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 ◽  
...  

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.

2021 ◽  
Author(s):  
Mina Ebrahimi ◽  
Narges Nazari Harmooshi ◽  
Fakher Rahim

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.


2021 ◽  
Author(s):  
Somayeh Ghasemi ◽  
Narges Nazari Harmooshi ◽  
Fakher Rahim

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.


Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 363
Author(s):  
Vânia M. Moreira ◽  
Paulo Mascarenhas ◽  
Vanessa Machado ◽  
João Botelho ◽  
José João Mendes ◽  
...  

The rapid and accurate testing of SARS-CoV-2 infection is still crucial to mitigate, and eventually halt, the spread of this disease. Currently, nasopharyngeal swab (NPS) and oropharyngeal swab (OPS) are the recommended standard sampling techniques, yet, these have some limitations such as the complexity of collection. Hence, several other types of specimens that are easier to obtain are being tested as alternatives to nasal/throat swabs in nucleic acid assays for SARS-CoV-2 detection. This study aims to critically appraise and compare the clinical performance of RT-PCR tests using oral saliva, deep-throat saliva/posterior oropharyngeal saliva (DTS/POS), sputum, urine, feces, and tears/conjunctival swab (CS) against standard specimens (NPS, OPS, or a combination of both). In this systematic review and meta-analysis, five databases (PubMed, Scopus, Web of Science, ClinicalTrial.gov and NIPH Clinical Trial) were searched up to the 30th of December, 2020. Case-control and cohort studies on the detection of SARS-CoV-2 were included. The methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS 2). We identified 1560 entries, 33 of which (1.1%) met all required criteria and were included for the quantitative data analysis. Saliva presented the higher accuracy, 92.1% (95% CI: 70.0–98.3), with an estimated sensitivity of 83.9% (95% CI: 77.4–88.8) and specificity of 96.4% (95% CI: 89.5–98.8). DTS/POS samples had an overall accuracy of 79.7% (95% CI: 43.3–95.3), with an estimated sensitivity of 90.1% (95% CI: 83.3–96.9) and specificity of 63.1% (95% CI: 36.8–89.3). The remaining index specimens could not be adequately assessed given the lack of studies available. Our meta-analysis shows that saliva samples from the oral region provide a high sensitivity and specificity; therefore, these appear to be the best candidates for alternative specimens to NPS/OPS in SARS-CoV-2 detection, with suitable protocols for swab-free sample collection to be determined and validated in the future. The distinction between oral and extra-oral salivary samples will be crucial, since DTS/POS samples may induce a higher rate of false positives. Urine, feces, tears/CS and sputum seem unreliable for diagnosis. Saliva testing may increase testing capacity, ultimately promoting the implementation of truly deployable COVID-19 tests, which could either work at the point-of-care (e.g. hospitals, clinics) or at outbreak control spots (e.g., schools, airports, and nursing homes).


2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Wenjun Zhu ◽  
XiaoXiao Ling ◽  
Wenru Shang ◽  
Yanqiu Du ◽  
Jinyu Liu ◽  
...  

2016 ◽  
Vol 15 (1) ◽  
Author(s):  
Alinune N. Kabaghe ◽  
Benjamin J. Visser ◽  
Rene Spijker ◽  
Kamija S. Phiri ◽  
Martin P. Grobusch ◽  
...  

2018 ◽  
Vol 5 (6) ◽  
pp. e277-e290 ◽  
Author(s):  
Carmen Figueroa ◽  
Cheryl Johnson ◽  
Nathan Ford ◽  
Anita Sands ◽  
Shona Dalal ◽  
...  

Author(s):  
Alice Berger ◽  
Marie Therese Ngo Nsoga ◽  
Francisco Javier Perez-Rodriguez ◽  
Yasmine Abi Aad ◽  
Pascale Sattonnet-Roche ◽  
...  

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.


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