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Performance Evaluation of the DxH 800 Hematology Analyzer.

Dong Hee SEO ; Eun Jin HA ; Sung Eun CHO ; So Young KIM

Journal of Laboratory Medicine and Quality Assurance.2016;38(4):253-256. doi:10.15263/jlmqa.2016.38.4.253

In this study, the performance of a hematology analyzer, DxH 800 (Beckman Coulter, USA) was evaluated. The precision, carry-over, linearity, and comparison studies were performed according to the Clinical Laboratory Standards Institute guidelines. The test items were white blood cell, red blood cell, hemoglobin, red blood cell index, platelet, and reticulocyte counts. The 6C control and Retic-X cell control (Beckman Coulter) were used for precision evaluation. For the correlation study, the test results were compared with those obtained from the ADVIA 2120i (Siemens, USA) using 120 blood samples. The results of precision and carry-over evaluations were within acceptable range. The coefficient of determination (R 2) for linearity was good, being more than 0.99. The correlation coefficient (R) ranged from 0.945 to 0.996. DxH 800 was evaluated as an acceptable hematology analyzer for the automation of large volume of laboratory samples.
Automation ; Blood Platelets ; Erythrocytes ; Hematology* ; Leukocytes ; Reticulocyte Count ; Statistics as Topic

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Analysis of Recent Four Years' Cross-Matching Tests of One Commercial Laboratory.

Dong Hee SEO ; Mi Young PARK ; Jeong Ryull KWAK

Journal of Laboratory Medicine and Quality Assurance.2016;38(4):249-252. doi:10.15263/jlmqa.2016.38.4.249

The cross-matching test, an essential pre-transfusion test, is usually performed using only a segment of a blood bag and a recipient's blood sample at a commercial laboratory. We analyzed cross-matching test results obtained at LabGenomics laboratory, client of which were mainly small- and medium-sized medical clinics. Data for a total of 12,902 cross-matching tests referred from January 2012 to December 2015 were analyzed for incompatibility in the results and trends based on the distribution of medical clinics. Medical clinics were categorized as nursing home, obstetrics and gynecology, plastic surgery, dental clinic, orthopedic surgery, and others. Incompatible results were observed for 35 cases (1.09%) in 2012, 22 cases (0.68%) in 2013, 31 cases (1.02%) in 2014, and 41 cases (1.20%) in 2015. Overall, 55.4% of referrals came from a nursing home, 6.4% from obstetrics and gynecology, 4.4% from plastic surgery, 20.0% from dental clinic, 5.9 % from orthopedic surgery, and 7.9% from others. Further studies are required to evaluate the efficacy of cross-matching test results and its relationship with transfusion requirements.
Dental Clinics ; Gynecology ; Nursing Homes ; Obstetrics ; Orthopedics ; Referral and Consultation ; Surgery, Plastic

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Assessment of the Precision and Functional Sensitivity of Two Thyroglobulin Assays: Comparison of the Second-Generation Roche Electrochemiluminescent Immunoassay and BRAHAMS Radioimmunoassay.

Aerin KWON ; Eun Hee LEE ; Young Kyung LEE ; Hee Jung KANG

Journal of Laboratory Medicine and Quality Assurance.2016;38(4):243-248. doi:10.15263/jlmqa.2016.38.4.243

BACKGROUND: Thyroglobulin (Tg) is the primary biochemical marker used to monitor patients with differentiated thyroid cancer (DTC) for residual or recurrent disease after total thyroidectomy, as only normal or well-differentiated malignant thyroid cells produce Tg. Here, we evaluated the precision and functional sensitivity (FS) of a recently developed highly sensitive Tg (hsTg) electrochemiluminescent immunoassay (ECLIA) and compared it to that of the radioimmunoassay (RIA) method using pooled human serum with low levels of Tg. METHODS: For the ECLIA method, the Elecsys Tg II kit (Roche Diagnostics, Germany) was used with an E170 analyzer (Roche Diagnostics). For the RIA method, the Tg-plus-RIA kit (BRAHAMS, Germany) was used with a Cobra Quantum gamma counter (Packard Instrument Company, USA). The precision and limit of detection (LOD) were determined according to the Clinical and Laboratory Standards Institute (CLSI) guidelines. FS was determined using a modification of the CLSI guideline. RESULTS: The total precision of the hsTg ECLIA and RIA methods was 9.6% and 48.2%, respectively. The manufacturer-reported LOD was verified by the hsTg ECLIA (0.04 ng/mL), but not by the RIA method (>0.08 ng/mL). The hsTg ECLIA showed better FS (0.04 ng/mL at a coefficient of variation [CV] of 10%) than the RIA method (0.37 ng/mL at a CV of 20%). CONCLUSIONS: Thus, the hsTg ECLIA performed better than the RIA method in terms of FS, which is extremely important for the early detection of residual or recurrent disease in DTC patients after total thyroidectomy. The excellent performance of the hsTg ECLIA could allow for clinical Tg measurement without thyroid-stimulating hormone stimulation, in contrast to the insufficient performance of the RIA method.
Biomarkers ; Elapidae ; Humans ; Immunoassay* ; Limit of Detection ; Methods ; Radioimmunoassay* ; Thyroglobulin* ; Thyroid Gland ; Thyroid Neoplasms ; Thyroidectomy ; Thyrotropin

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Performance Evaluation of B. Braun Omnitest 5 Blood Glucose Monitoring System for Self-Monitoring of Blood Glucose.

Kyungso JEON ; Miseon SHIN

Journal of Laboratory Medicine and Quality Assurance.2016;38(4):234-242. doi:10.15263/jlmqa.2016.38.4.234

BACKGROUND: We evaluated the accuracy of the B. Braun Omnitest 5 blood glucose monitoring system (BGMS; Infopia Co. Ltd., Korea), which was recently developed for self-monitoring of blood glucose. METHODS: Precision was assessed according to Clinical and Laboratory Standards Institute guideline EP5-A3 with control materials containing low, normal, and high levels of glucose. Linearity was evaluated over the range of 52.5–548.0 mg/dL prepared from patient samples. For system accuracy, 100 capillary blood samples measured by the B. Braun Omnitest 5 BGMS were compared to plasma-equivalent blood glucose values of the fingertip blood samples measured by the YSI 2300 STAT PLUS glucose analyser (YSI Life Sciences, USA). Accuracy was evaluated according to the International Organization for Standardization (ISO) 15197: 2013 criteria. RESULTS: The range for the total coefficient of variation (%) was 1.5%–4.9% for three lots of strips. Both within-run precision and within-laboratory precision fulfilled the manufacturer's claim. ISO 15197: 2013 states that more than 95% of blood glucose measurement values must be within ±15 mg/dL for ranges below 100 mg/dL and ±15% for ranges above 100 mg/dL. Each of B. Braun Omnitest 5 lots satisfied ISO 15197: 2013, as 98.5% (197/200), 97.0% (194/200), and 99.5% (199/200) of values were within range. In consensus error grid analysis, respectively, 99.5%, 99.0%, and 100.0% of measurement values of each lot were within zone A, indicating that an average of over 99.0% of values were within zone A. CONCLUSIONS: B. Braun Omnitest 5 provided reliable results and satisfied the ISO 15197: 2013 accuracy criteria. This test is an appropriate BGMS for the self-monitoring of blood glucose.
Biological Science Disciplines ; Blood Glucose* ; Capillaries ; Consensus ; Glucose ; Humans

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Evaluation of the i-STAT Point-of-Care Analyser.

YeJin OH ; Sun Hoe KOO ; Gye Cheol KWON

Journal of Laboratory Medicine and Quality Assurance.2016;38(4):225-233. doi:10.15263/jlmqa.2016.38.4.225

BACKGROUND: Point-of-care testing (POCT) is designed to be used near the site where the clinical care is being delivered. The demand for POCT in the medical field is expanding significantly, given that rapid results can eventually lead to early diagnosis and immediate clinical management of diseases. Therefore, the aim of this study was to evaluate the performance of the i-STAT POC analyser (Abbott Diagnostics, USA) for testing 8 chemical analytes (viz., sodium, potassium, chloride, total carbon dioxide, blood urea nitrogen, creatinine, glucose, and ionised calcium) and 2 hematological analytes (hematocrit [HCT], hemoglobin [Hb]). METHODS: The precision and linearity of the 10 analytes were measured according to Clinical and Laboratory Standards Institute (CLSI) EP15-A3 and EP6-A guidelines. Comparisons with a central laboratory hematology analyser, Coulter LH 780 (Beckman Coulter Inc., USA), and a chemical analyser, UniCel DxC 880i (Beckman Coulter Inc.), were performed using 85 patient samples according to CLSI EP9-A3. RESULTS: The coefficient of variation values for the within-run precision and total precision at 3 levels of all analytes were within 5%, except those for low level creatinine. In the aspect of linearity, the correlation coefficient values of all analytes were over 0.975 in the clinically important concentration range. A very high correlation was observed in glucose, blood urea nitrogen and creatinine (R>0.975), high correlation was observed in sodium, potassium, Hct and Hb (R>0.9), and relatively good correlation was observed in chloride and total carbon dioxide (R>0.7) compared to the central laboratory analysers. CONCLUSIONS: i-STAT showed relatively high precision and linearity, and comparable data to that of routine hematology and chemistry analysers. This device was concluded to have potential for providing faster results and relatively acceptable values to clinicians in need of immediate results.
Blood Glucose ; Blood Urea Nitrogen ; Carbon Dioxide ; Chemistry ; Creatinine ; Early Diagnosis ; Glucose ; Hematology ; Humans ; Nitrogen ; Point-of-Care Systems* ; Point-of-Care Testing ; Potassium ; Sodium ; Urea

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Annual Report on the External Quality Assessment Scheme of Viral Markers and Serological Tests for Syphilis in Korea (2015).

Young Joo CHA ; Jae Hoon BAE ; Young Soon JUNG ; Seok Lae CHAE

Journal of Laboratory Medicine and Quality Assurance.2016;38(4):214-224. doi:10.15263/jlmqa.2016.38.4.214

As the Immunoserology Subcommittee of the Korean Association of External Quality Assessment, we organized two trials on the external quality assessment of viral markers and serological tests for syphilis (STS) in 2015. For this purpose, we delivered three kinds of pooled sera specimens for external proficiency testing to 1,071 and 1,074 institutions for the first and second trials, respectively. Pooled sera were checked for their homogeneity and stability using multiple methods between the day of their manufacture and three days after dispatching. The number of participating laboratories was 1,055 (98.5%) and 1,055 (98.2%) in the first and second trial, respectively. The most commonly tested items were hepatitis B surface antigen, followed by the antibodies to hepatitis B surface antigen, antihuman immunodeficiency virus, anti-hepatitis C virus, STS, and anti-hepatitis B core. The most frequently used methods for detecting viral markers were the chemiluminescence immunoassay (CLIA) and the electrochemiluminescence immunoassay, which were found to generate few false positive results. In contrast, false negative results were frequently found when the immunochromatographic assay (ICA) was used; the use of ICA for detecting viral markers has been steadily increasing in recent years. Furthermore, the use of turbidoimmunoassay and CLIA, tests recently introduced for the measurement of nontreponemal and treponemal antibodies, is also increasing.
Antibodies ; Biomarkers* ; Hepatitis B ; Hepatitis B Surface Antigens ; Hepatitis C ; HIV ; Immunoassay ; Immunochromatography ; Korea* ; Laboratory Proficiency Testing ; Luminescence ; Serologic Tests* ; Syphilis*

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Annual Report on the External Quality Assessment Scheme for Immunoassay Tests in Korea (2015).

Hyon Suk KIM ; Young Lan KIM ; Jung Eun SHIM

Journal of Laboratory Medicine and Quality Assurance.2016;38(4):194-213. doi:10.15263/jlmqa.2016.38.4.194

Two trials of external quality assessment were performed in 2015, with 13 test items grouped into four test categories. The first trial materials were sent on May 19, 2015 and the second trial was performed on November 9, 2015 with 13 items including tumor markers, thyroid hormones, cardiac marker troponin (troponin T or troponin I), and procalcitonin (PCT) as biomarkers by immunoassay methods. The bone marker, carboxy-terminal collagen crosslinks (CTX) was replaced by procalcitonin since 2014, because a limited number of institutions performed assays with CTX. External quality surveys of 13 immunoassay test items with 16 control materials were conducted, as scheduled. In total, 13 control materials were used, which consisted of six tumor markers, namely alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), carcinoma antigen (CA) 125, carbohydrate antigen (CA) 19-9, human chorionic gonadotrophin (HCG), and prostate specific antigen (PSA). In addition to tumor markers, 5 thyroid markers, namely thyroid hormone (T)3, T4, thyroid stimulating hormone (TSH), free T4, and thyroglobulin (TG) were included. Furthermore, troponin, as a cardiac marker, and procalcitonin, as a new biomarker, have been adopted since 2014. Five home-made pooled sera and 3 commercial control sera were used as survey materials. MAS Tri-point Liquimmune level 3 (Medical Analysis Systems Inc., USA) was used for thyroid hormones. Procalcitonin and troponin control materials were from Elecsys Precis Control Varia and Elecsys Precis Control Troponin (Roche, Germany), respectively. The number of laboratories participating in the external quality assessment for Immunoassay Subcommittee was 719 institutions in the first trial survey (response rate 98.7%) and 730 institutions in the second survey (94.9%). The test items most frequently used in immunoassays were TSH (93.2%, 93.1%), free T4 (90.3%, 90.2%), and AFP (89.4%, 89.0%), whereas recently adopted biomarkers were less frequently used: troponin I (36.6%, 37.1%), procalcitonin (24.1%, 26.7%), and thyroglobulin (10.3%, 10.7%). The quality of the laboratories participating in the survey seems to be continuously improving, according to their peer group results.
alpha-Fetoproteins ; Biomarkers ; Biomarkers, Tumor ; Carcinoembryonic Antigen ; Chorion ; Collagen ; Humans ; Immunoassay* ; Korea* ; Peer Group ; Prostate-Specific Antigen ; Thyroglobulin ; Thyroid Gland ; Thyroid Hormones ; Thyrotropin ; Troponin ; Troponin I

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Annual Report on the External Quality Assessment Scheme for Clinical Microbiology in Korea (2015).

Jeonghyun CHANG ; Mi Na KIM ; Eui Chong KIM ; Jong Hee SHIN ; Nam Yong LEE ; Sunjoo KIM ; Seok Hoon JEONG ; Jae Seok KIM ; Chang Ki KIM ; Hye Gyung BAE ; Nam Surp YOON ; Se Ik JOO ; Dong Joon SONG ; Keonhan KIM ; Tae Jeon JEONG ; Jin HEO

Journal of Laboratory Medicine and Quality Assurance.2016;38(4):169-193. doi:10.15263/jlmqa.2016.38.4.169

Annual proficiency surveys were conducted in March, June, and September in 2015 by the Clinical Microbiology Subcommittee of the Korean Association of External Quality Assessment Service. The program covers the sections of bacteriology, advanced bacteriology and mycology, mycobacteriology, and parasitology. Each trial was composed of three sets of different combinations of five bacteria and yeasts. These sets were distributed among laboratories for Gram staining, culture, identification, and antimicrobial susceptibility tests. Five slides with fixed sputum smears were provided as part of each trial for acid-fast bacilli detection. The survey material distribution was section-based. Two survey materials were provided in each trial, while five specimens for mycobacterial culture and identification, five specimens for anti-tuberculosis susceptibility testing and two Mycobacterium tuberculosis strains for rapid detection of rifampin and isoniazid resistance were distributed in the March and June trials. Five virtual microscopy files for stool parasite examination were availed by registered participants in the June trial. Out of the 334 enrolled laboratories, 328 (98.2%), 328 (98.2%), and 329 (98.5%) submitted responses in trials I, II, and III, respectively. Identification of bacteria, namely, Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Pseudomonas aeruginosa, Streptococcus pneumoniae, and Vibrio fluvialis by more than 95% of participants was acceptable. Surveillance cultures for vancomycin-resistant enterococci and carbapenem-resistant Enterobacteriaceae were determined accurately by 75.8%–85.3% and 93.1% of the respondents, respectively. Species-level identification of Candida krusei, Candida lusitanae, and Candida guilliermondii was still low at 79.8%, 55.7%, and 42.7%, respectively. Disk diffusion method revealed an unacceptably high false-positive rate of resistance to glycopeptides in E. faecalis and to trimethoprim-sulfamethoxazole in S. pneumoniae. Advanced bacteriology trials revealed unsatisfactory results for species-level identification of moulds. Mycobacterial culture, identification and susceptibility testing, and molecular detection of rifampin and isoniazid resistance were performed exceedingly well by participants. Hymenolepsis diminuta could not be identified by participants, with a correct answer rate of only 46.5% and ‘no parasite seen’ answer rate of only 31.8% for negative specimens. Species-level identification of Candida and moulds was challenging for clinical microbiology laboratories. Disk diffusion method was found to be problematic in testing the susceptibility of microorganisms to glycopeptides and trimethoprim-sulfamethoxazole. Improvement is required in result interpretation of negative specimens in parasitology.
Bacteria ; Bacteriology ; Candida ; Diffusion ; Enterobacteriaceae ; Enterococcus faecalis ; Escherichia coli ; Glycopeptides ; Isoniazid ; Klebsiella pneumoniae ; Korea* ; Methods ; Microscopy ; Mycobacterium ; Mycobacterium tuberculosis ; Mycology ; Parasites ; Parasitology ; Pneumonia ; Pseudomonas aeruginosa ; Quality Control ; Rifampin ; Sputum ; Streptococcus pneumoniae ; Surveys and Questionnaires ; Trimethoprim, Sulfamethoxazole Drug Combination ; Vancomycin-Resistant Enterococci ; Vibrio ; Yeasts

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Detection of Helicobacter pylori and BabA (Blood-group Antigen Binding Adhesin) in Saliva and Gastric Tissue by Polymerase Chain Reaction.

Sun Kyung JIN ; Se Ran HEO ; Ae Ran JEON ; Ho Eun CHANG ; Hye Seung LEE ; Kyoung Un PARK ; Junghan SONG

Journal of Laboratory Medicine and Quality Assurance.2004;26(2):243-248.

BACKGROUND: Saliva is considered an important vector for the Helicobacter pylori infection. The presence of the babA2 gene, encoding for BabA (blood-group antigen binding adhesin), in the H. pylori genome is crucial for H. pylori-related pathogenesis. METHODS: The study was performed in the group of 215 patients. The detection of H. pylori and babA2 in saliva and gastric tissue was done by PCR (polymerase chain reaction). Moreover, gastric tissues were stained with hematoxylin-eosin as well as with modified Giemsa methods for the analysis of Helicobacter pylori density. RESULTS: The positive rate of H. pylori by nested PCR was 78.6% in gastric tissue and 72.7% in saliva. In addition, the positive rate of H. pylori was 55.5% by the histological analysis of Helicobacter pylori density in gastric tissue. The positive rate of babA2 by PCR was 33.9% in gastric tissue, and 8.2% in saliva. CONCLUSION: We revealed that the H. pylori PCR results obtained in gastric tissue correlated well with those obtained in saliva. As saliva is more available specimen, it is more suitable for clinical application of H. pylori detection by PCR. However, clinical use of - BabA PCR seems to be limited because of its low-sensitivity.
Genome ; Helicobacter pylori* ; Helicobacter* ; Humans ; Polymerase Chain Reaction* ; Saliva*

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A Case of Klebsiella pneumoniae Unidentified by Conventional Biochemical Tests.

Young Chul KIM ; Jae Seok KIM ; Ji Young PARK ; Han Sung KIM ; Wonkeun SONG ; Sung Ha KANG ; Hyoun Chan CHO ; Kyu Man LEE

Journal of Laboratory Medicine and Quality Assurance.2004;26(2):239-242.

A sixty-seven-year-old man was admitted to a hospital with symptoms of high fever and chill. Bacterial isolates were obtained from sputum and blood. These isolates were identified as Klebsiella terrigena by API 20E (BioMerieux, Marcy-l'Etoile, France). K. terrigena is very rarely isolated from humans and no case of K. terrigena bacteremia has been reported yet. We analyzed partial 16S rRNA gene sequences of these isolates. The 16S rRNA gene sequences were matched with that of Klebsiella pneumoniae (ATCC 13886). 16S rRNA gene sequencing has been recently introduced in clinical laboratories for unidentified organisms by conventional biochemical tests. For the precise identification of bacteria rarely causing clinical infection, it might be considered to use genotypic methods, such as 16S rRNA gene sequencing.
Bacteremia ; Bacteria ; Fever ; Genes, rRNA ; Humans ; Klebsiella pneumoniae* ; Klebsiella* ; Sputum

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