1.Evaluation of the MAS Quality Control Materials for Chemistry and Urinalysis.
Journal of Laboratory Medicine and Quality Assurance 2003;25(2):251-257
BACKGROUND: To evaluate the stability and the precision of quality control materials for clinical chemistry analytes, we compared liquid quality control materials, Moni-Trol H (MAS Inc., Camarillo, CA, USA) with lyophilized and other liquid quality control materials. For urinalysis, liquid MAS UA Controls were compared with analyte affixed-strip type quality control materials. METHODS: Using Hitachi-7600 (Hitachi, Tokyo, Japan), we analyzed lyophilized Seronorm & Pathonorm (SERO AS, Billingstad, Norway) and Moni-Trol H for 26 commonly measured chemistry analytes for 3~4 weeks. Using Synchron CX-7 (Beckman Coulter Inc., Fullerton, CA, USA), liquid Decision (Beckman Coulter) and Moni-Trol H were compared for 12 emergency chemistry analytes. For urinalysis, MAS UA Controls were compared with Chek-Stix (Bayer, Elkhart, IN, USA). We evaluate the stability of analyte by regression coefficient and the imprecision by coefficient of variation. RESULTS: Moni-Trol H was more stable than Seronorm & Pathonorm and Decision. The imprecision was more evident with Moni-Trol H than the others, but the CVs of Moni-Trol H were within 10%. In urinalysis, all the results were within two semi-quantity levels with both MAS UA Control and Chek-Stix. CONCLUSIONS: The MAS quality control materials for common chemistry analytes and urinalysis showed good stability and comparable precision. The materials were efficient for laboratory use due to the advantage of human source based liquid form and long-term stability after preparation.
Chemistry*
;
Chemistry, Clinical
;
Emergencies
;
Humans
;
Quality Control*
;
Urinalysis*
2.Evaluation of the Ez step FOBTM for Fecal Occult Blood Test.
Eun Ah CHANG ; Chae Seung LIM ; Young Kee KIM ; Kap No LEE
Journal of Laboratory Medicine and Quality Assurance 2003;25(2):247-250
BACKGROUND: Fecal occult blood tests (FOBT) have been recommended for gastro- intestinal bleeding and colon cancer screening. This study compared the effectiveness of two fecal blood screening kit, OC-Hemodia II and Ez step FOB for fecal occult blood. METHODS: The detection limit was evaluated by using OC-control and serially diluted samples. The comparison study between OC-hemodia II and Ez step FOB were evaluated in 143 cases. RESULTS: The concordance rate between OC-Hemodia II and Ez step FOB was 85.6% and 50% of non-concordance cases have history related to gatrointestinal bleeding. Ez step FOB was possible to detect 35 ng/mL in serially diluted OC-control. CONCLUSIONS: The result of Ez step FOB satisfactory to clinical application and showed good concordance rate compared to OC-Hemodia II.
Colonic Neoplasms
;
Hemorrhage
;
Limit of Detection
;
Mass Screening
;
Occult Blood*
3.Analysis of Classical Risk Factors and Homocysteine Level in Acute Myocardiac Infarction.
Journal of Laboratory Medicine and Quality Assurance 2003;25(2):243-246
BACKGROUND: Hyperhomocysteinemia can be treated and is more preventable compared to the classical risk factors such as age, sex, smoking, obesity, diabetes mellitus, hypertension and hyperlipidemia. METHODS: Serum homocysteine levels were analyzed with fluorescence polarized immunoassay (IMx, Abbott Diagnostics) for 63 patients with acute myocadiac infarction (AMI) and 43 controls who did not have coronary arterial disease from 1997 to 1998. Medical records were reviewed to compare the classical risk factors between the two groups. RESULTS: The mean homocysteine level of AMI was 9.3 +/-5.3 micronmol/L, which is slightly lower than 9.8+/-5.8 micronmol/L in the control group (P>0.05). Other risk factors were not significantly different between the two groups with the exception of serum cholesterol level. CONCLUSIONS: It is concluded that hypercholesterolemia is an important risk factor for AMI, while serum homocysteine level is not, as far as this study goes. Well planned follow up studies are needed to establish the degree to which homocysteine is a risk factor for AMI.
Cholesterol
;
Diabetes Mellitus
;
Fluorescence
;
Homocysteine*
;
Humans
;
Hypercholesterolemia
;
Hyperhomocysteinemia
;
Hyperlipidemias
;
Hypertension
;
Immunoassay
;
Infarction*
;
Medical Records
;
Obesity
;
Risk Factors*
;
Smoke
;
Smoking
4.The Use of Immatane to Total Neutrophil (IT) Ratio to Detect Bacteriemia in Neonatal Sepsis.
Diana AULIA ; Arief I SANJAYA ; Ina S TIMAN
Journal of Laboratory Medicine and Quality Assurance 2003;25(2):237-242
BACKGROUND: Infection is still a major problem in developing countries, including Indonesia. The incidence of neonatal infection in some referral hospital in Indonesia is quite high, between 8.76-30.29%, with a mortality rate of 11.56-49.9%. The early detection of neonatal sepsis is very important for the management of the patients, but many rural health centers do not have the required laboratory facilities available to diagnose it. The ratio of immature neutrophyl to total neutrophyl (IT ratio) is a simple test, requiring no sophisticated equipment, and can be done in a minimal laboratory setting to be used as a screening test to detect infection. In infection or sepsis a shift to the left of the neutrophil in the peripheral blood smear could be observed. An IT ratio of >0.2 and leukopenia is a marker for detecting neonatal infection. The aim of this study is to obtain the reference value of IT ratio in healthy newborn children and to know the IT ratio in neonatal sepsis and the difference of IT ratio of between capillary and K3EDTA blood. Blood smears were also made hourly with K3EDTA blood kept for 6 hours to observe any changes. METHODS: Materials were obtained from 70 healthy and 41 septic newborns. Capillary blood smear and K3EDTA blood smear were prepared using May-Grunwald-Giemsa staining, and a differential counts were performed manually using a binocular microscope. RESULTS: Reference IT Ratio in healthy newborns was 0.01-0.13 (mean 0.06), in septic newborns 0.13-0.60 (mean 0.26) and the cut off value for sepsis detection was 0.13. There were no difference in the IT ratio between direct capillary blood or K3EDTA blood smear. Samples could be kept until 6 hour without any deterioration. CONCLUSION: The reference value of IT ratio in healthy newborns were 0.01-0.13 (mean 0.06), in sepsis neonatus 0.13-0.60 (median 0.26) and the cut off value for sepsis detection was 0.13. IT ratio could be used as a marker for early detection of newborn septicemia.
Capillaries
;
Child
;
Developing Countries
;
Humans
;
Incidence
;
Indonesia
;
Infant, Newborn
;
Leukopenia
;
Mass Screening
;
Mortality
;
Neutrophils*
;
Reference Values
;
Referral and Consultation
;
Rural Health Services
;
Sepsis*
;
Telescopes
5.The Use of Ethanol Gelation Test to Screen the Activation of Coagulation and Disseminated Intravascular Coagulation.
Ina S TIMAN ; Diana AULIA ; ENNY
Journal of Laboratory Medicine and Quality Assurance 2003;25(2):231-235
BACKGROUND: Ethanol gelation test (EGT) is one of the paracoagulation test used to detect the activation of coagulation and formation of fibrin monomer complexes in the fibrinolytic process. Many patients with infectious diseases such as dengue haemorrhagic fever can develop disseminated intravacular coagulation (DIC), which should be diagnosed properly as soon as possible for the management of the patients. To diagnose the coagulation activation and DIC usually the laboratory has to perform the coagulation test, including fibrinopeptide A and D-dimer test. Many laboratories in rural areas in Indonesia do not have the facilities to do such test, and the cost will not be affordable by most of the patients. The aim for the study is to evaluate the EGT as a screening test to detect coagulation activation and DIC, the correlation of D-dimer and EGT. Method: Sixty citrated plasma were obtained from patients in Clinical Pathology Laboratory Cipto Mangunkusumo Hospital for D-dimer test. D-dimer were performed using Nycard Kit with cut off point of 300 ng/dl. The EGT were performed using the method described by Breen. Positive test could be observed by the clot formation. RESULTS: The result of the within-run test for normal and abnormal plasma for EGT showed good results. The plasma was stalell until day 22. The EGT was positive for all the plasma with D-dimer >700 ng/ml. The sensitivity for EGT was 81.6%, specificity 81.8%, positive predictive value 95.2% and negative predictive value 50%. Conclusion: EGT could be used as a screening test for thrombin activity in coagulation activation in rural laboratories with minimal facilities.
Communicable Diseases
;
Dacarbazine
;
Dengue
;
Disseminated Intravascular Coagulation*
;
Ethanol*
;
Fever
;
Fibrin
;
Fibrinopeptide A
;
Humans
;
Indonesia
;
Mass Screening
;
Pathology, Clinical
;
Plasma
;
Sensitivity and Specificity
;
Thrombin
6.Usefulness of the IMI Channel of Sysmex SE-9000(TM) Automated Hematology Analyzer Predicting the Optimal Timing of Peripheral Blood Stem Cell Harvest.
Seon Ju LEE ; Seong Geon HONG ; Jin Young BAEK ; Myung Seo KANG ; So Young CHONG ; Doyeon OH
Journal of Laboratory Medicine and Quality Assurance 2003;25(2):223-230
BACKGROUND: An essential prerequisite for successful procurement of sufficient peripheral blood stem cells (PBSC) for engraftment is the optimal timing of collection. The Sysmex SE-9000 automated hematology analyzer provides the immature information (IMI) channel for the identification and counting PBSC. In this study, The optimal timing of PBSC collection was studied using IMI channel. METHODS: 193 peripheral blood stem cell collections were performed from 52 patients with hematologic disorders or solid tumors and 15 donors. Pre-harvest peripheral blood WBC, mononuclear cells (MNC) and IMI were tested and compared with CD34+ cell count and CFU-GM count of harvested products. RESULTS: Peripheral blood WBC and MNC count showed a weak correlation with CD34+ cell yield (r=0.38, P<0.0001 and r=0.38, P<0.0001) and peripheral blood IMI had a stronger correlation (r=0.58, P<0.0001) with collected CD34+cells than did WBC and MNC count. A receiver operating characteristic (ROC) curve was drawn for cutoff value of IMI and predictive values of the chosen cutoff value of IMI for different target CD34+ cell collections were calculated. The ROC curve showed that the best cutoff value of IMI was 465/microliter for the target CD34+ cells >1x10(6)/kg with sensitivity of 88.7%. Positive and negative predictive values of IMI >465/microliter for CD34+ cell >1x10(6)/kg were 65.5% and 87.5%, respectively. CONCLUSIONS: The automated IMI might be used as a simple and efficient indicator of PBSC mobilization and applying variable cutoff values of IMI would be a useful tool to predict the optimal timing of PBSC collection.
Cell Count
;
Granulocyte-Macrophage Progenitor Cells
;
Hematology*
;
Humans
;
ROC Curve
;
Stem Cells*
;
Tissue Donors
7.Identification of Enterococcus Species Using a Microplate.
Young UH ; Gyu Yul HWANG ; In Ho JANG ; Kap Jun YOON ; Kyungwon LEE ; Hyung Hoan LEE
Journal of Laboratory Medicine and Quality Assurance 2003;25(2):215-221
BACKGROUND: The aim of the study was to develop an accurate, convenient, and easy microplate system for the identification of enterococcal species from clinical specimens. METHODS: The microplate identification method was composed of twelve biochemical tests and identification programs. The tests comprised in microplate were initially screened by a two-tube method, NaCl-esculin hydrolysis and pyrrolidonyl-beta-naphthylamide test; arginine dihydrolase, acid production from mannitol, sorbitol, sucrose, arabinose, raffinose, methyl-alpha-D-glucopyranoside, and ribose in the microplate; and pigment production and hemolytic pattern in blood agar plate. The performance of the microplate for identifying enterococci to the species level was evaluated in comparison with conventional reference tests and commercial kits. RESULTS: Among the 111 clinical isolates of Enterococcus species, the microplate system correctly identified 100% to genus level, and 91.0% to species level. All of E. casseliflavus, E. durans, and E. hirae were correctly identified by the microplate. The diagnostic sensitivity and specificity for identification of Enterococcus species were as follows: 100% and 96.7% in E. faecium, 93.5% and 100% in E. faecalis, 100% and 97.2% in E. raffinosus, and 33.3% and 98.1% in both E. avium and E. gallinarum. CONCLUSIONS: It is concluded that the microplate method offers a simple, cost-effective, rapid, and accurate identification system for the identification of most clinical isolates of Enterococcus species.
Agar
;
Arabinose
;
Arginine
;
Enterococcus*
;
Hydrolysis
;
Mannitol
;
Raffinose
;
Ribose
;
Sensitivity and Specificity
;
Sorbitol
;
Sucrose
8.False Susceptibility to Imipenem by Vitek GPS Card in Enterococcus faecium.
Hae Kyung LEE ; Yeon Joon PARK ; Hi Jeong KWON ; Eun Jung LEE ; Byung Kee KIM ; Chang Suk KANG
Journal of Laboratory Medicine and Quality Assurance 2003;25(2):211-214
BACKGROUND: Enterococcus faecium (E. faecium) is potential pathogens of mixed infections for which a broad-spectrum antimicrobial agents such as imipenem has a therapeutic role. But controversy continues concerning testing imipenem versus enterococci. The purpose of this study were 1) to investigate the ability of penicillin and ampicillin minimum inhibitory concentration (MIC) to predict in vitro susceptibility of E. faecium versus imipenem. and 2) to compare MICs of ampicillin, penicillin and imipenem by the Vitek system with those by agar dilution method. METHODS: Fifty-two isolates of E. faecium between April 2002 and May 2002 were tested. Each isolate was tested versus penicillin, ampicillin and imipenem. MICs were determined by Vitek system and agar dilution method according to NCCLS guidelines. Imipenem MIC determinations were repeated by E-test. RESULTS: MIC of Vitek system tends to be lower than that of agar dilution method, but there was good concordance between MICs of penicillin and ampicillin by Vitek system and agar dilution method. But for imipenem, the MICs by the agar dilution method did not correspond with the Vitek results. Of the 52 E. faecium isolates tested, in vitro activity of penicillin and ampicillin accurately predicts that of imipenem. CONCLUSIONS: MICs of ampicillin and penicillin are reliable, but imipenem MIC is not reliable for E. faecium by Vitek system. In vitro activity of penicillin and ampicillin versus E. faecium accurately predicts that of imipenem.
Agar
;
Ampicillin
;
Anti-Infective Agents
;
Coinfection
;
Enterococcus faecium*
;
Enterococcus*
;
Imipenem*
;
Microbial Sensitivity Tests
;
Penicillins
9.Cryptic Insertion of the BCR Gene at 9q34 in Philadelphia-Negative Chronic Myelogenous Leukaemia.
Hyun Jeong KIM ; Misuk JI ; Hanah KIM ; Hee Won MOON ; Mina HUR ; Yeo Min YUN
Journal of Laboratory Medicine and Quality Assurance 2015;37(2):110-114
Chronic myelogenous leukaemia (CML) is a myeloproliferative neoplasm that is almost always characterised by the presence of t(9;22)(q34;q11.2). Approximately 5% to 10% of CML patients lack cytogenetic evidence of t(9;22)(q34;q11.2) but have the breakpoint cluster region (BCR)/ABL1 fusion, as revealed by fl uorescence in situ hybridisation (FISH) or the reverse transcription-polymerase chain reaction (RT-PCR). We present a case of Philadelphia-negative CML with a cryptic insertion of BCR at 9q34. A 22-year-old woman incidentally presented with marked leucocytosis and anaemia. Her complete blood count results were as follows: white blood cells, 238.61x10(9)/L; haemoglobin, 9.6 g/dL; platelets, 395x10(9)/L. A peripheral blood smear showed leucocytosis with neutrophilia, basophilia, left-shifted neutrophils, and circulating blasts comprising 2% of the total leucocytes. The bone marrow showed a striking increase in megakaryocytes and granulocytic precursors. The myeloid/erythroid ratio was 7.4:1, and blasts comprised up to 1.8% of all nucleated cells. Bone marrow sections revealed active megakaryopoiesis and granulopoiesis with 100% cellularity. Chromosomal analysis revealed a normal karyotype. However, interphase FISH using a dual-colour BCR/ABL1 fusion probe showed an atypical pattern consisting of one red, two green, and one fusion (1R2G1F) signal in 97.5% of the 200 analysed cells. Metaphase FISH revealed a single BCR/ABL1 fusion signal on chromosome 9. RT-PCR was positive for BCR/ABL1 (b3a2). Quantitative PCR revealed a normalised copy number of 15.32. The patient started her treatment with imatinib, reached a complete molecular response eight months afterwards, and has been coping well without any adverse events.
Blood Cell Count
;
Bone Marrow
;
Chromosomes, Human, Pair 9
;
Cytogenetics
;
Female
;
Humans
;
Interphase
;
Karyotype
;
Leukocytes
;
Megakaryocytes
;
Metaphase
;
Neutrophils
;
Polymerase Chain Reaction
;
Strikes, Employee
;
Young Adult
;
Imatinib Mesylate
10.Evaluation of Analytical Performance of the Cobas 8000 Analyzer Series Module e602.
Kiwoong KO ; Min Jung KWON ; Hee Yeon WOO ; Hyosoon PARK
Journal of Laboratory Medicine and Quality Assurance 2015;37(2):101-109
BACKGROUND: The e602, a module of the recently released cobas 8000 modular analyzer series, is an automated system for immunoassays. In this study, we evaluated its analytical performance using 17 immunoassay analytes. METHODS: The Clinical Laboratory Standards Institute guidelines were used to determine the efficiency of the cobas 8000 e602 based on its precision, linearity, assay comparison, and reference range validation. Performance analyses were completed using two levels of quality control materials and pooled sera from our institution. The performance of the cobas 8000 e602 was compared to that of the modular analytics E170. Statistical analyses were performed using Excel 2010 (Microsoft Co., USA) and EP Evaluator Release 10 (Data Innovations, USA). RESULTS: For all analytes, except level 1 total vitamin D, the coefficients of variation were <5%. The linearity results were within the allowable systemic error limits. The performance comparison revealed that the two systems are comparable, with correlation coefficients (r) >0.975 for all analytes. The reference range validation was also within the allowable criteria. CONCLUSIONS: Taken together, these findings demonstrate that the cobas 8000 e602 analyzer has good precision, linearity, performance comparison, and reference range validation. Thus, e602 is a useful module of the cobas 8000 modular analyzer series.
Immunoassay
;
Quality Control
;
Reference Values
;
Vitamin D