scholarly journals Evaluation of a Rapid Immunochromatographic test kit to the Gold Standard Fluorescent Antibody test for diagnosis of rabies in animals in Bhutan

2019 ◽  
Author(s):  
Tenzin Tenzin ◽  
Kelzang Lhamo ◽  
Purna B Rai ◽  
Dawa Tshering ◽  
Pema Gyamtsho ◽  
...  
Keyword(s):  
Gold Standard ◽  
Fluorescent Antibody ◽  
False Negative ◽  
Rapid Test ◽  
Antibody Test ◽  
Perfect Agreement ◽  
Tissue Samples ◽  
Test Kit ◽  
Resource Poor ◽  
Test Result

Abstract Background: Rabies kills approximately 59,000 people in the world each year worldwide. Rapid and accurate diagnosis of rabies is important for instituting rapid containment measures and for advising the exposed people for postexposure treatment. The application of a rapid diagnostic tests in the field can greatly enhance disease surveillance activities, especially in resource poor settings.Methods: From 2012 to 2017, a total of 179 brain tissue samples collected from different animal species (113 dogs, 50 cattle, 10 cats, 3 goats, 2 horses, and 1 bear) suspected of having died due to rabies were selected and tested using the rapid immunochromatographic kit from BioNote© company and compared to the Gold Standard Fluorescent Antibody test (FAT) for diagnosis of rabies.Results: Among 179 samples examined in this study, there was concordance in results by the rapid test and FAT in 115 positive samples and 54 negative samples. Test result were discordant in 10 samples which were positive by FAT, but negative (false negative) by rapid kit. The rapid test kit showed a sensitivity of 92% (95% CI: 85.9 – 95.6) and specificity of 100% (95% CI: 93.4 – 100) using FAT as the gold standard. The positive and negative predicative values were found to be 100% (95% CI:96.7 – 100) and 84% (95% CI: 73.6 – 91.3), respectively. Overall there was 94.41% (95% CI: 90 – 96.9) test agreement (almost perfect agreement) between rapid test and FAT (Kappa value = 0.874).Conclusions: Our results demonstrate the potential value of the rapid test kit for countries with limited diagnostic resources, including Bhutan. The rapid kit’s inability to correctly detect 10 FAT-positive samples (10 out of 179 (5.6%) were false negatives) in our study could have been due to the low viral load in the samples (< 102.0LD50/0.03ml) which could not be detected by the rapid kit as compared with the FAT. The human factor related to the varying experiences of the technicians who performed the test in the field also may have influenced the test result. The rapid test kit is inexpensive, rapid and easy to use in the field or in laboratory setting without the need for special training and can support to enhance rabies surveillance in resource poor countries.

Evaluation of a Rapid Immunochromatographic test kit to the Gold Standard Fluorescent Antibody test for diagnosis of rabies in animals in Bhutan 

2020 ◽  
Author(s):  
Tenzin Tenzin ◽  
Kelzang Lhamo ◽  
Purna B Rai ◽  
Dawa Tshering ◽  
Pema Jamtsho ◽  
...  
Keyword(s):  
Predictive Value ◽  
Fluorescent Antibody ◽  
False Negative ◽  
Rapid Test ◽  
Antibody Test ◽  
Reference Standard ◽  
Predictive Values ◽  
Percent Agreement ◽  
Test Kit ◽  
Resource Poor

Abstract Background: Rabies kills approximately 59,000 people in the world each year worldwide. Rapid and accurate diagnosis of rabies is important for instituting rapid containment measures and for advising the exposed people for postexposure treatment. The application of a rapid diagnostic tests in the field can greatly enhance disease surveillance and diagnostic activities, especially in resource poor settings. In this study, a total of 179 brain tissue samples collected from different rabies suspect animal species (113 dogs, 50 cattle, 10 cats, 3 goats, 2 horses, and 1 bear) were selected and tested using both rapid immunochromatographic kit and the reference standard fluorescent antibody test (FAT). We evaluated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of a rapid antigen detection test kit produced by BioNote, Inc. (Hwaseong-si, Korea) relative to a FAT for its fit-for-purpose for confirmation of clinical cases of rabies for early response and enhancing rabies surveillance. Results: Among 179 samples examined in this study, there was a concordance in results by the rapid test and FAT in 115 positive samples and 54 negative samples. Test results were discordant in 10 samples which were positive by FAT, but negative (false negative) by rapid kit. The rapid test kit showed a sensitivity of 92% (95% CI: 85.9 – 95.6) and specificity of 100% (95% CI: 93.4 – 100) using FAT as the reference standard. The positive and negative predictive values were found to be 100% (95% CI:96.7 – 100) and 84.4% (95% CI: 73.6 – 91.3), respectively. Overall, there was 94.4% (95% CI: 90 – 96.9) test agreement between rapid test and FAT (Kappa value = 0.874) with a positive percent agreement and negative percent agreement of 92 and 100%, respectively. Conclusions: Our finding demonstrated that the rapid test kit (BioNote) can be used for rabies surveillance and confirming clinical case of rabies in animals for making rapid decisions particularly controlling rabies outbreaks in resource poor settings.

scholarly journals Evaluation of a Rapid Immunochromatographic test kit to the Gold Standard Fluorescent Antibody Test for Diagnosis of Rabies in Animals in Bhutan

2020 ◽  
Author(s):  
Tenzin Tenzin ◽  
Kelzang Lhamo ◽  
Purna B Rai ◽  
Dawa Tshering ◽  
Pema Gyamtsho ◽  
...  
Keyword(s):  
Predictive Value ◽  
Fluorescent Antibody ◽  
Rapid Test ◽  
Antibody Test ◽  
Immunochromatographic Test ◽  
Reference Standard ◽  
Predictive Values ◽  
Percent Agreement ◽  
Test Kit ◽  
Resource Poor

Abstract Background Rabies kills approximately 59,000 people in the world each year worldwide. Rapid and accurate diagnosis of rabies is important for instituting rapid containment measures and for advising the exposed people for postexposure treatment. The application of a rapid diagnostic tests in the field can greatly enhance disease surveillance and diagnostic activities, especially in resource poor settings. A total of 179 brain tissue samples collected from different rabies suspect animal species (113 dogs, 50 cattle, 10 cats, 3 goats, 2 horses, and 1 bear) were selected and tested using both rapid immunochromatographic kit and the reference standard fluorescent antibody test (FAT). We evaluated the test sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of a rapid antigen detection test kit produced by BioNote, Inc. (Hwaseong-si, Korea) to a FAT for its fit-for-purpose for confirmation of clinical cases of rabies for early response, prevalence of infection (rabies surveillance), freedom for infection and eradication of rabies. ResultsAmong 179 samples examined in this study, there was a concordance in results by the rapid test and FAT in 115 positive samples and 54 negative samples. Test results were discordant in 10 samples which were positive by FAT, but negative (false negative) by rapid kit. The rapid test kit showed a sensitivity of 92% (95% CI: 85.9 – 95.6) and specificity of 100% (95% CI: 93.4 – 100) using FAT as the reference standard. The positive and negative predictive values were found to be 100% (95% CI:96.7 – 100) and 84.4% (95% CI: 73.6 – 91.3), respectively. Overall there was 94.4% (95% CI: 90 – 96.9) test agreement between rapid test and FAT (Kappa value = 0.874) with a positive percent agreement and negative percent agreement of 92 and 100%, respectively.Conclusions Our finding demonstrated that the rapid test kit (BioNote) can be used for confirming clinical case of rabies in animals for making rapid decisions including early medical intervention in human exposure and controlling rabies outbreaks in resource poor settings. Keywords: rabies virus; diagnostic test; fluorescent antibody test; rapid anigen test; rapid immunochromatographic test; Bhutan

scholarly journals A Targeted Survey for Scrapie in Jos Plateau State, Nigeria

2013 ◽  
Vol 2013 ◽  
pp. 1-5
Author(s):  
O. O. Nwankiti ◽  
E. I. Ikeh ◽  
O. A. Arowolo ◽  
A. J. Nwankiti ◽  
M. O. Odugbo ◽  
...  
Keyword(s):  
Fluorescent Antibody ◽  
Fatal Outcome ◽  
Small Ruminants ◽  
Rapid Test ◽  
Antibody Test ◽  
Economic Losses ◽  
Sheep And Goats ◽  
Test Kit ◽  
Casualty Slaughter ◽  
Plateau State

Scrapie, a disease of sheep and goats with a progressive course and fatal outcome, has not been identified in Nigeria. Anecdotal scrapie reports by livestock workers abound. Livestock diseases like scrapie form huddles in livestock economics of countries. For 8 months we surveyed for scrapie targeting emergency/casualty slaughter sheep and goats in Jos, Nigeria. We clinically examined 510 sheep and 608 goats of local breeds, aged from 12 months to 5 years. In total 31 (5.10%) goats and no sheep were clinically suspicious for scrapie. Caudal brainstem tissues of suspect animals collected postmortem were analyzed for the disease specific form of the prion protein, PrPSc, using Bio-Rad’s TeSeE ELISA rapid test kit. No sample was positive for scrapie. Fluorescent antibody test for rabies and H&E staining on samples were carried out for differential diagnosis. These showed no pathological lesions indicative for neurological disease. While our findings do not exclude the presence of scrapie in Jos, we demonstrate that targeted sampling of small ruminants for neuroinfectious disease is feasible in developing countries, pointing to the possibility of implementing such a monitoring scheme in Nigeria to prevent economic losses in small ruminant livestock as scrapie caveats from endemic countries have shown.

scholarly journals Evaluation of an Immunochromatographic Assay as a Canine Rabies Surveillance Tool in Goa, India

Viruses ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 649 ◽  
Author(s):  
Yale ◽  
Gibson ◽  
Mani ◽  
P.K. ◽  
Costa ◽  
...  
Keyword(s):  
Brain Tissue ◽  
Low Cost ◽  
Antibody Test ◽  
Immunochromatographic Assay ◽  
Human Rabies ◽  
Post Mortem ◽  
Laboratory Equipment ◽  
Tissue Samples ◽  
Test Kit ◽  
The Government

Rabies is a fatal zoonotic disease transmitted by the bite of a rabid animal. More than 95% of the human rabies cases in India are attributed to exposure to rabid dogs. This study evaluated the utility of a lateral flow immunochromatographic assay (LFA) (Anigen Rapid Rabies Ag Test Kit, Bionote, Hwaseong-si, Korea) for rapid post mortem diagnosis of rabies in dogs. Brain tissue was collected from 202 animals that were screened through the Government of Goa rabies surveillance system. The brain tissue samples were obtained from 188 dogs, nine cats, three bovines, one jackal and one monkey. In addition, 10 dogs that died due to trauma from road accidents were included as negative controls for the study. The diagnostic performance of LFA was evaluated using results from direct fluorescence antibody test (dFT); the current gold standard post mortem test for rabies infection. Three samples were removed from the analysis as they were autolysed and not fit for testing by dFT. Of the 209 samples tested, 117 tested positive by LFA and 92 tested negative, while 121 tested positive by dFT and 88 tested negative. Estimates of LFA sensitivity and specificity were 0.96 (95% CI 0.91–0.99) and 0.99 (95% CI 0.94–1.00), respectively. The LFA is a simple and low-cost assay that aids in the rapid diagnosis of rabies in the field without the need for expensive laboratory equipment or technical expertise. This study found that Bionote LFA has potential as a screening tool in rabies endemic countries.

scholarly journals Malignant Catarrhal Fever in a Captive American Bison (Bison Bison) in Italy

2008 ◽  
Vol 20 (6) ◽  
pp. 843-846 ◽  
Author(s):  
Marco Campolo ◽  
Maria Stella Lucente ◽  
Viviana Mari ◽  
Gabriella Elia ◽  
Antonella Tinelli ◽  
...  
Keyword(s):  
Fluorescent Antibody ◽  
Systemic Disease ◽  
Clinical Signs ◽  
Antibody Test ◽  
Ovis Aries ◽  
Bison Bison ◽  
Domestic Sheep ◽  
Malignant Catarrhal Fever ◽  
Tissue Samples ◽  
Acute Form

Malignant catarrhal fever (MCF) is a fatal, systemic disease of cattle and other domestic and wild ruminants that, in Europe, is caused by Ovine herpesvirus 2 (OvHV-2). American bison ( Bison bison) are highly susceptible to the disease. An adult American bison, housed in a zoo in southern Italy in close cohabitation with a group of domestic sheep ( Ovis aries aries) displayed clinical signs that resembled the acute form of MCF. By real-time polymerase chain reaction, OvHV-2 DNA was detected intravitam in blood, in nasal and ocular swabs, and postmortem in tissue samples of the bison. By indirect fluorescent antibody test, high MCF antibody titers were found in the bison serum. Ovine herpesvirus 2 DNA and antibodies were also found in blood samples from the domestic sheep, thus suggesting a potential role of these animals as a source of the infection. To the authors' knowledge, this is the first MCF case in captive ruminants in Italy and the second confirmed case in captive bison of European zoos.

scholarly journals Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar

2021 ◽  
Author(s):  
Jesha Mundodan ◽  
Samina Hasnain ◽  
Hayat Khogali ◽  
Soha Shawqi Al Bayat ◽  
Dina Ali ◽  
...  
Keyword(s):  
Predictive Value ◽  
Local Population ◽  
Rapid Test ◽  
Antibody Test ◽  
Molecular Testing ◽  
Rt Pcr ◽  
Test Kit ◽  
Asymptomatic Individuals ◽  
Sensitivity Specificity ◽  
Rapid Antibody

Background: In response to the growing coronavirus disease 2019 (COVID-19) pandemic and the shortage of laboratory based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed rapid and easy to use devices to facilitate testing outside laboratory settings. These kits are either based on detection of proteins from SARS-CoV-2 virus or detection of antigen or human antibodies generated in response to the infection. However, it is important to understand their performance characteristics and they must be validated in the local population setting.Design and Methods: The objective is to assess the validity of the rapid test for IgG and IgM immunoglobulins compared to the current gold standard reverse transcription polymerase chain reaction (RT-PCR) test. A total of 16951 asymptomatic individuals were tested by the Ministry of Public Health track-and-trace team using both rapid immunodiagnostic test and RT-PCR as part of screening across various random settings with potential risk of community interaction prior to gradual lifting of restrictions in Qatar.  Rapid test was considered to be posiive if both IgG and IgM are positive, while only IgG/IgM positive was considered as rapid test negative. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated.Results: The sensitivity of rapid test kit was found to be 0.9%, whereas the specificity was found to be 97.8%. the PPV was found to be 0.3% whereas the NPV was found to be 99.4%.Conclusion: Based on the outcome and results of the study, it appears that the sensitivity and PPV of the rapid antibody test are low. As such, this test is not recommended for use to assist in taking clinic-based decisions or decisions related to quarantine/isolation.

scholarly journals Development and clinical evaluation of a rapid antibody lateral flow assay for the diagnosis of SARS-CoV-2 infection

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kesheng Li ◽  
Chongxiang Tong ◽  
Xiaoqin Ha ◽  
Chaoning Zeng ◽  
Xia Chen ◽  
...  
Keyword(s):  
Clinical Evaluation ◽  
False Negative ◽  
Antibody Test ◽  
Cross Reactivity ◽  
Respiratory Pathogens ◽  
Analytical Sensitivity ◽  
N Protein ◽  
Test Kit ◽  
Positive Rate ◽  
Rapid Antibody

Abstract Background The novel coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which has quickly spread worldwide since its outbreak in December 2019. One of the primary measures for controlling the spread of SARS-CoV-2 infection is an accurate assay for its diagnosis. SARS-CoV-2 real-time PCR kits suffer from some limitations, including false-negative results in the clinic. Therefore, there is an urgent need for the development of a rapid antibody test kit for COVID-19 diagnosis. Methods The nuclear capsid protein (N) and spike protein 1 (S1) fragments of SARS-CoV-2 were expressed in Escherichia coli, and rapid antibody-based tests for the diagnosis of SARS-CoV-2 infection were developed. To evaluate their clinical applications, the serum from COVID-19 patients, suspected COVID-19 patients, recovering COVID-19 patients, patients with general fever or pulmonary infection, doctors and nurses who worked at the fever clinic, and health professionals was analyzed by the rapid antibody test kits. The serum from patients infected with Mycoplasma pneumoniae and patients with respiratory tract infection was further analyzed to test its cross-reactivity with other respiratory pathogens. Results A 47 kDa N protein and 67 kDa S1 fragment of SARS-CoV-2 were successfully expressed, purified, and renatured. The rapid antibody test with recombinant N protein showed higher positive rate than the rapid IgM antibody test with recombinant S1 protein. Clinical evaluation showed that the rapid antibody test kit with recombinant N protein had 88.56 % analytical sensitivity and 97.42 % specificity for COVID-19 patients, 53.48 % positive rate for suspected COVID-19 patients, 57.14 % positive rate for recovering COVID-19 patients, and 0.5−0.8 % cross-reactivity with other respiratory pathogens. The analytical sensitivity of the kit did not significantly differ in COVID-19 patients with different disease courses (p < 0.01). Conclusions The rapid antibody test kit with recombinant N protein has high specificity and analytical sensitivity, and can be used for the diagnosis of SARS-CoV-2 infection combined with RT-PCR.

scholarly journals Validation of OraQuick HCV Rapid Antibody Test in Postmortem Specimens

2020 ◽  
Vol 10 (2) ◽  
pp. 81-86
Author(s):  
Claire E. Rose ◽  
Lisa Duncan ◽  
Amy M. Hawes
Keyword(s):  
Hepatitis C ◽  
Gold Standard ◽  
Rapid Test ◽  
Antibody Test ◽  
Acquisition Time ◽  
Hepatitis C Infection ◽  
Postmortem Blood ◽  
Gold Standard Reference ◽  
Antibody Positivity ◽  
Rapid Antibody

INTRODUCTION: The objective of this study is to evaluate the performance of OraQuick HCV Rapid Antibody Test against a “gold-standard”, FDA-approved, laboratory-based serum immunoassay (SI) in postmortem blood. To date, OraQuick HCV Rapid Antibody Test has not been evaluated for use in postmortem testing. This OraQuick test is a manually performed, visually interpreted, single use immunoassay for the qualitative detection of antibodies to the hepatitis C virus (HCV). METHODS: Blood was collected from 51 decedents whose deaths were investigated in the jurisdiction of the Knox and Anderson County Medical Examiner’s Office (MEO) January 2017 through April 2017. For each consented case, blood was tested using both the OraQuick HCV Rapid Antibody Test and a laboratory-based hepatitis C serum immunoassay (“gold standard” reference assay). Results from the OraQuick HCV Rapid Antibody Test were compared against a laboratory-based hepatitis C serum immunoassay. RESULTS: Using the laboratory-based serum immunoassay (SI) as the “gold standard” for assessing true HCV antibody positivity, and comparing SI against OraQuick rapid test, sensitivity for the OraQuick rapid test was 95.65% and specificity was 96.15% in postmortem blood. DISCUSSION: Our results demonstrate that OraQuick HCV rapid antibody test is reliable for diagnosis of hepatitis C infection in postmortem blood with a relatively short (less than approximately 21.5 hours) postmortem sample acquisition time. The OraQuick in some cases may be superior to traditional, laboratory-based HCV SI due to potential increased viscosity of postmortem blood.

scholarly journals False negative HIV antibody test in HIV infected children who receive early antiretroviral treatment in a resource-limited setting

2012 ◽  
Vol 4 (1) ◽  
pp. 6 ◽  
Author(s):  
Gerardo Alvarez-Uria ◽  
Praveen K. Naik ◽  
Manoranjan Midde ◽  
Shanmugamari Kannan ◽  
Raghuprakash Reddy
Keyword(s):  
False Negative ◽  
Rapid Test ◽  
Antibody Test ◽  
Rural Setting ◽  
World Health ◽  
Enzyme Linked Immunosorbent Assay ◽  
Resource Limited ◽  
One Year ◽  
Health Organization ◽  
Early Antiretroviral Treatment

<p>With the implementation of 2010 World Health Organization guidelines, the number of infants from developing countries who will initiate antiretroviral therapy (ART) will increase considerably. In this study we describe the HIV antibody tests of 14 HIV infected children who initiated ART at age less than one year in a rural setting of India. The HIV rapid test was negative in seven and indeterminate in two cases, whereas the HIV enzyme-linked immunosorbent assay (ELISA) antibody test was negative in three and indeterminate in one case. In one child who had both negative HIV rapid test and ELISA initially, HIV serology turned positive after having a virological failure to ART, suggesting the possibility of utilizing HIV serology for monitoring ART effectiveness in children who experience HIV seroreversion. In conclusion, HIV seroreversion of children with early initiation of ART is common and should be considered for avoiding misdiagnosis of HIV infection.</p><p> </p>

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