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In the context of the coronavirus disease 2019 (COVID-19) pandemic there has been an increase of the use of antigen-detection rapid diagnostic tests (Ag-RDT). The performance of Ag-RDT vary greatly between manufacturers and evaluating their analytical limit of detection (LOD) has become high priority. Here we describe a manufacturer-independent evaluation of the LOD of 19 marketed Ag-RDT using live SARS-CoV-2 spiked in different matrices: direct culture supernatant, a dry swab, and a swab in Amies. Additionally, the LOD using dry swab was investigated after 7 days’ storage at − 80 °C of the SARS-CoV-2 serial dilutions. An LOD of ≈ 5.0 × 10 2  pfu/ml (1.0 × 10 6  genome copies/ml) in culture media is defined as acceptable by the World Health Organization. Fourteen of 19 Ag-RDTs (ActiveXpress, Espline, Excalibur, Innova, Joysbio, Mologic, NowCheck, Orient, PanBio, RespiStrip, Roche, Standard-F, Standard-Q and Sure-Status) exceeded this performance criteria using direct culture supernatant applied to the Ag-RDT. Six Ag-RDT were not compatible with Amies media and a decreased sensitivity of 2 to 20-fold was observed for eleven tests on the stored dilutions at − 80 °C for 7 days. Here, we provide analytical sensitivity data to guide appropriate test and sample type selection for use and for future Ag-RDT evaluations.

Background Rapid determination of an individual’s antibody status can be beneficial in understanding an individual’s immune response to SARS-CoV-2 and for initiation of therapies that are only deemed effective in sero-negative individuals. Antibody lateral flow tests (LFTs) have potential to address this need as a rapid, point of care test. Methods Here we present a proof-of-concept evaluation of eight LFT brands using sera from 95 vaccinated individuals to determine sensitivity for detecting vaccination generated antibodies. Samples were analysed on eight different brands of antibody LFT and an automated chemiluminescent microparticle immunoassay (CMIA) that identifies anti-spike antibodies which was used as our reference standard. Results All 95 (100%) participants tested positive for anti-spike antibodies by the chemiluminescent microparticle immunoassay (CMIA) reference standard post-dose two of their SARS-CoV-2 vaccine: BNT162b2 (Pfizer/BioNTech, n = 60), AZD1222 (AstraZeneca, n = 31), mRNA-1273 (Moderna, n = 2) and Undeclared Vaccine Brand (n = 2). Sensitivity increased from dose one to dose two in six out of eight LFTs with three tests achieving 100% sensitivity at dose two in detecting anti-spike antibodies. Conclusions These tests are demonstrated to be highly sensitive to detect raised antibody levels in vaccinated individuals. RDTs are low cost and rapid alternatives to ELISA based systems.

The emergence of severe acute respiratory syndrome 2 (SARS-CoV-2) variants of concern (VOCs), with mutations linked to increased transmissibility, vaccine escape and virulence, has necessitated the widespread genomic surveillance of SARS-CoV-2. This has placed a strain on global sequencing capacity, especially in areas lacking the resources for large scale sequencing activities. Here we have developed three separate multiplex high-resolution melting assays to enable the identification of Alpha, Beta, Delta and Omicron VOCs. The assays were evaluated against whole genome sequencing on upper-respiratory swab samples collected during the Alpha, Delta and Omicron [BA.1] waves of the UK pandemic. The sensitivities of the eight individual primer sets were all 100%, and specificity ranged from 94.6 to 100%. The multiplex HRM assays have potential as a tool for high throughput surveillance of SARS-CoV-2 VOCs, particularly in areas with limited genomics facilities.

RT-qPCR is commonly used for virological endpoints during clinical trials for antiviral therapy to determine the quantity and presence of virus in a sample. However, RT-qPCR identifies viral RNA and cannot determine if viable virus is present. Existing culture-based techniques for SARS-CoV-2 are insensitive and not sufficiently standardized to be employed as clinical study endpoints. The use of a culture system to monitor replicating viruses could mitigate the possibility of molecular techniques identifying viral RNA from inactive or lysed viral particles. The methodology optimized in this study for detecting infectious viruses may have application as a secondary virological endpoint in clinical trials of therapeutics for SARS-CoV-2 in addition to numerous research processes.

Evidence supporting the association of COPD or airflow obstruction with use of solid fuels is conflicting and inconsistent. To assess the association of airflow obstruction with self-reported use of solid fuels for cooking or heating. We analysed 18,554 adults from the BOLD study, who had provided acceptable post-bronchodilator spirometry measurements and information on use of solid fuels. The association of airflow obstruction with use of solid fuels for cooking or heating was assessed by sex, within each site, using regression analysis. Estimates were stratified by national income and meta-analysed. We carried out similar analyses for spirometric restriction, chronic cough and chronic phlegm. We found no association between airflow obstruction and use of solid fuels for cooking or heating (ORmen=1.20, 95%CI 0.94-1.53; ORwomen=0.88, 95%CI 0.67-1.15). This was true for low/middle and high income sites. Among never smokers there was also no evidence of an association of airflow obstruction with use of solid fuels (ORmen=1.00, 95%CI 0.57-1.76; ORwomen=1.00, 95%CI 0.76-1.32). Overall, we found no association of spirometric restriction, chronic cough or chronic phlegm with the use of solid fuels. However, we found that chronic phlegm was more likely to be reported among female never smokers and those who had been exposed for ≥20 years. Airflow obstruction assessed from post-bronchodilator spirometry was not associated with use of solid fuels for cooking or heating.

Smoking is the most well-established cause of chronic airflow obstruction (CAO) but particulate air pollution and poverty have also been implicated. We regressed sex-specific prevalence of CAO from 41 Burden of Obstructive Lung Disease study sites against smoking prevalence from the same study, the gross national income per capita and the local annual mean level of ambient particulate matter (PM2.5) using negative binomial regression. The prevalence of CAO was not independently associated with PM2.5 but was strongly associated with smoking and was also associated with poverty. Strengthening tobacco control and improved understanding of the link between CAO and poverty should be prioritised.

Background:The frequency of lymph node metastases in stage IA2 cervical cancer is reported to range from 0% to 9.7%. Treatment recommendations vary likewise from a cone biopsy to a Wertheim radical hysterectomy and pelvic lymph node dissection. The objective of this study was to get insight into the true frequency of lymph node metastases and/or parametrial involvement in stage IA2 cervical cancer.Methods:The hospital records of 48 patients with stage IA2 cervical carcinoma who registered from 1994 to 2006 were reviewed, and a literature search was performed.Results:Of 48 registered patients, 14 were confirmed to have stage IA2. No lymph node metastases or parametrial invasion and recurrences were found. The collated literature data showed a risk of lymph node metastases of 4.8% (range, 0%-9.7%). The presence of adenocarcinoma and the absence of lymph vascular space invasion resulted in a low risk on lymph node metastases (0.3% and 1.3%, respectively). Parametrial involvement has not been reported.Conclusions:The risk of the selected patients with stage IA2 cervical cancer on lymph node metastases is low. In patients with stage IA2 squamous cell cancer with lymph vascular space invasion, a standard pelvic lymph node dissection should be recommended. Parametrectomy should be included if the nodes are positive. In the other patients, the treatment can be individualized and does not have to include lymph node dissection or parametrectomy.

Introduction and Methods: Specific alterations in gene expression patterns might be used for molecular classification, prediction of disease outcome and treatment response. We determined the gene expression profile in tumours of 28 patients with early stage cervical cancer with (P) and without (N) lymph node metastasis after radical hysterectomy, using whole human genome oligonucleotide microarrays. Results: We used an ANOVA based approach with multiple testing correction to identify signatures of gene expression. A group of 15 differentially expressed genes between the two groups was found, including genes that have been related in the literature to tumour growth and metastasis. Using a classifier, with 1000 random splits of the data in a training set of 20 patients (11N/9P) and a test set of 8 patients (4N/4P), the mean error rate was 36% with a 0-62 95% CI. Varying the training set size showed that the proportion of misclassification decreased as the training set size increased. Conclusion: We found a possible signature of differentially expressed genes in patients with early stage cervical cancer with and without lymph node metastases. Our limited group size probably accounts for the 36% the misclassification rate, but a decreasing trend is seen when increasing the training set size. More samples are necessary to build a significant model.

Background: SCNC is a rare and aggressive tumour. The optimal therapeutic approach has not been defined. Objective: Evaluate the outcome of the treatment of SCNC patients. Methods: Clinical data and histological slides of patients with SCNC (1990-2004) were reviewed. Patient characteristics, treatment, recurrence and survival were studied. Results: Ten patients met the criteria of SCNC, 5 were diagnosed stage Ib and 5 stage IIb-IIIb. Eight patients were treated with chemotherapy, consisting of cyclophosphamide, doxorubicin and etoposide (CDE), followed by high dose radiotherapy to the pelvis in 7/8 patients. in 2 cases also para-aortic irradiation was given, because of suspicious lymphnodes. in 2 cases with complete remission prophylactic cranial irradiation was added. Two of all patients were treated with radical hysterectomy and adjuvant chemo/radiation. Six patients developed distant metastases (2 had only brain metastases) after a median of 11.5 months (range 7-85), two of them had also a pelvic recurrence. Four out of six died of disease after a median of 14.5 months (8-24). Overall survival rates were 50% and 33% at 2 and 5 years respectively. Six out of ten survived, 4 without evidence of disease after a median follow-up of 44 months (7-78). Two survived with disease after a follow-up of respectively 15 and 90 months. Conclusions: Our treatment with CDE chemotherapy showed similar survival rates when compared to platinum-based regimens. The occurrence of brain metastases may support the use of prophylactic cranial irradiation.