• 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.

• Laboratory Medicine Online
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• v.1 no.1
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• pp.26-34
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• 2011

Background: Laboratory diagnosis of new influenza A (H1N1) is crucial for managing patients and establishing control and prevention measures. We compared the diagnostic accuracies of the real time RT-PCR (rRT-PCR) test recommended for the confirmation of the new flu and the viral culture method used conventionally for viral disease with that of the rapid antigen test (RAT). Methods: We performed RAT, R-mix culture, and real-time PCR by using 861 respiratory samples collected from December 2009 to January 2010 and evaluated the abilities of these methods to detect new influenza A. The relationship among the positive rates of RAT, grades of culture, and the cycle threshold (Ct) values of rRT-PCR was also evaluated. Results: Of the 861 patients, 308 (35.8%) were diagnosed with new influenza A. The sensitivities, specificities, positive predictive values, and negative predictive values of the tests were respectively as follows: 59.7%, 99.5%, 98.4%, and 81.6% for RAT; 93.2%, 100%, 100%, and 96.3% for R-mix culture; and 95.8%, 100%, 100%, and 97.7% for rRT-PCR. Samples with weak positive grade in culture and those with Ct values of 30-37 in rRT-PCR showed positivities as low as 25.3% and 2.3% in RAT, respectively. The hospitalization rate and death rate of the confirmed patients were 3.2% and 0.3%, respectively, and gastrointestinal symptoms were observed in 7.2% of the patients. Conclusions: R-mix culture and rRT-PCR tests showed excellent reliability in the diagnosis of new influenza A and could be very useful, especially for samples with low viral load.

• Pediatric Infection and Vaccine
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• v.24 no.1
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• pp.31-36
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• 2017

Purpose: This study aimed to examine the accuracy of rapid influenza diagnostic tests (RIDT) in children with an influenza-like illness and to evaluate factors associated with greater accuracy. Methods: Pediatric patients, who visited Hallym University Sacred Heart Hospital with an influenza-like illness between June 2011 and May 2016, were enrolled in this study. We tested 798 samples using a real-time polymerase chain reaction (PCR) for respiratory viruses and compared the results with rapid influenza tests. Results: In comparison with the results of the multiplex PCR, the positive agreement rates of RIDT for influenza A and B virus were 75.7% and 60.0%, respectively. The performance of RIDT varied according to days after fever onset. The positive agreement rates of RIDT for influenza A and B tests, performed within 4 days of fever onset, were 77.6% and 73.2%, but the rates for tests performed more than 5 days after fever onset were 66.7% and 21.4%, respectively. Conclusions: The RIDT is a quick and simple aid to diagnosis, but is less sensitive than the labeled sensitivity. Moreover, test performance varied according to days after fever onset. Test specimens for RIDT should be collected as soon as possible after the onset of symptoms (less than 4 days).

• Clinical and Experimental Pediatrics
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• v.45 no.8
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• pp.973-979
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• 2002

Purpose : Recently, a number of rapid antigen detection tests have been available to diagnose group A streptococcal pharyngotonsillitis. The purpose of this study was to determine the sensitivity, specificity and consistency of the two rapid antigen detection tests. Methods : Among the patients who visited our clinic from November 2001 to February 2002, 61 patients who had clinical findings of pharyngeal erythema or edema, pharyngeal exudates and soft palatine petechiae were enrolled in our study. A total of 61 patients were tested with rapid antigen detection tests and throat culture. BD $LINK2^{TM}$ Strep A(Becton, Dickinson & Company, U.S.A.) and $QuickVue^{(R)}$ $In-Line^{TM}$(Quidel Corporation, U.S.A.) were selected for rapid antigen detection tests. Results : Of the 61 patients tested, 22 patients were confirmed as group A streptococcal pharyngotonsillitis by throat culture. The BD $LINK2^{TM}$ Strep A had a sensitivity of 81.8% and a specificity 89.7%. The positive and negative predictive values were 81.8% and 89.7%, respectively. The $QuickVue^{(R)}$ $In-Line^{TM}$ had a sensitivity of 77.3% and a specificity of 100%. The positive and negative predictive values were 100% and 88.6%, respectively. The kappa values of BD $LINK2^{TM}$ Strep A and $QuickVue^{(R)}$ $In-Line^{TM}$ were 0.72 and 0.81, respectively. Conclusion : In addition to high sensitivity, specificity and consistency, both kits are easy to use and simple to interpret, and therefore have the potential to be used with backup throat culture for diagnosis of acute pharyngotonsillitis.

• Clinical and Experimental Pediatrics
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• v.51 no.10
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• pp.1071-1076
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• 2008

Purpose : Respiratory syncytial virus (RSV) is the most frequent cause of lower respiratory infections in infants and young children. Early detection allows quarantining of infected inpatients to prevent nosocomial transmission and to choose a treatment. To achieve rapid reporting, to facilitate prompt antiviral therapy, and to avoid unnecessary use of antibiotics, an easy, rapid diagnostic method for RSV is needed. We evaluated a lateral flow immunochromatography (RSV Respi-Strip test) and EIA (Enzyme immuno assay) compared to RT-PCR. Methods : From April 2007 to March 2008, 112 consecutive respiratory specimens (nasopharyngeal aspirates, throat swabs, tracheal aspirates, sputum) from patients who were suffering from the clinical signs and symptoms of respiratory tract infection were enrolled in Busan. A total of 112 patients were tested with RSV Respi-Strip (Corio-BioConcept, Belgium), EIA, and RT-PCR at the same time. Results : Of the 112 specimens tested, the number of children who showed positive results at RT-PCR and Respi-Strip were 45 and 42, respectively. The Respi-Strip rapid antigen test had a sensitivity of 88% and a specificity of 94%. The positive and negative predictive values were 90% and 92%, respectively. The agreement was 83%. Conclusion : In our study, the rapid antigen test had as much sensitivity as any method for detection of RSV. The test has many advantages such as easy performance, simple interpretation, and rapid results. If the rapid antigen test is widely applied in the clinical setting, the may be useful for diagnostic and epidemiological studies of RSV infection.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.14 no.7
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• pp.3419-3424
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• 2013

Diverse immunoassays including a chemiluminescent immunoassay (CIA) are used to detect hepatitis B surface antigen (HBsAg) and antibody (anti-HBs). Recently, an increasing number of institutions have been utilizing an immunochromatography assay (ICA), which is easy to use. In this study, We evaluated ICA kits for the rapid detection of HBsAg and anti-HBs by comparing them with a CIA. A total of 120 serum hospital samples, were collected for the whole month, were assayed using ICA kit. The Concordance rate, sensitivity, specificity, positive predictive value and negative predictive value of the ICA for HBsAg based on CIA results were 97%, 97%, 100%, 100%, and 96.8%, respectively. The diagnostic performances of the ICA for Anti-HBs were 90%, 90%, 93.3%, 93.1%, and 90.3%, respectively. The ICA kit failed to detect HBsAg and anti-HBs in low reactive samples. The ICA kits for the rapid detection of HBsAg might be recommended for interpreted with caution and dual analysis in the clinical laboratory.

• Pediatric Infection and Vaccine
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• v.12 no.2
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• pp.124-134
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• 2005

Purpose : It has been known that the diagnostic confirmation of group A streptococcal pharyngitis is accompanied with the results of throat culture and/or rapid antigen detection test(RADT). This study was designed to evaluate the usefulness and cost benefits of the RADT in patients with a sore throat compared the empirical antibiotic treated group without using RADT or throat culture with the antibiotic treated group according to the results of RADT test and/or throat culture. Methods : From April 2003 to August 2003, total 369 patients were enrolled this study. They were redistributed into two groups. In one group, the RADT test and throat culture were used and the patients received antibiotic treatment according to the results of test and in the other group, no diagnostic examinations were used and the patients were treated with antibiotics which were chosen empirically. The flow sheet with questionnaire was drawing up and obtained the clinical symptoms, signs and the name of antibiotics that were administered. Results : A total of 244 patients were treated after the throat culture and/or RADT, and 125 patients were treated empirically. The prevalence of bacteriologically confirmed group A streptococcal pharyngitis was 20.1%. The sensitivity and specificity of RADT were 89.8% and 86.1%, respectively. Positive predictive value and negative predictive value were 62.0% and 97.1%, respectively. The rate of antibiotic use was high in both groups. Because the physician used the antibiotics even if the result of RADT was negative. So about 37% of reduction of antibiotics use might be possible if we used antibiotics according to the results of RADT. There were no cost differences between the RADT applied group and the empirically treated antibiotic group if we could reduce the price of RADT to 63% of the current price. Conclusion : The RADT could be applied for the easy and rapid diagnosis and prompt treatment for group A streptococcal pharyngitis, and RADT could reduced the number of antibiotics used if the price of RADT was reduced to 63% of current price. For accurate evaluation of efficacy and cost effect, further controlled study is needed.

• 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.

• Journal of the Korean Society of Visualization
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• v.13 no.1
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• pp.35-42
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• 2015

CD4+ T-cell count determines the effectiveness for antiretroviral therapy (ART) in patients with human immunodeficiency virus (HIV). Although ART slows the progression of HIV to AIDS, rapid counting of CD4+ T lymphocytes with a drop of patient's blood sample is urgently needed to ensure timely ART treatment in rural areas. Recently point-of-care CD4 testing devices have been developed by using non-flow based imaging cytometer incorporated with a sample cartridge where CD4+ T cells are reacted with fluorescently tagged specific antibodies. Here we conducted an experimental study using a conventional fluorescence microscope-based imaging system to quantitate the interaction of CD4 antibodies with CD4+ T cells at different reaction conditions. We demonstrated that a fast and affordable point-of-care CD4 test is feasible with a far less amount of antibodies and a shorter incubation time compared with a conventional sample preparation protocol for flow cytometry. We also proposed a general method to evaluate and compare the detection limit across different CD4 counting platforms by using fluorescently labelled microbeads for intensity calibration.

• Pediatric Infection and Vaccine
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• v.26 no.2
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• pp.81-88
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• 2019

Purpose: Early detection of Mycoplasma pneumoniae is important for appropriate antimicrobial therapy in children with pneumonia. This study aimed to evaluate the diagnostic value of a rapid antigen test kit in detecting M. pneumoniae from respiratory specimens in children with lower respiratory tract infection (LRTI). Methods: A total of 215 nasopharyngeal aspirates (NPAs) were selected from a pool of NPAs that had been obtained from children admitted for LRTI from August 2010 to August 2018. The specimens had been tested for M. pneumoniae by culture and stored at $-70^{\circ}C$ until use. Tests with Ribotest $Mycoplasma^{(R)}$ were performed and interpreted independently by two investigators who were blinded to the culture results. Results: Among the 215 NPAs, 119 were culture positive for M. pneumoniae and 96 were culture negative. Of the culture-positive specimens, 74 (62.2%) were positive for M. pneumoniae by Ribotest $Mycoplasma^{(R)}$, and 92 of the 96 (95.8%) culture-negative specimens were negative for M. pneumoniae by Ribotest $Mycoplasma^{(R)}$. When culture was used as the standard test, the sensitivity and specificity of Ribotest $Mycoplasma^{(R)}$ were 62.2% and 95.8%, respectively. Additionally, the positive predictive value, negative predictive value, and overall agreement rates with Ribotest $Mycoplasma^{(R)}$ were 94.9%, 67.2%, and 77.2%, respectively. Conclusions: A positive test result of Ribotest $Mycoplasma^{(R)}$ suggests a high likelihood of culture-positive M. pneumoniae infection. However, a negative test result should be interpreted with caution because nearly one-third of negative test results reveal culture-positive M. pneumoniae infections.