scholarly journals Feasibility and Diagnostic Accuracy of Saliva-Based SARS-CoV-2 Screening in Educational Settings and Children Aged <12 Years

Diagnostics ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. 1797
Author(s):  
Martin Hoch ◽  
Sebastian Vogel ◽  
Ute Eberle ◽  
Laura Kolberg ◽  
Valerie Gruenthaler ◽  
...  
Keyword(s):  
Viral Load ◽  
Primary Schools ◽  
Diagnostic Performance ◽  
High Viral Load ◽  
Collection Method ◽  
Asymptomatic Children ◽  
Significant Difference ◽  
Sampling Systems ◽  
Saliva Collection ◽  
Testing Algorithm

Children have been disproportionately affected during the COVID-19 pandemic. We aimed to assess a saliva-based algorithm for SARS-CoV-2 testing to be used in schools and childcare institutions under pandemic conditions. A weekly SARS-CoV-2 sentinel study in primary schools, kindergartens, and childcare facilities was conducted over a 12-week-period. In a sub-study covering 7 weeks, 1895 paired oropharyngeal and saliva samples were processed for SARS-CoV-2 rRT-PCR testing in both asymptomatic children (n = 1243) and staff (n = 652). Forty-nine additional concurrent swab and saliva samples were collected from SARS-CoV-2 infected patients (patient cohort). The Salivette® system was used for saliva collection and assessed for feasibility and diagnostic performance. For children, a mean of 1.18 mL saliva could be obtained. Based on results from both cohorts, the Salivette® testing algorithm demonstrated the specificity of 100% (95% CI 99.7–100) and sensitivity of 94.9% (95% CI 81.4–99.1) with oropharyngeal swabs as reference. Agreement between sampling systems was 100% for moderate to high viral load situations (defined as Ct-values <33 from oropharyngeal swabs). Comparative analysis of Ct-values derived from saliva vs. oropharyngeal swabs demonstrated a significant difference (mean 4.23; 95% CI 2.48–6.00). In conclusion, the Salivette® system proved to be an easy-to-use, safe and feasible saliva collection method and a more pleasant alternative to oropharyngeal swabs for SARS-CoV-2 testing in children aged 3 years and above.

scholarly journals Evaluation of saliva sampling procedures for SARS-CoV-2 diagnostics reveals differential sensitivity and association with viral load

2020 ◽  
Author(s):  
Pieter Mestdagh ◽  
Michel Gillard ◽  
Marc Arbyn ◽  
Jean-Paul Pirnay ◽  
Jeroen Poels ◽  
...  
Keyword(s):  
Viral Load ◽  
High Risk ◽  
Health Professionals ◽  
High Viral Load ◽  
Sampling Procedure ◽  
Differential Sensitivity ◽  
Collection Method ◽  
Viral Loads ◽  
Saliva Collection ◽  
Sampling Procedures

AbstractNasopharyngeal sampling has been the preferential collection method for SARS-CoV-2 diagnostics. Alternative sampling procedures that are less invasive and do not require a healthcare professional would be more preferable for patients and health professionals. Saliva collection has been proposed as such a possible alternative sampling procedure. We evaluated the sensitivity of SARS-CoV-2 testing on two different saliva collection devices (spitting versus swabbing) compared to nasopharyngeal swabs in over 2500 individuals that were either symptomatic or had high-risk contacts with infected individuals. We observed an overall poor sensitivity in saliva for SARS-CoV-2 detection (30.8% and 22.4% for spitting and swabbing, respectively). However, when focusing on individuals with medium to high viral load, sensitivity increased substantially (97.0% and 76.7% for spitting and swabbing, respectively), irrespective of symptomatic status. Our results suggest that saliva cannot readily replace nasopharyngeal sampling for SARS-CoV-2 diagnostics but may enable identification of cases with medium to high viral loads.

scholarly journals Clinical Features and Resistance to Entecavir Monotherapy of Patients with Hepatitis B

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Hideo Takayama ◽  
Takuya Komura ◽  
Takashi Kagaya ◽  
Saiho Sugimoto ◽  
Noriaki Orita ◽  
...  
Keyword(s):  
Viral Load ◽  
Hepatitis B ◽  
Clinical Features ◽  
High Viral Load ◽  
Hbv Dna ◽  
Health Concern ◽  
Naive Group ◽  
Rescue Treatment ◽  
Significant Difference ◽  
B Virus

Aim. Hepatitis B virus (HBV) infection is a major public health concern worldwide. Entecavir (ETV), a first-line nucleos(t)ide analogue (NA) for HBV, has a low risk of resistance. We evaluated the efficacy of ETV monotherapy, ratio of ETV-resistant, and the clinical features of patients with ETV resistance. Methods. A total of 130 patients (72 males, 58 females; mean age, 61 ± 15 years) were divided into a NA-naïve group (n = 108) and NA-experienced group (n = 22). We examined the clinical outcomes of ETV monotherapy and associated factors. We also assessed the clinical features of 15 patients with resistance to ETV (mean, 51.0 ± 27.4 weeks). Results. Among the 130 patients, 94.1% achieved ALT normalization and 63.6% achieved serum HBV DNA negativity after ETV monotherapy for 96 weeks. Of the patients in the NA-naïve group, 93.1% and 60.4% achieved ALT normalization and HBV DNA negativity, respectively. Of the patients in the NA-experienced group, 100% and 74.9% achieved ALT normalization and HBV DNA negativity, respectively. Compared to patients on ETV continuously, 15 ETV-resistant patients had a higher baseline HBV viral load. There was a significant difference in the time to HBV DNA negativity, but not ALT normalization after ETV monotherapy in these groups. Rescue treatment with other NAs led to ALT normalization in all of these patients, but not HBV DNA negativity. Conclusions. ETV monotherapy has a long-term clinical efficacy. While some patients especially with HBV DNA high viral load developed ETV resistance, rescue treatment led to ALT normalization in these patients.

scholarly journals Clinical, immunological and genomic characterization of asymptomatic and symptomatic cases with SARS-CoV-2 infection, India

2021 ◽  
Author(s):  
Sanchari Chatterjee ◽  
Ankita Datey ◽  
Soumya Sengupta ◽  
Arup Ghosh ◽  
Atimukta Jha ◽  
...  
Keyword(s):  
Viral Load ◽  
Biochemical Parameters ◽  
Mutational Analysis ◽  
Control Strategies ◽  
High Viral Load ◽  
Whole Genome Sequence ◽  
Whole Genome ◽  
Serum Samples ◽  
Asymptomatic Patients ◽  
Significant Difference

Background: The current global pandemic of Coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2 led to the investigation with clinical, biochemical, immunological and genomic information of the patients to understand the pathophysiology of this viral infection. Methods: Samples were collected from six asymptomatic and six symptomatic SARS-CoV-2 confirmed hospitalized patients in Bhubaneswar, Odisha, India. Clinical details, biochemical parameters, treatment regime were collected from hospital, viral load was determined by RT-PCR, levels of cytokines and circulating antibodies in plasma were assessed by Bioplex and isotyping respectively. In addition, the whole genome sequencing of viral strains and mutational analysis were carried out. Findings Analysis of the biochemical parameters highlighted the increased levels of C-Reactive protein (CRP), lactate dehydrogenase (LDH), serum SGPT, serum SGOT and ferritin in symptomatic patients indicating that patients with higher levels of few biochemical parameters might experience severe pathophysiological complications after SARS-CoV-2 infection. This was also observed that symptomatic patients were mostly with one or more comorbidities, especially diabetes (66.6%). Surprisingly the virological estimation revealed that there was no significant difference in viral load of oropharyngeal (OP) samples between the two groups. This suggests that the viral load in OP sample does not correlate with disease severity and both asymptomatic and symptomatic patients are equally capable of transmitting the virus. Whereas, viral load was higher in plasma and serum samples of symptomatic patients suggesting that the development of clinical complications is mostly associated to high viral load in plasma and serum. This also demonstrated that the patients with high viral load in plasma and serum samples were found to develop sufficient amounts of antibodies (IgG, IgM and IgA). Interestingly, the levels of 7 cytokines (IL-6, IL-1@, IP-10, IL-8, IL-10, IFN-@2, IL-15) were found to be highly elevated in symptomatic patients, while three cytokines (soluble CD40L, GRO and MDC) were remarkably higher in asymptomatic patients. Therefore, this data suggest that cytokines and chemokines may serve as predictive indicator of SARS-CoV-2 infection and contribute to understand the pathogenesis of COVID-19. The whole genome sequence analysis revealed that the current isolates were clustered with 19B, 20A and 20B clades, however acquired 11 additional changes in Orf1ab, spike, Orf3a, Orf8 and nucleocapsid proteins. The data also confirmed that the D614G mutation in spike protein is mostly linked with severe SARS-CoV-2 infection as two patients with this mutation passes away. Interpretation This is the first comprehensive study of SARS CoV-2 patients from India. This will contribute to a better understanding of the pathophysiology of SARS-CoV-2 infection and advance in the implementation of effective disease control strategies.

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 Diagnostic Performance of Automated SARS-CoV-2 Antigen Assay in Nasal Swab during COVID-19 Vaccination Campaign

Diagnostics ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. 2110
Author(s):  
Haya Altawalah ◽  
Wadha Alfouzan ◽  
Talal Al-Fadalah ◽  
Sayeh Ezzikouri
Keyword(s):  
Viral Load ◽  
Diagnostic Performance ◽  
Vaccination Campaign ◽  
Real Life ◽  
High Viral Load ◽  
Laboratory Method ◽  
Life Study ◽  
Viral Loads ◽  
Antigen Assay ◽  
A Prospective Study

Background: To control the spread of the pandemic brought about by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, it is necessary to have an automated reliable diagnostic assay. To date, the RT-PCR (RT-qPCR) has been the recommended laboratory method to diagnose SARS-CoV-2 infection, but there is a need for more automated and reliable tests. The aim of this real-life study was to assess the diagnostic performance of DiaSorin’s LIAISON SARS-CoV-2 antigen (Ag) chemiluminescence immunoassay in detecting SARS-CoV-2 in vaccinated and unvaccinated individuals. Methods: A prospective study was performed on 300 nasopharyngeal swabs randomly collected from 31 May to 6 July 2021. Nasopharyngeal samples were assayed with DiaSorin’s LIAISON SARS-CoV-2 Ag and TaqPath™ COVID-19 multiplex RT-qPCR. Results: Of 300 participants, 150 had a RT-qPCR confirmed SARS-CoV-2 infection of whom 113 (75.33%) were also detected by the DiaSorin LIAISON SARS-CoV-2 Ag. Taking RT-qPCR as a reference, the sensitivity and specificity of the DiaSorin LIAISON SARS-CoV-2 Ag assay were evaluated as 75.33% (95% CI = 67.64–82) and 100% (95% CI = 97.57–100), respectively. When a viral load cut-off was applied for high viral load (median cycle threshold (Ct) < 18.57), the overall sensitivity was increased to 96.55% (95% CI = 88.09–99.58). Interestingly, median RT-qPCR Ct and SARS-CoV-2 Ag values were similar between fully vaccinated and unvaccinated subjects. Conclusions: Automated, quantitative LIAISON SARS-CoV-2 Ag assay shows good performance to identify SARS-CoV-2-infected individuals with moderate to high viral loads. LIAISON SARS-CoV-2 Ag testing could be used as frontline testing for COVID-19 diagnosis and be more suitable for large utilization.

scholarly journals Rapid diagnosis of SARS-CoV-2 pneumonia on lower respiratory tract specimens

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Vanessa De Pace ◽  
Patrizia Caligiuri ◽  
Valentina Ricucci ◽  
Nicola Nigro ◽  
Barbara Galano ◽  
...  
Keyword(s):  
Intensive Care ◽  
Viral Load ◽  
Lower Respiratory Tract ◽  
Diagnostic Performance ◽  
High Viral Load ◽  
Load Cycle ◽  
Rt Pcr ◽  
Cycle Threshold ◽  
Viral Loads ◽  
Rapid Pcr

Abstract Background The ongoing SARS-CoV-2 pandemic requires the availability of accurate and rapid diagnostic tests, especially in such clinical settings as emergency and intensive care units. The objective of this study was to evaluate the diagnostic performance of the Vivalytic SARS-CoV-2 rapid PCR kit in lower respiratory tract (LRT) specimens. Methods Consecutive LRT specimens (bronchoalveolar lavage and bronchoaspirates) were collected from Intensive Care Units of San Martino Hospital (Genoa, Italy) between November 2020 and January 2021. All samples underwent RT-PCR testing by means of the Allplex™ SARS-CoV-2 assay (Seegene Inc., South Korea). On the basis of RT-PCR results, specimens were categorized as negative, positive with high viral load [cycle threshold (Ct) ≤ 30] and positive with low viral load (Ct of 31–35). A 1:1:1 ratio was used to achieve a sample size of 75. All specimens were subsequently tested by means of the Vivalytic SARS-CoV-2 rapid PCR assay (Bosch Healthcare Solutions GmbH, Germany). The diagnostic performance of this assay was assessed against RT-PCR through the calculation of accuracy, Cohen’s κ, sensitivity, specificity and expected positive (PPV) and negative (NPV) predictive values. Results The overall diagnostic accuracy of the Vivalytic SARS-CoV-2 was 97.3% (95% CI: 90.9–99.3%), with an excellent Cohen’s κ of 0.94 (95% CI: 0.72–1). Sensitivity and specificity were 96% (95% CI: 86.5–98.9%) and 100% (95% CI: 86.7–100%), respectively. In samples with high viral loads, sensitivity was 100% (Table 1). The distributions of E gene Ct values were similar (Wilcoxon’s test: p = 0.070), with medians of 35 (IQR: 25–36) and 35 (IQR: 25–35) on Vivalytic and RT-PCR, respectively (Fig. 1). NPV and PPV was 92.6% and 100%, respectively.Table 1 Demographic characteristics and data sample type of the study cases (N = 75) Male, N (%) 56 (74.6%) Age (yr), Median (IQR) 65 (31–81) BAS, N (%) 43 (57.3%)  Negative 30.2%  Positive—High viral load [Ct ≤ 30] 27.9%  Positive—Low viral load [Ct 31–35] 41.9% BAL, N (%) 32 (42.7%)  Negative 37.5%  Positive—High viral load [Ct ≤ 30] 40.6%  Positive—Low viral load [Ct 31–35] 21.9% Data were expressed as proportions for categorical variables. Specimens were categorized into negative, positive with high viral load [cycle threshold (Ct) ≤ 30] and positive with low viral load (Ct of 31–35). BAS bronchoaspirates, BAL bronchoalveolar lavage, Ct cycle threshold Conclusions Vivalytic SARS-CoV-2 can be used effectively on LRT specimens following sample liquefaction. It is a feasible and highly accurate molecular procedure, especially in samples with high viral loads. This assay yields results in about 40 min, and may therefore accelerate clinical decision-making in urgent/emergency situations.

scholarly journals Interface Hepatitis over Grade 2 May Differentiate Chronic Inflammation Associated with CHB from NAFLD in the Early Stage

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Yong-fen Zhu ◽  
Jin Wang ◽  
Jia-zhui Fang ◽  
Qiao Yang ◽  
Fang-fang Lv
Keyword(s):  
Viral Load ◽  
Chronic Inflammation ◽  
Early Stage ◽  
Antiviral Treatment ◽  
High Viral Load ◽  
Nonalcoholic Fatty Liver ◽  
Viral Loads ◽  
Pathological Characteristics ◽  
Significant Difference ◽  
Lobular Inflammation

Background. Patients with chronic hepatitis B (CHB) concomitant with nonalcoholic fatty liver disease (NAFLD) are increasing. Objectives. To identify pathological features that can be used to differentiate between chronic inflammation caused by CHB and that caused by NAFLD. Methods. Patients with CHB (n=31) needing antiviral treatment, NAFLD (n=50), or CHB-NAFLD (n=51) who underwent biopsy were retrospectively enrolled. Pathological characteristics of chronic inflammation were evaluated using the METAVIR scoring system. The rates of three pathological characteristics were first compared in patients with NAFLD and those with CHB, then compared after fibrosis matching, and were finally compared in CHB-NAFLD patients with different viral loads. Results. The rates of interface hepatitis over grade 2 and fibrosis over grade 2 were significantly higher in the CHB group than in the NAFLD group (100% vs. 4% and 80.6% vs. 22%; both P<0.0001), while no significant difference was observed in the rate of lobular inflammation over grade 2 between the two groups. After fibrosis matching, in patients with F0–2 fibrosis, the rate of interface hepatitis over grade 2 in CHB was significantly higher than that in NAFLD (100% vs. 0%; P<0.0001). In CHB-NAFLD patients with F0–2 fibrosis, the rate of interface hepatitis over grade 2 in cases with a high viral load was significantly higher than cases with a low viral load (66.6% vs. 0%; P<0.0001). The rate of lobular inflammation showed no difference between groups. Conclusion. Interface hepatitis over grade 2 can be used for the differential diagnosis of chronic inflammation associated with CHB or NAFLD in the early stage.

Update in management of hepatitis B in pregnancy and prevention of mother to child hepatitis B transmission

2018 ◽  
Vol 1 (3) ◽  
pp. 1-8
Author(s):  
Naichaya Chamroonkul
Keyword(s):  
Chronic Hepatitis ◽  
Viral Load ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
High Viral Load ◽  
World Population ◽  
Hepatitis B Infection ◽  
Mother To Child Transmission ◽  
Child Transmission ◽  
Mother To Child

Even with two decades of widespread using hepatitis B vaccination, chronic hepatitis B remains a major global health problem. In Thailand, the prevalence of chronic hepatitis B infection was down from 8 - 10% in last decade to 5% recently. Failure to control mother to child transmission is one of the important barriers to the total elimination of hepatitis B infection from world population. In the majority, vertical transmission can be prevented with a universal screening program, immunoprophylaxis by administration of hepatitis B vaccine and hepatitis B immunoglobulin (HBIg) for babies born to mothers with HBV. However, in mothers with a high viral load, the chance of immunoprophylaxis failure remains high. To date, there are standard recommendations by all international liver societies including AASLD, EASL and APASL suggest introducing an antiviral agent during the third trimester to CHB pregnant women with a high viral load. Previous US FDA pregnancy category B agents such as Tenofovir and Telbivudine are allowed through all trimesters of pregnancy and are effective for prevention of mother to child transmission. Breastfeeding for patients who receive antiviral agents can be allowed after a risk-benefit discussion with the patient and family.

scholarly journals Adapting the role of handheld echocardiography during the COVID-19 pandemic: A practical guide

Perfusion ◽  
2021 ◽  
pp. 026765912098653
Author(s):  
Hafiz Naderi ◽  
Shaun Robinson ◽  
Martin J Swaans ◽  
Nina Bual ◽  
Wing-See Cheung ◽  
...  
Keyword(s):  
Viral Load ◽  
Potential Role ◽  
Assessment Tool ◽  
High Viral Load ◽  
First Line ◽  
Scanning Time ◽  
Contagious Disease ◽  
Core Dataset ◽  
Clinical Questions

The COVID-19 pandemic has altered our approach to inpatient echocardiography delivery. There is now a greater focus to address key clinical questions likely to make an immediate impact in management, particularly during the period of widespread infection. Handheld echocardiography (HHE) can be used as a first-line assessment tool, limiting scanning time and exposure to high viral load. This article describes a potential role for HHE during a pandemic. We propose a protocol with a reporting template for a focused core dataset necessary in delivering an acute echocardiography service in the setting of a highly contagious disease, minimising risk to the operator. We cover the scenarios typically encountered in the acute cardiology setting and how an expert trained echocardiography team can identify such pathologies using a limited imaging format and include cardiac presentations encountered in those patients acutely unwell with COVID-19.

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