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.

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.

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

BACKGROUND:In vitro lymphocyte proliferation test is often used to detect the potential immunogenicity of medical devices,but no detailed extraction conditions and dose are given in the relevant standards. OBJECTIVE:To investigate the effects of different extraction conditions of the test product and different doses of the extract on in vitro human lymphocyte proliferation,and to consider the factors that need to be considered when selecting test conditions for in vitro lymphocyte proliferation test. METHODS:In the experiment,the homogenous bone repair material and heparin-modified intraocular lens were divided into the following 12 groups:(1)Experimental group 1:24-hour complete medium(RPMI modified medium containing 10%fetal bovine serum)extract of 200 μL + lymphocyte suspension of 50 μL;(2)negative control group 1:24-hour complete medium 200 μL + lymphocyte suspension 50 μL;(3)experimental group 2:24-hour complete medium extract 100 μL + lymphocyte suspension 100 μL;(4)negative control group 2:24-hour complete medium 100 μL + lymphocyte suspension 100 μL;(5)experimental group 3:72-hour RPMI modified medium extract(addition of 10%fetal bovine serum before experiment)200 μL + lymphocyte suspension 50 μL;(6)negative control group 3:72-hour RPMI modified medium(addition of 10%fetal bovine serum before experiment)200 μL + lymphocyte suspension 50 μL;(7)experimental group 4:72-hour RPMI modified medium extract(addition of 10%fetal bovine serum before experiment)100 μL + lymphocyte suspension 100 μL;(8)negative control group 4:72-hour RPMI modified medium(addition of 10%fetal bovine serum before experiment)100 μL + lymphocyte suspension 100 μL;(9)positive control group 1:complete medium containing 10 μg/mL plant hemagglutinin-M 200 μL + lymphocyte suspension 50 μL;(10)positive control group 2:complete medium containing 10 μg/mL plant hemagglutinin-M 100 μL + lymphocyte suspension 100 μL;(11)blank control group 1:250 μL complete medium;(12)control group 2:200 μL complete medium.After 3 days of culture,the proliferation of lymphocytes was detected by CCK-8 assay. RESULTS AND CONCLUSION:(1)Under different test conditions,the extracts of the allogeneic bone repair material could enhance the activity of human lymphocytes.Under the condition of 72-hour leaching in RPMI modified medium and the volume ratio of leaching solution and lymphocyte suspension was 4:1,the most significant effect was observed.Heparin-modified intraocular lens extract also had obvious inhibitory effect on lymphocyte activity under this condition;its inhibitory effect on lymphocyte activity may be related to the heparin in the extract.However,the activity of lymphocytes was slightly enhanced by heparin-modified intraocular lens extract under the experimental conditions of complete medium extraction for 24 hours and the volume ratio of extract to lymphocyte suspension was 4:1.(2)Under different extraction conditions and doses,the results of in vitro lymphocyte proliferation test may be quite different.The selection of test conditions should be combined with the clinical application of the product,and the inherent characteristics of the product should also be considered.

Objective To evaluate the quality status of rubel a virus IgM diagnostic kits by national supervising sampling. Methods Using legal inspection combining with exploratory study, the positive and negative coincidence rate, detection limit and repeatability of kits were verified. Results The 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. Conclusion At present, rubel a 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 wil prompt enterprises to improve quality.

The importance of structural variants(SVs)for human phenotypes and diseases is now recognized.Although a variety of SV detection platforms and strategies that vary in sensitivity and specificity have been developed,few benchmarking procedures are available to confidently assess their performances in biological and clinical research.To facilitate the validation and application of these SV detection approaches,we established an Asian reference material by characterizing the genome of an Epstein-Barr virus(EBV)-immortalized B lymphocyte line along with identified benchmark regions and high-confidence SV calls.We established a high-confidence SV callset with 8938 SVs by integrating four alignment-based SV callers,including 109x Pacific Biosciences(PacBio)continuous long reads(CLRs),22 x PacBio circular consensus sequencing(CCS)reads,104x Oxford Nanopore Technologies(ONT)long reads,and 114×Bionano optical mapping plat-form,and one de novo assembly-based SV caller using CCS reads.A total of 544 randomly selected SVs were validated by PCR amplification and Sanger sequencing,demonstrating the robustness of our SV calls.Combining trio-binning-based haplotype assemblies,we established an SV benchmark for identifying false negatives and false positives by constructing the continuous high-confidence regions(CHCRs),which covered 1.46 gigabase pairs(Gb)and 6882 SVs supported by at least one diploid haplotype assembly.Establishing high-confidence SV calls for a benchmark sample that has been characterized by multiple technologies provides a valuable resource for investigating SVs in human biology,disease,and clinical research.

OBJECTIVE: To evaluate the capacity of laboratories participated in the proficiency testing (PT) of determination potassium in serum and improve the quality of testing, and put forward technical suggestions for unsatisfied laboratories. METHODS: According to the requirements of CNAS related documents, the homogeneity and stability of the real PT sample were evaluated by one-way ANOVA and t test, respectively. The values of real PT samples were assigned by reference method which was used in PT results assay. It is required that the deviation of value of real PT samples (code:2, 3, 5) between the measured value and the assigned value shall be within ±15.0%. The precision of values for all samples should not be greater than 3.0%. RESULTS: All the laboratories submitted valid data according to the requirements. Only one laboratory did not meet the requirements, and the satisfaction rate was 90.9%. CONCLUSIONS The ability of most of laboratories are accurate and reliable.
Drinking Water/analysis* ; Laboratories ; Laboratory Proficiency Testing ; Potassium