Diagnostic Accuracy of Rapid Antigen Test Kits for Detecting SARS-CoV-2: A Systematic Review and Meta-Analysis of 17,171 Suspected COVID-19 Patients

Khandker, Shahad Saif; Hashim, Nik Haszroel Hysham Nik; Deris, Zakuan Zainy; Shueb, Rafidah Hanim; Islam, Asiful

doi:10.3390/jcm10163493

Cited by 91 publications

(83 citation statements)

References 58 publications

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“…RT-PCR is used to detect reinfection cases after vaccination. Mass testing with highly sensitive rapid antigen testing (RAT), capable of detecting COVID-19 infection in the acute phase, is crucial in monitoring reinfection cases post-vaccination [240][241][242]. Vaccine antigen-specific sero-monitoring and memory T/B-cell persistence are also essential determinants for the requirement of booster doses and epitope modification in vaccine designing.…”

Section: Importance Of the Integration Of Diagnostic Assays Pre-and Post-vaccinationmentioning

confidence: 99%

A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

Khandker¹,

Godman

Jawad

et al. 2021

Vaccines

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COVID-19 vaccines are indispensable, with the number of cases and mortality still rising, and currently no medicines are routinely available for reducing morbidity and mortality, apart from dexamethasone, although others are being trialed and launched. To date, only a limited number of vaccines have been given emergency use authorization by the US Food and Drug Administration and the European Medicines Agency. There is a need to systematically review the existing vaccine candidates and investigate their safety, efficacy, immunogenicity, unwanted events, and limitations. The review was undertaken by searching online databases, i.e., Google Scholar, PubMed, and ScienceDirect, with finally 59 studies selected. Our findings showed several types of vaccine candidates with different strategies against SARS-CoV-2, including inactivated, mRNA-based, recombinant, and nanoparticle-based vaccines, are being developed and launched. We have compared these vaccines in terms of their efficacy, side effects, and seroconversion based on data reported in the literature. We found mRNA vaccines appeared to have better efficacy, and inactivated ones had fewer side effects and similar seroconversion in all types of vaccines. Overall, global variant surveillance and systematic tweaking of vaccines, coupled with the evaluation and administering vaccines with the same or different technology in successive doses along with homologous and heterologous prime-booster strategy, have become essential to impede the pandemic. Their effectiveness appreciably outweighs any concerns with any adverse events.

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Section: Importance Of the Integration Of Diagnostic Assays Pre-and Post-vaccinationmentioning

confidence: 99%

A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

Khandker¹,

Godman

Jawad

et al. 2021

Vaccines

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“…Before this study, we previously assumed that COVID-19 and dengue diagnoses could be affected by a misclassification bias which could stem from the poor sensitivity of both SARS-CoV-2 molecular and DENV NS1 antigen tests rather than from their false positives [ 9 ]. This putative bias was believed to be minimal given that, firstly, on Reunion Island, like anywhere else during the rise of the COVID-19 pandemic [ 21 ], there was little cocirculation of other respiratory viruses that could have competed with SARS-CoV-2 and caused false negatives, [ 22 ], and secondly, for COVID-19, negative samples were retested by RT-PCR upon onset of new symptoms, meaning that rapid antibody or antigenic tests were ruled out, while for dengue, the workup was completed by a RT-PCR or a serology test to downsize false negative and false positive proportions [ [23] , [24] , [25] ]. This caution decision rule likely pledges the diagnostic accuracy of our gold standards.…”

Section: Discussionmentioning

confidence: 99%

“…At an individual risk level, predictions should be guided using first of all calibration performances (calibration plots and goodness-of-fit metrics) [ 25 ]. Our findings showed that the calibration of the models ( Tables S6–S8 ) and their derived scores ( Table S9 ) were excellent and consensual for dengue which enables individual risk prediction and satisfactory for COVID-19 which suggests caution for individual risk prediction.…”

Section: Discussionmentioning

confidence: 99%

Differentiating COVID-19 and dengue from other febrile illnesses in co-epidemics: Development and internal validation of COVIDENGUE scores

Gérardin

Maillard

Bruneau

et al. 2022

Travel Medicine and Infectious Disease

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Objectives The purpose of this cohort study was to develop two scores able to differentiate coronavirus 2019 (COVID-19) from dengue and other febrile illnesses (OFIs). Methods All subjects suspected of COVID-19 who attended the SARS-CoV-2 testing center of Saint-Pierre hospital, Reunion, between March 23 and May 10, 2020, were assessed for identifying predictors of both infectious diseases from a multinomial logistic regression model. Two scores were developed after weighting the odd ratios then validated by bootstrapping. Results Over 49 days, 80 COVID-19, 60 non-severe dengue and 872 OFIs were diagnosed. The translation of the best fit model yielded two scores composed of 11 criteria: contact with a COVID-19 positive case (+3 points for COVID-19; 0 point for dengue), return from travel abroad within 15 days (+3/-1), previous individual episode of dengue (+1/+3), active smoking (−3/0), body ache (0/+5), cough (0/-2), upper respiratory tract infection symptoms (−1/-1), anosmia (+7/-1), headache (0/+5), retro-orbital pain (−1/+5), and delayed presentation (>3 days) to hospital (+1/0). The area under the receiver operating characteristic curve was 0.79 (95%CI 0.76–0.82) for COVID-19 score and 0.88 (95%CI 0.85–0.90) for dengue score. Calibration was satisfactory for COVID-19 score and excellent for dengue score. For predicting COVID-19, sensitivity was 97% at the 0-point cut-off and specificity 99% at the 10-point cut-off. For predicting dengue, sensitivity was 97% at the 3-point cut-off and specificity 98% at the 11-point cut-off. Conclusions COVIDENGUE scores proved discriminant to differentiate COVID-19 and dengue from OFIs in the context of SARS-CoV-2 testing center during a co-epidemic.

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“…Previous publications have identified the sensitivity and specificity of other antigen-detection methods, including a meta-analysis of 29 studies on rapid antigen tests that indicate overall pooled sensitivity and specificity as 68% and 99% [ 38 ], and a recent large-scale study on a rapid antigen test (Roche/SD Biosensor) has shown similar diagnostic accuracy with 65% sensitivity and 100% specificity [ 39 ]. The immunofluorescence assay yields comparable sensitivity of 59% and specificity of 98%, owing to cross-reactivity with SARS-CoV.…”

Section: Discussionmentioning

confidence: 99%

In-House Immunofluorescence Assay for Detection of SARS-CoV-2 Antigens in Cells from Nasopharyngeal Swabs as a Diagnostic Method for COVID-19

et al. 2021

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Immunofluorescence is a traditional diagnostic method for respiratory viruses, allowing rapid, simple and accurate diagnosis, with specific benefits of direct visualization of antigens-of-interest and quality assessment. This study aims to evaluate the potential of indirect immunofluorescence as an in-house diagnostic method for SARS-CoV-2 antigens from nasopharyngeal swabs (NPS). Three primary antibodies raised from mice were used for immunofluorescence staining, including monoclonal antibody against SARS-CoV nucleocapsid protein, and polyclonal antibodies against SARS-CoV-2 nucleocapsid protein and receptor-binding domain of SARS-CoV-2 spike protein. Smears of cells from NPS of 29 COVID-19 patients and 20 non-infected individuals, and cells from viral culture were stained by the three antibodies. Immunofluorescence microscopy was used to identify respiratory epithelial cells with positive signals. Polyclonal antibody against SARS-CoV-2 N protein had the highest sensitivity and specificity among the three antibodies tested, detecting 17 out of 29 RT-PCR-confirmed COVID-19 cases and demonstrating no cross-reactivity with other tested viruses except SARS-CoV. Detection of virus-infected cells targeting SARS-CoV-2 N protein allow identification of infected individuals, although accuracy is limited by sample quality and number of respiratory epithelial cells. The potential of immunofluorescence as a simple diagnostic method was demonstrated, which could be applied by incorporating antibodies targeting SARS-CoV-2 into multiplex immunofluorescence panels used clinically, such as for respiratory viruses, thus allowing additional routine testing for diagnosis and surveillance of SARS-CoV-2 even after the epidemic has ended with low prevalence of COVID-19.

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Diagnostic Accuracy of Rapid Antigen Test Kits for Detecting SARS-CoV-2: A Systematic Review and Meta-Analysis of 17,171 Suspected COVID-19 Patients

Cited by 91 publications

References 58 publications

A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

Differentiating COVID-19 and dengue from other febrile illnesses in co-epidemics: Development and internal validation of COVIDENGUE scores

In-House Immunofluorescence Assay for Detection of SARS-CoV-2 Antigens in Cells from Nasopharyngeal Swabs as a Diagnostic Method for COVID-19

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