• Title/Summary/Keyword: Rapid diagnostic kit

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Development of COVID-19 Neutralizing Antibody (NAb) Detection Kits Using the S1 RBD Protein of SARS-CoV-2 (코로나 바이러스 감염증-19의 재조합 S1 RBD 단백질을 이용한 COVID-19 바이러스의 중화항체 검사 키트의 개발)

  • Choi, Dong Ok;Lee, Kang Moon
    • Korean Journal of Clinical Laboratory Science
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    • v.53 no.3
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    • pp.257-265
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    • 2021
  • The COVID-19 virus is a β-genus virus that causes infection by mediating the angiotensin convertible enzyme 2 (ACE2) receptor, which is distributed in large numbers in the human respiratory tract. The disease requires effective post-management of antibody production by complete healers and vaccinators because there is no perfect remedy for the virus infection. This study aimed to develop recombinant proteins specifically responsive to neutralizing antibodies in clinical specimens and use them to develop a rapid diagnostic kit to diagnose neutralizing antibodies quickly and conveniently against the COVID-19 virus and confirm the possibility of commercialization through a performance evaluation. Rapid diagnostic kits using COVID-19 S1 RBD recombinant proteins can be applied to rapid diagnostic kits, with positive percentage agreement (PPA) and negative percentage agreement (NPA) of 100% and 98.3%, respectively, compared to the U.S. FDA-approved ELISA kits. If the performance of the rapid diagnostic kit is improved and neutralizing antibodies can be analyzed quantitatively using quantitative analysis equipment, it can be used as important data to predict immunity to the COVID-19 virus and determine additional vaccinations.

Malaria Endemicity in the Rural Communities of Ebonyi State, Nigeria

  • Nwele, David Ekene;Onyali, Ikechukwu Oliver;Iwueze, Milliam Okwudili;Elom, Michael Okpara;Uguru, Ogbonna Elom Sabastian
    • Parasites, Hosts and Diseases
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    • v.60 no.3
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    • pp.173-179
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    • 2022
  • Malaria remains a global health threat. Approximately 97% of the population is at risk in sub-Saharan countries, particularly Nigeria. This study compared the performance of 2 diagnostic methods in assessing malaria endemicity in the rural communities of Ebonyi State, Nigeria. A total of 1,140 study participants were screened for malaria parasite using Rapid Diagnostic Test kits (RDT) in the field, while thick and thin films for microscopy were examined in the laboratory. Our result showed that malaria prevalence was 56.8 by RDT and 38.6% by microscopic test. Age group under 10 years had the highest prevalence of 28.9% (RDT) and 23.6% (microscopy), respectively. The highest prevalence of 19.5% by RDT was recorded in Onicha Local Government Area, while the highest prevalence of 13.4% with microscopy was recorded in Ezza North Local Government Area. The sensitivity and specificity of microscopic examination were both 100%, while those of RDT were 95.5% and 75.9%, respectively.

Ebola Hemorrhagic Fever Outbreaks: Diagnosis for Effective Epidemic Disease Management and Control (에볼라 출혈열 발병 : 효과적인 전염병 관리 및 통제를 위한 진단)

  • Kang, Boram;Kim, Hyojin;Macoy, Donah Mary;Kim, Min Gab
    • Microbiology and Biotechnology Letters
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    • v.45 no.2
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    • pp.87-92
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    • 2017
  • The first Ebola hemorrhagic fever outbreak occurred in the Democratic Republic of Congo and Sudan in 1976 and then emerged in West Africa in 2014 with a total of 27,741 cases and 11,284 deaths. The fever is caused by the Ebola virus, which belongs to the Filoviridae family and contains a ssRNA genome. The known subtypes of the virus are Bundibugyo ebolavirus, Reston ebolavirus, Sudan ebolavirus, $Ta\ddot{i}$ Forest ebolavirus, and Zaire ebolavirus. The Ebola outbreak was historically originated majorly from the East and Central African tropical belt. The current outbreaks in West Africa caused numerous deaths and spread fear in global society. In the absence of effective treatment strategies and any vaccine, accurate diagnosis is the most important contributing factor in the management and control of the epidemic disease. WHO (World Health Organization) has announced emergency guidance for the selection and use of Ebola in in vitro diagnostic assays. Numerous companies and research institutions have studied the various diagnosis methods and identified four WHO procurement approved as diagnosis kits: RealStar Ebolavirus Screen RT-PCR kit 1.0 (Altona), Liferiver-Ebola Virus (EBOV) Real time RT-PCR kit, Xpert Ebola Assay, and ReEBOV Antigen Rapid Test Kit. The efficiency of novel diagnostic kits such as Rapid Diagnosis Test (RDT) is currently being evaluated.

Analysis of prevalence and risk factors of calf diarrhea using rapid diagnosis kit (신속 진단 킷트를 활용한 송아지 설사병의 유병률과 위험요인 분석)

  • Taemook Park;Gil Jae Cho;Young Jin Yang;Il-Sun Ryu
    • Korean Journal of Veterinary Service
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    • v.46 no.1
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    • pp.47-58
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    • 2023
  • Between February 2020 and September 2021, 378 calves with diarrhea were investigated across 96 cattle breeding farms in Korea, using a rapid diagnostic kit. The study examined the infection rates of major pathogens causing diarrhea in calves, which were categorized by season, age, birth month, and region. Additionally, logistic regression analysis was conducted to investigate the factors affecting the infection rate. The study found that the five representative pathogens causing calf diarrhea exhibited differences in infection rates based on season, region, age, and birth month. Bovine rotavirus, bovine coronavirus, Cryptosporidium, and Giardia commonly exhibited varying risks of infection based on season and age. Furthermore, in addition to these risk factors, bovine rotavirus and Cryptosporidium were found to impact the infection risk of each pathogen by region, while Giardia was found to be affected by birth month.

A Rapid Diagnostic Test for Toxoplasmosis using Recombinant Antigenic N-terminal Half of SAG1 Linked with Intrinsically Unstructured Domain of GRA2 Protein

  • Song, Kyoung Ju;Yang, Zhaoshou;Chong, Chom-Kyu;Kim, Jin-Soo;Lee, Kyung Chan;Kim, Tong-Soo;Nam, Ho-Woo
    • Parasites, Hosts and Diseases
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    • v.51 no.5
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    • pp.503-510
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    • 2013
  • Toxoplasma gondii is an apicomplexan parasite with a broad host range of most warm-blooded mammals including humans, of which one-thirds of the human population has been infected worldwide which can cause congenital defects, abortion, and neonatal complications. Here, we developed a rapid diagnostic test (RDT) for T. gondii infection. Antigenic N-terminal half of the major surface antigen (SAG1) was linked with intrinsically unstructured domain (IUD) of dense granule protein 2 (GRA2). The recombinant GST-GRA2-SAG1A protein was successfully expressed and purified as 51 kDa of molecular weight. Furthermore, antigenicity and solubility of the rGST-GRA2-SAG1A protein were significantly increased. The overall specificity and sensitivity of GST-GRA2-SAG1A loaded RDT (TgRDT) were estimated as 100% and 97.1% by comparing with ELISA result which uses T. gondii whole cell lysates as the antigen. The TgRDT tested with Uganda people sera for field trial and showed 31.9% of seroprevalence against T. gondii antibody. The TgRDT is proved to be a kit for rapid and easy to use with high accuracy, which would be a suitable serodiagnostic tool for toxoplasmosis.

Evaluation of a rapid diagnostic kit "BIOLINE RSVTM" for the detection of respiratory syncytial virus (Respiratory Syncytial Virus 감염의 조기 진단 kit "바이오라인 알에스브이TM"의 평가)

  • Kim, So-Hee;Sung, Ji-Yeon;Yang, Mi-Ae;Eun, Byung-Wook;Lee, Jin-A;Choi, Eun-Hwa;Lee, Hoan-Jong
    • 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.

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Clinical assessment of periodontitis in dogs using the MiriChekTM Oral Bacter test kit: An in vivo study (MiriChekTM Oral Bacter test kit를 활용한 개 치주염의 임상적 평가)

  • Choi, Hyuck;Roh, Jae-Hee;Kim, Yun-Jeong;Hwang, In-Soo;Park, Woo-Dae;Kim, Min-Seok;Jeong, Young-Eui
    • Journal of Korean society of Dental Hygiene
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    • v.21 no.4
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    • pp.337-348
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    • 2021
  • Objectives: To determine the usefulness of MiriChekTM Oral Bacter as compared to traditional clinical methods in the periodontal assessment of dogs with and without periodontitis. Methods: In this study, 61 dogs were clinically examined using the MiriChekTM Oral Bacter test kit, and information regarding breed, age (months), sex, weight, presence of disease, and periodontitis stage was recorded. The test used a sample of supragingival plaque from the upper left premolar of the dogs. Results: This study included 30 and 31 dogs with and without periodontitis, respectively. Periodontitis was more common in older dogs than in younger dogs. The average positive and negative sensitivity rates of the MiriChekTM Oral Bacter test kit were 73.3% and 80.7%, respectively, and were both strongly correlated with the severity of periodontitis. Conclusions: The findings of this study encourage the use of new diagnostic assist test kits, such as MiriChekTM Oral Bacter, for appropriately detecting and diagnosing periodontal disease in dogs.

Clinical Evaluation of a Rapid Diagnostic Test Kit for Canine Parvovirus and Coronavirus (개 파보바이러스와 코로나바이러스 진단을 위한 신속진단키트의 임상적 유용성)

  • Chaeyeong MIN;Won-Shik KIM;Chom-Kyu CHONG;Yong LIM
    • 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.

Comparison of the non-invasive diagnostic methods, stool antigen test and PCR assay, for Helicobacter felis detection in dogs

  • Hong, Sunhwa;Lee, Hak-Yong;Kim, Tae-Wan;Kim, Okjin
    • Korean Journal of Veterinary Service
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    • v.38 no.1
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    • pp.37-42
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    • 2015
  • The aim of the present study was to compare the non-invasive methods for the diagnosis of H. felis with HpSA kit-based detection method and H. felis-specific PCR assay with dog's stool samples without sacrifice. Male Beagle dogs (n=6) were infected with H. felis ATCC 49179 ($1.0{\times}10^9CFU/dog$) by intra-gastric inoculation two times at 3-day intervals, and the stool specimens of dogs were collected 1, 3, 5, 7, 14, 21 days after infection to submit to HpSA test and H. felis-specific PCR. As the results, the sensitivity of the HpSA and the PCR analysis was 50.0%, 83.3% respectively. Although HpSA test is less sensitive, it could be used for rapid, cheap and easy screening assay for H. felis infection in dog and cats. We suggest that the H. pylori stool antigen kit, HpSA, is useful and effective for monitoring H. felis infection. If HpSA test would be made with H. felis antibodies in the future, its sensitivity could be increased. Also, PCR assay could be successfully used to detect the H. felis in stools. Applying the H. pylori stool antigen kit and PCR assay may be the recommended non-invasive strategy to identify H. felis in dog and cats.

Rapid Determining for Subtypes and Pandemic Type of Swine Influenza Virus by Diagnostic One-step RT-PCR (진단용 one-step RT-PCR을 통한 돼지 인플루엔자 바이러스의 아형 및 pandemic 유형에 대 한 신속한 결정)

  • Kim, Gwang Il;Kim, Jee In;Kwon, Jin-Hyeap;Min, Yoo Hong;Kang, Joo Il;Lee, Chang-Ho;Kim, Sung-Hee;Lim, Jae-Hwan
    • Journal of Life Science
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    • v.28 no.5
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    • pp.555-562
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    • 2018
  • Swine influenza virus (SIV) causes one of the most common diseases of the pig population, and its subtypes are determined by hemagglutinin (HA) and neuraminidase (NA). Recently, the SIV subtype diagnosis has been developed. The method using antigen-antibody reaction rather than PCR was mainly used because of the large change in the ribonucleotide sequences of SIV. Here, we have developed 10 diagnostic primer sets through multi-nucleotide sequences alignment of spreaded SIV since 2008 in Korea and then optimized the reaction of the one-step RT-PCR for rapid determination of SIV subtype. In addition, specific primers were designed to early determine the pandemic SIV by detecting unique M sequences proven in highly infectious and virulent subtypes of the influenza H1N1 (pH1N1). Here, some of the SIVs spread in Korea from 2008 to 2014 have been tested to determine the subtypes and pandemic potential of SIV. All diagnostic primer sets were found to be able to accurately determine the SIV subtype and to detect the pandemic SIV. In conclusion, it was confirmed that the optimized one-step RT-PCR analysis using these primer sets is useful for rapid diagnosis of SIV subtypes. These results can be used for development of SIV subtype diagnostic kit to early detect before virulent SIV spreads do.