scholarly journals Prevalence of Immunoglobulin G (IgG) Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Evaluation of a Rapid MEDsan IgG Test in Children Seeking Medical Care

2020 ◽  
Author(s):  
Klara M Posfay-Barbe ◽  
Diego O Andrey ◽  
Julien Virzi ◽  
Patrick Cohen ◽  
Fiona Pigny ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Medical Care ◽  
Diagnostic Test ◽  
Rapid Diagnostic Test ◽  
Infection Rate ◽  
Immunoglobulin G ◽  
Gold Standard ◽  
Igg Antibodies ◽  
Rt Pcr ◽  
Seropositivity Rate

Abstract In 208 children seeking medical care, the seropositivity rate of anti–SARS-CoV-2 IgG antibodies was 8.7%, suggesting an infection rate similar to that observed in adults but >100-fold the incidence of RT-PCR–confirmed pediatric cases. Compared with the gold-standard combined ELISA + immunofluorescence, the MEDsan IgG rapid diagnostic test performed accurately.

scholarly journals Development and evaluation of a new IgM/IgG rapid diagnostic test for SARS-CoV-2

2020 ◽  
Author(s):  
P.J. Ducrest
Keyword(s):  
Diagnostic Test ◽  
Rapid Diagnostic Test ◽  
Gold Standard ◽  
Diagnostic Performance ◽  
Point Of Care ◽  
Negative Control ◽  
Simple Point ◽  
Rt Pcr ◽  
High Diagnostic Accuracy ◽  
Plasma Displays

AbstractThere is an urgent need in rapid diagnostic test (RDT) to detect antibodies against SARS-CoV-2. We have developed a rapid and simple point-of-care lateral flow immunoassay (LFIA) detecting IgM and IgG against SARS-CoV-2 in 10 minutes. The aim of this study is to evaluate the diagnostic performance of this RDT. RT-PCR positive plasma samples (n=35) for SARS-CoV-2 and 97 negative control samples were studied. Diagnostic performance of IgG/IgM RDT was assessed using both gold standard RT-PCR and Electro-chemiluminescence immunoassay (ECLIA) Elecsys® Anti-SARS-CoV-2 total Ig. Overall, RDT sensitivity was 100% (95% confidence interval [95%CI]: 88-100%) and specificity 93% (95% CI: 85-97%). This IgG/IgM RDT done in plasma displays a high diagnostic accuracy for SARS-CoV-2 IgG/IgM in high COVID-19 prevalence settings. Its use could be considered in the absence of routine diagnostic serology facilities for samples collected between 10 and 180 days after symptoms onset.

scholarly journals Performance evaluation of the Simtomax® CoronaCheck rapid diagnostic test

2020 ◽  
Author(s):  
P. J. Ducrest ◽  
A. Freymond ◽  
J.-M. Segura
Keyword(s):  
Diagnostic Test ◽  
Rapid Diagnostic Test ◽  
Diagnostic Performance ◽  
High Sensitivity ◽  
High Specificity ◽  
Negative Control ◽  
List Type ◽  
Plasma Samples ◽  
Rt Pcr ◽  
Two Samples

AbstractThe aim of this study was to evaluate the diagnostic performance of Simtomax® CoronaCheck, a serology rapid diagnostic test (RDT) for the detection of IgG and IgM against SARS-CoV-2. 48 plasma samples positive for SARS-CoV-2 based on RT-PCR and 98 negative control samples were studied. Diagnostic performance of the IgG/IgM RDT was assessed against RT-PCR and the electro-chemiluminescence immunoassay (ECLIA) Elecsys® Anti-SARS-CoV-2 total Ig. Overall, the RDT sensitivity was 92% (95% confidence interval [95%CI]: 79-97), specificity 97% (95% CI: 91-99%), PPV 94% (95% CI: 81-98) and the NPV 96% (95% CI: 89-99). When considering only samples collected ≥ 15 days post-symptoms (DPS), the sensitivity increased to 98% (95%CI: 86-100) and the specificity was 97% (95% CI: 91-99%). Two samples with 180 DPS were still positive for IgG. Globally, this IgG/IgM RDT displayed a high diagnostic accuracy for SARS-CoV-2 IgG/IgM detection in plasma samples in high COVID-19 prevalence settings. It could be effectively used, in absence of facilities for routine diagnostic serology, for samples with a DPS between 15 and 180 days.Highlights–The rapid diagnostic test Simtomax CoronaCheck displays a high sensitivity of 98% and a high specificity of 97% for SARS-CoV-2 IgG/IgM detection in plasma samples after 15 days post-symptoms.–The rapid diagnostic test Simtomax CoronaCheck can detect SARS-CoV-2 antibodies in plasma up to 180 days after symptom onset.–The rapid diagnostic test Simtomax CoronaCheck could be effectively used as an alternative to serological analysis using laboratory facilities.

scholarly journals Seroprevalence of Severe Acute Respiratory Syndrome-Coronavirus-2 Immunoglobulin M and Immunoglobulin G Antibodies among the Population of Koya University

2021 ◽  
Vol 9 (2) ◽  
pp. 51-57
Author(s):  
Safia S. I. Blbas ◽  
Hiwa A. Ahmad ◽  
Dawan J. Hawezy ◽  
Hemn Shawgery ◽  
Hersh N. Bahadin
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Infection Rate ◽  
Immunoglobulin G ◽  
Prevalence Rate ◽  
Complete Blood Count ◽  
Immunoglobulin M ◽  
Teaching Staff ◽  
Serological Detection ◽  
Population Total ◽  
Elisa Technique

Coronavirus is a pandemic disease. In most cases, the exact infection rate cannot be determined as not everybody can be tested for the virus, even though some of them carry the virus silently. Therefore, detection of antibodies of this virus is more practical to give us a better clue about the rate of infection because the asymptomatic people can be tested too. The serological detection of anti-Severe Acute Respiratory Syndrome-Coronavirus (SARS-COV-2) antibodies among asymptomatic and moderate symptomatic individuals gives us the vital point to understanding the prevalence rate of COVID-19 among the population. Total of (436) volunteers were participated, (96) from teaching staff, (172) employee, and (168) students. Anti-SARS-COV-2 immunoglobulin G (IgG) and Immunoglobulin M (IgM) were detected in the serum by ELISA technique, and complete blood count was performed for all participants. The number of seropositive of anti-SARS-COV-2/IgG was (159), whereas IgM was (66). The highest prevalence rate of IgG detected among participants with family member infected with coronavirus (42.7%). Total WBCs count significantly increased among IgM positive participants. Many asymptomatic people were infected with coronavirus, which lead to more spreading of the virus among the population. Therefore, mass screening of the population for specific antibody against coronavirus is important to reduce the infection rate.

scholarly journals Performance of Commercially Available Rapid Serological Assays for the Detection of SARS-CoV-2 Antibodies

Pathogens ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. 1067
Author(s):  
Anwar M. Hashem ◽  
Rowa Y. Alhabbab ◽  
Abdullah Algaissi ◽  
Mohamed A. Alfaleh ◽  
Sharif Hala ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Significant Variation ◽  
High Specificity ◽  
Lateral Flow ◽  
Igg Antibodies ◽  
Rt Pcr ◽  
Standard Methods ◽  
Specific Antibodies ◽  
Time Points

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several rapid commercial serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2-specific antibodies in COVID-19 patient samples. Here, we have evaluated the performance of seven commercially available rapid lateral flow immunoassays (LFIA) obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2-specific IgM and IgG antibodies in RT-PCR-confirmed COVID-19 patients. While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays, which ranged from 0% to 54% for samples collected early during infection (3–7 days post symptoms onset) and from 54% to 88% for samples collected at later time points during infection (8–27 days post symptoms onset). Therefore, we recommend prior evaluation and validation of these assays before being routinely used to detect IgM and IgG in COVID-19 patients. Moreover, our findings suggest the use of LFIA assays in combination with other standard methods, and not as an alternative.

scholarly journals Performance Evaluation of Commercial Dengue Diagnostic Tests for Early Detection of Dengue in Clinical Samples

2017 ◽  
Vol 2017 ◽  
pp. 1-4 ◽  
Author(s):  
Tuan Nur Akmalina Mat Jusoh ◽  
Rafidah Hanim Shueb
Keyword(s):  
Dengue Virus ◽  
Real Time ◽  
Diagnostic Test ◽  
Rapid Diagnostic Test ◽  
Dengue Infection ◽  
Clinical Samples ◽  
Enzyme Linked Immunosorbent Assay ◽  
Rt Pcr ◽  
Serum Samples ◽  
Kappa Agreement

The shattering rise in dengue virus infections globally has created a need for an accurate and validated rapid diagnostic test for this virus. Rapid diagnostic test (RDT) and reverse transcription-polymerase chain reaction (RT-PCR) diagnostic detection are useful tools for diagnosis of early dengue infection. We prospectively evaluated the diagnostic performance of nonstructural 1 (NS1) RDT and real-time RT-PCR diagnostic kits in 86 patient serum samples. Thirty-six samples were positive for dengue NS1 antigen while the remaining 50 were negative when tested with enzyme-linked immunosorbent assay (ELISA). Commercially available RDTs for NS1 detection, RTK ProDetect™, and SD Bioline showed high sensitivity of 94% and 89%, respectively, compared with ELISA. GenoAmp® Trioplex Real-Time RT-PCR and RealStar® Dengue RT-PCR tests presented a comparable kappa agreement with 0.722. The result obtained from GenoAmp® Real-Time RT-PCR Dengue test showed that 14 samples harbored dengue virus type 1 (DENV-1), 8 samples harbored DENV-2, 2 samples harbored DENV-3, and 1 sample harbored DENV-4. 1 sample had a double infection with DENV-1 and DENV-2. The NS1 RDTs and real-time RT-PCR tests were found to be a useful diagnostic for early and rapid diagnosis of acute dengue and an excellent surveillance tool in our battle against dengue.

scholarly journals Antibody response and viraemia during the course of severe acute respiratory syndrome (SARS)-associated coronavirus infection

2004 ◽  
Vol 53 (5) ◽  
pp. 435-438 ◽  
Author(s):  
Weijun Chen ◽  
Zuyuan Xu ◽  
Jingsong Mu ◽  
Ling Yang ◽  
Haixue Gan ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Antibody Response ◽  
Time Course ◽  
Recovery Phase ◽  
Antibody Responses ◽  
Igg Antibodies ◽  
Rt Pcr ◽  
Blood Samples ◽  
Convalescent Phase ◽  
Coronavirus Infection

To understand the time-course of viraemia and antibody responses to severe acute respiratory syndrome-associated coronavirus (SARS-CoV), RT-PCR and ELISA were used to assay 376 blood samples from 135 SARS patients at various stages of the illness, including samples from patients who were in their early convalescent phase. The results showed that IgM antibodies decreased and became undetectable 11 weeks into the recovery phase. IgG antibodies, however, remained detectable for a period beyond 11 weeks and were found in 100 % of patients in the early convalescent phase. SARS-CoV viraemia mainly appeared 1 week after the onset of illness and then decreased over a period of 1 month, becoming undetectable in the blood samples of the convalescent patients. At the peak of viraemia, viral RNA was detectable in 75 % of blood samples from patients who were clinically diagnosed with SARS 1 or 2 weeks before the test.

scholarly journals The Use of Latent Class Analysis to Estimate the Sensitivities and Specificities of Diagnostic Tests for Squash vein yellowing virus in Cucurbit Species When There Is No Gold Standard

2013 ◽  
Vol 103 (12) ◽  
pp. 1243-1251 ◽  
Author(s):  
William W. Turechek ◽  
Craig G. Webster ◽  
Jingyi Duan ◽  
Pamela D. Roberts ◽  
Chandrasekar S. Kousik ◽  
...  
Keyword(s):  
Latent Class Analysis ◽  
Diagnostic Test ◽  
Test Performance ◽  
Gold Standard ◽  
Diagnostic Tests ◽  
Latent Class ◽  
Visual Assessment ◽  
Class Analysis ◽  
Rt Pcr ◽  
Yellowing Virus

Squash vein yellowing virus (SqVYV) is the causal agent of viral watermelon vine decline, one of the most serious diseases in watermelon (Citrullus lanatus L.) production in the southeastern United States. At present, there is not a gold standard diagnostic test for determining the true status of SqVYV infection in plants. Current diagnostic methods for identification of SqVYV-infected plants or tissues are based on the reverse-transcription polymerase chain reaction (RT-PCR), tissue blot nucleic acid hybridization assays (TB), and expression of visual symptoms. A quantitative assessment of the performance of these diagnostic tests is lacking, which may lead to an incorrect interpretation of results. In this study, latent class analysis (LCA) was used to estimate the sensitivities and specificities of RT-PCR, TB, and visual assessment of symptoms as diagnostic tests for SqVYV. The LCA model assumes that the observed diagnostic test responses are linked to an underlying latent (nonobserved) disease status of the population, and can be used to estimate sensitivity and specificity of the individual tests, as well as to derive an estimate of the incidence of disease when a gold standard test does not exist. LCA can also be expanded to evaluate the effect of factors and was done here to determine whether diagnostic test performances varied among the type of plant tissue being tested (crown versus vine tissue), where plant samples were taken relative to the position of the crown (i.e., distance from the crown), host (i.e., genus), and habitat (field-grown versus greenhouse-grown plants). Results showed that RT-PCR had the highest sensitivity (0.94) and specificity (0.98) of the three tests. TB had better sensitivity than symptoms for detection of SqVYV infection (0.70 versus 0.32), while the visual assessment of symptoms was more specific than TB and, thus, a better indicator of noninfection (0.98 versus 0.65). With respect to the grouping variables, RT-PCR and TB had better sensitivity but poorer specificity for diagnosing SqVYV infection in crown tissue than it did in vine tissue, whereas symptoms had very poor sensitivity but excellent specificity in both tissues for all cucurbits analyzed in this study. Test performance also varied with habitat and genus but not with distance from the crown. The results given here provide quantitative measurements of test performance for a range of conditions and provide the information needed to interpret test results when tests are used in parallel or serial combination for a diagnosis.

scholarly journals Performance comparison of two malaria rapid diagnostic test with real time polymerase chain reaction and gold standard of microscopy detection method

2020 ◽  
Author(s):  
Puspa Wardhani ◽  
Trieva Verawaty Butarbutar ◽  
Christophorus Oetama Adiatmaja ◽  
Amarensi Milka Betaubun ◽  
Nur Hamidah ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Real Time ◽  
Diagnostic Test ◽  
Real Time Pcr ◽  
Predictive Value ◽  
Gold Standard ◽  
Detection Method ◽  
Rt Pcr ◽  
Chain Reaction ◽  
Polymerase Chain

Background: The diagnostic test for malaria is mostly based on Rapid Diagnostic Test (RDT) and detection by microscopy. Polymerase Chain Reaction (PCR) is also a sensitive detection method that can be considered as a diagnostic tool. The outcome of malaria microscopy detection depends on the examiner's ability and experience. Some RDT has been distributed in Indonesia, which needs to be evaluated for their results. Objective: This study aimed to compare the performance of RightSign RDT and ScreenPlus RDT for detection of Plasmodium in human blood. We used specific real-time polymerase chain reaction abTESTMMalaria qPCRII) and gold standard of microscopy detection method to measure diagnostic efficiency. Methods: Blood specimens were evaluated using RightSign RDT, ScreenPlus RDT, Microscopy detection, and RT-PCR as the protocol described. The differences on specificity (Sp), sensitivity (Sn), positive predictive value (PPV), and negative predictive value (NPV) were analyzed using McNemar and Kruskal Wallis analysis. Results: A total of 105 subjects were recruited. Based on microscopy test, RightSign RDT had sensitivity, Specificity, PPV, NPV, 100%, 98%, 98.2%, 100%, respectively. ScreenPlus showed 100% sensitivity, 98% specificity, 98.2% PPV, 100% NPV. The sensitivity of both RDTs became lower (75%) and the specificity higher (100 %) when using real-time PCR. Both RDTs showed a 100% agreement. RT-PCR detected higher mix infection when compared to microscopy and RDTs. Conclusion: RightSign and ScreenPlus RDT have excellent performance when using microscopy detection as a gold standard. Real-time PCR method can be considered as a confirmation tool for malaria diagnosis.

scholarly journals Comparative Study of Malaria Diagnosis: Rapid Diagnostic Test (RDTs) Against Microscopy among Pregnant Women Attending Antenatal Clinic in Specialist Hospital, Sokoto

2021 ◽  
pp. 9-16
Author(s):  
K. Mohammed ◽  
M. U. Iduh ◽  
S. M. Saheed ◽  
O. F. Ashcroft ◽  
M. K. Garba ◽  
...  
Keyword(s):  
Comparative Study ◽  
Pregnant Women ◽  
Diagnostic Test ◽  
Rapid Diagnostic Test ◽  
Study Design ◽  
Gold Standard ◽  
Malaria Parasite ◽  
Malaria Diagnosis ◽  
Sub Saharan Africa ◽  
Cross Sectional

Background: Malaria is an infectious disease caused by a protozoan parasite of the genus Plasmodium. It was estimated that 219 million cases of malaria occur in 87 countries, with an estimated death of 435,000 in 2017 among pregnant women. Other species include P. ovale, P. vivax, and P. malariae is a blood parasite of human and is one of the major public health burdens in developing countries, particularly in Sub-Saharan Africa. It is estimated that about 3.5 billion people globally and 450 million people are thought to be ill as a result of such infections, the majority being children. Aims: This study was aimed at comparing RDTs against microscopy in the detection of malaria parasite among pregnant women. Samples were collected and analyzed following cross-sectional comparative study design. It was conducted between Septembers to November 2019. Study Design: This was a cross-sectional, comparative study Place and Duration of Study: This study was conducted among patients attending Specialist Hospital Sokoto, Sokoto State, between March and November, 2019. Methodology: A total of 106 participants were enrolled for the study. Standard parasitological examination was carried out on blood samples using microscopy followed by Rapid Diagnostic test (RDTs). Results: Finding revealed, in this study, CareStart kit had sensitivity of 77.7%, specificity of 100s%. It is expected that any RDT used for malaria diagnosis should have a high sensitivity of 95% and specificity 97% (WHO, 2003); this is in contrast with the RDTs results in this study. The false negative (FN) Carestart and SD-Bioline kits in this study were 10% and 21%, respectively using microscopy as the gold standard due to lack of sensitivity of RDTs at low parsitaemia compared to microscopy. The false positive rate in this study for the Carestart and SD-Bioline kits are 0% and 0% respectively. Out of 106 patients screened, 35% and 24% tested positive for Plasmodiumfalciparum using Carestart and SD-Bioline RDTs respectively, while 45% were positive to malaria by microscopic examination. There was high prevalence of malaria parasite among age group 18-23 which is 42.2%. Conclusion: It can be concluded that using microscopy is more time consuming compared to RDTs due to the fact that the time taken to read the results for RDTs is within five minutes and that of microscopy is higher compared to RDTs. Over all prevalence of malaria by microscopy was 42.5% while the prevalence of malaria by Carestart and SD-bioline was 33% and 22.6% respectively. Conventional microscopy remains the gold standard compared to RDTs according to this study with the level of its sensitivity and specificity which is higher than RDTs.

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