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Evaluation of Two Lateral-Flow Chromatographic Membrane Immunoassays for Rapid Detection of Influenza Virus in Limited Respiratory Specimens.

Le Thi Quynh MAI ; Pham Thi HIEN ; Nguyen Le Khanh HANG ; J S OH ; G W HA ; J A KWON ; C K LEE ; K N LEE

Journal of Laboratory Medicine and Quality Assurance.2005;27(2):243-249.

BACKGROUND: The diagnosis of influenza based on clinical grounds alone may be inaccurate, because the presenting symptoms of influenza are similar to those caused by other infectious agents. We evaluate two influenza rapid tests, SD BIOLINE Influenza Ag (Standard Diagnostic inc., Yongin, Korea) and QuickVueTM Influenza Test (Quidel corporation, San Diego, USA) with influenza virus culture and RT-PCR. METHODS: The two commercially available rapid test kits, SD BIOLINE Influenza Ag and QuickVueTM Influenza Test, for influenza virus detection were evaluated with 189 respiratory specimens collected during Dec. 2004 to Nov. 2005 in Vietnam and compared with viral culture and RT-PCR. RESULTS: Overall, the SD BIOLINE Influenza Ag and QuickVueTM Influenza Test showed high sensitivities (88.4% and 82.6%, respectively) and high specificities (99.0% and 99.0%, respectively), high positive predictive value (PPV) (98.7% and 98.6%, respectively) and high negative predictive value (NPV) (91.1% and 87.2%, respectively). CONCLUSION: Both SD BIOLINE Influenza Ag and QuickVueTM Influenza Test were easy to perform and showed high sensitivity and can be used as an additional tool for rapid diagnosis of influenza virus.
Diagnosis ; Gyeonggi-do ; Immunoassay* ; Influenza, Human* ; Membranes* ; Orthomyxoviridae* ; Sensitivity and Specificity ; Vietnam

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Immunodiagnosis of Latent Tuberculosis through Interferon-gamma Measurement Following Stimulation of Tuberculosis-Specific Antigens (ESAT-6 and CFP-10).

Kyoung Un PARK ; Hyun Jung LEE ; Mi Jung KIM ; Kwang Woo LEE ; Ju Young KIM ; Hong Bin KIM ; Eun Hwa CHOI ; Jae Ho LEE ; Choon Taek LEE ; Junghan SONG

Journal of Laboratory Medicine and Quality Assurance.2005;27(2):237-242.

BACKGROUND:The tuberculin skin test, which has been used for years for the diagnosis of latent tuberculosis, has many limitations, including false-positive results in individuals who were vaccinated with BCG. We evaluated the usefulness of a recently developed interferon-gamma assay (QuantiFERON-TB Gold) in the diagnosis of latent tuberculosis. METHODS:We performed the QuantiFERON-TB Gold assay in the following groups: 1) individuals with negative responses of tuberculin skin test in the regular health checkups for two consecutive years (n = 14), 2) individuals with no abnormal findings in low dose computed tomography in a health checkup (n = 22), 3) individuals with stable tuberculosis in low dose computed tomography in a health checkup (n = 10), 4) patients with M. tuberculosis in culture (n = 23), 5) patients with nontuberculous mycobacteria in culture (n = 6). RESULTS:In the QuantiFERON-TB Gold assay, all the group 1 showed negative results. 65.2% of the group 4 showed positive QuantiFERON-TB Gold results, while all the group 5 showed negative results. 22.7% of the group 2 and 60.0% of the group 3 showed positive QuantiFERON-TB Gold results. In addition, it was revealed that the stimulation with CFP-10 played a major role in the induction of interferon-gamma secretion. CONCLUSION:The QuantiFERON-TB Gold assay shows promise for the immunodiagnosis of latent tuberculosis using a whole-blood.
Diagnosis ; Humans ; Immunologic Tests* ; Interferon-gamma* ; Latent Tuberculosis* ; Mycobacterium bovis ; Nontuberculous Mycobacteria ; Skin Tests ; Tuberculin ; Tuberculosis

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An Experience of Using the Harmony Test for Genomics-Based Non-Invasive Prenatal Testing.

Dong Hee SEO ; Sung Eun CHO ; Jeong Ryull KWAK

Journal of Laboratory Medicine and Quality Assurance.2015;37(1):44-46. doi:10.15263/jlmqa.2015.37.1.44

Serological prenatal screening tests are widely used to detect fetal chromosomal abnormalities such as Down and Edward syndromes. Amniocentesis is conducted as a confirmatory test in the screening-positive case. After discovering of presence of fetal cell-free DNA in maternal blood, non-invasive prenatal test (NIPT) coupled with next generation sequencing are performed in abroad. Results of genomics-based NIPT results supplied to Labgenomics laborotory from June, 2013 to August, 2014 were analyzed. Maternal blood samples were collected into specific Cell-Free DNA BCT tube and were transported. The samples were then delivered to Ariosa Diagnostics by FEDEX. Fetal cell-free DNA samples were analyzed using the Harmony test with sequencing of relevant chromosomes and by using the FORTE (fetal-fraction optimized risk of trisomy evaluation) algorism at Ariosa Diagnostics. In all, 149 cases from 28 medical clinics were analyzed. Six subjects were required recollection of samples because of a low fetal DNA fraction in the initially obtained samples. Of these 6 subjects, no sample could be collected from one. Of the remaining 148 cases, 144 had a low risk of trisomy, and 4 had a high risk for Down syndrome, thus providing a positivity percentage of 2.7%. Fetal DNA fraction in the maternal blood samples ranged from 4.2% to 23.7% with a mean value of 12.0%. We have experienced cases with a high risk for Down syndrome with genomics-based NIPT referred to abroad.
Amniocentesis ; Chromosome Aberrations ; DNA ; Down Syndrome ; Prenatal Diagnosis ; Trisomy

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Comparison of the Real-Time PCR Tests for Factor V G1691A and Prothrombin G20210A with PCR-Restriction Fragment Length Polymorphism and Direct Sequencing Tests.

Hyunjung KIM ; Gun Dong LEE ; Sang Yoon LEE ; Woori JANG ; Joonhong PARK ; Hyojin CHAE ; Myungshin KIM ; Yonggoo KIM

Journal of Laboratory Medicine and Quality Assurance.2015;37(1):37-43. doi:10.15263/jlmqa.2015.37.1.37

BACKGROUND: Factor V (FV) G1691A and prothrombin G20210A mutations are the most common targets of genetic tests for thromboembolism. This study compared the ability of real-time PCR to detect FV G1691A and prothrombin G20210A (BioSewoom, Korea) with that of PCR-restriction fragment length polymorphism (RFLP) and direct sequencing, to evaluate diagnostic equivalency. METHODS: Real-time PCR was compared with PCR-restriction fragment length polymorphism (RFLP) and direct sequencing using patients' samples as well as heterozygous and homozygous World Health Organization (WHO) reference reagent DNA. The limit of detection (LoD) for real-time PCR was determined using WHO reference reagents. RESULTS: All 141 and 156 patient samples were tested for the FV G1691A and prothrombin G20210A mutations, respectively; the results from all three methods (real-time PCR, PCR-RFLP, and direct sequencing) consistently showed that the samples were wild type. Each of the three methods showed the same results in tests using heterozygous and homozygous DNA from the WHO reference reagents. The LoD of wild type and homozygous samples was 65.16 pg/mL for FV G1691A, and 61.3 pg/mL for prothrombin G20210A. The LoD of heterozygous samples was 1,650.0 pg/mL for FV G1691A and 1,640.0 pg/mL for prothrombin G20210A. CONCLUSIONS: The real-time PCR test kits for FV G1691A and prothrombin G20210A showed reliable equivalency with PCR-RFLP and direct sequencing, and could be useful tests to detect gene polymorphisms for thromboembolism.
DNA ; Factor V* ; Humans ; Indicators and Reagents ; Limit of Detection ; Polymerase Chain Reaction ; Prothrombin* ; Real-Time Polymerase Chain Reaction* ; Thromboembolism ; World Health Organization

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Evaluation of AutoLab Rapid Plasma Reagin and AutoLab Treponema pallidum Latex Agglutination for Syphilis Infection Testing.

Mi Jung PARK ; Pil Whan PARK ; Yiel Hea SEO ; Jeong Yeal AHN ; Kyung Hee KIM ; Ja Young SEO ; Ji Hun JEONG ; Moon Jin KIM ; Hwan Tae LEE

Journal of Laboratory Medicine and Quality Assurance.2015;37(1):29-36. doi:10.15263/jlmqa.2015.37.1.29

BACKGROUND: Automated assays have recently been developed for efficient serological testing of syphilis infection. Here, we evaluate the performance of new automated serological assays for syphilis infection. METHODS: The precision, linearity, and detection limit of the automated kits AutoLab rapid plasma reagin (RPR) (IVD-RPR) and AutoLab (Treponema pallidum Latex Agglutination) TPLA (IVD-TPLA) (IVDLab Co., Korea) were evaluated using an immunoturbidimetric method. In addition, the results of these tests were compared with those obtained using the HiSens Auto RPR LTIA (HBi-RPR) and HiSens Auto TP LTIA (HBi-TPLA) tests (HBi Co., Korea) with 122 serum samples. RESULTS: Both the IVD-RPR and IVD-TPLA kits showed acceptable precision for the positive controls (IVDLab Co., Korea). The within-run and total precision of IVD-RPR were better than those of HBi-RPR at cut-off levels (CV, 7.0% to 7.4% for IVD-RPR; CV, 33.3% to 40.0% for HBi-RPR). The IVD-RPR and IVD-TPLA kits demonstrated acceptable linearity and limits of detection. The agreement rate between IVD-RPR and HBi-RPR was 83.60% (102/122). Nineteen samples were IVD-RPR negative but HBi-RPR positive; 12 of these were from patients with a history of syphilis. The agreement rate between IVD-TPLA and HBi-TPLA was 96.72% (118/122). All discrepant results were IVD-TPLA positive and HBi-TPLA negative. CONCLUSIONS: IVD-RPR and IVD-TPLA exhibited acceptable precision, linearity, and limits of detection for the diagnosis of syphilis infection. IVD-RPR was suitable for monitoring syphilis infections with good precision that was near cut-off levels. IVD-TPLA was useful for detecting primary syphilis infection.
Agglutination* ; Diagnosis ; Humans ; Latex* ; Limit of Detection ; Plasma* ; Serologic Tests ; Syphilis* ; Treponema pallidum*

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Evaluation of Blood Culture System for Culture of Body Fluids.

Soon Deok PARK ; Young UH ; In Ho JANG ; Maria HONG ; Hyeun Gyeo LEE ; Kwan Soo LEE ; Dong Hyun LEE

Journal of Laboratory Medicine and Quality Assurance.2015;37(1):23-28. doi:10.15263/jlmqa.2015.37.1.23

BACKGROUND: Invasive and life-threatening infections such as meningitis, pericarditis, peritonitis, empyema, and septic arthritis are diagnosed via culture of relevant body fluids (BFs). The blood culture system (BCS) has been reported to be a useful alternative for BFs culture to enhance recovery of fastidious microorganisms and reduce detection time. The aim of this study was to evaluate the diagnostic performance of BCS as compared to conventional culture method (CCM) in terms of culture yield. METHODS: The samples collected between October 2011 and September 2012 were processed using CCM, while those collected between October 2012 and September 2013 were processed using BCS. The 2 processes were compared in terms of total number of requests, recovery rate, turnaround time (TAT), and detection time. RESULTS: The positive rate using CCM was 18.2% (575/3,151), where 845 isolates were recovered from 575 specimens. Using BCS, the positive rate was 28.3% (922/3,260), where 1,472 isolates were recovered from 922 specimens. While comparing the 2 methods on terms of yield of clinically significant isolates, a greater number of fungi (1.2%) and anaerobic bacteria (1.4%) were recovered using BCS as compared to using CCM. The difference in TAT for positive samples was 24 hours and 40 minutes, where BCS had a shorter TAT than CCM. The mean detection time of 951 positive samples by BCS was 19 hours and 56 minutes. Growth of clinically significant isolates was detected within 24 hours. CONCLUSIONS: BCS for culture of BFs showed an improvement in recovery rate, number of isolates, and TAT as compared to CCM. Thus, BCS is a suitable alternative for culture of BFs.
Arthritis, Infectious ; Bacteria, Anaerobic ; Body Fluids* ; Empyema ; Fungi ; Meningitis ; Pericarditis ; Peritonitis

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Annual Report on the External Quality Assessment Scheme for Therapeutic Drug Monitoring and Testing for Drugs of Abuse in Korea (2014).

Dae Hyun KO ; Tae Dong JEONG ; Gum Gyoung GU ; Sail CHUN ; Jeong Ho KIM

Journal of Laboratory Medicine and Quality Assurance.2015;37(1):12-22. doi:10.15263/jlmqa.2015.37.1.12

As the Therapeutic Drug Monitoring Subcommittee (TDMS) of the Korean Association of Quality Assurance for Clinical Laboratories (KAQACL), we organised two trials as an external quality assessment of therapeutic drug monitoring (TDM) and testing for drugs of abuse (DOA) in 2014. In each trial, low and high level control materials for TDM testing, and positive and negative control materials for DOA testing, were requested from institutions. The number of participating laboratories was 107 for the first trial and 106 for the second. The average number of drug items provided was 5.7 per institution. The most commonly tested substances were, in descending order, valproic acid, digoxin, tacrolimus, phenytoin, and vancomycin. The mean inter-laboratory coefficients of variation for low- and high-level TDM control materials were 8.5% and 7.2%, respectively. The most widely used TDM analysers were the Architect i System (Abbott Diagnostics, USA), followed by the Cobas Integra (Roche Diagnostics, Switzerland) and the Cobas c501 analyser (Roche Diagnostics). The number of participating laboratories for DOA testing was 23% higher that than in 2013. In 96.9% of cases, our analysis confirmed the suitability of the tests at participating DOA laboratories in both trials. In the external quality assessment of TDM by the TDMS of KAQACL in 2014, the overall performance of TDM testing was found to be similar to that observed in the previous years, and inter-laboratory precision was higher than that in 2013. Continuous quality improvement of TDM testing by participation in a proficiency-testing program is necessary.
Digoxin ; Drug Monitoring* ; Korea ; Laboratory Proficiency Testing ; Phenytoin ; Quality Improvement ; Street Drugs* ; Tacrolimus ; Valproic Acid ; Vancomycin

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Annual Report on the External Quality Assessment Scheme for Diagnostic Hematology in Korea (2014).

Gye Cheol KWON ; Jimyung KIM ; Gee Su RA

Journal of Laboratory Medicine and Quality Assurance.2015;37(1):1-11. doi:10.15263/jlmqa.2015.37.1.1

During 2014, the Diagnostic Hematology Subcommittee of the Korean Association of Quality Assurance for Clinical Laboratories performed laboratory proficiency testing for blood cell count, cell morphology, and coagulation tests. Four trials for blood cell count and cell morphology tests and 2 trials for coagulation tests were performed. The trials for blood cell counts had a reply rate of 96.8% among 1,343 laboratories, compared to 99.3% among 489 laboratories for cell morphology and 98.6% among 565 laboratories for coagulation tests. The homogeneity of the external quality materials was stable (<3%), and the use of instruments and reagents was similar to that observed during the previous year. The CVs for white blood cell counts, red blood cell counts, platelet counts, hemoglobin tests, and hematocrit tests were 4.46%, 2.12%, 2.21%, 5.08%, and 8.31%, respectively. For cell morphology tests, concordant rates were >80% for most of the participating laboratories. The CVs for the coagulation tests varied according to the specific instruments or reagents that were used. An educational workshop was held in July to provide hands-on experience in diagnostic hematology. During 2014, the number of participating laboratories was increased, while the performance of hematology tests was similar to that observed in the previous year.
Blood Cell Count ; Education ; Erythrocyte Count ; Hematocrit ; Hematology* ; Indicators and Reagents ; Korea ; Laboratory Proficiency Testing ; Leukocyte Count ; Partial Thromboplastin Time ; Platelet Count ; Prothrombin Time

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Performance of Automated Chemiluminescence Assay for Antiphospholipid Antibody Testing.

Shuhua LI ; Jae Lim CHOI ; Bo Ram KIM ; Cheol Soo KANG ; Ri Young GOH ; Kwang Sook WOO ; Jin Yeong HAN

Journal of Laboratory Medicine and Quality Assurance.2015;37(3):134-140. doi:10.15263/jlmqa.2015.37.3.134

BACKGROUND: Detection of antiphospholipid antibodies (aPL) can be considered problematic due to assay variability and reagent sensitivity, high false-positive and false-negative rates, and lack of assay standardization. Therefore, utilizing an automated system can improve reproducibility and reduce interlaboratory variation. Here, we evaluated the analytical performance of the new automated ACL AcuStar chemiluminescence assay (Instrumentation Laboratory, USA). This was compared to the results of a panel analyzed with the QUANTA Lite ELISA (INOVA Diagnostics Inc., USA). METHODS: We evaluated the inter-assay precision, linearity, and carry-over between the two methods, ACL and ELISA. A reference range study for each of the anticardiolipin (aCL) and anti-beta2 glycoprotein-I (abeta2GPI) IgG and IgM antibodies were performed using 135 healthy patient samples, which served as controls. We then compared the accuracy among the AcuStar and ELISA systems via four aPL tests. For this comparison, 69 patient samples suspected of an autoimmune disorder were used as the experimental panel. RESULTS: The AcuStar analyzer showed excellent precision, linearity, and carry-over for all four assays. The calculated cutoff values were 20.3 U/mL for aCL IgG, 20.3 U/mL for aCL IgM, 26.3 U/mL for abeta2GPI IgG, and 11.9 U/mL for abeta2GPI IgM. The consensus between AcuStar and ELISA results were generally comparable. Total agreement varied between 82.6% and 95.7%, and kappa values showed moderate to good agreement. CONCLUSIONS: Our study demonstrates that the new AcuStar chemiluminescence assay showed better performance. This automated system leads to improved reproducibility and reduces interlaboratory variability.
Antibodies ; Antibodies, Anticardiolipin ; Antibodies, Antiphospholipid* ; Antiphospholipid Syndrome ; Automation ; Consensus ; Enzyme-Linked Immunosorbent Assay ; Humans ; Immunoglobulin G ; Immunoglobulin M ; Luminescence* ; Reference Values

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Annual Report on the External Quality Assessment Scheme of Viral Markers and Serological Tests for Syphilis in Korea (2014).

Young Joo CHA ; Jae Hoon BAE ; Quehn PARK ; Seok Lae CHAE

Journal of Laboratory Medicine and Quality Assurance.2015;37(3):124-133. doi:10.15263/jlmqa.2015.37.3.124

As Immunoserology Subcommittee of the Korean Association of External Quality Assessment Service, we organized two trials on the external quality assessment of viral markers and serological tests for syphilis (STS) in 2014. For this purpose, we delivered three kinds of pooled sera specimens for external proficiency testing to 1,060 and 1,064 institutions for the first and second trials, respectively. Pooled sera were checked for their homogeneity and stability by using more than three other methods between the day of their manufacture and 3 days after despatching. The numbers of participating laboratories were 1,053 (99.3%) and 1,046 (99.3%) in the first and second trials, respectively. The most commonly tested items were hepatitis B surface antigen, followed by antibody to hepatitis B surface antigen, anti-human 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 generated few false positive results. In contrast, false negative results were frequently found through the immunochromatography assay, the use of which for detecting viral markers has been steadily increasing in recent years. Furthermore, the use of turbidoimmunoassay and CLIA, which are new tests recently introduced for the measurement of non-treponemal 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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