• Pediatric Infection and Vaccine
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• v.31 no.1
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• pp.113-121
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• 2024

Purpose: In response to the surge in coronavirus disease 2019 (COVID-19) omicron variant cases, we have implemented preemptive testing for preschool and school. The purpose is to quickly detect COVID-19 cases using a rapid antigen test (RAT) kit so that normal school activities can continue. Methods: The results entered in The Healthcare Self-Test App were merged with the information on the status of confirmed cases in the COVID-19 Information Management System by Korea Disease Control and Prevention Agency (KDCA) for preschool and school of students and staffs March 2 to May 1, 2022 to analyze the RAT positive rate and positive predictive value of RAT. Results: In preschool and school 19,458,575 people were tested, weekly RAT positive rate ranged from 1.10% to 5.90%, positive predictive value of RAT ranged from 86.42% to 93.18%. By status, RAT positive rate ranged from 1.13% to 6.16% for students, 0.99% to 3.93% for staffs, positive predictive value of RAT ranged from 87.19% to 94.03% for students, 77.55% to 83.10% for staffs. RAT positive rate by symptoms ranged from 76.32% to 88.02% for those with symptoms and 0.34% to 1.11% for those without symptoms. As a result of preschool and school RAT, 943,342 confirmed cases were preemptively detected, before infection spread in preschool and school. Conclusions: RAT was well utilized to detect confirmed cases at an early stage, reducing the risk of transmission to minimize the educational gap in preschool and school. To compensate for the limitations of RAT, further research should continue to reevaluate the performance of RAT as new strains of viruses continue to emerge. We will have to come up with various ways to utilize it, such as performing periodic and repeated RAT and parallel polymerase chain reaction.

• Parasites, Hosts and Diseases
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• v.52 no.2
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• pp.143-149
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• 2014

To evaluate the seroprevalence against circumsporozoite protein (CSP) of Plasmodium vivax in sera of Korean patients, the central repeating domain (CRD) of CSP was cloned and analyzed. From the genomic DNA of patient's blood, 2 kinds of CSPs were identified to belong to a VK210 type, which is the dominant repeating of GDRA(D/A)GQPA, and named as PvCSPA and PvCSPB. Recombinantly expressed his-tagged PvCSPA or PvCSPB in Escherichia coli reacted well against sera of patients in western blot, with the detecting rate of 47.9% (58/121), which included 15 cases positive for PvCSPA, 6 cases positive for PvCSPB, and 37 cases for both. The mixture of PvCSPA and PvCSPB was loaded to a rapid diagnostic test kit (RDT) and applied with the same set of patient sera, which resulted in detection rates of 57.0% (69/121). When the protein sequences of PvCSPA were compared with those of P. vivax in endemic regions of India and Uganda, they were compatibly homologous to PvCSPA with minor mutations. These results suggested that the recombinant PvCSPA and PvCSPB loaded RDT may be a milestone in latent diagnosis which has been a hot issue of domestic malaria and important for radical therapy in overlapped infections with P. falciparum in tropical and subtropical areas. During the biological process of malarial infection, exposure of CSP to antigen-antibody reaction up to 57.0% is the first report in Korea.

• Parasites, Hosts and Diseases
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• v.55 no.1
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• pp.9-13
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• 2017

Seroprevalence of Toxoplasma gondii infection among the residents of Seokmo-do (Island) in Ganghwa-gun, Incheon, Korea was surveyed for 4 years by a rapid diagnostic test (RDT) using recombinant fragment of major surface antigen (SAG1), GST-linker-SAG1A. Sera from 312, 343, 390, and 362 adult residents were collected on a yearly basis from 2010 to 2013, respectively. Total positive seroprevalence regardless of gender was 29.2, 35.3, 38.7, and 45.3% from 2010 to 2013, respectively. Positive seroprevalence in male adults was 43.9, 48.2, 45.4, and 55.3%, which was far higher than that of the corresponding female adults which was 20.7, 29.2, 33.9, and 38.9%, from 2010 to 2013, respectively. This high seroprevalence of toxoplasmosis in Seokmo-do may have been caused in part by peculiar changes in the toxoplasmic environment of the island as it is a relatively isolated area preserving its natural habitat while also being connected by a bridge to the mainland. Further study is necessary to find out symptomatic patients and to confirm the risk factors.

• Journal of Medicine and Life Science
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• v.17 no.1
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• pp.29-32
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• 2020

As respiratory syncytial virus(RSV) is transmitted either via directly contact with an infected case or via indirectly contaminated fomites or skin, the major preventive measures are strict hand hygiene, early detection of transmitted sources, and rapid isolation of RSV patients. Especially early detection of hidden cases is the most critical control measure when an index case was notified in a postpartum center. The Guideline of Korea Centers for Diseases Control and Prevention defines potential contacts in an epidemiologic survey as admitted newborns, parents of index cases, center's workers, and visitors for 10 days before the first diagnosis day of index case. However, it needs to classify potential contacts in more detail in order to conduct a successful survey. Authors conducted to search related literatures and appraise the evidences. Firstly, potential contacts would be classified into RSV-related symptomatic contacts(SxC) and asymptomatic contacts. And then, mother, caring workers, and visitors of the index cases among asymptomatic contacts would be defined as the asymptomatic close contacts(ASCC). Finally, the rest would be defined as the asymptomatic regular contacts(ASRC). The defined test using reverse transcription-PCR is applied to SxC and ASCC, and decision of isolation or regular activities are made according to the results. The rapid antigen detection test kits are applied to ASRC. These suggestions might be helpful to detect hidden cases earlier and prevent a further infection.

• KSBB Journal
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• v.15 no.3
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• pp.243-246
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• 2000

One of recent topics in the case of hepatits B virus(HVB) is the value of hepatitis B surface antigen(HBsAg) concentration as a prognostic maker. We developed uantitative method of rapid immunochromatographic assay(ICA) kit for HBsAg using computer image analysis (CIA) for the purpose of home diagnosis. uantitative ICA using CIA demonstrated integrated optical density(IOD) values proportional to log of reference HBsAg concentrations in the range of 2-200 ng/mL and enzyme-linked immunosorbent assay(ELISA) demonstrated the same in the range of 0.1-100 ng/mL however the test results with sample sear showed the same concentration on both kits. Furthermore repeated tests with the same samples revealed that this quantitative ICA using CIA would be reproducible and coefficient of variation(CV) of the results was 1.38~6.30%.

• 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.

• Journal of Biosystems Engineering
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• v.32 no.6
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• pp.440-447
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• 2007

In this study, a biosensor was developed using an enzyme-linked immunosorbent assay (ELISA) to rapidly measure the fungicide iprovalicarb residues in agricultural products. The biosensor was designed to include micro-pumps and solenoid valves for fluid transport, a spectrophotometer cuvet as a reaction chamber, a photodiode with a light-emitting diode for optical density measurement, and a control microcomputer to implement assay. The rate of change in optical density of the cuvet was read as final signal output. Micro-pumps were evaluated to investigate their delivery capability, the highest values of the error and the coefficient of variation were 4.3% and 4.6% respectively. As the incubation period was reduced from 15 minutes to 11 minutes to shorten the total processing time, the sensor sensitivity was decreased as the antibody dilution ratio was reduced to a half. The maximum usable period of the coated cuvet was found to be two days with 1% error limit. To predict the concentration of the iprovalicarb residue in agricultural products, a linear calibration model was obtained with r-square values of 0.992 for potato and 0.985 for onion. In validation test for the samples of potatoes and onions against the high performance liquid chromatography, very high correlation values were obtained as 0.996 and 0.993 respectively. Using the cuvet immobilized with antigen, it took 21-minutes for the biosensor to complete the measuring process of the iprovalicarb residues.

• Korean Journal of Veterinary Service
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• v.42 no.4
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• pp.285-288
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• 2019

Foot-and-mouth disease (FMD) causes economic problems in livestock industry because of fast spread and inducing low productivity. FMD outbreaks occurred in South Korea over the period from 2000 to 2019. Vaccination is the most practical and effective means of controlling or preventing these outbreaks, and a national vaccination policy has been in place for all FMD-susceptible animals since 2010. To prevent and control of FMD, South Korea has been using vaccines imported from the United Kingdom, Argentina, and Russia. The Animal and Plant Quarantine Agency of South Korea oversees continuous quality control of imported FMD vaccines. FMD vaccines were evaluated characteristics, sterility, pH, inactivation, safety, potency test by Korean FMD vaccine standard assay (Test for National Lot Release). The 6 company vaccines (A~F) were used Test for National Lot Release by each method. We evaluated quality of each FMD vaccine from 2015 to 2019. All batch of vaccine showed good quality control and were passed the Test for National Lot Release. The serotypes of vaccine are increasingly changing to multiple vaccine because the FMD was outbreak by various serotype virus in South Korea. Furthermore, this data may be useful as a basis for ensuring the quality of FMD vaccines and for base data to manage them. Additional study is required to simple approach for rapid evaluation of quality and antigen content identification in vaccines.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.7 no.2
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• pp.153-162
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• 2004

Purpose: The Helicobacter pylori stool antigen (HpSA) enzyme immunoassay is a non-invasive test for the diagnosis and monitoring of H. pylori infection. But, there are few validation studies on the HpSA test after eradication in children. The aim of this study was to assess the diagnostic accuracy of HpSA enzyme immunoassay for the detection of H. pylori to confirm eradication in children. Methods: From January 2001 to October 2003, 164 tests were performed in 146 children aged 1 to 17.5 years (mean $9.3{\pm}4.3$ years). H. pylori infection was confirmed by endoscopy-based tests (rapid urease test, histology, and culture). All H. pylori infected children were treated with quadruple regimens (Omeprazole, amoxicillin, metronidazole and bismuth subcitrate for 7 days). Stool specimens were collected from all patients for the HpSA enzyme immunoassay (Primier platinum HpSA). The results of HpSA tests were interpreted as positive for $OD{\geq}0.160$, unresolved for $$0.140{\leq_-}OD$$<0.160, and negative for OD<0.140 at 450 nm on spectrophotometer. Results: 1) One hundred thirty-one HpSA tests were performed before treatment. The result of HpSA enzyme immunoassay showed three false positive cases and one false negative case. The sensitivity, specificity, positive predictive value, and negative predictive value of HpSA enzyme immunoassay before treatment were 96.4%, 97.1%, 90%, and 99%, respectively. 2) Thirty-three HpSA enzyme immunoassay were performed at least 4 weeks after eradication therapy. The results of HpSA enzyme immunoassay showed two false positive cases and one false negative case. The sensitivity, specificity, positive predictive value, and negative predictive value after treatment were 88.9%, 91.7%, 80%, and 95.7%, respectively. Conclusion: Diagnostic accuracy of the HpSA enzyme immunoassay after eradication therapy was as high as that of the HpSA test before eradication therapy. The HpSA enzyme immunoassay was found to be a useful non-invasive method to confirm H. pylori eradication in children.

• The Korean Journal of Nuclear Medicine Technology
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• v.13 no.3
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• pp.189-192
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• 2009

Purpose: Autopipetting system is an efficient automated equipment pipetting patient samples and reagents for rapid and accurate test. However, it can cause carryover between high concentration sample and low concentration sample. We evaluated carryover contamination of TECAN freedom Evo 100 autopipetting system. Materials and Method: We studied carryover contamination of $\alpha$-fetoprotein (AFP) and carcinoembryonic antigen (CEA) test on TECAN freedom Evo 100 autopipetting system. Very low concentration control samples were pipetted for comparison to the contaminated very low concentration samples. Then, The contaminated very low concentration samples were pipetted following the high concentration samples were pipetted alternately. The difference of low concentration samples represents carryover. The target value to decide carryover was 1ppm (parts per million). Results: For AFP, the mean values of the uncontaminated control samples and the contaminated samples were less than 0.6 IU/mL (the l imit of detection (LoD)). Carryover did not occur even though the high concentration sample which value was 650000 IU/mL. For CEA, the values of the low concentration control samples and the contaminated samples were less than 0.2 ng/mL (LoD). Carryover did not occur even though the high concentration sample which value was 65,000 ng/mL. Conclusions: Sample carryover was not found on TECAN freedom Evo 100 autopipetting system for AFP, CEA. However, carryover is a potential problem with automated instruments and robotic pipetting systems. Therefore, Clinical laboratories must periodically verify carryover contamination for the accurate and confidential test results.