scholarly journals Diagnosis value of SARS-CoV-2 antigen/antibody combined testing using rapid diagnostic tests at hospital admission

2020 ◽  
Author(s):  
Nicolas Veyrenche ◽  
Karine Bollore ◽  
Amandine Pisoni ◽  
Anne-Sophie Bedin ◽  
Anne-Marie Mondain ◽  
...  
Keyword(s):  
Emergency Department ◽  
Hospital Admission ◽  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Rt Pcr ◽  
Cycle Threshold ◽  
Igm Elisa ◽  
Antigen Antibody ◽  
Negative Controls

Objectives: The implementation of rapid diagnostic tests (RDTs) may enhance the efficiency of SARS-CoV-2 testing, as RDTs are widely accessible and easy to use. The aim of this study was to evaluate the performance of a diagnosis strategy based on a combination of antigen and IgM/IgG serological RDTs. Methods: Plasma and nasopharyngeal samples were collected between 14 March and 11 April 2020 at hospital admission from 45 patients with RT-PCR confirmed COVID-19 and 20 negative controls. SARS-CoV-2 antigen (Ag) was assessed in nasopharyngeal swabs using the Coris Respi-Strip. For IgM/IgG detection, SureScreen Diagnostics and Szybio Biotech RDTs were used in addition to laboratory assays (Abbott Alinity i SARS-CoV-2 IgG and Theradiag COVID-19 IgM ELISA). Results: Using the Ag RDT, 13 out of 45 (29.0%) specimens tested positive, the sensitivity was 87.0% for Cycle Threshold (CT) values ≤ 25 and 0% for CT values > 25. IgG detection was associated with high CT values and the amount of time after the onset of symptoms. The profile of isolated IgM on RDTs was more frequently observed during the first and second week after the onset of symptoms. The combination of Ag and IgM/IgG RDTs enabled the detection of up to 84.0% of COVID-19 confirmed cases at hospital admission. Conclusion: Antigen and antibody-based RDTs showed suboptimal performances when used alone. However when used in combination, they are able to identify most COVID-19 patients admitted in an emergency department.

scholarly journals Diagnosis value of SARS‐CoV‐2 antigen/antibody combined testing using rapid diagnostic tests at hospital admission

2021 ◽  
Vol 93 (5) ◽  
pp. 3069-3076
Author(s):  
Nicolas Veyrenche ◽  
Karine Bolloré ◽  
Amandine Pisoni ◽  
Anne‐Sophie Bedin ◽  
Anne‐Marie Mondain ◽  
...  
Keyword(s):  
Hospital Admission ◽  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Antigen Antibody

scholarly journals Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests

2020 ◽  
Vol 9 (8) ◽  
pp. 2369 ◽  
Author(s):  
Diego O. Andrey ◽  
Patrick Cohen ◽  
Benjamin Meyer ◽  
Giulia Torriani ◽  
Sabine Yerly ◽  
...  
Keyword(s):  
Whole Blood ◽  
Case Control Study ◽  
Case Control ◽  
Immunofluorescence Assay ◽  
Rapid Diagnostic Tests ◽  
Rt Pcr ◽  
Accuracy Comparison ◽  
Rapid Tests ◽  
Negative Controls ◽  
Control Study

Background: Comparative data of SARS-CoV-2 IgM/IgG serology rapid diagnostic tests (RDTs) is scarce. We thus performed a head-to-head comparison of three RDTs. Methods: In this unmatched case-control study, blood samples from 41 RT-PCR-confirmed COVID-19 cases and 50 negative controls were studied. The diagnostic accuracy of three commercially available COVID-19 RDTs: NTBIO (RDT-A), Orient-Gene (RDT-B), and MEDsan (RDT-C), against both a recombinant spike-expressing immunofluorescence assay (rIFA) and Euroimmun IgG ELISA, was assessed. RDT results concordant with the reference methods, and between whole blood and plasma, were established by the Kendall coefficient. Results: COVID-19 cases’ median time from RT-PCR to serology was 22 days (interquartile range (IQR) 13–31 days). Whole-blood IgG detection with RDT-A, -B, and -C showed 0.93, 0.83, and 0.98 concordance with rIFA. Against rIFA, RDT-A sensitivity (SN) was 92% (95% CI: 78–98) and specificity (SP) 100% (95% CI: 91–100), RDT-B showed 87% SN (95% CI: 72–95) and 98% SP (95% CI: 88–100), and RDT-C 100% SN (95% CI: 88–100) and 98% SP (95% CI: 88–100). Against ELISA, SN and SP were above 90% for all three RDTs. Conclusions: RDT-A and RDT-C displayed IgG detection SN and SP above 90% in whole blood. These RDTs could be considered in the absence of routine diagnostic serology facilities.

scholarly journals Diagnostic accuracy of two commercial SARS-CoV-2 Antigen-detecting rapid tests at the point of care in community-based testing centers

2020 ◽  
Author(s):  
Alice Berger ◽  
Marie Therese Ngo Nsoga ◽  
Francisco Javier Perez-Rodriguez ◽  
Yasmine Abi Aad ◽  
Pascale Sattonnet-Roche ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Point Of Care ◽  
Rapid Test ◽  
Diagnostic Value ◽  
Rapid Diagnostic Tests ◽  
Ease Of Use ◽  
Rt Pcr ◽  
Test Device ◽  
Community Based ◽  
Rapid Tests

AbstractBackgroundAntigen-detecting rapid diagnostic tests for SARS-CoV-2 offer new opportunities for the quick and laboratory-independent identification of infected individuals for control of the SARS-CoV-2 pandemic.MethodsWe performed a prospective, single-center, point of care validation of two antigen-detecting rapid diagnostic tests (Ag-RDT) in comparison to RT-PCR on nasopharyngeal swabs.FindingsBetween October 9th and 23rd, 2020, 1064 participants were enrolled. The Panbio™Covid-19 Ag Rapid Test device (Abbott) was validated in 535 participants, with 106 positive Ag-RDT results out of 124 positive RT-PCR individuals, yielding a sensitivity of 85.5% (95% CI: 78.0–91.2). Specificity was 100.0% (95% CI: 99.1–100) in 411 RT-PCR negative individuals. The Standard Q Ag-RDT (SD Biosensor, Roche) was validated in 529 participants, with 170 positive Ag-RDT results out of 191 positive RT-PCR individuals, yielding a sensitivity of 89.0% (95%CI: 83.7–93.1). One false positive result was obtained in 338 RT-PCR negative individuals, yielding a specificity of 99.7% (95%CI: 98.4–100). For individuals presenting with fever 1-5 days post symptom onset, combined Ag-RDT sensitivity was above 95%.InterpretationWe provide an independent validation of two widely available commercial Ag-RDTs, both meeting WHO criteria of ≥80% sensitivity and ≥97% specificity. Although less sensitive than RT-PCR, these assays could be beneficial due to their rapid results, ease of use, and independence from existing laboratory structures. Testing criteria focusing on patients with typical symptoms in their early symptomatic period onset could further increase diagnostic value.FundingFoundation of Innovative Diagnostics (FIND), Fondation privée des HUG, Pictet Charitable Foundation.

LABORATORY METHODS AND PREVALENCE OF SARS-COV-2 INFECTIONS IN THE 2ND SEMESTER OF 2021 IN THE EMERGENCY CLINICAL COUNTY HOSPITAL OF CONSTANTA

2021 ◽  
Author(s):  
Stoicescu Ramona ◽  
Stoicescu Razvan-Alexandru ◽  
Codrin Gheorghe ◽  
Schroder Verginica
Keyword(s):  
Respiratory Tract ◽  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Antigen Detection ◽  
Nucleic Acid Amplification ◽  
Rt Pcr ◽  
Laboratory Methods ◽  
Rapid Tests ◽  
Polymerase Chain ◽  
Tract Infections

"Diagnosing infections with SARS-CoV-2 is still of great interest due to the health and economic impact of COVID pandemic. The 4th wave of the COVID-19 pandemic is expected and is considered to be stronger and faster due to the dominance of Delta variant which is highly contagious [1]. SARS-CoV-2 also known as 2019-nCoV is one of the three coronaviruses (together with SARS-CoV or SARS-CoV1/Severe acute respiratory syndrome coronavirus), MERS-CoV /Middle East Respiratory Syndrome coronavirus) which can cause severe respiratory tract infections in humans [2]. Early diagnosis in COVID 19 infection is the key for preventing infection transmission in collectivity and proper medical care for the ill patients. Gold standard for diagnosing SARS-Co-V-2 infection according to WHO recommendation is using nucleic acid amplification tests (NAAT)/ reverse transcription polymerase chain reaction (RT-PCR). The search is on to develop reliable but less expensive and faster diagnostic tests that detect antigens specific for SARS-CoV-2 infection. Antigen-detection diagnostic tests are designed to directly detect SARSCoV-2 proteins produced by replicating virus in respiratory secretions so-called rapid diagnostic tests, or RDTs. The diagnostic development landscape is dynamic, with nearly a hundred companies developing or manufacturing rapid tests for SARS-CoV-2 antigen detection [3]. In the last 3 months our hospital introduced the antigen test or Rapid diagnostic tests (RDT) which detects the presence of viral proteins (antigens) expressed by the COVID-19 virus in a sample from the respiratory tract of a person. All RDT were confirmed next day with a RT-PCR. The number of positive cases detected during 3 months in our laboratory was 425. There were 326 positive tests in April, 106 positive tests in May and 7 positive tests in June. Compared with the number of positive tests in the 1st semester of 2021, the positive tests have significantly declined."

scholarly journals Point-of-Care Diagnostic Tests for Detecting SARS-CoV-2 Antibodies: A Systematic Review and Meta-Analysis of Real-World Data

2020 ◽  
Vol 9 (5) ◽  
pp. 1515 ◽  
Author(s):  
Matteo Riccò ◽  
Pietro Ferraro ◽  
Giovanni Gualerzi ◽  
Silvia Ranzieri ◽  
Brandon Michael Henry ◽  
...  
Keyword(s):  
Systematic Review ◽  
Diagnostic Tests ◽  
Large Scale ◽  
Point Of Care ◽  
Meta Analysis ◽  
Rapid Diagnostic Tests ◽  
Diagnostic Methods ◽  
Rt Pcr ◽  
Real World Data ◽  
Healthcare Facilities

SARS-CoV-2 is responsible for a highly contagious infection, known as COVID-19. SARS-CoV-2 was discovered in late December 2019 and, since then, has become a global pandemic. Timely and accurate COVID-19 laboratory testing is an essential step in the management of the COVID-19 outbreak. To date, assays based on the reverse-transcription polymerase chain reaction (RT-PCR) in respiratory samples are the gold standard for COVID-19 diagnosis. Unfortunately, RT-PCR has several practical limitations. Consequently, alternative diagnostic methods are urgently required, both for alleviating the pressure on laboratories and healthcare facilities and for expanding testing capacity to enable large-scale screening and ensure a timely therapeutic intervention. To date, few studies have been conducted concerning the potential utilization of rapid testing for COVID-19, with some conflicting results. Therefore, the present systematic review and meta-analysis was undertaken to explore the feasibility of rapid diagnostic tests in the management of the COVID-19 outbreak. Based on ten studies, we computed a pooled sensitivity of 64.8% (95%CI 54.5–74.0), and specificity of 98.0% (95%CI 95.8–99.0), with high heterogeneity and risk of reporting bias. We can conclude that: (1) rapid diagnostic tests for COVID-19 are necessary, but should be adequately sensitive and specific; (2) few studies have been carried out to date; (3) the studies included are characterized by low numbers and low sample power, and (4) in light of these results, the use of available tests is currently questionable for clinical purposes and cannot substitute other more reliable molecular tests, such as assays based on RT-PCR.

scholarly journals PREDICTIVE VALUE OF SMELL AND TASTE TEST VS PCR-RT SARS-COV-2 AND RAPID DIAGNOSTIC TESTS IN THE DIAGNOSIS OF INFECTION BY COVID-19. A PROSPECTIVE MULTI-CENTRIC STUDY.

2020 ◽  
Author(s):  
Rosalinda Pieruzzini ◽  
Carlos Ayala ◽  
Jose Navas ◽  
Wilneg Carolina Rodriguez ◽  
Nathalia Parra ◽  
...  
Keyword(s):  
Predictive Value ◽  
Diagnostic Tests ◽  
Rapid Diagnostic Tests ◽  
Variable Degree ◽  
Rt Pcr ◽  
Taste Test ◽  
Taste Disorders ◽  
Coronavirus Infection ◽  
Diagnosis Of Infection

There is a relationship between smell and taste disturbances and coronavirus infection. These symptoms have been considered the best predictor of coronavirus infection, for this reason, it was decided to evaluate the predictive value of the smell and taste test and its association with the results of SARS-CoV-2 PCR-RT and rapid diagnostic tests. in the diagnosis of pathology. Methodology: 248 patients divided into 3 groups: asymptomatic, symptomatic without chemosensory disorders, and chemosensory disorders alone. All of them underwent SARS-CoV-2 PCR-RT, a rapid diagnostic test and a test of Venezuelan smell and basic taste at the beginning. Weekly follow-up with smell and taste test and SARS-CoV-2 PCR-RT until recovery. Results: 20.56% of patients had smell and taste disorders to a variable degree and were positive by SARS-CoV-PCR-RT. 2.15.3% of patients with chemosensory disorders were negative for COVID-19. The positive predictive value of the smell and taste test was 57.3; Sensitivity 41.13% and specificity 69.35%. There were no statistically significant differences by age, sex and chemosensory disorders. The predominant chemosensory disorder was the combination of mild hyposmia and hypogeusia and appeared in the company of other symptoms. Recovery occurred in an average of 8.5 days, asynchronously with the SARS-CoV-2 RT-PCR negativization, which occurred up to more than 15 days after the senses recovered. Maximum time of negativization of the RT-PCR of 34 days. Conclusion: chemosensory disorders are a symptom and / or sign of coronavirus disease but cannot be considered as predictors of said disease in this population studied. The gold standard remains the SARS-CoV-2 PCR-RT test. Rapid diagnostic tests should be used for follow-up. Recommendations: it is necessary to expand the sample, include routine psychophysical smell and taste tests to screen cases and take race and virus mutations into consideration to explain behavior in certain populations. Key words: Smell, taste, coronavirus, test, diagnosis.

scholarly journals A prospective diagnostic evaluation of accuracy of self-taken and healthcare worker-taken swabs for rapid COVID-19 testing

2021 ◽  
Author(s):  
Helen R. Savage ◽  
Lorna Finch ◽  
Richard Body ◽  
Rachel L. Watkins ◽  
Gail Hayward ◽  
...  
Keyword(s):  
Healthcare Worker ◽  
Diagnostic Tests ◽  
Nasal Swab ◽  
Rapid Diagnostic Tests ◽  
Absolute Difference ◽  
Accuracy Evaluation ◽  
List Type ◽  
Rt Pcr ◽  
Predictive Values ◽  
Nasal Swabs

AbstractObjectivesTo compare self-taken and healthcare worker (HCW)-taken throat/nasal swabs to perform rapid diagnostic tests (RDT) for SARS-CoV-2, and how these compare to RT-PCR. We hypothesised that self-taken samples are non-inferior for use with RDTs and in clinical and research settings could have substantial individual and public health benefit.DesignA prospective diagnostic accuracy evaluation as part of the ‘Facilitating Accelerated Clinical Evaluation of Novel Diagnostic Tests for COVID -19 (FALCON C-19), workstream C (undifferentiated community testing)’.SettingNHS Test and Trace drive-through community PCR testing site (Liverpool, UK). ParticipantsEligible participants 18 years or older with symptoms of COVID-19. 250 participants recruited; one withdrew before analysis.SamplingSelf-administered throat/nasal swab for the Covios® RDT, a trained HCW taken throat/nasal sample for PCR and HCW comparison throat/nasal swab for RDT.Main outcome measuresSensitivity, specificity, and positive and negative predictive values (PPV, NPV) were calculated; comparisons between self-taken and HCW-taken samples used McNemar’s test.ResultsSeventy-five participants (75/249, 30.1%) were positive by RT-PCR. RDTs with self-taken swabs had a sensitivity of 90.5% (67/74, 95% CI: 83.9-97.2), compared to 78.4% (58/74, 95% CI: 69.0-87.8) for HCW-taken swabs (absolute difference 12.2%, 95% CI: 4.7-19.6, p=0.003). Specificity for self-taken swabs was 99.4% (173/174, 95% CI: 98.3-100.0), versus 98.9% (172/174, 95% CI: 97.3-100.0) for HCW-taken swabs (absolute difference 0.6%, 95% CI: 0.5-1.7, p=0.317). The PPV of self-taken RDTs (98.5%, 67/68, 95% CI: 95.7-100.0) and HCW-taken RDTs (96.7%, 58/60, 95% CI 92.1-100.0) were not significantly different (p=0.262). However, the NPV of self-taken swab RDTs was significantly higher (96.1%, 173/180, 95% CI: 93.2-98.9) than HCW-taken RDTs (91.5%, 172/188, 95% CI 87.5-95.5, p=0.003).ConclusionSelf-taken swabs for COVID-19 testing offer substantial individual benefits in terms of convenience, accuracy, and reduced risk of transmitting infection. Our results demonstrate that self-taken throat/nasal samples can be used by lay individuals as part of rapid testing programmes for symptomatic adults.Trial RegistrationIRAS ID:28422, clinical trial ID: NCT04408170SummaryWhat is already known on this topic?Rapid diagnostic tests (RDTs)for SARS-CoV-2 Ag are a cheaper point-of-care alternative to RT-PCR for diagnosing COVID-19 disease.The accuracy of tests can vary dependent on sampling technique, test processing and reading of results.What this study adds?Self-taken throat-nasal swabs for RDTs can be used by symptomatic adults to give reliable results to diagnose SARS-CoV-2.Self-sampling can be implemented with little training and no assistance.

scholarly journals Assessment of dengue and COVID-19 antibody rapid diagnostic tests cross-reactivity in Indonesia

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Marsha S. Santoso ◽  
Sri Masyeni ◽  
Sotianingsih Haryanto ◽  
Benediktus Yohan ◽  
Martin L. Hibberd ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
High Specificity ◽  
Cross Reactivity ◽  
Rapid Diagnostic Tests ◽  
Rt Pcr ◽  
Delayed Treatment ◽  
Health Practitioners ◽  
The World ◽  
Laboratory Features ◽  
Positive Results

Abstract Background The coronavirus disease 2019 (COVID-19) pandemic remains ongoing around the world, including in areas where dengue is endemic. Dengue and COVID-19, to some extent, have similar clinical and laboratory features, which can lead to misdiagnosis, delayed treatment and patient’s isolation. The use of rapid diagnostic tests (RDT) is easy and convenient for fast diagnosis, however there may be issues with cross-reactivity with antibodies for other pathogens. Methods We assessed the possibility of cross-reactivity between SARS-CoV-2 and dengue antibodies by: (1) testing five brands of COVID-19 IgG / IgM RDTs on 60 RT-PCR-confirmed dengue samples; (2) testing 95 RT-PCR-confirmed COVID-19 samples on dengue RDT; and (3) testing samples positive for COVID-19 IgG and/or IgM on dengue RDT. Results We observed a high specificity across all five brands of COVID-19 RDTs, ranging from 98.3 to 100%. Out of the confirmed COVID-19 samples, one patient tested positive for dengue IgM only, another tested positive for dengue IgG only. One patient tested positive for dengue IgG, IgM, and NS1, suggesting a co-infection. In COVID-19 IgG and/or IgM samples, 6.3% of COVID-19 IgG-positive samples also tested positive for dengue IgG, while 21.1% of COVID-19 IgM-positive samples also tested positive for dengue IgG. Conclusion Despite the high specificity of the COVID-19 RDT, we observed cross-reactions and false-positive results between dengue and COVID-19. Dengue and COVID-19 co-infection was also found. Health practitioners in dengue endemic areas should be careful when using antibody RDT for the diagnosis of dengue during the COVID-19 pandemic to avoid misdiagnosis.

scholarly journals Comparative performance study of three Ebola rapid diagnostic tests in Guinea

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Zelda Moran ◽  
William Rodriguez ◽  
Doré Ahmadou ◽  
Barré Soropogui ◽  
N’ Faly Magassouba ◽  
...  
Keyword(s):  
Viral Load ◽  
Diagnostic Tests ◽  
High Viral Load ◽  
Rapid Diagnostic Tests ◽  
Local Health ◽  
Performance Study ◽  
Rt Pcr ◽  
Effective Response ◽  
Ct Value ◽  
Panel Test

Abstract Background The 2014/15 Ebola outbreak in West Africa resulted in 11,000 deaths and massive strain on local health systems, and the ongoing outbreak in Democratic Republic of Congo has afflicted more than 3000 people. Accurate, rapid Ebola diagnostics suitable for field deployment would enable prompt identification and effective response to future outbreaks, yet remain largely unavailable. The purpose of this study was to assess the accuracy of three novel rapid diagnostic tests (RDTs): an Ebola, an Ebola-Malaria, and a Fever Panel test that includes Ebola, all from a single manufacturer. Methods We evaluated the three RDTs in 109 Ebola-positive and 96 Ebola-negative stored serum samples collected during the outbreak in Guinea in 2014/15, and tested by real-time polymerase chain reaction (RT-PCR). Sensitivity, specificity, and overall percent agreement were calculated for each RDT using RT-PCR as a reference standard, stratified by Ct value ranges. Results All tests performed with high accuracy on samples with low Ct value (high viral load). The Fever Panel test performed with the highest accuracy, with a sensitivity of 89.9% and specificity of 90.6%. The Ebola and Ebola-Malaria tests performed comparably to each other: sensitivity was 77.1 and 78% respectively, and specificity was 91.7% for the Ebola test and 95.8% for the Ebola-Malaria test. Conclusions This study evaluated the accuracy of three novel rapid diagnostic tests for Ebola. The tests may have significant public health relevance, particularly the Fever Panel test, which detects seven pathogens including Ebola. Given limitations to the study resulting from uncertain sample quality, further evaluation is warranted. All tests performed with highest accuracy on samples with low Ct value (high viral load), and the data presented here suggests that these RDTs may be useful for point-of-care diagnosis of cases in the context of an outbreak. Restrictions to their use in non-severe Ebola cases or for longitudinal monitoring, when viral loads are lower, may be appropriate. Highlighting the challenge in developing and evaluating Ebola RDTs, there were concerns regarding sample integrity and reference testing, and there is a need for additional research to validate these assays.

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