scholarly journals Diagnostic Utility of Antigen Detection Rapid Diagnostic Tests for Covid- 19: A Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
Mina Ebrahimi ◽  
Narges Nazari Harmooshi ◽  
Fakher Rahim
Keyword(s):  
Diagnostic Tests ◽  
Point Of Care ◽  
Meta Analysis ◽  
False Negative ◽  
Rapid Test ◽  
Rapid Diagnostic Tests ◽  
Lower Sensitivity ◽  
Sample Type ◽  
Rt Pcr ◽  
Asymptomatic Patients

Background: Early detection of coronavirus disease (COVID-19) infection to improve disease management, becomes the greatest challenge. Despite high sensitivity of RT-PCR, not only it was reported that 20-67% of infected patients have false negative results. Rapid diagnostic tests (RDTs) are widely used as a point-of-care test for SARS-CoV-2 detection in both pharyngeal and blood specimens. To be less time-consuming, not seem so costly, and requiring no special training make it more favorable, but the low sensitivity is the main limitation. Several reports indicated rapid test of blood and pharyngeal samples has the same sensitivity as the RT-PCR, but some reports have lower sensitivity especial in asymptomatic patients. Methods: In the present survey, we investigate the eligible studies for sensitivity and specificity of rapid tests and explore the factors that influence the result to help better diagnose COVID-19 infection. 20 studies met the inclusion criteria, which impose 33 different tests. Results: Our findings showed, type of sample, type of assay, time of sampling, and load of virus influence on sensitivity of RDTs. Conclusion: This research extends our knowledge of how to improve the sensitivity of RDTs to better diagnose of infected patients to address the controlling COVID-19 pandemic.

scholarly journals Diagnostic Utility of Antigen Detection Rapid Diagnostic Tests for Covid- 19: a Systematic Review and Meta-analysis

2021 ◽  
Author(s):  
Somayeh Ghasemi ◽  
Narges Nazari Harmooshi ◽  
Fakher Rahim
Keyword(s):  
Diagnostic Tests ◽  
Point Of Care ◽  
Meta Analysis ◽  
False Negative ◽  
Rapid Test ◽  
Rapid Diagnostic Tests ◽  
Lower Sensitivity ◽  
Sample Type ◽  
Rt Pcr ◽  
Asymptomatic Patients

Abstract Background: Early detection of coronavirus disease (COVID-19) infection to improve disease management, becomes the greatest challenge. Despite high sensitivity of RT-PCR, not only it was reported that 20-67% of infected patients have false negative results. Rapid diagnostic tests (RDTs) are widely used as a point-of-care test for SARS-CoV-2 detection in both pharyngeal and blood specimens. To be less time-consuming, not seem so costly, and requiring no special training make it more favorable, but the low sensitivity is the main limitation. Several reports indicated rapid test of blood and pharyngeal samples has the same sensitivity as the RT-PCR, but some reports have lower sensitivity especial in asymptomatic patients. Methods: In the present survey, we investigate the eligible studies for sensitivity and specificity of rapid tests and explore the factors that influence the result to help better diagnose COVID-19 infection. 20 studies met the inclusion criteria, which impose 33 different tests. Results: Our findings showed, type of sample, type of assay, time of sampling, and load of virus influence on sensitivity of RDTs. Conclusion: This research extends our knowledge of how to improve the sensitivity of RDTs to better diagnose of infected patients to address the controlling COVID-19 pandemic.

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.

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

PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248921
Author(s):  
Alice Berger ◽  
Marie Therese Ngo Nsoga ◽  
Francisco Javier Perez-Rodriguez ◽  
Yasmine Abi Aad ◽  
Pascale Sattonnet-Roche ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Rapid Test ◽  
Diagnostic Value ◽  
Ease Of Use ◽  
Lower Sensitivity ◽  
Rt Pcr ◽  
Test Device ◽  
Community Based ◽  
Rapid Tests

Objectives Determine the diagnostic accuracy of two antigen-detecting rapid diagnostic tests (Ag-RDT) for SARS-CoV-2 at the point of care and define individuals’ characteristics providing best performance. Methods We performed a prospective, single-center, point of care validation of two Ag-RDT in comparison to RT-PCR on nasopharyngeal swabs. Results Between October 9th and 23rd, 2020, 1064 participants were enrolled. The PanbioTM 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%. Lower sensitivity of 88.2% was seen on the same day of symptom development (day 0). Conclusions We 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.

scholarly journals Nasopharyngeal Panbio COVID-19 antigen performed at point-of-care has a high sensitivity in symptomatic and asymptomatic patients with higher risk for transmission and older age

2021 ◽  
Author(s):  
Mar Masiá ◽  
Marta Fernández-González ◽  
Manuel Sánchez ◽  
Mar Carvajal ◽  
José Alberto García ◽  
...  
Keyword(s):  
Test Performance ◽  
Point Of Care ◽  
Rapid Test ◽  
High Sensitivity ◽  
Older Age ◽  
Antigen Test ◽  
Rt Pcr ◽  
Asymptomatic Patients ◽  
Clinical Scenarios ◽  
Nasal Swabs

Abstract Background Performance of point-of-care tests in different clinical scenarios and on different samples remains undetermined. We comprehensively evaluated the performance of the nasopharyngeal Panbio COVID-19 antigen Rapid-Test-Device. Method Prospective study including consecutive patients attending three primary care centers (PCC) and an emergency department. The antigen test was performed at point-of-care in nasopharyngeal and nasal swabs, and in saliva. Positive and negative percent agreement (PPA, NPA) were calculated with the RT-PCR assay as reference standard. Results Of 913 patients included, 296 (32.3%) were asymptomatic and 690 (75.6%) came from the PCC. Nasopharyngeal swabs were collected from 913, nasal swabs from 659, and saliva from 611 patients. RT-PCR was positive in 196 (21.5%) nasopharyngeal samples (NPS). Overall PPA (95% CI) in NPS was 60.5% (53.3-67.4), and it was lower in nasal swabs (44.7%) and saliva (23.1%). Test performance in NPS was largely dependent on the cycle threshold (Ct) in RT-PCR, with PPA of 94% for Ct≤25 and 80% for Ct<30. In symptomatic patients, the PPA was 95% for Ct≤25; 85% for Ct<30, and 89% for the symptom triad of fever, cough and malaise. Performance was also dependent on age, with PPA of 100% in symptomatic patients >50 years with Ct<25. In asymptomatic patients, the PPA was 86% for Ct<25. In all cases, NPA was 100%. Conclusion The nasopharyngeal Panbio COVID-19 antigen test performed at point-of-care has a good sensitivity in symptomatic patients with Ct<30 and older age. The test was useful to identify asymptomatic patients with lower Ct values.

scholarly journals Performance of SARS-CoV-2 antigen testing in symptomatic and asymptomatic adults: a single-center evaluation

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Stephanie L. Mitchell ◽  
Steven Orris ◽  
Tanner Freeman ◽  
Megan C. Freeman ◽  
Michelle Adam ◽  
...  
Keyword(s):  
Symptom Onset ◽  
Point Of Care ◽  
False Negative ◽  
Poor Performance ◽  
Nasopharyngeal Swab ◽  
Lower Sensitivity ◽  
Negative Results ◽  
Asymptomatic Patients ◽  
False Negative Results ◽  
Antigen Testing

Abstract Background Antigen testing offers rapid and inexpensive testing for SARS-CoV-2 but concerns regarding performance, especially sensitivity, remain. Limited data exists for use of antigen testing in asymptomatic patients; thus, performance and reliability of antigen testing remains unclear. Methods 148 symptomatic and 144 asymptomatic adults were included. A nasal swab was collected for testing by Quidel Sofia SARS IFA (Sofia) as point of care. A nasopharyngeal swab was also collected and transported to the laboratory for testing by Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV RT-PCR (Cepheid). Results Overall, Sofia had good agreement with Cepheid (> 95%) in adults, however was less sensitive. Sofia had a sensitivity of 87.8% and 33.3% for symptomatic and asymptomatic patients, respectively. Among symptomatic patients, testing > 5 days post symptom onset resulted in lower sensitivity (82%) when compared with testing within 5 days of symptom onset (90%). Of the four Sofia false-negative results in the asymptomatic cohort, 50% went on to develop COVID-19 disease within 5 days of testing. Specificity in both symptomatic and asymptomatic cohorts was 100%. Conclusions Sofia has acceptable performance in symptomatic adults when tested < 5 days of symptom onset. Caution should be taken when testing patients with ≥ 5 days of symptoms. The combination of low prevalence and reduced sensitivity results in relatively poor performance of in asymptomatic patients. NAAT-based diagnostic assays should be considered in when antigen testing is unreliable, particularly in symptomatic patients with > 5 days of symptom onset and asymptomatic patients.

scholarly journals Evaluation of saliva molecular point of care for detection of SARS-CoV-2 in ambulatory care

2021 ◽  
Author(s):  
Jerome Le Goff ◽  
Solen Kerneis ◽  
Caroline Elie ◽  
Severine Mercier Delarue ◽  
Nabil Gastli ◽  
...  
Keyword(s):  
Point Of Care ◽  
False Negative ◽  
Lamp Assay ◽  
Rapid Identification ◽  
Ambulatory Setting ◽  
Nasopharyngeal Swab ◽  
Lower Sensitivity ◽  
Rt Pcr ◽  
A Prospective Study ◽  
Antigen Testing

Background: The rapid identification of SARS-CoV-2 infected individuals is a cornerstone in strategies for the control of virus spread. The sensitivity of SARS-CoV-2 RNA detection by RT-PCR is similar in saliva and nasopharyngeal swab. Rapid molecular point-of-care tests in saliva could facilitate, broaden and speed up the diagnosis. Objectives and methods: We conducted a prospective study in two community COVID-19 screening centers to evaluate the performances of a CE-marked RT-LAMP assay (EasyCoV) specifically designed for the detection of SARS-CoV-2 RNA from fresh saliva samples, compared to nasopharyngeal RT-PCR as reference test, saliva RT-PCR and nasopharyngeal antigen testing. Results: Overall, 117 of the 1718 participants (7%) were tested positive with nasopharyngeal RT-PCR. Sensitivities of saliva RT-PCR and nasopharyngeal antigen test were 93% (95% Confidence Interval (95%CI): 86-97) and 85% (95%CI: 77-91), respectively. The sensitivity and specificity of the RT-LAMP assay in saliva were 34% (95%CI: 26-44) and 97% (95%CI: 96-98). The performance was similar in symptomatic and asymptomatic participants and whatever the reference standard considered. Ct values of nasopharyngeal RT-PCR were significantly lower in the 40 true positive subjects with saliva RT-LAMP (Ct 25.9) than in the 48 false negative subjects with saliva RT-LAMP (Ct 28.4) (p=0.028). Conclusion: In the ambulatory setting, the detection of SARS-CoV-2 from crude saliva samples with the RT-LAMP assay had a lower sensitivity than nasopharyngeal RT-PCR, saliva RT-PCR and nasopharyngeal antigen testing.

scholarly journals Antibody tests in detecting SARS-CoV-2 infection: a meta-analysis

2020 ◽  
Author(s):  
Panagiota I Kontou ◽  
Georgia G Braliou ◽  
Niki L Dimou ◽  
Georgios Nikolopoulos ◽  
Pantelis G Bagos
Keyword(s):  
Diagnostic Tests ◽  
Point Of Care ◽  
Meta Analysis ◽  
High Specificity ◽  
Enzyme Linked Immunosorbent Assay ◽  
Lower Sensitivity ◽  
Serological Tests ◽  
Bivariate Method ◽  
Acid Test ◽  
Antibody Tests

SummaryBackgroundWith the emergence of SARS-CoV-2 and the associated Coronavirus disease 2019 (COVID-19), there is an imperative need for diagnostic tests that can identify the infection. Although Nucleic Acid Test (NAT) is considered to be the gold standard, serological tests based on antibodies could be very helpful. However, individual studies measuring the accuracy of the various tests are usually underpowered and inconsistent, thus, a comparison of different tests is needed.MethodsWe performed a systematic review and meta-analysis following the PRISMA guidelines. We conducted the literature search in PubMed, medRxiv and bioRxiv. For the statistical analysis we used the bivariate method for meta-analysis of diagnostic tests pooling sensitivities and specificities. We evaluated IgM and IgG tests based on Enzyme-linked immunosorbent assay (ELISA), Chemiluminescence Enzyme Immunoassays (CLIA), Fluorescence Immunoassays (FIA) and the point-of-care (POC) Lateral Flow Immunoassays (LFIA) that are based on immunochromatography.FindingsIn total, we identified 38 eligible studies that include data from 7,848 individuals. The analyses showed that tests using the S antigen are more sensitive than N antigen-based tests. IgG tests perform better compared to IgM ones, and show better sensitivity when the samples were taken longer after the onset of symptoms. Moreover, irrespective of the method, a combined IgG/IgM test seems to be a better choice in terms of sensitivity than measuring either antibody type alone. All methods yielded high specificity with some of them (ELISA and LFIA) reaching levels around 99%. ELISA- and CLIA-based methods performed better in terms of sensitivity (90-94%) followed by LFIA and FIA with sensitivities ranging from 80% to 86%.InterpretationELISA tests could be a safer choice at this stage of the pandemic. POC tests (LFIA), that are more attractive for large seroprevalence studies show high specificity but lower sensitivity and this should be taken into account when designing and performing seroprevalence studies.FundingNone

scholarly journals Diagnostic accuracy of SARS-CoV-2 rapid antigen detection testing in symptomatic and asymptomatic children in the clinical setting

2021 ◽  
Author(s):  
Arnaud G. L’Huillier ◽  
Matthieu Lacour ◽  
Debora Sadiku ◽  
Mehdi A. Gadiri ◽  
Loraine De Siebenthal ◽  
...  
Keyword(s):  
Viral Load ◽  
Diagnostic Accuracy ◽  
Diagnostic Tests ◽  
Diagnostic Performance ◽  
Rapid Test ◽  
Rapid Diagnostic Tests ◽  
Rt Pcr ◽  
Test Device ◽  
Asymptomatic Children ◽  
Post Onset

Background. Antigen-based rapid diagnostic tests (RDTs) are used in children despite the lack of data. We evaluated the diagnostic performance of the Panbio TM -COVID-19 Ag Rapid Test Device (P-RDT) in children. Methods. Symptomatic and asymptomatic participants 0-16yo had two NPS for both RT-PCR and P-RDT Results. 822 participants completed the study, of which 533 (64.9%) were symptomatic. Among the 119 (14.5%) RT-PCR-positive patients, the P-RDT sensitivity was 0.66 (95%CI 0.57-0.74). Mean viral load (VL) was higher among P-RDT-positive than negative ones (p<0.001). Sensitivity was 0.91 in specimens with VL>1.0E6 IU/mL (95%CI 0.83-0.99), and decreased to 0.75 (95%CI 0.66-0.83) for specimens >1.0E3 IU/mL. Among symptomatic participants, the P-RDT displayed a sensitivity of 0.73 (95%CI 0.64-0.82), which peaked at 1.00 at 2 days post-onset of symptoms (DPOS; 95%CI 1.00-1.00), then decreased to 0.56 (95%CI 0.23-0.88) at 5 DPOS. There was a trend towards lower P-RDT sensitivity in symptomatic children <12 years (0.62 [95%CI 0.45-0.78]) versus ≥12 years (0.80 [95%CI 0.69-0.91]; p=0.09). In asymptomatic participants, the P-RDT displayed a sensitivity of 0.43 (95%CI 0.26-0.61). Specificity was 1.00 in symptomatic and asymptomatic children (95%CI 0.99-1.00). Conclusion . The overall respective 73% and 43% sensitivities of P-RDT in symptomatic and asymptomatic children was below the 80% cut-off recommended by the WHO. We observed a correlation between VL and P-RDT sensitivity as well as variation of sensitivity according to DPOS, a major determinant of VL. These data highlight the limitations of RDTs in children, with the potential exception in early symptomatic children ≥12yrs.

scholarly journals Evaluation of saliva molecular point of care for detection of SARS-CoV-2 in ambulatory care

2021 ◽  
Author(s):  
Jérôme LeGoff ◽  
Solen Kernéis ◽  
Caroline Elie ◽  
Séverine Mercier Delarue ◽  
Nabil Gastli ◽  
...  
Keyword(s):  
Point Of Care ◽  
False Negative ◽  
Lamp Assay ◽  
Rapid Identification ◽  
Nasopharyngeal Swab ◽  
Lower Sensitivity ◽  
Rt Pcr ◽  
Registration Number ◽  
A Prospective Study ◽  
Antigen Testing

Abstract Background Rapid identification of SARS-Cov-2 infected individuals is a cornerstone for the control of virus spread. The sensitivity of SARS-CoV-2 RNA detection by RT-PCR is similar in saliva and nasopharyngeal swab. Rapid molecular point-of-care tests in saliva could facilitate, broaden and speed up the diagnosis. Methods We conducted a prospective study in two community COVID-19 screening centers to evaluate the performances of a CE-marked RT-LAMP assay (EasyCoV™) designed for the detection of SARS-CoV2 RNA from fresh saliva samples, compared to nasopharyngeal RT-PCR, to saliva RT-PCR and to nasopharyngeal antigen testing. Results Overall, 117 of the 1718 participants (7%) were tested positive with nasopharyngeal RT-PCR. Compared to nasopharyngeal RT-PCR, the sensitivity and specificity of the RT-LAMP assay in saliva were 34% and 97% respectively. The Ct values of nasopharyngeal RT-PCR were significantly lower in the 40 true positive subjects with saliva RT-LAMP (Ct 25.9) than in the 48 false negative subjects with saliva RT-LAMP (Ct 28.4) (p = 0.028). Considering six alternate criteria for reference test, including saliva RT-PCR and nasopharyngeal antigen, the sensitivity of saliva RT-LAMP ranged between 27 and 44%. Conclusion The detection of SARS-CoV-2 from crude saliva samples with a RT-LAMP assay had a lower sensitivity than nasopharyngeal RT-PCR, saliva RT-PCR and nasopharyngeal antigen testing. Registration number : NCT04578509

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