RESUMO
BACKGROUND: To verify and evaluate the performance characteristics of an enzyme-linked immunosorbent assay (ELISA) assay kit (Hangzhou Cancer probe Biotech Company) for seven autoantibodies (7-AABS), including p53, GAGE7, PGP9.5, CAGE, MAGEA1, SOX2, and GBU4-5. METHODS: Evaluation was carried out according to "Guidelines for performance evaluation of in vitro diagnostic reagent". The performance parameters included detection limit, reportable range, precision, accuracy, and method comparison. RESULTS: The detection limit was less than 3.75 U/mL. Reportable range was from 3.75 U/mL to 60 U/mL. The coefficient of variations (CVs) of within-run of 7-AABS were 5.15% - 10.13%, and between-run of CVs were 3.41% - 8.80%. For accuracy verification, the relative deviations (Bias) were all lower than 15% in the indicated concentration range. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and ac-curacy were 35.9%, 90.0%, 80.3%, 55.3%, 61.3%, respectively. CONCLUSIONS: Overall, the verification study demonstrated the performance of the kit meets the testing requirements. It is qualified for clinical applications.
Assuntos
Autoanticorpos/sangue , Química Clínica/métodos , Ensaio de Imunoadsorção Enzimática/métodos , Neoplasias Pulmonares/sangue , Neoplasias Pulmonares/imunologia , Antígenos de Neoplasias/sangue , Biomarcadores Tumorais/sangue , Calibragem , Química Clínica/instrumentação , Humanos , Limite de Detecção , Modelos Lineares , Proteínas de Neoplasias/sangue , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Sensibilidade e EspecificidadeRESUMO
<p><b>OBJECTIVE</b>To explore the sigificance of HBV-LP in the HBV replication and anti-virus treatment efficacy assessment by detect the serum HBV-LP and HBV DNA and Pre-S1 and HBV serum markers.</p><p><b>METHODS</b>Serum HBV-LP, Pre-S1 and HBV serologic markers were measured by enzyme-linked immunosobent assay(ELISA), fluorescent PCR method to detect serum HBV DNA content in the 220 cases infected serum of CHB. Treated with adefovir dipivoxil antiviral therapy, and mesured the setologic indicators after 12 weeks, 24 weeks,36 weeks and 48 weeks.</p><p><b>RESULTS</b>The detection rate of HBV-LP and HBV DNA detection rate no significant difference in patients with chronic hepatitis B, and significantly higher than the Pre-S1 and HBeAg detection rate. HBV-LP positive rate also similar to the HBV DNA positive rate in HBeAg negative CHB patients. In the anti-virus therapy, the declined of HBV-LP similar to HBV DNA.</p><p><b>CONCLUSIONS</b>HBV-LP can reflect the HBV replication, is a good chronic hepatitis B diagnosis and efficacy evaluation index.</p>
Assuntos
Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Adenina , Usos Terapêuticos , Antivirais , Usos Terapêuticos , Antígenos de Superfície da Hepatite B , Sangue , Genética , Vírus da Hepatite B , Genética , Metabolismo , Hepatite B Crônica , Sangue , Diagnóstico , Tratamento Farmacológico , Virologia , Organofosfonatos , Usos TerapêuticosRESUMO
<p><b>OBJECTIVE</b>To explore the diagnostic value of the measurement of serum Golgi protein 73 (GP73) in the diagnosis of hepatocellular carcinoma (HCC).</p><p><b>METHODS</b>Enzyme-linked immunosorbent assay (ELISA) was used to detect the serum GP73 in the 81 cases of HCC, 71 cases of chronic hepatitis or cirrhosis (CH/LC) and 65 cases of healthy blood donors, and to evaluate the sensitivity and specificity in the diagnosis of HCC through the ROC curves.</p><p><b>RESULTS</b>The average levels of serum GP73 in HCC, CH/LC and Normal groups were (152.67 +/- 33.59) ng/ml, (93.15 +/- 20.02) ng/ml and (58.95 +/- 17.29) ng/ml(o) After calculating through the ROC curves, 120 ng/ml was set as the optimal cut-off point, GP73 has a sensitivity of 77.80% and a specificity of 78.00%.</p><p><b>CONCLUSIONS</b>GP73 as a serum marker in the diagnosis of HCC had a higher sensitivity than AFP, and the combined detection of GP73 and AFP could improve HCC diagnosis.</p>
