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

ABSTRACT Importance. Antigen-based rapid diagnostic tests (RDTs) have shown good sensitivity for SARS-CoV-2 detection in adults and are used in children despite the lack data from children. Objective. We evaluated the diagnostic performance of the PanbioTM-COVID-19 Ag Rapid Test Device (P-RDT) in symptomatic and asymptomatic children against reverse-transcription polymerase chain reaction (RT-PCR) on nasopharyngeal swabs (NPS). Design. Prospective diagnostic study from 11.2020 to 03.2021 Setting. Single-center Participants. Consecutive symptomatic and asymptomatic participants 0-16yo Intervention. Two NPS for both RT-PCR and P-RDT Main outcome. P-RDT sensitivity and specificity Results. Eight-hundred and twenty-two participants completed the study, of which 533 (64.9%) were symptomatic. Among the 119 (14.5%) RT-PCR positive patients, the overall 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 0.87 in specimens with VL>1.0E6 copies/mL (95%CI 0.87-1.00), which is the accepted cut-off for the presence of infectious virus, and decreased to 0.67 (95%CI 0.59-0.76) for specimens >1.0E3 copies/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). VL which was significantly lower in asymptomatic participants than in symptomatic ones (p<0.001). 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 and relevance. The overall respective 73% and 43% sensitivities of P-RDT in symptomatic and asymptomatic children was below the 80% cut-off recommended by the World Health Organization. These findings are likely explained by lower VLs in children at the time of diagnosis. As expected, we observed a direct 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 both in symptomatic and asymptomatic children, with the potential exception in early symptomatic children >12yrs where sensitivity reached 80%.

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

Journal of Clinical Microbiology ◽

10.1128/jcm.00991-21 ◽

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.

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Persistent Detection and Infectious Potential of SARS-CoV-2 Virus in Clinical Specimens from COVID-19 Patients

Viruses ◽

10.3390/v12121384 ◽

2020 ◽

Vol 12 (12) ◽

pp. 1384

Author(s):

Michael Zapor

Keyword(s):

Pcr Amplification ◽

World Health ◽

Rt Pcr ◽

Chain Reaction ◽

Distinctive Features ◽

Clinical Specimens ◽

Polymerase Chain ◽

Health Organization ◽

Infectious Potential ◽

Infective Potential

The Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) that emerged in December 2019 as the causative agent of Coronavirus 2019 (COVID-19) and was declared a pandemic by the World Health Organization in March 2020 has several distinctive features, including extensive multiorgan involvement with a robust systemic inflammatory response, significant associated morbidity and mortality, and prolonged persistence of viral RNA in the clinical specimens of infected individuals as detected by Reverse Transcription Polymerase Chain Reaction (RT-PCR) amplification. This review begins with an overview of SARS-CoV-2 morphology and replication and summarizes what is known to date about the detection of the virus in nasal, oropharyngeal, and fecal specimens of patients who have recovered from COVID-19, with a focus on the factors thought to contribute to prolonged detection. This review also provides a discussion on the infective potential of this material from asymptomatic, pre-symptomatic, and convalescing individuals, to include a discussion of the relative persistence and infectious potential of virus in clinical specimens recovered from pediatric COVID-19 patients.

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Multisystem inflammatory syndrome in children - a clinical example in pediatrics

Reports of Vinnytsia National Medical University ◽

10.31393/reports-vnmedical-2021-25(2)-12 ◽

2021 ◽

Vol 25 (2) ◽

pp. 258-260

Author(s):

V. M. Dudnyk ◽

V. Н. Furman ◽

I. I. Andrikevych ◽

N. O. Buglova ◽

O. V. Кutsak ◽

...

Keyword(s):

Serological Test ◽

World Health ◽

Rt Pcr ◽

The Us ◽

Control And Prevention ◽

Coronavirus Infection ◽

Polymerase Chain ◽

Health Organization ◽

Inflammatory Syndrome

Annotation. Peculiarities of clinical course and differential diagnosis of multisystem inflammatory syndrome (MIS-C) in children with coronavirus infection are described. The main features of this disease are long-term fever, multiorgan dysfunction, laboratory signs of inflammation and positive tests for SARS-CoV-2 (polymerase chain reaction using reverse transcription (RT-PCR), antigen test or positive serological test). The criteria of the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) are used to confirm the MIS-C diagnosis.

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An atypical case: RT-PCR-negative, sero-positive covid-19 patient

Pneumologia ◽

10.2478/pneum-2020-0013 ◽

2020 ◽

Vol 69 (2) ◽

pp. 107-114

Author(s):

William Suriady ◽

Andika Chandra Putra ◽

Wiwien Heru Wiyono ◽

Mohammad Fahmi Alatas ◽

Bettia Bermawi ◽

...

Keyword(s):

False Negative ◽

Severe Pneumonia ◽

World Health ◽

Diagnostic Process ◽

The Novel ◽

Rt Pcr ◽

Atypical Case ◽

Polymerase Chain ◽

Novel Coronavirus ◽

Health Organization

Abstract The novel coronavirus disease-2019 (COVID-19), caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), has become a public health emergency of international concern. The first confirmed COVID-19 case in Indonesia was announced on 2 March 2020, and later on, 11,192 confirmed cases were reported as of 3 May. The World Health Organization has stated that performing a real-time reverse transcription–polymerase chain reaction (RT-PCR) specific for SARS-CoV-2 on specimens from the upper and the lower respiratory tracts, especially nasopharyngeal and oropharyngeal swabs, is the standard diagnostic procedure for COVID-19. In Indonesia, we also use other diagnostic tests, such as rapid antibody tests specific for SARS-CoV-2. Herein, we report an atypical case of COVID-19 and describe the diagnostic process, the clinical course, with progression to severe pneumonia on Week 3 of illness and the case management. We also try to highlight the possibility of false-negative RT-PCR tests.

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Combating the Coronavirus Pandemic: Early Detection, Medical Treatment, and a Concerted Effort by the Global Community

Research ◽

10.34133/2020/6925296 ◽

2020 ◽

Vol 2020 ◽

pp. 1-35 ◽

Cited By ~ 3

Author(s):

Zichao Luo ◽

Melgious Jin Yan Ang ◽

Siew Yin Chan ◽

Zhigao Yi ◽

Yi Yiing Goh ◽

...

Keyword(s):

Respiratory Illness ◽

Viral Disease ◽

Disease Diagnosis ◽

World Health ◽

Rt Pcr ◽

Sudden Loss ◽

Difficulty Breathing ◽

Polymerase Chain ◽

Novel Coronavirus ◽

Health Organization

The World Health Organization (WHO) has declared the outbreak of 2019 novel coronavirus, known as 2019-nCoV, a pandemic, as the coronavirus has now infected over 2.6 million people globally and caused more than 185,000 fatalities as of April 23, 2020. Coronavirus disease 2019 (COVID-19) causes a respiratory illness with symptoms such as dry cough, fever, sudden loss of smell, and, in more severe cases, difficulty breathing. To date, there is no specific vaccine or treatment proven effective against this viral disease. Early and accurate diagnosis of COVID-19 is thus critical to curbing its spread and improving health outcomes. Reverse transcription-polymerase chain reaction (RT-PCR) is commonly used to detect the presence of COVID-19. Other techniques, such as recombinase polymerase amplification (RPA), loop-mediated isothermal amplification (LAMP), clustered regularly interspaced short palindromic repeats (CRISPR), and microfluidics, have allowed better disease diagnosis. Here, as part of the effort to expand screening capacity, we review advances and challenges in the rapid detection of COVID-19 by targeting nucleic acids, antigens, or antibodies. We also summarize potential treatments and vaccines against COVID-19 and discuss ongoing clinical trials of interventions to reduce viral progression.

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Multisystem Inflammatory Syndrome in Infant with Negative SARS-CoV-2 RT-PCR and Antibodies

Osteopathic Family Physician ◽

10.33181/13036 ◽

2021 ◽

pp. 35-39

Author(s):

Hanna Sahhar ◽

Karly Derwitz ◽

Erica Rubin

Keyword(s):

Polymerase Chain Reaction ◽

Severe Acute Respiratory Syndrome ◽

Early Diagnosis ◽

World Health ◽

Rt Pcr ◽

Chain Reaction ◽

The World ◽

Polymerase Chain ◽

Health Organization ◽

Inflammatory Syndrome

Since the declaration of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in March 2020 by the World Health Organization (WHO), there has been an emergence of a new syndrome termed multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19. MIS-C is defined by the presence of fever, systemic inflammation and multiorgan dysfunction in association with SARS-CoV-2 infection or COVID-19 exposure. Knowledge of this syndrome’s presentation and pathophysiology is constantly evolving as more cases are reported in the literature. This case identifies a 3-month-old patient who tested negative for SARS-CoV-2 antigen, reverse transcriptase polymerase chain reaction (RT-PCR) and antibodies but qualified for MIS-C diagnosis. To the best of our knowledge and through extensive research at the time of diagnosing and reporting this condition to the healthcare authorities, we report the youngest pediatric patient with MIS-C diagnosis. We document this case to contribute to further understanding the variable manifestations of MIS-C and the importance of early diagnosis and treatment with intravenous immunoglobulin (IVIG).

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A comprehensive review on epidemiology, aetiopathogenesis, diagnosis and treatment of the novel coronavirus syndrome – COVID-19

Iberoamerican Journal of Medicine ◽

10.53986/ibjm.2020.0019 ◽

2020 ◽

Vol 2 (2) ◽

pp. 110-123

Author(s):

Kulvinder Kochar Kaur ◽

◽

Gautam Allahbadia ◽

Mandeep Singh ◽

◽

...

Keyword(s):

Respiratory Illness ◽

World Health ◽

The Novel ◽

Rt Pcr ◽

Chain Reaction ◽

Rapid Spread ◽

Polymerase Chain ◽

Novel Coronavirus ◽

Health Organization ◽

Severe Respiratory Illness

Since the outbreak of the novel Coronavirus in December 2019 in Wuhan China, this novel Coronavirus disease(COVID-19) has spread worldwide taking not only epidemic proportions but with its rapid spread world health organization(WHO) was forced to declare it as a pandemic. The Severe Acute respiratory syndrome (SARS)-Coronavirus (CoV2) virus is responsible for clusters of severe respiratory illness that simulates acute respiratory syndrome that was what was initially. It is thought although that it is equivalent to the high altitude pulmonary oedema (HAPE), showing glass ground opacities in lungs. More experience is getting acquired with changes in treatment approaches from PEEP to avoid intubation and just ensure oxygen levels maintained. Human to human transmission through droplets, contaminated hands as well as surfaces, has been revealed with an incubation period varying from 2-14 days. Early diagnosis using reverse transcription polymerase chain reaction (RT-PCR) or computed tomography (CT) scan chest, quarantine, as well as supportive treatment are necessary for getting a cure. In this review we have tried to analyze the epidemiology, diagnosis, isolation, and treatment, including antiviral drugs like remdesivir, favipiravir, chloroquine and hydroxychloroquine, corticosteroids, antibiotics, and ivermectin. With 3 successful cases of convalescent plasma achieved in USA, trials going on in India along with vaccines are also detailed in this article.

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Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test

Medical Microbiology and Immunology ◽

10.1007/s00430-021-00710-9 ◽

2021 ◽

Author(s):

Julian A. F. Klein ◽

◽

Lisa J. Krüger ◽

Frank Tobian ◽

Mary Gaeddert ◽

...

Keyword(s):

High Viral Load ◽

Performance Comparison ◽

World Health ◽

Nasopharyngeal Swab ◽

Rapid Diagnostics ◽

Sample Collection ◽

Rt Pcr ◽

Percent Agreement ◽

Polymerase Chain ◽

Health Organization

AbstractIn 2020, the World Health Organization (WHO) recommended two SARS-CoV-2 lateral flow antigen-detecting rapid diagnostics tests (Ag-RDTs), both initially with nasopharyngeal (NP) sample collection. Independent head-to-head studies are necessary for SARS-CoV-2 Ag-RDT nasal sampling to demonstrate comparability of performance with nasopharyngeal (NP) sampling. We conducted a head-to-head comparison study of a supervised, self-collected nasal mid-turbinate (NMT) swab and a professional-collected NP swab, using the Panbio™ Ag-RDT (distributed by Abbott). We calculated positive and negative percent agreement between the sampling methods as well as sensitivity and specificity for both sampling techniques compared to the reference standard reverse transcription polymerase chain reaction (RT-PCR). A SARS-CoV-2 infection could be diagnosed by RT-PCR in 45 of 290 participants (15.5%). Comparing the NMT and NP sampling the positive percent agreement of the Ag-RDT was 88.1% (37/42 PCR positives detected; CI 75.0–94.8%). The negative percent agreement was 98.8% (245/248; CI 96.5–99.6%). The overall sensitivity of Panbio with NMT sampling was 84.4% (38/45; CI 71.2–92.3%) and 88.9% (40/45; CI 76.5–95.5%) with NP sampling. Specificity was 99.2% (243/245; CI 97.1–99.8%) for both, NP and NMT sampling. The sensitivity of the Panbio test in participants with high viral load (> 7 log10 SARS-CoV-2 RNA copies/mL) was 96.3% (CI 81.7–99.8%) for both, NMT and NP sampling. For the Panbio supervised NMT self-sampling yields comparable results to NP sampling. This suggests that nasal self-sampling could be used for to enable scaled-up population testing.Clinical Trial DRKS00021220.

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Imaging in coronavirus disease 2019 (COVID-19) pneumonia

10.17727/jmsr.2020/8s1-7 ◽

2020 ◽

Vol 8 (S1) ◽

pp. 59-68

Author(s):

Srikala MJ ◽

Yadav A

Keyword(s):

False Negative ◽

Primary Diagnosis ◽

World Health ◽

Rt Pcr ◽

Peripheral Lung ◽

The Common ◽

Polymerase Chain ◽

Novel Coronavirus ◽

Health Organization ◽

Respiratory Droplets

In December 2019, an outbreak of coronavirus disease 2019 (COVID-19) (formerly known as 2019-nCoV) pneumonia began in Wuhan (Hubei Province, China). The COVID-19 spread rapidly across China and many other countries and assumed a pandemic proportion. As of January 30, 2020, the World Health Organization (WHO) has designated this outbreak as a global health emergency. Respiratory droplets and direct contact are likely to be the most important routes of transmission. Therefore, early diagnosis and isolation becomes essential against novel coronavirus. Reverse transcriptase polymerase chain reaction (RT-PCR) is the reference standard to confirm the diagnosis of COVID-19 infection. However, more and more false negative RT-PCR results have been reported recently making the diagnosis rather challenging. Currently, HRCT is one of the best tools for screening, primary diagnosis, estimation of disease severity, and prediction of the prognosis. HRCT manifestations of COVID-19 pneumonia have not been well known. Recent studies showed that typical HRCT findings included bilateral pulmonary parenchymal ground glass and consolidative opacities, with a peripheral lung distribution However, the HRCT features of COVID-19 are very diverse, and it is difficult to differentiate it from other kinds of viral pneumonia. This article describes the salient features of COVID-19 pneumonia in lung and the temporal progression of the changes and also the common and important imaging differential diagnoses to be considered. Keywords: COVID-19; pneumonia; SARS-CoV-2; coronavirus disease; pandemic

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Contribution of CT Features in the Diagnosis of COVID-19

Canadian Respiratory Journal ◽

10.1155/2020/1237418 ◽

2020 ◽

Vol 2020 ◽

pp. 1-16

Author(s):

Houdong Zuo

Keyword(s):

World Health ◽

Rt Pcr ◽

Chain Reaction ◽

The World ◽

Novel Virus ◽

Polymerase Chain ◽

Novel Coronavirus ◽

Health Organization ◽

Diagnostic Criterion ◽

Ct Features

The outbreak of novel coronavirus disease 2019 (COVID-19) first occurred in Wuhan, Hubei Province, China, and spread across the country and worldwide quickly. It has been defined as a major global health emergency by the World Health Organization (WHO). As this is a novel virus, its diagnosis is crucial to clinical treatment and management. To date, real-time reverse transcription-polymerase chain reaction (RT-PCR) has been recognized as the diagnostic criterion for COVID-19. However, the results of RT-PCR can be complemented by the features obtained in chest computed tomography (CT). In this review, we aim to discuss the diagnosis and main CT features of patients with COVID-19 based on the results of the published literature, in order to enhance the understanding of COVID-19 and provide more detailed information regarding treatment.

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