• Pediatric Infection and Vaccine
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• v.14 no.1
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• pp.91-96
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• 2007

Purpose : This study was performed to evaluate a new rapid diagnostic kit (BIOLINE $RSV^{TM}$; Standard Diagnostics Inc., Yongin, Korea), a lateral-flow immunoassay, in the detection of respiratory syncytial virus (RSV) from the nasopharyngeal aspirates (NPA) of children with lower respiratory tract infections (LRTIs) in comparison with other diagnostic methods. Methods : Three hundred and nineteen NPAs were selected from a large pool of NPAs that had been obtained from children with LRTIs. All specimens had already been tested for RSV by culture and immunofluorescent (IF) test, and had been kept frozen. Tests with BIOLINE $RSV^{TM}$ were performed at least twice. All who conducted the experiments or interpreted the test results were blinded to the results of both culture and IF tests. Results : One hundred seven (97.3%) of 110 specimens that were positive for RSV by both culture and IF test, 29 (87.9%) of 33 that were positive by IF test only, 20 (76.9%) of 26 that were positive by culture only, and 140 (93.3%) of 150 that were negative by both methods were negative for RSV by BIOLINE $RSV^{TM}$. By combining the above results, the following 5 diagnostic values of BIOLINE $RSV^{TM}$ were determined in comparison with viral culture or IF test; sensitivity, 92.3% (156/169, 95% confidence interval [CI], 87.1-97.5%); specificity, 93.3% (140/150, 95% CI, 88.4-98.2%); positive predictive value, 94.0% (156/166, 95% CI, 89.5-98.5%); negative predictive value, 91.5% (140/143, 95% CI, 86.0-97.0%); and agreement, 95.9% (306/319, 95% CI, 92.1-99.7%), respectively. Conclusion : This study revealed that BIOLINE $RSV^{TM}$ demonstrated good sensitivity and specificity for the detection of RSV antigen from NPAs of children with LRTIs. Because of simple methods and quick results, this test may be useful for the diagnosis of RSV infection during the epidemic periods.

• Journal of Gastric Cancer
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• v.9 no.4
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• pp.172-176
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• 2009

Purpose: The rapid urease test is a rapid and reliable method for diagnosing Helicobacter pylori infection. However it requires gastric mucosal biopsies during endoscopy, and the test is not covered by national health insurance for patients with gastric cancer. So, we introduced an alternative method for a rapid urease test using back-table gastric mucosal biopsies from gastrectomy specimen. Materials and Methods: Ninety gastric cancer patients underwent an anti H. pylori IgG ELISA test and gastrectomy. Just after gastrectomy, two gastric mucosal biopsies from the prepyloric antrum and lower body of the gastrectomy specimen were taken from the back table in the operative room, and these were fixed immediately with the rapid urease test kit, and the color change was monitored for up to 24 hours. In this study, H. pylori infection was defined as positive when the serology or rapid urease test showed positive results. Results: The positive rate of the rapid urease test and serology was 91.1% and 77.8%, respectively. The sensitivity, specificity, positive predictive value and negative predictive value of the rapid urease test and serology were 94.3 and 80.5%, 100 and 100%, 100 and 100%, and 37.5 and 15%, respectively. The accuracy of the rapid urease test was higher than that of serology (94.4 vs. 81.1%, respectively). The rapid urease test showed a higher rate of detecting H. pylori infection than that of serology (McNemar's test, P=0.019). Conclusion: The result of the rapid urease test using back-table gastric mucosal biopsies from a gastrectomy specimen is comparable to the reference data of the conventional rapid urease test using gastric mucosal endoscopic biopsies. Therefore, it can be an alternative diagnostic method for H. pylori infection.

• Parasites, Hosts and Diseases
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• v.56 no.5
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• pp.447-452
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• 2018

Prompt diagnosis of malaria cases with rapid diagnostic tests (RDTs) has been widely adopted as an effective malaria diagnostic tool in many malaria endemic countries, primarily due to their easy operation, fast result output, and straightforward interpretation. However, there has been controversy about the diagnostic accuracy of RDTs. This study was conducted to evaluate the diagnostic performances of the 2 commercially available malaria RDT kits, RapiGEN Malaria Ag Pf/Pv (pLDH/pLDH) and Asan $EasyTest^{TM}$ Malaria Ag Pf/Pv (HRP-2/pLDH) for their abilities to detect Plasmodium species in blood samples collected from Ugandan patients with malaria. To evaluate the diagnostic performances of these 2 RDT kits, 229 blood samples were tested for malaria infection by microscopic examination and a species-specific nested polymerase chain reaction. The detection sensitivities for P. falciparum of Malaria Ag Pf/Pv (pLDH/pLDH) and Asan $EasyTest^{TM}$ Malaria Ag Pf/Pv (HRP-2/pLDH) were 87.83% and 89.57%, respectively. The specificities of the 2 RDTs were 100% for P. falciparum and mixed P. falciparum/P. vivax infections. These results suggest that the 2 RDT kits showed reasonable levels of diagnostic performances for detection of the malaria parasites from Ugandan patients. However, neither kit could effectively detect P. falciparum infections with low parasitaemia (<$500parasites/{\mu}l$).

• Biomedical Science Letters
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• v.3 no.2
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• pp.107-114
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• 1997

Recent reports indicate that the clinical usefulness of prostate specific antigen (PSA), particulary in the differentiation of benign prostate hyperplasia from prostate cancer, can be improved by measuring the amount of free PSA in serum. Measuring free PSA is especially useful in attempts to improve diagnositc performance of PSA in the diagnostic gray zone of total PSA. The objective of this study was to develop free PSA assay kit using sandwich microplate enzyme immunoassay format. We chose a test format with polyclonal anti-PSA antibodies coated on the wells and monoclonal anti-free PSA antibodies for quantification to gain higher test sensitivity. We adpoted 10 uL of specimen and 2 hours of first incubation time with detecting antibody for free PSA EIA format using microplate. The within-day and between-day precision (%CV) in the high and low concentration ranges were below 4%. The correlation coefficient between in-house free PSA assay and commercial assay kit was r=0.9965 (slope=0.0984, y intercept=0.0173, N=27). No hook effect was found by 40 ng/mL and correlation coefficient (r) value of the fitted linear regression was over 0.995. The recovery tests were in the range of 98.9∼104.1％ for free PSA. In conclusion, in-house free PSA enzyme immune assay is cost effective, simple and rapid and could be useful for the prognosis after theraphy as well as for the differential diagnosis between prostate cancer and benign prostate hyperplasia.

• Asian-Australasian Journal of Animal Sciences
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• v.17 no.12
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• pp.1746-1750
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• 2004

The PBM ${BioSign}^{TM}$ Salmonella (PBMS) test kit based on an mmunochromatographic method was evaluated for the screening of Salmonella spp. in pure cultures, and 80, 15, and 10 artificially and naturally contaminated, and negative controlled food samples, respectively. The PBMS test involves presumptive qualitative procedures, detecting the presence of Salmonella spp. in foods within 26 h total testing period and allowing the user to release negative products 70 h earlier than the conventional methods. The PBMS test using Buffered Peptone Water and Rappaport-Vassiliadis broth was evaluated for 10 different food types for various Salmonella spp. It showed detection limits of 1 to 25 colony forming units (CFU)/25 g. No cross-reaction was observed, particularly to other gramnegative bacteria. These results indicate the PBMS test is a rapid and inexpensive procedure for the screening of Salmonella spp. present at low concentrations (1 to 25 CFU/25 g) in foods.

• Korean Journal of Agricultural Science
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• v.39 no.4
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• pp.613-618
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• 2012

This study was performed to optimize the basic platform of a lateral flow immunoassay. Improvement of the limit of detection (LOD) was evaluated according to the width of a nitrocellulose membrane with varying concentrations of analyte. The analyte, neutravidin was detected based on the avidin-biotin interaction. The antibody-Au nanoparticle conjugation was mostly stabled in a PBS buffer of pH 7.3. The optimal widths of a nitrocellulose membrane were 4 and 6 mm considering the sample flow rate and signal strength of the test line on the membrane. The LOD of neutravidin was 0.001 mg/ml in the optimum conditions.

• Journal of the Korea Convergence Society
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• v.9 no.3
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• pp.165-171
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• 2018

In this study, to analyze the detection of limit for sensitivity of the influenza rapid antigen test kit, the positive detection of limits were analyzed by serial dilution of influenza virus A and B type for five influenza rapid antigen test kits in Korea. As a result of analysis, visual measurement of type A were up to 1:8192 for the Wellsbio product and up to 1:4096 for the II product, up to 1:512 for the I and III products, and only 1:128 for the IV product, and type B were positive for up to 1:8192 for the Wellsbio product, up to 1: 4096 for the II product and up to 1:1024 for the I, III and IV products. For instrument readings with the same specimen, both A and B types were found to be positive for up to 1:8192 for the Wellsbio product, up to 1: 4096 for the II product, and up to 1:2048 for the I product. The sensitivity of the rapid antigen test for influenza differs greatly depending on the sampling area of the patient, infection period, specimen volume, etc. Therefore, it is necessary to observe exactly the collection timing and method of the specimen. And it is necessary further study to improve the sensitivity for influenza rapid antigen test.

• Bulletin of the Korean Chemical Society
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• v.28 no.6
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• pp.929-935
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• 2007

The objective of this study was to develop a rapid, simple, and qualitative acetylcholinesterase (AChE)- detection kit, based on a modification of the Ellman and ELISA methods, for the detection of organophosphorus (OP) and carbamate (CB) pesticide. The developed kits were used to screen a large number of agricultural samples (spiked and real) for OP and CB pesticide residues. AChE was extracted from the heads of honeybees (Apis mellifera L.) using Triton X-100, and was purified through 3 steps: diethylaminoethylcellulose chromatography (DEAE), affinity chromatography and membrane filtering, and Mono-Q column chromatography. Epoxy-activated Sepharose 6B affinity chromatography was used for large-scale purification. The presence of OP and CB pesticide residues in agricultural samples was assayed on the basis of AchE inhibition value. The presence (6 bands) or absence of some colored bands on the test line indicated a negative or positive result, respectively. The limits of detection for measured organophosphorus (OP) and carbamates (CB) pesticide residues in standard pesticide solutions and fortified samples were ranged from 0.50 to 2.50 ppm and 0.50 to 4.75 ppm, respectively.

• Journal of Yeungnam Medical Science
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• v.2 no.1
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• pp.183-190
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• 1985

The glucose nonfermenting gram-negative bacilli encountered about 10% of all gram-negative bacilli isolated from clinical material. Therefore, a rapid and correct identification of glucose nonfermenting gram-negative bacilli is impostent for a better management of infectious disease. There are many conventional systems for the Identification of glucose nonfermenting gram-negative bacilli but most of them have problems and difficulties. Commercial Kit Systems exist and they are too expensive for dally use 10 Korea because of high cost. Based on 12 selected tests we propose a new code system, MCRCODE-N for rapid and 10-expensive identification of glucose nonfermenting gram-negative bacilli. The selective 12 tests are oxidase, glucose oxidation motility, urease, DNase arginine dehydrolase, nitrate reduction, gelatin Liquefaction, esculin hydrolysis, mannitol oxidation, maltose oxidation, Lactose oxidation. The 12 tests are divided 4 group and then each group has 3 tests. The result of each group is expressed by the number as below. The positive test is given by specific number (1st test = 1, 2nd test = 2, 3rd test = 4), while any negative result is 0. Each 3 numbers of one group are added and make number of 1 digit. Four digit number is refered to the code book of MCRCODE-N system or MCRCODE system using computer (Apple-II model) created by authors. This MCRCODE-N system is suitable ones for our use 10 Korea. We propose the MCRCODEN-N system for clinical use.

• Korean Journal of Clinical Laboratory Science
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• v.55 no.1
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• pp.45-51
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• 2023

Canine parvovirus type 2 (CPV-2) and canine coronavirus (CCoV) are major pathogens that can induce gastroenteritis in dogs. They are highly contagious and have a high morbidity rate. There are no specific treatments available for them to date. Therefore, rapid and accurate diagnosis becomes essential. The rapid diagnostic test (RDT) for animals can be used widely in the field because it is fast and easy to use for diagnosis. Thus, this study aimed to clinically evaluate and confirm the clinical utility of CPV-2/CCoV RDT. The parameters evaluated included the limit of detection (LoD), cross-reactivity, interference, sensitivity, specificity, negative likelihood ratio (NLR), and kappa value. The results revealed that the LoD values for CPV-2 and CCoV were 9.7×10 50% tissue culture infectious dose (TCID₅₀)/mL and 2.5×10² TCID₅₀/mL, respectively. There was no cross-reactivity with nine pathogens or interference by interfering materials. The RDT showed a sensitivity of 90.0%, a specificity of 100.0%, NLR of 0.1, and a kappa value of 0.90 for diagnosing both viruses. In conclusion, CPV-2/CCoV RDT is useful as a screening test because of its high sensitivity, specificity, kappa value, and low NLR.