Wide Variability in the Sensitivity and Specificity of Rotavirus Immunoassay Diagnostic Kits in Practice

Introduction: Most hospitals rely on rapid antigen-detection kits for the diagnosis of rotavirus infection. Several small studies reviewed the sensitivity and specificity of some of these kits. These studies showed discrepancy in results obtained for sensitivity and specificity that varied according to the type of kit used, area of study, and type of test used as standard for diagnosis of rotavirus infection. The objective of the study is to determine the sensitivity and specificity of five commonly used rotavirus immunoassay kits in comparison to RT-PCR as standard. Methodology: Stool samples (N = 1,414) collected from children under 5 years of age hospitalized with gastroenteritis were tested for rotavirus by immunoassay kits and RT-PCR in a prospective hospital-based surveillance study conducted at 7 centers in Lebanon. Concordance and discrepancy between the two methods was used to calculate sensitivity and specificity, using RT-PCR as the “gold standard”. Results: The sensitivity and specificity were respectively 95.08% and 86.62% for the SD Bioline® (Standard Diagnostics, Inc, South Korea) kit calculated on 645 samples, 65.86% and 45.90% for the VIROTECT® (Trinity Biotech, Ireland) kit calculated on 327 samples, 83.9% and 64.2% for the Rota-Strip (C-1001) (Coris Bioconcept, Belgium) calculated on 95 samples, 52.3% and 10.9% for the Acon® (Acon Laboratories, Inc, California, USA) kit calculated on 122 samples, 68.1% and 20% for the VIKIA® Rota-Adéno (Biomerieux, France) kit calculated on 32 samples. Conclusion: A wide discrepancy was detected between the calculated and advertised sensitivity and specificity for most of the kits.

Download Full-text

A study of rotavirus infection in acute diarrhoea in children less than 5 years of age

Indian Journal of Microbiology Research ◽

10.18231/j.ijmr.2021.064 ◽

2021 ◽

Vol 8 (4) ◽

pp. 321-326

Author(s):

Pramod N Sambrani ◽

Pooja Mansabdar ◽

Mahesh Kumar S

Keyword(s):

Acute Diarrhoea ◽

High Sensitivity ◽

Childhood Mortality ◽

Major Morbidity ◽

Rotavirus Infection ◽

Stool Samples ◽

Diarrhoeal Diseases ◽

Rotavirus Diarrhea ◽

A Prospective Study ◽

Children Under 5

: Diarrhoeal diseases account for an estimated 1.5 million deaths globally every year making it the second leading cause of childhood mortality. In India 1 out of every 250 children die of rotavirus diarrhea each year.: To find out the incidence of rotavirus infection in acute diarrhoeal cases in children under 5 years of age.: A prospective study was conducted on 100 non repetetive stool samples of Children under 5 years of age, presenting with acute diarrhea and hospitalized in the pediatric ward, during December 2015 to November 2016. Stool samples were processed according to premier rotaclone enzyme immunoassay protocol for the detection of rotavirus antigen, adhering to standard laboratory precautions.: The incidence of acute diarrhoeal diseases was 5.86% in our setting. was detected in 29% cases by ELISA method.The antigen detection by EIA is a reliable test, as it is quantitative and also has high sensitivity and specificity. Hence, can be routinely employed to prevent major morbidity and mortality among children, especially less than 5 years of age.

Download Full-text

Assessment of the Rapid Immunochromatographic Test as a Diagnostic Tool for Norovirus Related Diarrhea in Children

Folia Medica Indonesiana ◽

10.20473/fmi.v55i1.12557 ◽

2019 ◽

Vol 55 (1) ◽

pp. 48

Author(s):

Reza Gunadi Ranuh ◽

Alpha Fardah Athiyyah ◽

Deanty Ayu PA ◽

Andy Darma ◽

Dadik Rahardjo ◽

...

Keyword(s):

Developing Countries ◽

Diagnostic Tool ◽

Predictive Value ◽

Gold Standard ◽

Pediatric Patients ◽

Immunochromatographic Test ◽

Rt Pcr ◽

Gold Standard Method ◽

Stool Samples ◽

Sensitivity Specificity

In developing countries, Norovirus is the second-leading cause of acute diarrhea, after rotavirus. The approved gold standard method for diagnosis of norovirus infection is RT-PCR. The rapid immunochromatographic test is a novel and expedient method for diagnosing norovirus that is relatively affordable. However, the use of the rapid immunochromatographic test remains controversial because of its accuracy. This study aimed to explore whether the rapid immunochromatographic test could be used for diagnosing norovirus-related diarrhea in children. Rapid immunochromatographic test (QuickNaviTM-Norovirus2) and RT-PCR on stool samples was used to diagnose norovirus. Stool samples were obtained from pediatric patients aged between 1 and 60 months who had diarrhea and were admitted to the pediatric ward at Dr. Soetomo General Hospital Surabaya, between April 2013 and March 2014. Ninety-four subjects provided stool samples that were tested using QuickNaviTM-Noro2 and RT-PCR. Using the test, 64 samples tested positive for norovirus and 30 tested negatives. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the rapid immunochromatographic test were consecutively 90.3%, 42.9%, 43.8%, 90%, and 58.5%. RT-PCR was used to test all samples to assess the accuracy, which showed that one from 31 samples contained the GI strain (1.1%), while 30 samples (32%) contained the GII strain. This study definitively establishes that the rapid immunochromatography test is not sufficiently accurate for use as a screening or diagnostic tool in norovirus-related diarrhea cases in children.

Download Full-text

ACUTE GASTROENTERITIS ASSOCIATED WITH NOROVIRUS GII.4 VARIANTS

Arquivos de Gastroenterologia ◽

10.1590/s0004-2803.201800000-67 ◽

2018 ◽

Vol 55 (3) ◽

pp. 264-266 ◽

Cited By ~ 3

Author(s):

Fabiana Lopes de PAULA ◽

Silvia Inês SARDI ◽

Dellane Martins TIGRE ◽

Flora Maria de Campos FERNANDES ◽

Gúbio Soares CAMPOS

Keyword(s):

Molecular Epidemiology ◽

New Orleans ◽

Acute Gastroenteritis ◽

Etiologic Agent ◽

Rt Pcr ◽

Stool Samples ◽

Sequences Analysis ◽

Norovirus Gii ◽

The City ◽

Children Under 5

ABSTRACT BACKGROUND: Norovirus (NoV) is an important etiologic agent of acute gastroenteritis and infects individuals of all ages, especially children in Brazil and worldwide. NoV GII.4 was the most prevalent genotype worldwide because of your extensive genetic diversity. In Brazil, especially in the Northeast, few studies have been developed for identify and molecularly characterize NoV. OBJECTIVE: The present study aimed to detect and describe the molecular epidemiology of NoV associated with acute gastroenteritis. METHODS: The viral RNA extracted from stool samples were subjected to Nested RT-PCR and the genotypes were determined by nucleotide sequences analysis. In total, 278 stool samples assisted at Aliança Hospital in the city of Salvador, with acute gastroenteritis were examined, between March 2009 and July 2012. RESULTS: A high NoV rate (54.2%) was identified in children under 5 years of age. We detected the circulation of different NoV GII.4 variants in Salvador, during the study period as Den Haag 2006b, New Orleans 2009 and Sydney 2012. CONCLUSION: These findings reinforce the need to study the molecular epidemiology of NoV infections in acute gastroenteritis.

Download Full-text

Performance of Latex agglutination, ELISA and RT-PCR for diagnosis of Rotavirus infection

Journal of Biological Research - Bollettino della Società Italiana di Biologia Sperimentale ◽

10.4081/jbr.2017.6522 ◽

2018 ◽

Vol 90 (2) ◽

Author(s):

Hosna Hamzavi ◽

Azarakhsh Azaran ◽

Manoochehr Makvandi ◽

Sahar Karami ◽

Mohammad Roayaei Ardakani ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Acute Gastroenteritis ◽

Laboratory Diagnosis ◽

Latex Agglutination ◽

Enzyme Linked Immunosorbent Assay ◽

Rt Pcr ◽

Rotavirus Infection ◽

Polymerase Chain ◽

Major Factors ◽

Positive Results

The rotavirus is one of the major factors of inducing the acute gastroenteritis infection in children under 5 years of age. The laboratory diagnosis is progress and bringing it under control as well as avoiding its diffusion. The purpose of the present study was to determine the performance of enzyme linked immunosorbent assay (ELISA) and Latex agglutination (LA) tests against reverse transcription-polymerase chain reaction (RT-PCR) for evaluating the children’s acute gastroenteritis by rotavirus. One hundred feces specimens were collected from February to May 2014 and analyzed by LA, ELISA and RT-PCR. In this study, the positive results for rotavirus detected by ELISA, LA and RT-PCR were 37, 43 and 27%, respectively. In addition, the result showed that the sensitivity and specificity of ELISA and LA were 74 and 85%, respectively, when compared to RT-PCR. For laboratory detection of Rotavirus infection, RT-PCR has the highest sensitivity and specificity but because of the high costs, ELISA and LA based kits with good performance, as shown by this study, can be preferred for the routine use.

Download Full-text

Evaluation of RNA extraction free method for detection of SARS-COV-2 in salivary samples for mass screening for COVID-19

10.1101/2021.03.15.21253570 ◽

2021 ◽

Author(s):

Sally A. Mahmoud ◽

Esra Ibrahim ◽

Subhashini Ganesan ◽

Bhagyashree Thakre ◽

Juliet G Teddy ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Gold Standard ◽

Rna Extraction ◽

High Sensitivity ◽

High Specificity ◽

Cost Effective ◽

Kappa Coefficient ◽

Nasopharyngeal Swab ◽

Rt Pcr ◽

Good Percentage

AbstractIn this current COVID - 19 pandemic, there is a dire need for cost effective and less time-consuming alternatives for SARS-COV-2 testing. The RNA extraction free method for detecting SARS-COV-2 in saliva is a promising option, this study found that it has high sensitivity (85.34%), specificity (95.04%) and was comparable to the gold standard nasopharyngeal swab. The method showed good percentage of agreement (kappa coefficient) 0.797 between salivary and NPS samples. However, there are variations in the sensitivity and specificity based on the RT-PCR kit used. The Thermo Fischer-Applied biosystems showed high sensitivity, PPV and NPV but also showed higher percentage of invalid reports. Whereas the BGI kit showed high specificity, better agreement (kappa coefficient) between the results of saliva and NPS samples and higher correlation between the Ct values of saliva and NPS samples. Thus, the RNA extraction free method for salivary sample serves as an effective alternative for SARS-CoV 2-testing.

Download Full-text

Comparative Assessment of Sensitivity and Specificity of Rose Bengal Test and Modified In-house ELISA by using IS711 TaqMan Real Time PCR Assay as a Gold Standard for the Diagnosis of Bovine Brucellosis

Biomedical & Pharmacology Journal ◽

10.13005/bpj/1453 ◽

2018 ◽

Vol 11 (2) ◽

pp. 951-957

Author(s):

Amira M. Zakaria

Keyword(s):

Positive Predictive Value ◽

Real Time ◽

Sensitivity And Specificity ◽

Rose Bengal ◽

Real Time Pcr ◽

Predictive Value ◽

Gold Standard ◽

Bovine Brucellosis ◽

Rt Pcr ◽

Rose Bengal Test

Serological approaches such as Rose Bengal Test (RBT) and enzyme linked immunosorbent assay (ELISA) are common tests, however they are generally not sensitive or specific enough for diagnosis of Brucella because of cross-reactivity with different bacterial antigens. The work objected to evaluate the sensitivity and specificity of rose Bengal and modified in-house ELISA using IS711 real time PCR as a gold test to detect Brucella in calves sera. Two hundred and thirty (n=230) blood samples were collected from (2-3) years asymptomatic male calves in two Egyptian abattoirs. Rose Bengal test (RBT) and modified in-house ELISA were applied to determine the seroprevalence of brucellosis in abattoirs animals while quantitative Taqman real-time PCRs (RT-PCR) were implemented for the identification of Brucella genus. The overall prevalence of brucellosis was (53.9 %), (75.2 %) and (79.1 %) as determined by ELISA,RBT and RT- PCR assays respectively. Regarding statistical analysis of the reported data and considering real time PCR the gold standard, the RBT recorded a sensitivity of (79.12%) and a specificity of (39.58 %) with an accuracy of (70.87%). While (83.24%) was reported as positive predictive value and (33.33 %) as a negative predictive value. The sensitivity and specificity of ELISA were (55.49%) and (52.08 %) respectively while the accuracy was (54.78%). Positive predictive value and negative predictive value for ELISA were determined as (81.45%) and (23.58 %) respectively. RBT can be routinely used for diagnosis of Brucella as cost effective , more sensitive and accurate test than ELISA However, real time PCR is highly recommend as gold test for identification and differentiation of bovine brucellosis.

Download Full-text

Nasopharyngeal versus nasal swabs for detection of SARS-CoV-2: a systematic review

Rhinology Journal ◽

10.4193/rhin21.162 ◽

2021 ◽

Vol 0 (0) ◽

pp. 0-0

Author(s):

A.J. Gadenstaetter ◽

C.D. Mayer ◽

L.D. Landegger

Keyword(s):

Systematic Review ◽

Sensitivity And Specificity ◽

Gold Standard ◽

Medical Staff ◽

Rt Pcr ◽

Testing Strategies ◽

Specimen Collection ◽

Nasal Swabs ◽

Oropharyngeal Swab ◽

Collection Methods

Nasopharyngeal swabbing (NPS) coupled with RT-PCR is the current gold standard for detecting SARS-CoV-2 infections. However, numerous studies have recently demonstrated the advantages of alternative nasal specimen collection approaches over NPS specifically for COVID-19 diagnosis. The present review was conducted according to PRISMA guidelines and summarises the current literature to give a clear overview of nasal specimen collection methods for SARS-CoV-2 detection. Publications investigating NPS and at least one other form of nasal specimen collection in combination with RT-PCR for viral detection in the context of COVID-19 were assessed. We identified 425 articles and ultimately included 18 studies in this systematic review. The suitable publications evaluated different forms of nasal specimen collection, with anterior nasal swabbing (ANS) and midturbinate swabbing (MTS) being the most frequently examined techniques. The analysed studies report sensitivity and specificity results (74.59-96.2% and 97.9-100.0%, respectively) similar to those achieved via NPS, especially in the early stages of disease or when paired with an oropharyngeal swab. Results from these studies suggest that ANS and MTS are suitable alternatives to NPS for COVID-19 testing. Due to their ease of collection, ANS and MTS collection techniques may facilitate broader testing strategies and allow for economization of medical staff.

Download Full-text

The sensitivity and specificity of chest CT in the diagnosis of COVID-19

European Radiology ◽

10.1007/s00330-020-07347-x ◽

2020 ◽

Cited By ~ 2

Author(s):

Anita Kovács ◽

Péter Palásti ◽

Dániel Veréb ◽

Bence Bozsik ◽

András Palkó ◽

...

Keyword(s):

Sensitivity And Specificity ◽

Gold Standard ◽

Clinical Symptoms ◽

Close Contact ◽

Chest Ct ◽

Added Value ◽

Ct Scans ◽

Diagnostic Tools ◽

Diagnostic Process ◽

Rt Pcr

Abstract Purpose The identification of patients infected by SARS-CoV-2 is highly important to control the disease; however, the clinical presentation is often unspecific and a large portion of the patients develop mild or no symptoms at all. For this reason, there is an emphasis on evaluating diagnostic tools for screening. Chest CT scans are emerging as a useful tool in the diagnostic process of viral pneumonia cases associated with COVID-19. This review examines the sensitivity, specificity, and feasibility of chest CT in detecting COVID-19 compared with real-time polymerase chain reaction (RT-PCR). Methods Sensitivity and specificity of chest CT in detecting COVID-19 in its various phases was compared using RT-PCR as a gold standard. A “reverse calculation approach” was applied and treated chest CT as a hypothetical gold standard and compared RT-PCR to it point out the flaw of the standard approach. Results High sensitivity (67–100%) and relatively low specificity (25–80%) was reported for the CT scans. However, the sensitivity of RT-PCR was reported to be modest (53–88%), hence cannot serve as an appropriate ground truth. The “reverse calculation approach” showed that CT could have a higher specificity (83–100%) if we consider the modest sensitivity of the RT-PCR. Conclusions The sensitivity and specificity of the chest CT in diagnosing COVID-19 and the radiation exposure have to be judged together. Arguments are presented that chest CT scans have added value in diagnosing COVID-19 especially in patients, who exhibit typical clinical symptoms and have negative RT-PCR results in highly infected regions. Key Points • CT scans have higher specificity if we take into account the low sensitivity of the RT-PCR. • Avoid chest CT as a sole diagnostic approach for COVID-19 infection. • Patients who had negative RT-PCR result with typical clinical symptoms in highly infected regions or with close contact of COVID-19-infected patients; the use of chest CT is warranted.

Download Full-text

Assessment of the Rapid Immunochromatographic Test as a Diagnostic Tool for Norovirus Related Diarrhea in Children

Folia Medica Indonesiana ◽

10.20473/fmi.v55i1.24377 ◽

2021 ◽

Vol 55 (1) ◽

pp. 48

Author(s):

Reza Gunadi Ranuh ◽

Alpha Fardah Athiyyah ◽

Deanty Ayu PA ◽

Andy Darma ◽

Dadik Raharjo ◽

...

Keyword(s):

Developing Countries ◽

Diagnostic Tool ◽

Predictive Value ◽

Gold Standard ◽

Pediatric Patients ◽

Immunochromatographic Test ◽

Rt Pcr ◽

Gold Standard Method ◽

Stool Samples ◽

Sensitivity Specificity

Download Full-text

Laboratory evaluation of the rapid diagnostic tests for the detection of Vibrio cholerae O1 using diarrheal samples

PLoS Neglected Tropical Diseases ◽

10.1371/journal.pntd.0009521 ◽

2021 ◽

Vol 15 (6) ◽

pp. e0009521

Author(s):

Goutam Chowdhury ◽

Tarosi Senapati ◽

Bhabatosh Das ◽

Asha Kamath ◽

Debottam Pal ◽

...

Keyword(s):

Vibrio Cholerae ◽

Sensitivity And Specificity ◽

Gold Standard ◽

Diagnostic Tests ◽

Diarrheal Disease ◽

High Sensitivity ◽

Rapid Diagnostic Tests ◽

Laboratory Evaluation ◽

Specificity And Sensitivity ◽

Stool Samples

Background Cholera, an acute diarrheal disease is a major public health problem in many developing countries. Several rapid diagnostic tests (RDT) are available for the detection of cholera, but their efficacies are not compared in an endemic setting. In this study, we have compared the specificity and sensitivity of three RDT kits for the detection of Vibrio cholerae O1 and compared their efficiency with culture and polymerase chain reaction (PCR) methods. Methods Five hundred six diarrheal stool samples collected from patients from two different hospitals in Kolkata, India were tested using SD Bioline Cholera, SMART-II Cholera O1 and Crystal-VC RDT kits. All the stool samples were screened for the presence of V. cholerae by direct and enrichment culture methods. Stool DNA-based PCR assay was made to target the cholera toxin (ctxAB) and O1 somatic antigen (rfb) encoding genes. Statistical evaluation of the RDTs has been made using STATA software with stool culture and PCR results as the gold standards. The Bayesian latent class model (LCM) was used to evaluate the diagnostic tests in the absence of the gold standard. Results Involving culture technique as gold standard, the sensitivity and specificity of the cholera RDT kits in the direct testing of stools was highest with SAMRT-II (86.1%) and SD-Cholera (94.4%), respectively. The DNA based PCR assays gave very high sensitivity (98.4%) but the specificity was comparatively low (75.3%). After enrichment, the high sensitivity and specificity was detected with SAMRT-II (78.8%) and SD-Cholera (99.1%), respectively. Considering PCR as the gold standard, the sensitivity and specificity of the RDTs remained between 52.3–58.2% and 92.3–96.8%, respectively. In the LCM, the sensitivity of direct and enrichment testing was high in SAMRT-II (88% and 92%, respectively), but the specificity was high in SD cholera for both the methods (97% and 100%, respectively). The sensitivity/specificity of RDTs and direct culture have also been analyzed considering the age, gender and diarrheal disease severity of the patients. Conclusion Overall, the performance of the RDT kits remained almost similar in terms of specificity and sensitivity. Performance of PCR was superior to the antibody-based RDTs. The RTDs are very useful in identifying cholera cases during outbreak/epidemic situations and for making them as a point-of-care (POC) testing tool needs more improvement.

Download Full-text