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15 pages, 3551 KiB

Open AccessArticle

Rapid Shift from SARS-CoV-2 Delta to Omicron Sub-Variants within a Dynamic Southern U.S. Borderplex

by Elisa Robles-Escajeda, Jonathon E. Mohl, Lisett Contreras, Ana P. Betancourt, Bibiana M. Mancera, Robert A. Kirken and Georgialina Rodriguez

Viruses 2023, 15(3), 658; https://doi.org/10.3390/v15030658 - 28 Feb 2023

Cited by 3 | Viewed by 1393

Abstract

COVID-19, caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), remains an ongoing global health challenge. This study analyzed 3641 SARS-CoV-2 positive samples from the El Paso, Texas, community and hospitalized patients over 48 weeks from Fall 2021 to Summer 2022. The [...] Read more.

COVID-19, caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), remains an ongoing global health challenge. This study analyzed 3641 SARS-CoV-2 positive samples from the El Paso, Texas, community and hospitalized patients over 48 weeks from Fall 2021 to Summer 2022. The binational community along the U.S. southern border was predominantly SARS-CoV-2 Delta variant (B.1.617.2) positive for a 5-week period from September 2021 to January 2022 and quickly transitioned to the Omicron variant (B.1.1.529), which was first detected at the end of December 2021. Omicron replaced Delta as the predominant detectable variant in the community and was associated with a sharp increase in COVID-19 positivity rate, related hospitalizations, and newly reported cases. In this study, Omicron BA.1, BA.4, and BA.5 variants were overwhelmingly associated with S-gene dropout by qRT-PCR analysis unlike the Delta and Omicron BA.2 variants. The study reveals that a dominant variant, like Delta, can be rapidly replaced by a more transmissible variant, like Omicron, within a dynamic metropolitan border city, necessitating enhanced monitoring, readiness, and response from public health officials and healthcare workers. Full article

(This article belongs to the Special Issue COVID-19 Diagnostics in Clinical Applications and Pandemic Control)

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13 pages, 800 KiB

Open AccessArticle

Baseline Plasma Osteopontin Protein Elevation Predicts Adverse Outcomes in Hospitalized COVID-19 Patients

by Stelvio Tonello, Davide D’Onghia, Daria Apostolo, Erica Matino, Martina Costanzo, Giuseppe Francesco Casciaro, Alessandro Croce, Eleonora Rizzi, Erika Zecca, Anita Rebecca Pedrinelli, Veronica Vassia, Paolo Ravanini, Maria Grazia Crobu, Manuela Rizzi, Raffaella Landi, Luigi Mario Castello, Rosalba Minisini, Gian Carlo Avanzi, Mario Pirisi, Daniele Lilleri, Mattia Bellan, Donato Colangelo and Pier Paolo Sainaghi Show full author list Hide full author list

Viruses 2023, 15(3), 630; https://doi.org/10.3390/v15030630 - 25 Feb 2023

Cited by 7 | Viewed by 1634

Abstract

More than three years have passed since the first case, and COVID-19 is still a health concern, with several open issues such as the lack of reliable predictors of a patient’s outcome. Osteopontin (OPN) is involved in inflammatory response to infection and in [...] Read more.

More than three years have passed since the first case, and COVID-19 is still a health concern, with several open issues such as the lack of reliable predictors of a patient’s outcome. Osteopontin (OPN) is involved in inflammatory response to infection and in thrombosis driven by chronic inflammation, thus being a potential biomarker for COVID-19. The aim of the study was to evaluate OPN for predicting negative (death or need of ICU admission) or positive (discharge and/or clinical resolution within the first 14 days of hospitalization) outcome. We enrolled 133 hospitalized, moderate-to-severe COVID-19 patients in a prospective observational study between January and May 2021. Circulating OPN levels were measured by ELISA at admission and at day 7. The results showed a significant correlation between higher plasma concentrations of OPN at hospital admission and a worsening clinical condition. At multivariate analysis, after correction for demographic (age and gender) and variables of disease severity (NEWS2 and PiO2/FiO2), OPN measured at baseline predicted an adverse prognosis with an odds ratio of 1.01 (C.I. 1.0–1.01). At ROC curve analysis, baseline OPN levels higher than 437 ng/mL predicted a severe disease evolution with 53% sensitivity and 83% specificity (area under the curve 0.649, p = 0.011, likelihood ratio of 1.76, (95% confidence interval (CI): 1.35–2.28)). Our data show that OPN levels determined at the admission to hospital wards might represent a promising biomarker for early stratification of patients’ COVID-19 severity. Taken together, these results highlight the involvement of OPN in COVID-19 evolution, especially in dysregulated immune response conditions, and the possible use of OPN measurements as a prognostic tool in COVID-19. Full article

(This article belongs to the Special Issue COVID-19 Diagnostics in Clinical Applications and Pandemic Control)

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14 pages, 2743 KiB

Open AccessArticle

Efficacy Validation of SARS-CoV-2-Inactivation and Viral Genome Stability in Saliva by a Guanidine Hydrochloride and Surfactant-Based Virus Lysis/Transport Buffer

by James Gitau Komu, Dulamjav Jamsransuren, Sachiko Matsuda, Haruko Ogawa and Yohei Takeda

Viruses 2023, 15(2), 509; https://doi.org/10.3390/v15020509 - 11 Feb 2023

Cited by 3 | Viewed by 2089

Abstract

To enhance biosafety and reliability in SARS-CoV-2 molecular diagnosis, virus lysis/transport buffers should inactivate the virus and preserve viral RNA under various conditions. Herein, we evaluated the SARS-CoV-2-inactivating activity of guanidine hydrochloride (GuHCl)- and surfactant (hexadecyltrimethylammonium chloride (Hexa-DTMC))-based buffer, Prep Buffer A, (Precision [...] Read more.

To enhance biosafety and reliability in SARS-CoV-2 molecular diagnosis, virus lysis/transport buffers should inactivate the virus and preserve viral RNA under various conditions. Herein, we evaluated the SARS-CoV-2-inactivating activity of guanidine hydrochloride (GuHCl)- and surfactant (hexadecyltrimethylammonium chloride (Hexa-DTMC))-based buffer, Prep Buffer A, (Precision System Science Co., Ltd., Matsudo, Japan) and its efficacy in maintaining the stability of viral RNA at different temperatures using the traditional real-time one-step RT-PCR and geneLEAD VIII sample-to-result platform. Although Prep Buffer A successfully inactivated SARS-CoV-2 in solutions with high and low organic substance loading, there was considerable viral genome degradation at 35 °C compared with that at 4 °C. The individual roles of GuHCl and Hexa-DTMC in virus inactivation and virus genome stability at 35 °C were clarified. Hexa-DTMC alone (0.384%), but not 1.5 M GuHCl alone, exhibited considerable virucidal activity, suggesting that it was essential for potently inactivating SARS-CoV-2 using Prep Buffer A. GuHCl and Hexa-DTMC individually reduced the viral copy numbers to the same degree as Prep Buffer A. Although both components inhibited RNase activity, Hexa-DTMC, but not GuHCl, directly destroyed naked viral RNA. Our findings suggest that samples collected in Prep Buffer A should be stored at 4 °C when RT-PCR will not be performed for several days. Full article

(This article belongs to the Special Issue COVID-19 Diagnostics in Clinical Applications and Pandemic Control)

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19 pages, 3720 KiB

Open AccessArticle

Single-Center Experience in Detecting Influenza Virus, RSV and SARS-CoV-2 at the Emergency Department

by Manfred Nairz, Theodora Todorovic, Clemens M. Gehrer, Philipp Grubwieser, Francesco Burkert, Martina Zimmermann, Kristina Trattnig, Werner Klotz, Igor Theurl, Rosa Bellmann-Weiler and Günter Weiss

Viruses 2023, 15(2), 470; https://doi.org/10.3390/v15020470 - 08 Feb 2023

Cited by 3 | Viewed by 1965

Abstract

Reverse transcription polymerase chain reaction (RT-PCR) on respiratory tract swabs has become the gold standard for sensitive and specific detection of influenza virus, respiratory syncytial virus (RSV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In this retrospective analysis, we report on the [...] Read more.

Reverse transcription polymerase chain reaction (RT-PCR) on respiratory tract swabs has become the gold standard for sensitive and specific detection of influenza virus, respiratory syncytial virus (RSV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In this retrospective analysis, we report on the successive implementation and routine use of multiplex RT-PCR testing for patients admitted to the Internal Medicine Emergency Department (ED) at a tertiary care center in Western Austria, one of the hotspots in the early coronavirus disease 2019 (COVID-19) pandemic in Europe. Our description focuses on the use of the Cepheid^® Xpert^® Xpress closed RT-PCR system in point-of-care testing (POCT). Our indications for RT-PCR testing changed during the observation period: From the cold season 2016/2017 until the cold season 2019/2020, we used RT-PCR to diagnose influenza or RSV infection in patients with fever and/or respiratory symptoms. Starting in March 2020, we used the RT-PCR for SARS-CoV-2 and a multiplex version for the combined detection of all these three respiratory viruses to also screen subjects who did not present with symptoms of infection but needed in-hospital medical treatment for other reasons. Expectedly, the switch to a more liberal RT-PCR test strategy resulted in a substantial increase in the number of tests. Nevertheless, we observed an immediate decline in influenza virus and RSV detections in early 2020 that coincided with public SARS-CoV-2 containment measures. In contrast, the extensive use of the combined RT-PCR test enabled us to monitor the re-emergence of influenza and RSV detections, including asymptomatic cases, at the end of 2022 when COVID-19 containment measures were no longer in place. Our analysis of PCR results for respiratory viruses from a real-life setting at an ED provides valuable information on the epidemiology of those infections over several years, their contribution to morbidity and need for hospital admission, the risk for nosocomial introduction of such infection into hospitals from asymptomatic carriers, and guidance as to how general precautions and prophylactic strategies affect the dynamics of those infections. Full article

(This article belongs to the Special Issue COVID-19 Diagnostics in Clinical Applications and Pandemic Control)

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15 pages, 1336 KiB

Open AccessArticle

Seroprevalence of Natural and Acquired Immunity against the SARS-CoV-2 Virus in a Population Cohort from Two Chilean Cities, 2020–2022

by Loreto Núñez-Franz, Muriel Ramírez-Santana, Paola Rubilar, Cecilia Vial, Mauricio Apablaza, Claudia González, Macarena Said, Kathya Olivares, Lina Jimena Cortés, Juan Hormazábal, Luis Canales, Pablo Vial, Gloria Icaza, Rubén Quezada-Gaete and Ximena Aguilera

Viruses 2023, 15(1), 201; https://doi.org/10.3390/v15010201 - 10 Jan 2023

Cited by 3 | Viewed by 1594

Abstract

Background: Chile has achieved the highest coverage for vaccines against the SARS-CoV-2 virus worldwide. Objective: To assess the progression of immunity (natural and acquired by vaccine) in a cohort from two Chilean cities. Methods: Individuals (n = 386) who participated in three [...] Read more.

Background: Chile has achieved the highest coverage for vaccines against the SARS-CoV-2 virus worldwide. Objective: To assess the progression of immunity (natural and acquired by vaccine) in a cohort from two Chilean cities. Methods: Individuals (n = 386) who participated in three phases of population-based serial prevalence studies were included (2020–2021 and 2022). Presence of SARS-CoV-2 antibodies was measured in serum. Data including time of vaccination and type of vaccine received were analysed with descriptive statistics. Results: Seroprevalence was 3.6% in the first round and increased to 96.9% in the second and 98.7% in the third. In the third round, 75% of individuals who had received the basal full scheme were seropositive at 180 days or more since their last dose; 98% of individuals who received one booster dose were seropositive at 180 days or more, and 100% participants who received two boosters were seropositive, regardless of time since their last dose. Participants receiving mRNA vaccines had higher seroprevalence rates over time. Conclusions: The high vaccination coverage in Chile enabled the population to maintain high levels of antibodies. Vaccination boosters are essential to maintain immunity over time, which also depends on the type of vaccine administered. Full article

(This article belongs to the Special Issue COVID-19 Diagnostics in Clinical Applications and Pandemic Control)

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11 pages, 3354 KiB

Open AccessArticle

Sensibility and Specificity of the VitaPCR™ SARS-CoV-2 Assay for the Rapid Diagnosis of COVID-19 in Older Adults in the Emergency Department

by Francesco Piacenza, Antonio Cherubini, Roberta Galeazzi, Maurizio Cardelli, Robertina Giacconi, Elisa Pierpaoli, Francesca Marchegiani, Fiorella Marcheselli, Rina Recchioni, Tiziana Casoli, Elisabetta Farnocchia, Beatrice Bartozzi, Belinda Giorgetti, Pierpaolo Stripoli, Anna Rita Bonfigli, Massimiliano Fedecostante, Fabio Salvi, Adolfo Pansoni, Mauro Provinciali and Fabrizia Lattanzio

Viruses 2023, 15(1), 189; https://doi.org/10.3390/v15010189 - 09 Jan 2023

Viewed by 1221

Abstract

(1) Background: During the COVID-19 pandemic, rapid and reliable diagnostic tools are needed for detecting SARS-CoV-2 infection in urgent cases at admission to the hospital. We aimed to assess the performances of the rapid molecular VitaPCR™ test (Menarini Diagnostics) in a sample of [...] Read more.

(1) Background: During the COVID-19 pandemic, rapid and reliable diagnostic tools are needed for detecting SARS-CoV-2 infection in urgent cases at admission to the hospital. We aimed to assess the performances of the rapid molecular VitaPCR™ test (Menarini Diagnostics) in a sample of older adults admitted to the Emergency Department of two Italian hospitals (2) Methods: The comparison between the rapid VitaPCR™ and the RT-PCR was performed in 1695 samples. Two naso-pharyngeal swab samplings from each individual were obtained and processed using the VitaPCR™ and the RT-PCR for the detection of SARS-CoV-2 (3) Results: VitaPCR™ exhibited good precision (<3% CV) and an almost perfect overall agreement (Cohen’s K = 0.90) with the RT-PCR. The limit of detection of the VitaPCR™ was 4.1 copies/µL. Compared to the RT-PCR, the sensitivity, the specificity, and the positive and negative predictive values of VitaPCR™ were 83.4%, 99.9%, 99.2% and 98.3%, respectively (4) Conclusions: The VitaPCR™ showed similar sensitivity and specificity to other molecular-based rapid tests. This study suggests that the VitaPCR™ can allow the rapid management of patients within the Emergency Department. Nevertheless, it is advisable to obtain a negative result by a RT-PCR assay before admitting a patient to a regular ward. Full article

(This article belongs to the Special Issue COVID-19 Diagnostics in Clinical Applications and Pandemic Control)

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14 pages, 3034 KiB

Open AccessArticle

Clinical Application of Detecting COVID-19 Risks: A Natural Language Processing Approach

by Syed Raza Bashir, Shaina Raza, Veysel Kocaman and Urooj Qamar

Viruses 2022, 14(12), 2761; https://doi.org/10.3390/v14122761 - 11 Dec 2022

Cited by 1 | Viewed by 2125

Abstract

The clinical application of detecting COVID-19 factors is a challenging task. The existing named entity recognition models are usually trained on a limited set of named entities. Besides clinical, the non-clinical factors, such as social determinant of health (SDoH), are also important to [...] Read more.

The clinical application of detecting COVID-19 factors is a challenging task. The existing named entity recognition models are usually trained on a limited set of named entities. Besides clinical, the non-clinical factors, such as social determinant of health (SDoH), are also important to study the infectious disease. In this paper, we propose a generalizable machine learning approach that improves on previous efforts by recognizing a large number of clinical risk factors and SDoH. The novelty of the proposed method lies in the subtle combination of a number of deep neural networks, including the BiLSTM-CNN-CRF method and a transformer-based embedding layer. Experimental results on a cohort of COVID-19 data prepared from PubMed articles show the superiority of the proposed approach. When compared to other methods, the proposed approach achieves a performance gain of about 1–5% in terms of macro- and micro-average F1 scores. Clinical practitioners and researchers can use this approach to obtain accurate information regarding clinical risks and SDoH factors, and use this pipeline as a tool to end the pandemic or to prepare for future pandemics. Full article

(This article belongs to the Special Issue COVID-19 Diagnostics in Clinical Applications and Pandemic Control)

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15 pages, 1321 KiB

Open AccessArticle

CGRP Plasma Levels Correlate with the Clinical Evolution and Prognosis of Hospitalized Acute COVID-19 Patients

by Manuela Rizzi, Stelvio Tonello, Francesca Morani, Eleonora Rizzi, Giuseppe Francesco Casciaro, Erica Matino, Martina Costanzo, Erika Zecca, Alessandro Croce, Anita Pedrinelli, Veronica Vassia, Raffaella Landi, Venkata Ramana Mallela, Davide D’Onghia, Rosalba Minisini, Mattia Bellan, Luigi Mario Castello, Francesco Gavelli, Gian Carlo Avanzi, Filippo Patrucco, Mario Pirisi, Donato Colangelo and Pier Paolo Sainaghi Show full author list Hide full author list

Viruses 2022, 14(10), 2123; https://doi.org/10.3390/v14102123 - 26 Sep 2022

Cited by 5 | Viewed by 1725

Abstract

SARS-CoV-2 is the etiological agent of COVID-19, an extremely heterogenous disease that can cause severe respiratory failure and critical illness. To date, reliable biomarkers allowing for early patient stratification according to disease severity are still lacking. Calcitonin gene-related peptide (CGRP) is a vasoactive [...] Read more.

SARS-CoV-2 is the etiological agent of COVID-19, an extremely heterogenous disease that can cause severe respiratory failure and critical illness. To date, reliable biomarkers allowing for early patient stratification according to disease severity are still lacking. Calcitonin gene-related peptide (CGRP) is a vasoactive neuropeptide involved in lung pathophysiology and immune modulation and is poorly investigated in the COVID-19 context. In this observational, prospective cohort study, we investigated the correlation between CGRP and clinical disease evolution in hospitalized moderate to severe COVID-19 patients. Between January and May 2021 (Italian third pandemic wave), 135 consecutive SARS-CoV-2 patients were diagnosed as being eligible for the study. Plasma CGRP level evaluation and routine laboratory tests were performed on blood samples collected at baseline and after 7 days of hospitalization. At baseline, the majority our patients had a moderate to severe clinical presentation, and higher plasma CGRP levels predicted a higher risk of in-hospital negative evolution (odds-ratio OR 2.84 [IQR 1.07–7.51]) and were correlated with pulmonary intravascular coagulopathy (OR 2.92 [IQR 1.19–7.17]). Finally, plasma CGRP levels were also correlated with plasma IP10 levels. Our data support a possible crosstalk between the lung and the neuroimmune axis, highlighting a crucial role for plasma CGRP in sustaining COVID-19-related hyperinflammation. Full article

(This article belongs to the Special Issue COVID-19 Diagnostics in Clinical Applications and Pandemic Control)

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23 pages, 3333 KiB

Open AccessArticle

Risk of Death in Comorbidity Subgroups of Hospitalized COVID-19 Patients Inferred by Routine Laboratory Markers of Systemic Inflammation on Admission: A Retrospective Study

by Relu Cocoş, Beatrice Mahler, Adina Turcu-Stiolica, Alexandru Stoichiță, Andreea Ghinet, Elena-Silvia Shelby and Laurențiu Camil Bohîlțea

Viruses 2022, 14(6), 1201; https://doi.org/10.3390/v14061201 - 31 May 2022

Cited by 12 | Viewed by 2609

Abstract

Our study objective was to construct models using 20 routine laboratory parameters on admission to predict disease severity and mortality risk in a group of 254 hospitalized COVID-19 patients. Considering the influence of confounding factors in this single-center study, we also retrospectively assessed [...] Read more.

Our study objective was to construct models using 20 routine laboratory parameters on admission to predict disease severity and mortality risk in a group of 254 hospitalized COVID-19 patients. Considering the influence of confounding factors in this single-center study, we also retrospectively assessed the correlations between the risk of death and the routine laboratory parameters within individual comorbidity subgroups. In multivariate regression models and by ROC curve analysis, a model of three routine laboratory parameters (AUC 0.85; 95% CI: 0.79–0.91) and a model of six laboratory factors (AUC 0.86; 95% CI: 0.81–0.91) were able to predict severity and mortality of COVID-19, respectively, compared with any other individual parameter. Hierarchical cluster analysis showed that inflammatory laboratory markers grouped together in three distinct clusters including positive correlations: WBC with NEU, NEU with neutrophil-to-lymphocyte ratio (NLR), NEU with systemic immune-inflammation index (SII), NLR with SII and platelet-to-lymphocyte ratio (PLR) with SII. When analyzing the routine laboratory parameters in the subgroups of comorbidities, the risk of death was associated with a common set of laboratory markers of systemic inflammation. Our results have shown that a panel of several routine laboratory parameters recorded on admission could be helpful for early evaluation of the risk of disease severity and mortality in COVID-19 patients. Inflammatory markers for mortality risk were similar in the subgroups of comorbidities, suggesting the limited effect of confounding factors in predicting COVID-19 mortality at admission. Full article

(This article belongs to the Special Issue COVID-19 Diagnostics in Clinical Applications and Pandemic Control)

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6 pages, 890 KiB

Open AccessBrief Report

#Stayathome If You Have a Cold: High SARS-CoV-2 Salivary Viral Loads in Pediatric Patients with Nasopharyngeal Symptoms

by Alice Monzani, Cinzia Borgogna, Daniela Ferrante, Benedetta Ciacchini, Enrico Felici, Marisa Gariglio and Ivana Rabbone

Viruses 2023, 15(1), 81; https://doi.org/10.3390/v15010081 - 28 Dec 2022

Viewed by 1598

Abstract

The choice of the best SARS-CoV-2 detection approach is crucial to predict which children with SARS-CoV-2 are at high risk of spreading the virus in order to manage public health measures and policies. In this prospective observational study of 35 children admitted to [...] Read more.

The choice of the best SARS-CoV-2 detection approach is crucial to predict which children with SARS-CoV-2 are at high risk of spreading the virus in order to manage public health measures and policies. In this prospective observational study of 35 children admitted to the Pediatric Emergency Departments of two tertiary hospitals in Northern Italy who tested positive for SARS-CoV-2 by standard RT-PCR in nasopharyngeal swab (NPS), we evaluated their presenting symptoms according to their salivary viral load (SVL) determined by droplet digital PCR (ddPCR). Despite an overall low concordance between SARS-CoV-2 detected by salivary ddPCR and NPS RT-PCR (54.3%), when only patients with nasopharyngeal symptoms were analyzed, the sensitivity of ddPCR in saliva specimens increased to 71.4%, and over half of these patients had high SVL (>10⁵ copies/mL), which was significantly more frequent than in children without nasopharyngeal symptoms (57.1% vs. 14.3%, OR = 8, CI 95% 1.28–50.03, p = 0.03). All asymptomatic children had low SVL values. Our findings support the hypothesis that children with nasopharyngeal symptoms are at higher risk of spreading SARS-CoV-2 due to their high SVL and, conversely, asymptomatic children are unlikely to spread the virus due to their low SVL, regardless of their NPS positivity. Full article

(This article belongs to the Special Issue COVID-19 Diagnostics in Clinical Applications and Pandemic Control)

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17 pages, 3871 KiB

Open AccessSystematic Review

Clinical Performance of Rapid and Point-of-Care Antigen Tests for SARS-CoV-2 Variants of Concern: A Living Systematic Review and Meta-Analysis

by Jimin Kim, Heungsup Sung, Hyukmin Lee, Jae-Seok Kim, Sue Shin, Seri Jeong, Miyoung Choi, Hyeon-Jeong Lee and on behalf of the Development Committee and Clinical Evidence Research Team in National Evidence-Based Healthcare Collaborating Agency

Viruses 2022, 14(7), 1479; https://doi.org/10.3390/v14071479 - 06 Jul 2022

Cited by 12 | Viewed by 2674

Abstract

Rapid antigen tests (RATs) for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are widely used in the Coronavirus disease 2019 (COVID-19) pandemic caused by diverse variants. Information on the real-world performance of RATs for variants is urgently needed for decision makers. Systematic [...] Read more.

Rapid antigen tests (RATs) for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are widely used in the Coronavirus disease 2019 (COVID-19) pandemic caused by diverse variants. Information on the real-world performance of RATs for variants is urgently needed for decision makers. Systematic searches of the available literature and updates were conducted in PubMed, Ovid-MEDLINE, Ovid-EMBASE, CENTRAL, and KMBASE for articles evaluating the accuracy of instrument-free RATs for variants up until 14 March 2022. A bivariate random effects model was utilized to calculate pooled diagnostic values in comparison with real-time reverse transcription-polymerase chain reaction as the reference test. A total of 7562 samples from six studies were available for the meta-analysis. The overall pooled sensitivity and specificity of RATs for variants were 69.7% (95% confidence interval [CI] = 62.5% to 76.1%) and 100.0% (95% CI = 98.8% to 100.0%), respectively. When an additional 2179 samples from seven studies reporting sensitivities only were assessed, the pooled sensitivity dropped to 50.0% (95% CI = 44.0% to 55.0%). These findings suggest reassessment and monitoring of the diagnostic utility of RATs for variants, especially for the sensitivity aspect, to facilitate appropriate diagnosis and management of COVID-19 patients. Full article

(This article belongs to the Special Issue COVID-19 Diagnostics in Clinical Applications and Pandemic Control)

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