Replicate and repeat faecal immunochemical tests in symptomatic patients: A systematic review.

BACKGROUND: Faecal Immunochemical tests (FITs) in the assessment of patients presenting with symptoms have generally used a single sample. Little evidence pertains to the use of replicate, where a number of tests are done prior to decision-making or repeat FIT, where additional FIT are performed following clinical decision-making. Overwhelmingly, research has focussed on FIT to help identify colorectal cancer (CRC). The aim of this review is to assess the available literature concerning replicate and repeat FIT in symptomatic patients to help generate consensus and guide future research. METHODS: The terms 'faecal immunochemical test' or 'FIT' were combined with 'multiple' or 'repeat'. EMBASE, Medline and PubMed database and other searches were conducted. All papers published in English were included with no exclusion date limits until November 2021. RESULTS: Of the 161 initial papers screened, seven were included for review. Qualitative and quantitative FIT outcomes were assessed in the studies. The primary aims of most related to whether replicate FIT increased diagnostic yield of CRC, with colonoscopy used as the reference standard. One publication assessed the impact of a new COVID-adapted pathway on CRC detection. No consensus on replicate FIT was apparent. Some concluded that FITs may help minimise missed CRC diagnoses: others showed no increase in diagnostic yield of CRC. CONCLUSIONS: Current evidence on replicate and repeat FIT is both minimal and conflicting. FIT is a superb clinical tool, but significant gaps surrounding application remain. Further studies relating to replicate and repeat FIT are required.

Prevalence of and factors associated with COVID-19 diagnosis in symptomatic patients followed in general practices in Germany between March 2020 and March 2021.

AIMS: This study aimed to investigate the prevalence of and the factors associated with the diagnosis of coronavirus disease 2019 (COVID-19) in symptomatic patients followed in general practices in Germany between March 2020 and March 2021. METHODS: Symptomatic patients tested for COVID-19 and followed in one of 962 general practices in Germany from March 2020 to March 2021 were included in this study. Covariates included sex, age, and comorbidities present in at least 3% of the population. The association between these factors and the diagnosis of COVID-19 was analyzed using an adjusted logistic regression model. RESULTS: A total of 301,290 patients tested for COVID-19 were included in this study (54.7% women; mean [SD] age 44.6 [18.5] years). The prevalence of COVID-19 was 13.8% in this sample. Male sex and older age were positively and significantly associated with COVID-19. In terms of comorbidities, the strongest positive associations with COVID-19 were observed for cardiac arrhythmias, depression, and obesity. There was also a negative relationship between the odds of being diagnosed with COVID-19 and several conditions such as chronic sinusitis, asthma, and anxiety disorders. CONCLUSIONS: Approximately 14% of symptomatic patients tested for COVID-19 were diagnosed with COVID-19 in German general practices from March 2020 to March 2021.

Prevalence of Bacterial Pathogens among Symptomatic-SARS-CoV-2 PCR-Negative Patients.

The epidemiological and clinical aspects of coronavirus disease-2019 (COVID-19) have been subjected to several investigations, but little is known about symptomatic patients with negative SARS-CoV-2 PCR results. The current study investigated patients who presented to the hospital with respiratory symptoms (but negative SARS-CoV-2 RT-PCR results) to determine the prevalence of bacterial pathogens among these patients. A total of 1246 different samples were collected and 453 species of bacterial pathogens were identified by culture. Antibiotic susceptibility testing was performed via the Kirby Bauer disc diffusion test. Patients showed symptoms, such as fever (100%), cough (83%), tiredness (77%), loss of taste and smell (23%), rigors (93%), sweating (62%), and nausea (81%), but all tested negative for COVID-19 by PCR tests. Further examinations revealed additional and severe symptoms, such as sore throats (27%), body aches and pain (83%), diarrhea (11%), skin rashes (5%), eye irritation (21%), vomiting (42%), difficulty breathing (32%), and chest pain (67%). The sum of n = 1246 included the following: males, 289 were between 5 and 14 years, 183 (15-24 years), 157 (25-34 years), 113 (35-49 years), and 43 were 50+ years. Females: 138 were between 5 and 14 years, 93 (15-24 years), 72 (25-34 years), 89 (35-49 years), and 68 were 50+ years. The Gram-positive organisms isolated were Staphylococcus aureus (n = 111, 80.43%, MRSA 16.6%), E. faecalis (n = 20, 14.49%, VRE: 9.4%), and Streptococcus agalactiae (n = 7, 5.07%), while, Gram-negative organisms, such as E. coli (n = 135, 42.85%, CRE: 3.49%), K. pneumoniae (n = 93, 29.52%, CRE: 1.58%), P. aeruginosa (n = 43, 13.65%), C. freundii (n = 21, 6.66%), Serratia spp. (n = 8, 2.53%), and Proteus spp. (n = 15, 4.76%) were identified.

A Qualitative Study: Mothers' Experiences of Their Child's Late-Onset Pompe Disease Diagnosis Following Newborn Screening.

Pompe disease was added to the United States recommended uniform screening panel in 2015 to avoid diagnostic delay and implement prompt treatment, specifically for those with infantile-onset Pompe disease (IOPD). However, most newborns with abnormal newborn screening (NBS) for Pompe disease have late-onset Pompe disease (LOPD). An early diagnosis of LOPD raises the question of when symptoms will arise which is challenging for parents, patients, and providers managing an LOPD diagnosis. This study aimed to characterize mothers' experiences of their child's LOPD diagnosis and medical monitoring. A qualitative descriptive approach was chosen to gain an in-depth understanding of parental experiences. Eight mothers were interviewed about their experiences with positive NBS and diagnosis, experiences with living with the diagnosis, and experiences with medical monitoring. Interview transcripts were analyzed through conventional content analysis. Negative emotions like fear were more frequent with communication of NBS results. Participants expressed uncertainty surrounding age of symptom onset and the future. The medical monitoring experience increased worry but participants expressed that being vigilant with management reassured them. Parental emotions shifted to thankfulness and reassurance with time and education. These findings can provide guidance to providers about the psychosocial implications of receiving positive NBS results and an LOPD diagnosis.

Risk factors for the deterioration of patients with mild COVID-19 admitted to a COVID-19 community treatment center

Background: The rapid increase in the number of coronavirus disease (COVID-19) patients led to the operation of COVID-19 facilities for patients with mild COVID-19 in South Korea. We analyzed the correlation and effect of risk factors associated with the worsening of patients with mild COVID-19 leading to their transfer from a community treatment center to a hospital. Methods: This retrospective cohort observational study included 1,208 COVID-19 patients with mild symptoms who were admitted to the Namsan Community Treatment Center between June 2020 and January 2021. A chi-square test was performed to examine the differences in the transfer rate by age, sex, nationality, presence of symptoms at admission, and season, and a multivariable logistic regression analysis was performed to examine the association of variables to the hospitalization rate. Results: Of the 1,208 patients, 212 (17.5%) were transferred to a hospital due to clinical deterioration. Increasing odds of hospital transfer were associated significantly with higher age and presentation in autumn, whereas sex and symptomatic illness at admission did not show a statistically significant association. Conclusion: The findings indicate the importance of the initial risk classification of COVID-19 patients based on thorough assessment and close monitoring, timely allocation of appropriate resources to high-risk groups that are likely to develop severe disease, and reduction of medical resource wastage and limiting of administrative force to ensure that patients receive the best treatment.

Clinical, Virological, Immunological, and Genomic Characterization of Asymptomatic and Symptomatic Cases With SARS-CoV-2 Infection in India.

Purpose: The current global pandemic of coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), led to the investigation with clinical, biochemical, immunological, and genomic characterization from patients to understand the pathophysiology of 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, and treatment regimen were collected from a hospital; viral load was determined by RT-PCR; and the levels of cytokines and circulating antibodies in plasma were assessed by Bio-Plex and isotyping, respectively. In addition, whole-genome sequencing of viral strains and mutational analysis were carried out. Results: 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. Symptomatic patients were mostly with one or more comorbidities, especially type 2 diabetes (66.6%). The virological estimation revealed that there was no significant difference in viral load of oropharyngeal (OP) samples between the two groups. On the other hand, viral load was higher in plasma and serum samples of symptomatic patients, and they develop sufficient amounts of antibodies (IgG, IgM, and IgA). The levels of seven cytokines (IL-6, IL-1α, IP-10, IL-8, IL-10, IFN-α2, 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. The whole-genome sequence analysis revealed that the current isolates were clustered with 19B, 20A, and 20B clades; however, 11 additional changes in Orf1ab, spike, Orf3a, Orf8, and nucleocapsid proteins were acquired. The D614G mutation in spike protein is linked with higher virus replication efficiency and severe SARS-CoV-2 infection as three patients had higher viral load, and among them, two patients with this mutation passed away. Conclusions: 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 thereby advance the implementation of effective disease control strategies.

SARS-CoV2 infection in symptomatic patients: interest of serological tests and predictors of mortality: experience of DR Congo.

BACKGROUND: In symptomatic patients, the diagnostic approach of COVID-19 should be holistic. We aimed to evaluate the concordance between RT-PCR and serological tests (IgM/IgG), and identify the factors that best predict mortality (clinical stages or viral load). METHODS: The study included 242 patients referred to the University hospital of Kinshasa for suspected COVID-19, dyspnea or ARDS between June 1st, 2020 and August 02, 2020. Both antibody-SARS-CoV2 IgM/IgG and RT-PCR method were performed on the day of admission to hospital. The clinical stages were established according to the COVID-19 WHO classification. The viral load was expressed by the CtN2 (cycle threshold value of the nucleoproteins) and the CtE (envelope) genes of SARS- CoV-2 detected using GeneXpert. Kappa test and Cox regression were used as appropriate. RESULTS: The GeneXpert was positive in 74 patients (30.6%). Seventy two patients (29.8%) had positive IgM and 34 patients (14.0%) had positive IgG. The combination of RT-PCR and serological tests made it possible to treat 104 patients as having COVID-19, which represented an increase in cases of around 41% compared to the result based on GeneXpert alone. The comparison between the two tests has shown that 57 patients (23.5%) had discordant results. The Kappa coefficient was 0.451 (p < 0.001). We recorded 23 deaths (22.1%) among the COVID-19 patients vs 8 deaths (5.8%) among other patients. The severe-critical clinical stage increased the risk of mortality vs. mild-moderate stage (aHR: 26.8, p < 0.001). The values of CtE and CtN2 did not influence mortality significantly. CONCLUSION: In symptomatic patients, serological tests are a support which makes it possible to refer patients to the dedicated COVID-19 units and treat a greater number of COVID-19 patients. WHO Clinical classification seems to predict mortality better than SARS-Cov2 viral load.

Group Vaccination Five Days before a COVID-19 Outbreak in a Long-Term Care Facility.

Rapid vaccination may be of benefit in long-term care facilities (LTCF) that are affected by an ongoing COVID-19 outbreak. However, there are concerns regarding the safety and effectiveness of such an approach, particularly regarding the vaccination of pre-symptomatic patients. Here, we report the effectiveness of vaccination in a German LTCF hit by an outbreak that was detected 5 days after the first vaccine doses were administered. In detail, 66.7% of the unvaccinated patients experienced an unfavorable course; this proportion was much lower (33.3%) among the vaccinated patients. Even though this study is limited by a small number of patients, the observation and the comparison with related published data shows that vaccination (i) is safe and (ii) may still be of benefit when given shortly before an infection or even in pre-symptomatic LTCF-patients.

Clinical Features of COVID-19 Patients in Jordan: A Study of 508 Patients.

BACKGROUND: The symptoms of COVID-19 have a wide range of severity ranging from no symptoms at all to mild symptoms, such as fever, cough, sore throat, general weakness. Moreover, in some situations, patients may develop severe complications as pneumonia, and sepsis, leading to death. This study aims to investigate the characteristic features of COVID-19 patients based on their medical condition prior to COVID-19 diagnosis. METHODS: A retrospective cohort study took place between the 1st of April 2020 and the 31st of June 2020 in Prince Hamzah Hospital, Jordan. Patients were diagnosed by the Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel, either through screening or for those who developed symptoms. During this period, patients who tested positive for COVID 19 were admitted to the hospital regardless of their symptoms according to the local government health policies. A total of 508 Patients were involved and divided into two groups based on the presence or absence of chronic illnesses prior to COVID-19 diagnosis. RESULTS: A total of 371 patients were medically free (220 males and 151 females). Among them, 153 patients were symptomatic (41.2%), with an average hospitalization of 18 days. Generalized malaise, dry cough, and fever were the most common reported symptoms (51%, 45.8%, and 41.8%, respectively). On the other hand, the total number of COVID-19 patients with predefined comorbidities was 137 (93 males and 44 females). Among them, 86 patients (62.8%) were symptomatic, with an average duration of admission of 19.3 days. Similar to medically free patients, dry cough, generalized malaise, and fever were the most commonly reported symptoms (50%, 43%, and 38.4%, respectively). There was a statistically significant correlation between the presence of chronic illnesses and the development of symptoms among COVID-19 patients (P = 0.0001). CONCLUSION: Dry cough, generalized malaise, and fever were the most commonly reported symptoms among our patients regardless of their medical condition. The average duration of hospitalization in medically free patients was less than patients with comorbidities, and it was less among asymptomatic compared to symptomatic patients. More than half of our COVID-19 patients were male and asymptomatic. A significant correlation between patients' medical condition and the possibility of developing symptoms in response to COVID-19 was identified.

Virological and immunological features of SARS-COV-2 infected children with distinct symptomatology.

BACKGROUND: Although SARS-CoV-2 immunizations have started in most countries, children are not currently included in the vaccination programs; thus, it remains crucial to define their anti-SARS-CoV-2 immune response in order to minimize the risk for other epidemic waves. This study sought to provide a description of the virology ad anti-SARS-CoV-2 immunity in children with distinct symptomatology. METHODS: Between March and July 2020, we recruited 15 SARS-CoV-2 asymptomatic (AS) and 51 symptomatic (SY) children, stratified according to WHO clinical classification. We measured SARS-CoV-2 viral load using ddPCR and qPCR in longitudinally collected nasopharyngeal swab samples. To define anti-SARS-CoV-2 antibodies, we measured neutralization activity and total IgG load (DiaSorin). We also evaluated antigen-specific B and CD8+T cells, using a labeled S1+S2 protein and ICAM expression, respectively. Plasma protein profiling was performed with Olink. RESULTS: Virological profiling showed that AS patients had lower viral load at diagnosis (p = .004) and faster virus clearance (p = .0002) compared with SY patients. Anti-SARS-CoV-2 humoral and cellular response did not appear to be associated with the presence of symptoms. AS and SY patients showed similar titers of SARS-CoV-2 IgG, levels of neutralizing activity, and frequency of Ag-specific B and CD8+ T cells, whereas pro-inflammatory plasma protein profile was found to be associated with symptomatology. CONCLUSION: We demonstrated the development of anti-SARS-CoV-2 humoral and cellular response with any regard to symptomatology, suggesting the ability of both SY and AS patients to contribute toward herd immunity. The virological profiling of AS patients suggested that they have lower virus load associated with faster virus clearance.

Preventive home therapy for symptomatic patients affected by COVID-19 and followed by teleconsultations.

In this paper we present our experience on the treatment at home of Covid+ symptomatic patients. One hundred and eighty-two subjects (111 men and 71 women) aged from 32 to 71 years have been consecutively followed at home in telemedicine from 1st September to 24th December 2020. We were informed almost twice daily in morning and evening about body temperature, symptoms (cough, shortness of breath or difficulty breathing, fatigue, muscle of body aches, headache, loss of taste or smell, sore throat, congestion or runny nose, nausea and vomiting, diarrhea), oxygen saturation measured by digital pulse oximetry and blood pressure. Our protocol of treatment was based on early use of prednisone (25 mg in the morning and 12.5 mg in the afternoon) and low molecular weight heparin (4000 UI one or two times daily) initiated just after the positivity of molecular nasopharyngeal test (about 3-4 days as mean time after initiation of symptomatology and not after 7-8 days as suggested by other protocols) and oxygen therapy when necessary. Antibiotics such as azithromycin for six days was added. It is always recommended to associate lansoprazole 30 mg to prevent gastric hemorrhages and potassium and magnesium supplements. This treatment scheme was able to reduce the risk of hospitalization as only 4 patients needed to be admitted to the Hospital, and only two in subintensive department. After negativeness of molecular nasopharyngeal test, patients were invited for a thoracic computerized tomography and laboratory evaluation of d-dimer and other data of inflammation to show eventual lung interstitial involvement characteristic of COVID-19.