Objective:To establish the industry standard for growth hormone quantitative labelling immunoassay kit, and to validate it by chemiluminescence labeling and time-resolved fluorescence labeling method which are suitable for the standard.Methods: Different assay method kits, including magnetic particle chemiluminescent assay, electrochemiluminescence assay, chemiluminescence assay and time-resolved fluorescent assay, were used to verified the blank limitation, linearity, accuracy, precision, specificity and stability in accordance with protocol industry standard.Results: Other verification results could meet requirements of the protocol industry standard besides accuracy in part of kits couldn't achieve to anticipative remand (relative deviation couldn't be more than ±10%).Conclusion: According to the verification results, the accuracy requirements was adjusted to ±15%. The other items of industry standard were maintained. The industry standard for growth hormone quantitative labeling immunoassay kit is ultimately established. The standard would contribute to unity quality standard of growth hormone quantitative labeling immunoassay kit, and provide the basis for the supervision and administration of its production, examination, circulation, clinical application and other areas.

Autoimmune Diseases ; metabolism ; pathology ; surgery ; Chromogranin A ; metabolism ; Female ; Gastrectomy ; Gastric Mucosa ; pathology ; Gastrin-Secreting Cells ; metabolism ; pathology ; Gastrins ; metabolism ; Gastritis, Atrophic ; metabolism ; pathology ; surgery ; Humans ; Hyperplasia ; Middle Aged ; Mucin-6 ; metabolism ; Neuroendocrine Tumors ; metabolism ; pathology ; surgery ; Stomach ; pathology ; surgery ; Stomach Neoplasms ; metabolism ; pathology ; surgery ; Synaptophysin ; metabolism

Objective To prepare the HPV genotyping control materials. Methods Three hundred cervical smears with different HPV genotypes were collected and detected by surface plasmon resonance and sequencing. The primers for specific genotype were designed according to GenBank. The recombinant plasmid was constructed through PCR amplification, ligation and transformation. Thirty recombinant plasmids were identified through PCR amplification, sequencing, and the sequences were compared using BLAST. Results The collected HPV infectious samples contained 30 different genotypes including HPV 6,16,18 and so on.The fragment sequences of PCR amplification were concordant with the designed. The fragment sizes of the other types ranged from 1 500 to 2 000 bp except HPV CP8304. And the 30 recombinant plasmids identified by PCR were concordant with the target. The identity of BLAST was 99%. In the fragment of 1500 bp in length, 11 bases were inconsistent with the reference sequence. Conclusions Genotyping control materials were developed successfully. The human papillomavirns genotyping control materials covered all the most common types and included 14 types with high-risk, 3 types with medium-risk and 13 types with low-risk.

Objective To study the clinical and pathologic features of chromophobe cell renal carcinoma and to improve the diagnosis and treatment of the disease. Methods The clinical and pathologic data of 19 patients (10 men and 9 women;mean age,53 years) with chromophobe cell renal carcinoma (9 on the left and 10 on the right) were analyzed.Of the 19 cases,12 were incidentally diagnosed of renal tumor during physical examination.Gross hematuria,low back pain and discomfort and abdominal mass occurred in 7 cases. Results B-ultrasound was mainly characterized by low echo of mass with intact capsule.CT scan revealed that most of the tumors were homogeneous hypodense solid masses,which were well circumscribed.The tumors averaged 8.2 cm in diameter.By TNM staging,8 cases had T_1N_0M_0 stage tumors and 11 cases had T_2N_0M_0 stage tumors.Radical nephrectomy was performed in 17 cases,and partial nephrectomy,in 2 cases.Follow-up was available for 16 patients (mean,4.8 years;range,3 months to 16 years)who were alive without recurrence and metastasis.Pathological features were as follows.①The cross-sections of the tumors were grossly homogeneous, dark brown and solid. One case had fibrous bands coalescence in the center of the tumor.②Microscopically the tumors were composed of 2 types of cells, typical and eosinophilic types,with very distinct borders.③Immunohistochemical assay was positive for CK8 and negative for Vimentin, and Hale colloidal iron staining was positive for the carcinoma cells.④Electron microscopy showed large numbers of vesicles within the cytoplasm. Conclusions Chromophobe cell renal carcinoma is a morphologically distinctive neoplasm with no specific findings on B-ultrasound and CT examinations.The tumors are larger in most cases but usually at early TNM stages with a favorable prognosis.

OBJECTIVETo evaluate the quality status of rubella virus IgM diagnostic kits by national supervising sampling.

METHODSUsing legal inspection combining with exploratory study, the positive and negative coincidence rate, detection limit and repeatability of kits were verified.

RESULTSThe results showed that 15 of 16 batches of kits were qualified using legal inspection, and the passing rate was 93.8%. The unqualified item was negative coincidence rate. In exploratory study, only 11 batches (68.8%) complied with industry standard. The unqualified items were negative coincidence rate, detection limit and repeatability.

CONCLUSIONAt present, rubella virus IgM diagnostic Kits have some quality problems in the market. It is recommended that we adopt industry standard and national reference panel in the registration inspection for the future, which will prompt enterprises to improve quality.

Antibodies, Viral ; Humans ; Immunoglobulin M ; Quality Control ; Reagent Kits, Diagnostic ; standards ; Rubella ; diagnosis ; Rubella virus

Objective To evaluate the diagnosis and differentiation of solitary pulmonary nodule (SPN) using dynamic spiral CT scan of thin collimation.Methods The thin collimation no-enhanced CT scan and contrast enhanced scan in 30 seconds,1 minute,1 minutes,2 minutes,5 minutes,10 minutes,and 15 minutes after administration of media 100 ml were performed in 38 cases. Results The mean enhanced CT numbers of lung cancer and inflammatory pseudotumor were much higher than that of tuberculosis(TB) and hamartoma and statistically significant in different time of enhancement;20 HU was the threshold for a positive test,the sensitivity was 100% and the specificity was 96%.In time-attenuation curve analysis,lung cancer reached peak enhancement about 2 minutes,inflammatory pseudotumor in 5 minutes and keep longer enhanced time than that of lung cancer.No marked enhancement in SPN of TB and harmatoma,but ring-shaped enhancement can be seen in some of TB.More valuable imaging signs were found with thin collimation scan and more accurate to measure the CT numbers than traditional scan.Conclusion Dynamic spiral CT scan of thin collimation is a very valuable method for diagnosis and differentiation of SPN.

OBJECTIVETo study the basic morphological factors and the reliability and limitations of the diagnostic standards of fine needle aspiration cytology (FNAC) of breast masses which drafted.

METHODSA total of 4 309 fine needle aspiration biopsy cases of breast were performed and 951 cases of which were checked with their histological diagnosis.

RESULTSOf the 413 aspiration smear studies, relatively identical morphological features were found on the smears of lesions of the same nature. The sensitivity of diagnosis of malignant tumor in 732 cases, the specificity of diagnosis of benign lesion in 219 cases and the overall accuracy of diagnosis were 97.3%, 97.7%, and 97.4% respectively. The false negative rate, potential false positive rate and the overall misdiagnosis rate were 2.7%, 2.3% and 2.6% respectively, no false positive diagnosis case was found.

CONCLUSIONS(1) The differentiation and the arrangement pattern of the tubular epithelial cells and the amount of benign naked nuclear cells are the three essential factors in the analysis of morphological changes of FNAC of breast mass. (2) The examination of our diagnostic standards of FNAC of breast masses shows that the standards are very reliable but have certain limitations which need to be resolved by histopathological diagnosis.

Biopsy, Needle ; standards ; Breast Neoplasms ; diagnosis ; pathology ; Diagnostic Errors ; Female ; Humans ; Reproducibility of Results

Biopsy ; Dissection ; Gastric Mucosa ; pathology ; surgery ; Gastroscopy ; methods ; Humans ; Neoplasm Invasiveness ; Neoplasm Staging ; Neoplastic Cells, Circulating ; Stomach Neoplasms ; pathology ; surgery ; Stomach Ulcer ; pathology

OBJECTIVETo investigate the morphologic features and diagnostic criteria of various types pf renal adenomas of the kidney.

METHODSIn addition to light microscopy, electron microscopy, histochemical and immunohistochemical assays were applied. All 19 cases of adenomas were followed up.

RESULTSThree (3) cases of papillary adenoma were featured as papillary or tubulopapillary growth in patterns consisting of tumor cells with basophilic or acidophilic cytoplasm and were positive for both epithelial membrane antigen (EMA) and cytokeratin (CK7). Thirteen (13) cases of oncocytoma were characterized by the diversity of the structures including to be nest, tubular and papillary in pattern; a mixture of cell types including the classic oncocytes, oncoblasts and clear cells which were negative for vimentin and CK7 but positive for EMA. Enormous large mitochondria were obtained in 4 cases of oncocytoma by electronic microscopy. Three (3) cases of metanephric adenoma consisted of closely packed, round tubules lined by small bland cells with solid, glomeruloid constructure. Branching, elongated tubules and polypoid fronds were also detected. Tumor cells were negative for EMA, negative or only focally positive for CK7. Eighteen (18) patients were alive except one oncocytoma patient died 5 years after the diagnosis convinced. All the cases reported in this article had been followed up of 3 - 5 years.

CONCLUSIONSThere are 3 kinds of renal adenomas, namely, the papillary adenoma, oncocytoma, and metanephric adenoma and each kind has its own clincopathological features. The latter two can be recognized by their distinctive morphology, and the former can only be diagnosed according to the size of the tumor as the reference. Histochemical and immohistochemical assays are helpful in differential diagnosis.

Adenoma ; Adenoma, Oxyphilic ; Diagnosis, Differential ; Humans ; Kidney ; Kidney Neoplasms

OBJECTIVETo study the reasons for the discrepancies in pathologic diagnosis of gastric dysplasia/early cancer in endoscopic submucosal dissection (ESD) specimens, and how to cope with the discrepancies.

METHODSThe pathologic diagnoses in 60 cases of ESD specimens according to the three currently used classification systems (namely Western criteria, Japanese criteria and Vienna classification) were compared. The diagnostic discrepancies were analyzed.

RESULTSFifteen of the 17 cases diagnosed as low-grade intraepithelial neoplasia according to the Western criteria were revised as adenoma by the Japanese criteria. Amongst the 43 cases of gastric intramucosal adenocarcinoma diagnosed according to the Japanese criteria, 23 cases had concordant diagnosis by the Western criteria. While the diagnosis of low-grade intraepithelial neoplasia/adenoma was basically similar irrespective of classification system used, there were significant differences in the interpretation of gastric early cancer.

CONCLUSIONSThe diagnostic discrepancies in the gastric dysplasia/early cancer are mainly related to the morphologic criteria applied in different classifications. In order to facilitate clinical and pathologic communication, a consensus using Vienna/WHO classifications, supplemented with Japanese system, is desirable.

Adenoma ; pathology ; Carcinoma in Situ ; pathology ; Dissection ; methods ; Gastroscopy ; Humans ; Hyperplasia ; pathology ; Stomach ; pathology ; Stomach Neoplasms ; pathology