Evaluation of the Analytical Performance of Atellica CH 930 Automated Chemistry Analyzer

BACKGROUND: Recently, a new automated chemistry analyzer, Atellica CH930 (Siemens, Germany), was introduced. It automatically measures internal quality control (QC) materials according to a pre-determined schedule. For this purpose, the instrument has space for storage of QC materials. We evaluated the analytical performance of chemistry items by using the Atellica system. METHODS: The precision of 29 items was evaluated with three levels of QC materials with two storage methods. We stored the QC materials in the dedicated storage space in the instrument during the precision evaluation period. In addition, we aliquoted and stored the materials in the refrigerator, and then loaded the material in a timely manner. Linearity, carry-over, and agreement with current methods were also evaluated. RESULTS: The within-laboratory coefficient of variation (CV) of most items, except for total CO2 (tCO2), was within 5.0% in both QC storage methods without significant differences in CV between storage methods. The CV of tCO2 was 5.2%, 5.8%, and 5.1% at three different levels when the QC materials were stored in a dedicated space in the instrument. The linearity was acceptable, showing <5% nonlinearity. Although good agreement was observed for most items, some items, such as calcium, total bilirubin, aspartate transaminase, and chloride, showed unequivalent results. CONCLUSIONS: Atellica CH930 showed acceptable precision, linearity, and agreement in routine chemistry items. The automatic QC function using the storage device has no problem with stability or precision. It can reduce the manual process, allowing technicians to focus on reviewing the QC results and reporting reliable results.

Essential Elements for Establishing Clinical Next-generation Sequencing Testing

Over the past decade, next-generation sequencing (NGS) has evolved at an astonishing pace and has revolutionized clinical medicine as well as genomics research. The rapid advancements in NGS technologies have been accompanied by accumulating evidence of the analytical and clinical validity, and clinical utility of NGS. NGS is used worldwide. This review provides medical technicians and laboratory physicians with the essential elements for establishing clinical NGS testing. Here the authors briefly describe the advantages and drawbacks of currently available NGS platforms, potential sources of error in NGS workflow, and reference materials.

Acceptance Test and Image Quality Assurance of MRI Simulator Equipment / 中国医疗器械杂志

MRI simulator(MRI-Sim) images have unique clinical advantages with higher resolution of soft tissue and clearer visualization of tissue boundaries. Thus, the precise positioning of the tumor target area can be achieved and it is widely used in the field of radiotherapy. This article focuses on the acceptance test project and image quality assurance work of MRI-Sim equipment. The obtained ACR phantom images were used to analyze various image quality assurance indicators, and the results all reached the set standards, thereby ensuring that the obtained images meet the requirements of clinical applications.

Investigation and analysis of patient dose levels from diagnostic radiology in Beijing / 中华放射医学与防护杂志

Objective To investigate the radiation dose levels to the adults examined from diagnostic exposure in Beijing. Methods The radiation doses to the examined individuals were measured by using individual diagnostic radiology equipments in 30 random hospitals from a total of 10 districts and suburban areas, including 1 182 samples of X-ray photography,542 samples of mammography and 410 samples of CT examination. Results 2 134 samples were measured in this study. The dose ranges of X-ray photography, CR, and DR were 0?4 -24?1, 0?3 -13?9 and 0?1 -15?9 mGy, respectively. The average dose range of glandular breast was 0?3-5?4 mGy. In 410 CT samples the value of CTDIw , CTDIvol and DLP were 28?1 - 96?3 mGy, 7?0 - 23?4 mGy, and 162?2 - 898?1 mGy·cm, respectively. Conclusions Several dose levels from diagnostic examination were higher than guidance level for medical exposure in GB 18871-2002,which should be noted.

Image Quality Improvement after Implementation of a CT Accreditation Program

OBJECTIVE: The purpose of this study was to evaluate any improvement in the quality of abdominal CTs after the utilization of the nationally based accreditation program. MATERIALS AND METHODS: Approval was obtained from the Institutional Review Board, and informed consent was waived. We retrospectively analyzed 1,011 outside abdominal CTs, from 2003 to 2007. We evaluated images using a fill-up sheet form of the national accreditation program, and subjectively by grading for the overall CT image quality. CT scans were divided into two categories according to time periods; before and after the implementation of the accreditation program. We compared CT scans between two periods according to parameters pertaining to the evaluation of images. We determined whether there was a correlation between the results of a subjective assessment of the image quality and the evaluation scores of the clinical image. RESULTS: The following parameters were significantly different after the implementation of the accreditation program: identifying data, display parameters, scan length, spatial and contrast resolution, window width and level, optimal contrast enhancement, slice thickness, and total score. The remaining parameters were not significantly different between scans obtained from the two different periods: scan parameters, film quality, and artifacts. CONCLUSION: After performing the CT accreditation program, the quality of the outside abdominal CTs show marked improvement, especially for the parameters related to the scanning protocol.

Usefulness of Frozen-thawed-deglycerolized Red Blood Cells as Quality Control Materials for Red Blood Cell Deformability Test / 대한진단검사의학회지

BACKGROUND: The red blood cell (RBC) deformability test is a useful method for measuring the ability of RBCs to adapt their shape to the flow conditions. Using this test, several investigators have shown the relationship between RBC deformability and numerous clinical conditions. For the quality control (QC) of RBC deformability test, we evaluated whether frozen-thawed-deglycerolized RBCs can be used as QC materials. METHODS: Packed RBCs were frozen with 40% (wt/vol) glycerol and stored at -80degrees C for 3 months. For 10 different frozen RBC panels, RBCs were thawed, deglycerolized and stored at 4degrees C for 4 weeks. Using microfluidic ektacytometer, we measured RBC deformability of the thawed RBCs. The stability of thawed RBCs was tested once a day for 28 days of storage time and was analyzed by simple regression analysis. The precision of the test using thawed RBCs was analyzed for 7 days of storage time by calculation of CV values of intra-assay (10 measurements/assay) and between-day measurements. RESULTS: Frozen-thawed-deglycerolized RBCs were stable for 1 week. Within-run and between-day precisions of the RBC deformability test during 7 days of storage of thawed RBCs were 1.4-2.9%, and 1.9-2.8%, respectively. CONCLUSIONS: Frozen-thawed-deglycerolized RBCs used in RBC deformability test showed satisfactory within-run and between-run precisions and stability for one week after thawing, and may be used as QC materials for this test.

The Current Status of HIV Serologic Testing in Korean Clinical Laboratories during the Year 2007 / 대한수혈학회지

BACKGROUND: HIV serologic testing is essential for blood donor screening, and the test results should be accurate. It is important that clinical laboratories perform quality control, quality management and standardization for obtaining accurate laboratory results. The Korean National Institute of Health, the Division of AIDS and the Center for Immunology and Pathology have all performed annual external quality surveillance assessment (EQS, EQA) with using a 5 sera panel for all the Korean HIV testing laboratories that have collaborated with the Quality Assurance Committee of the Korean Society of Laboratory Medicine since 2005. The results of HIV testing in the clinical laboratories during the year 2007 were analyzed. METHODS: The results for the clinical laboratories that participated in the HIV EQAS during 2007 were collected and analyzed. The HIV test results and questionnaire data were sent to the web site "http://hivqa.nih.go.kr". Three hundred thirty two results from 303 institutions in 2007 were analyzed. RESULTS: The most widely used HIV testing method was an automated chemiluminescent immunoassay, such as the Abbott AxSym and the Architect system or the Roche Elecsys. About 5% of erroneous results were reported among 332 results. The causes of error were mostly clerical errors and specimen errors. CONCLUSION: The current status for HIV testing in Korean clinical laboratories was that fully automated immunoassay analyzers were used along with manual POCT tests.

Design of CT slice width measure system based VC in CT quality test / 医疗卫生装备

QA(Quality Assurance)of CT offers dependable guarantee for the daily work of hospital.Slice width is an important characteristic of the all parameters.In this study,we gained a new method to detect slice thickness work by computer from the analysis of the CT image of the phantom named Catphan412 in a programmed way.

False Negative Rate of Cervical Cytology Using the Autopap 300 QC System in Rescreening Modality / 대한부인종양콜포스코피학회잡지

OBJECTIVES: To estimate false-negative rate of cervical smears using Autopap 300 QC system in rescreening modality. METHODS: From September 1997 to December 1997, Total 26,983 cervical smears were obtained and 18,592 cervical smears were rescreened by Autopap 300 QC system with 10% review rate. The 274 cases of total 26,983 cervieal smears were confirmed histologically by colposcopic biopsy, cone biopsy and hysterectomy. The 274 cases of cervical smears, which obtained prior to pathologic diagnosis made, were evaluated based on cyto-histologic correlation and then the false negative rate were estimated. The cervical smears were reviewed, researching for the cause of false negative. RESULTS: (1) Histologic diagnosis of 274 cases include 65 cases of Low SIL, 173 cases of High SIL, 29 cases of SCC, 2 cases of adenocarcinoma in situ, and 5 cases of invasive adenocarcinoma. (2) The false negative rate were 3% (9/274). Those were 6.2%(4/65) of LSIL, 2.3% (4/173) Of HSIL, none of SCC and AIS, and 20%(5/1) of invasive adenocarcinoma. (3) The false negative cases were reviewed. The 6 cases were sampling enor and 3 cases were screening error. CONCLUSION: Using AutoPap 300 QC system in rescreening modality, The false negative rate of cervical smears were decreased, compared with our previous study.

Effectiveness of automated cervical cytology rescreening using the AutoPap 300 QC System / 대한산부인과학회잡지

OBJECTIVE: This study assessed the usefulness of the AutoPap 300 QC System in identifying of detection false negative(DFN) smears in a slide population previously screened as "within normal limits" and compared the rate of identification of DFN to that using 10% random selection. MATERIALS AND METHODS: From December 1996 to August 1998, we utilized the AutoPap 300 QC System at 30% selection rate to select cases for manual review. During the study period, 1,040(83.4%) among 1,247 smears and 7,848(84.0%) among 9,343 smears were screened as "within normal limits" and were included for the AutoPap 300 QC System and 10% random selection studies, respectively. RESULTS: 357(34.3%) among 1,040 were selected by the AutoPap 300 QC System at 30% QC selection rate and reviewed manually. Overall, 63 among 357 were determined to be abnormal including 47 ASCUS, 2 AGUS, and 14 LSIL. 785(10%) among 7,848 were selected by 10% random selection and reviewed manually. 96 among 785 were determined to be abnormal including 69 ASCUS, 3 AGUS, and 24 LSIL. These results represented an increase in pick up rate of DFN(detection false negative) of 5.1 and 4.4 fold for ASCUS/AGUS and LSIL, respectively and of 1.5 and 1.3 fold when accounting for the volume differences measured. CONCLUSIONS: The study demonstrated that the AutoPap 300 QC System is superior to 10% human random screening for the identification of DFN smears. Further studies are required using variable selection rates and a larger number of smears to fully assess the value of the device in quality control mode.

A CT Simulator Phantom for Geometrical Test / 대한방사선종양학회지

PURPOSE: To design and test the CT simulator phantom for geometrical test. MATERIAL AND METHODS: The PMMA phantom was designed as a cylinder which is 20 cm in diameter and 24 cm in length, along with a 25x25x31 cm3 rectangular parallelepiped. Radio-opaque wires of which diameter is 0.8 mm are attached on the other surface of the phantom as a spiral. The rectangular phantom was made of four 24x24x0.5 cm3 square plates and each plate had a 24x24 cm2, 12x12 cm2, 6x6 cm2 square line. The squares were placed to face the cylinder at angles 0degrees, 15degrees, 30degrees, respectively. The rectangular phantom made it possible to measure the field size, couch angle, the collimator angle, the isocenter shift and the SSD, the measurements of the gantry angle from the cylindrical part. A virtual simulation software, AcQSimTM, offered various conditions to perform virtual simulations and these results were used to perform the geometrical quality assurance of CT simulator. RESULTS: A 0.3~0.5 mm difference was found on the 24 cm field size which was created with the DRR measurements obtained by scanning of the rectangular phantom. The isocenter shift, the collimator rotation, the couch rotation, and the gantry rotation test showed 0.5~1 mm, 0.5~1degrees0.5~1degrees, and 0.5~ 1degreesdifferences, respectively. We could not find any significant differences between the results from the two scanning methods. CONCLUSION: The geometrical test phantom developed in the study showed less than 1 mm (or 1degrees) differences. The phantom could be used as a routine geometrical QC/QA tools, since the differences are within clinically acceptable ranges.

Development of Interpretative Reporting and Quality Control Program of Disk Susceptibility Test Using Antibiogram / 대한임상병리학회지

BACKGROUND: Some bacteria have typical antibiogram profiles which can be used to verify antimicrobial susceptibility tests and organisms identification. So, we developed interpretative reporting and quality control software program using antibiogram of disk susceptibility test for more accurate results and helping physician's decision making in antibiotic therapy. METHODS: A computer program was developed with knowledge base rules based on antimicrobial disks tested, bacterial classification, bacteria's resistance mechanism and phenotypic probability to antibiogram results. And comment contents according to detection code of antibiogram were coded. All comment code were displayed to computer's screen, and interpreted results were printed to the final report after the validation and correction of the disk susceptibility test results. RESULTS: Detection code for evaluating aminoglycoside susceptibility pattern of gram-negative bacilli were detected, in order of decreasing frequency, Stenotrophomonas maltophilia (9.1%), Citrobacter freundii (9.1%), Enterobacter species (8.3%), Klebsiella pneumoniae (7.6%), Escherichia coli (3.6%), and Acinetobacter species (3.3%). More than 5% of C. freundii, Enterobacter species, E. cloacae, E. aerogenes, and Morganella morganii were detected by detection code for evaluating natural resistance. CONCLUSIONS: It is considered that this program is useful in quality control of antimicrobial susceptibility test and decision making in antimicrobial therapy of patients. And detection rate of rule check codes on natural resistances of gram-negative bacilli in this study were higher than those previously reported. Finally, it is concluded that further studies on natural resistance of antimicrobials about gram-negative bacilli, and the addition and reformation of codes for rule check and comment contents are needed.

Sensitivity and Scoring of AutoPap 300 QC System for Abnormal Cervicovaginal Cytology / 대한세포병리학회지

The AutoPap 300 QC System is an automated device for the analysis and classification of conventional cervical cytology slides for quality control purpose. These studies evaluated the sensitivity of the AutoPap 300 QC System, and estimated morphologic features other than epithelial abnormality to identify a high quality control(QC) score with the AutoPap 300 QC System. The sensitivity of the AutoPap 300 QC System at 10% review rate for 210 cases of cervicovaginal cytology with low grade squamous intraepithelial lesion(LSIL) and higher grade lesion was assessed, and compared with a 10% random rescreening. The morphologic features, such as presence of endocervical component, dirty background, atrophy, abnormal cell size, and cellularity of single atypical cells were estimated in 45 cases of no review and 30 cases of QC review cases. The AutoPap 300 QC System identified 119(56.7%) out of 210 cases with LSIL and higher grade lesion at 10% review rate. It was more sensitive to squamous cell lesions(50-62%) than to glandular lesions(10%). The dirty background and the scanty cellularity of single atypical cells were significantly related to low QC score. Conclusively, AutoPap 300 QC System is superior to human random rescreen for the identification of false negative smears. The upgrading of this device is required to enhance the detection of glandular lesion and certain inadequate conditions of the slides.

Clinical Experience and Sensitivity of the AutoPap 300 QC System in Cervicovaginal Cytology / 대한세포병리학회지

OBJECTIVE: False negatives of cervical smears due to screening errors pose a significant and persistent problem. AutoPap 300 QC System, an automated screening device, is designed to rescreen conventionally prepared Pap smears initially screened by cytotechnologists as normal. Clinical experience and sensitivity of the AutoPap 300 QC System were assessed and compared with current 10% random quality control technique. MATERIALS AND METHODS: In clinical practice, a total of 18,592 "within normal limits" or "benign cellular changes" cases classified by The Bethesda System were rescreened by the AutoPap System. In study for sensitivity of The AutoPap System to detect false negatives, a total of 1,680 "within normal limits" or "benign cellular changes" cases were rescreened both manually and by the AutoPap System. The sensitivity of the AutoPap System to these false negatives was assessed at 10% review rate to compare 10% random manual rescreen. RESULTS: In clinical practice, 38 false negatives were identified by the AutoPap System and we had achieved 0.2% reduction in the false negative rate of screening error. In study for sensitivity, 37 false negatives were identified by manual rescreening, and 23 cases(62.2%) of the abnormal squamous cytology were detected by the AutoPap System at 10% review rate. CONCLUSONS: The AutoPap 300 QC System is a sensitive automated rescreening device that can detect potential false negatives prior to reporting and can reduce false negative rates in the laboratory. The device is confirmed to be about eight times superior to the 10% random rescreen in detecting false negatives.

Experience in conducting mass QC group activities / 中华医院管理杂志

The paper sums up the experience of Tianjin in conducting mass QC group activities for the past 12 years. The major steps taken include:(1)enhancing the awareness of the importance of and willingness to conduct QC group activities; (2)stepping up personnel training, improving their general quality and giving them correct guidance; (3)taking pains to organize and manage QC group activities; and (4)working hard to assess and release the results of QC groups. Persistent conduction of mass QC group activities has led to a higher QC level of the hospital and better delivered services to patients.

Quality assurance and quality control in X-ray stereotactic radiotherapy / 中华放射肿瘤学杂志

Purpose:To analyse the X-ray stereotactic treatment process during which errors induced and to establish a QA program and its checking frequency.Materials and Methods: Checking the parallelism and the asymmetry of the opposing plates containing localizing wires of the CT(MRI) stereotactic localizing frame; Checking the precision of the mechanical scaler of the target positioner; The influence of the laser alignment system in the treatment room of linear accelerator ; Determining the overall precisions available by a X-ray stereotactic treatment system; and small beam's data acquisition means, etc.Results: An overall target positions'precisions of 2.4mm,2.6mm(1mm CT slice thickness), and 3.7mm, 3.8mm (3mm CT slice thickness) for single and fractionated X-ray stereotactic irradiation respectively can be achieved if a QA program be seriously carried out.Conclusion: It is an essential to establish a comprehensive QA program to guarantee a good treatment precision of X-ray stereotactic irradiation.

Effects of Ternatolide on expression granulysin mRNAin the peripheral blood lymphocytes patients with mycobacterium tuberculosis / 中国药理学通报

AIM To study the effects of ternatolide(tern) on expression of granulysin mRNA in the activated peripheral blood lymphocytes(PBLS) of the adults and children with pulmonary Mycobacterium tuberculosis(PMTB). METHODS Using competitive quantitative reverse transcription polymerase chain reaction(QC TR PCR)analyze granulysin gene expression in the PBLs. RESULTS The dosage of 100 mg?L -1 , 200mg?L -1 of ternatolide significantly enhanced the granulysin mRNA experession in PBLs in vitro stimulated phytohemagglutinin (PHA) from adults and children with PMTB (P0 05). CONCLUSION The molecular mechanism of tern. against intracellular pathogens might be associated with the inducting highly level on the expression of granulysin mRNA, a anti bacterial peptide in activated human cytotoxic lymphocytes.