAT 280 assay (Stratec, Germany) for TgAb. METHODS: We prospectively collected blood samples from 99 patients thyroidectomized for thyroid cancer. The functional sensitivity was investigated in standards and human serum. Precision and linearity were evaluated according to the guidelines of the Clinical and Laboratory Standards Institute. The correlation between the two assays was assessed in samples with different Tg ranges. RESULTS: The functional sensitivity of the DxI 800 assay for serum Tg was between 0.0313 and 0.0625 ng/mL. The total CV was 3.9-5.6% for serum Tg and 5.3-6.9% for serum TgAb. The coefficient of determination (R2) was 1.0 and 0.99 for serum Tg and TgAb, respectively. The cut-offs for serum TgAb were 4.0 IU/mL (DxI 800) and 60.0 IU/mL (RIA-MAT 280), and the overall agreement was 68.7%. The correlation between the two assays was excellent; the correlation coefficient was 0.99 and 0.88 for serum Tg and TgAb, respectively. CONCLUSIONS: The DxI 800 is a sensitive assay for serum Tg and TgAb, and the results correlated well with those from the immunoradiometric assays (IRMA). This assay has several advantages over the IRMA and could be considered an alternative test for Tg measurement.
Autoantibodies/*blood ; Humans ; Immunoradiometric Assay ; Luminescent Measurements ; Prospective Studies ; Reagent Kits, Diagnostic ; Reproducibility of Results ; Thyroglobulin/*blood ; Thyroid Neoplasms/*diagnosis/surgery

Lipooligosacharide (LOS) of Neisseria gonorrhoeae (gonococci, GC) is involved in the interaction of GC with host cells. Deletion of the alpha-oligosaccharide (alpha-OS) moiety of LOS (lgtF mutant) significantly impairs invasion of GC into epithelial cell lines. GC opacity (Opa) proteins, such as OpaI, mediate phagocytosis and stimulate chemiluminescence responses in neutrophils in part through interaction with members of the carcinoembryonic antigen (CEA) family, which includes CEACAM3 (CD66d), a human neutrophil specific receptor for phagocytosis of bacteria. In the present work, we examined the effects of OpaI-expressing lgtF mutant on phagocytosis by HeLa-CEACAM3 cells and chemiluminescence responses in neutrophils. The results showed that lgtF mutant even expressing OpaI completely lost the ability to promote either phagocytosis mediated by CEACAM3 interaction in HeLa cells or chemiluminescence responses in neutrophils. These data indicated that Opa proteins in the lgtF mutant, which might result from the conformational change, cannot be functional.
Antigens, Bacterial ; chemistry ; genetics ; immunology ; metabolism ; Carbohydrate Sequence ; Carcinoembryonic Antigen ; genetics ; immunology ; Gene Expression Regulation ; HeLa Cells ; Host-Pathogen Interactions ; Humans ; Lipopolysaccharides ; chemistry ; immunology ; Luminescent Measurements ; Mutation ; Neisseria gonorrhoeae ; genetics ; metabolism ; pathogenicity ; Neutrophils ; immunology ; microbiology ; Phagocytosis

Immunoassays greatly contribute to veterinary drug residue analysis. However, there are few reports on detecting neomycin residues by immunoassay. Here, a rapid and sensitive chemiluminescent enzyme immunoassay (CLIEA) was successfully developed for neomycin residue analysis. CLIEA demonstrated good cross-reactivity for neomycin, and the IC50 value was 2.4 ng/mL in buffer. The average recovery range was 88.5%-105.4% for spiked samples (10, 50, and 100 μg/kg), and the coefficient of variation was in the range of 7.5%-14.5%. The limit of detection of CLEIA was 9.4 μg/kg, and this method was compared with the liquid chromatography-tandem mass spectrometry method using naturally contaminated samples, producing a correlation coefficient of >0.95. We demonstrate a reliable CLIEA for the rapid screening of neomycin in milk.
Animals ; Anti-Bacterial Agents ; metabolism ; Drug Residues ; metabolism ; Food Contamination ; analysis ; Immunoenzyme Techniques ; veterinary ; Limit of Detection ; Luminescent Measurements ; veterinary ; Milk ; chemistry ; Neomycin ; metabolism

BACKGROUNDIt is often challenging to distinguish tuberculous pleural effusion (TPE) from malignant pleural effusion (MPE); thoracoscopy is among the techniques with the highest diagnostic ability in this regard. However, such invasive examinations cannot be performed on the elderly, or on those in poor physical condition. The aim of this study was to explore the differential diagnostic value of carbohydrate antigen 125 (CA125), carbohydrate antigen 199 (CA199), carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), and squamous cell carcinoma (SCC) associated antigen in patients with TPE and MPE.

METHODSUsing electrochemiluminescence, we measured the concentration of tumor markers (TMs) in the pleural effusion and serum of patients with TPE (n = 35) and MPE (n = 95). We used receiver operating characteristic (ROC) curve analysis to evaluate the TMs and differentiate between TPE and MPE.

RESULTSThe cut-off values for each TM in serum were: CA125, 151.55 U/ml; CA199, 9.88 U/ml; CEA, 3.50 ng/ml; NSE, 13.27 ng/ml; and SCC, 0.85 ng/ml. Those in pleural fluid were: CA125, 644.30 U/ml; CA199, 12.08 U/ml; CEA, 3.35 ng/ml; NSE, 9.71 ng/ml; and SCC, 1.35 ng/ml. The cut-off values for the ratio of pleural fluid concentration to serum concentration (P/S ratio) of each TM were: CA125, 5.93; CA199, 0.80; CEA, 1.47; NSE, 0.76; and SCC, 0.90. The P/S ratio showed the highest specificity in the case of CEA (97.14%). ROC curve analysis revealed that, for all TMs, the area under the curve in pleural fluid (0.95) was significantly different from that in serum (0.85; P < 0.001).

CONCLUSIONSTMs in TPE differ significantly from those in MPE, especially when detected in pleural fluid. The combined detection of TMs can improve diagnostic sensitivity.

Adult ; Aged ; Aged, 80 and over ; Antigens, Neoplasm ; Antigens, Tumor-Associated, Carbohydrate ; blood ; Biomarkers, Tumor ; blood ; CA-125 Antigen ; Carcinoembryonic Antigen ; blood ; Electrochemical Techniques ; Female ; Humans ; Luminescent Measurements ; Male ; Middle Aged ; Pleural Effusion ; blood ; Pleural Effusion, Malignant ; blood ; Young Adult

The aim of this study is to prepare and characterize cardiac troponin T (cTnT) monoclonal antibodies (mAb), and further develop a chemiluminescence quantitative detection assay for cTnT. BALB/c mice were immunized with recombinant cTnT antigen, and specific mAbs were prepared using conventional hybridoma technique and screened by indirect ELISA method. To identify the epitopes, several cTnT peptide fragments were synthesized or expressed by genetic engineering. A double antibody sandwich ELISA method was used to screen the mAb pairs for cTnT detection, and the automatic chemiluminescence detection assay for cTnT was developed. In total 220 clinical specimens were used for system comparison between our assay and Roche cTnT assay; further performance characteristics was evaluated by testing 238 clinical samples and 784 physical examination samples. We successfully screened 33 strains of hybridoms against cTnT, and the mAbs' epitopes were identified. Mab E16H8 and C8G11 with a detection limit of 10 pg/mL cTnT antigen were selected to develop the full automatic chemiluminescence quantitative assay. The correlation coefficient of our reagent with Roche's was 0.959 9, with a coincidence rate of 95%. The assay presented a sensitivity of 97.5%, and a specificity of 99.15% in detection of clinical samples. The cTnT concentration was less than 0.080 6 ng/mL in 99% of general population, which agrees with the definition of WHO on patients with acute myocardial infarction (AMI). In summary, we developed monoclonal antibodies against predominant epitopes for diagnostics of cTnT, and an automatic tubular chemiluminescence quantitative detection assay was further developed, which presents a high coincidence rate with Roche's.
Antibodies, Monoclonal ; immunology ; Enzyme-Linked Immunosorbent Assay ; Epitopes ; immunology ; Humans ; Hybridomas ; Luminescent Measurements ; Myocardial Infarction ; Peptide Fragments ; Sensitivity and Specificity ; Troponin T ; immunology

PURPOSE: To compare the levels of serum cortisol and testosterone in acute and chronic central serous chorio-retinopathy (CSC). METHODS: Serum cortisol and testosterone levels in 30 patients with either acute or chronic CSC were evaluated using chemiluminescent immunoassay. RESULTS: The mean age was 42.43 +/- 6.37 years (range, 32 to 56 years). The mean 8:00 to 9.00 a.m. serum cortisol level was 12.61 +/- 4.74 microg/dL (range, 6.58 to 27.42 microg/dL). The mean serum testosterone level was 5.88 +/- 1.57 ng/dL (range, 2.81 to 9.94 ng/dL). The mean visual acuity was 20 / 65.07 +/- 40.56 (range, 20 / 25 to 20 / 200). There was no statistically significant difference in the mean levels of serum cortisol and testosterone between the acute and chronic cases (p > 0.05), but there was a statistically significant difference in the mean presenting visual acuity in the two groups (p < 0.05). CONCLUSIONS: All except one patient in the acute group had normal levels of serum cortisol. Testosterone levels were within the normal range in both the acute and chronic cases of CSC. There is unlikely to be any statistically significant difference in the mean levels of serum cortisol and testosterone between the acute and chronic cases, but there may be a statistically significant difference in the mean presenting visual acuity in these groups.
Acute Disease ; Adult ; Central Serous Chorioretinopathy/*blood ; Chronic Disease ; Female ; Humans ; Hydrocortisone/*blood ; Luminescent Measurements ; Male ; Middle Aged ; Testosterone/*blood ; Visual Acuity/physiology