BACKGROUND: Owing to shortage of surgical and N95 filtering facepiece respirators (FFRs) during the COVID-2019 pandemic, various masks were developed to prevent infection. This study aimed to examine the inward leakage rate (ILR) of sealed face masks and modified surgical masks using a quantitative fit test and compared it with the ILR of unmodified N95 FFRs. METHODS: We conducted paired comparisons of ILRs of bent nose-fit wire masks, double masks, and N95 FFRs from October to December 2021. To measure the protective effectiveness of masks, participants wore masks, and the number of particles outside and inside the mask were measured. The ILR was based on the percentage of particles entering the mask using a fit tester. RESULTS: We enrolled 54 participants (20 men and 34 women) in this study. The median ILR for surgical masks without and with a W-shaped bend in the nose-fit wire were 96.44% and 50.82%, respectively. The nose-fit wire adjustment reduced the ILR of surgical masks by a mean of 28.57%, which was significantly lower than the ILR without adjustment (P < 0.001). For double masks, with surgical or polyurethane masks on top of the W-shaped mask, the ILR did not differ significantly from that of N95. Although the filtration performance of double surgical masks matched that of N95 masks, their ILR was notably higher, indicating that double masks do not provide equivalent protection. CONCLUSIONS Wearing N95 masks alone is effective in many cases. However, surgical mask modifications do not guarantee consistent effectiveness. Properly selected, sealed masks with a good fit overcome leakage, emphasizing their crucial role. Without evidence, mask-wearing may lead to unexpected infections. Education based on quantitative data is crucial for preventing adverse outcomes.
Male ; Humans ; Female ; N95 Respirators ; COVID-19/epidemiology* ; Masks ; Pandemics/prevention & control* ; Respiratory Protective Devices ; Materials Testing ; Equipment Design ; Occupational Exposure/prevention & control*

Coronavirus disease 2019 (COVID-19) has continued to spread globally since late 2019, representing a formidable challenge to the world's healthcare systems, wreaking havoc, and spreading rapidly through human contact. With fever, fatigue, and a persistent dry cough being the hallmark symptoms, this disease threatened to destabilize the delicate balance of our global community. Rapid and accurate diagnosis of COVID-19 is a prerequisite for understanding the number of confirmed cases in the world or a region, and an important factor in epidemic assessment and the development of control measures. It also plays a crucial role in ensuring that patients receive the appropriate medical treatment, leading to optimal patient care. Reverse transcription-polymerase chain reaction (RT-PCR) technology is currently the most mature method for detecting viral nucleic acids, but it has many drawbacks. Meanwhile, a variety of COVID-19 detection methods, including molecular biological diagnostic, immunodiagnostic, imaging, and artificial intelligence methods have been developed and applied in clinical practice to meet diverse scenarios and needs. These methods can help clinicians diagnose and treat COVID-19 patients. This review describes the variety of such methods used in China, providing an important reference in the field of the clinical diagnosis of COVID-19.
Humans ; Artificial Intelligence ; China ; COVID-19/diagnosis* ; COVID-19 Testing

Humans ; SARS-CoV-2 ; COVID-19 ; Reverse Transcriptase Polymerase Chain Reaction ; Immunosuppression Therapy ; COVID-19 Testing

OBJECTIVE: To establish a rapid detection and genotyping method for SARS-CoV-2 Omicron BA.4/5 variants using CRISPPR-Cas12a gene editing technology. METHODS: We combined reverse transcription-polymerase chain reaction (RT-PCR) and CRISPR gene editing technology and designed a specific CRISPPR RNA (crRNA) with suboptimal protospacer adjacent motifs (PAM) for rapid detection and genotyping of SARS- CoV-2 Omicron BA.4/5 variants. The performance of this RT- PCR/ CRISPPR-Cas12a assay was evaluated using 43 clinical samples of patients infected by wild-type SARS-CoV-2 and the Alpha, Beta, Delta, Omicron BA. 1 and BA. 4/5 variants and 20 SARS- CoV- 2-negative clinical samples infected with 11 respiratory pathogens. With Sanger sequencing method as the gold standard, the specificity, sensitivity, concordance (Kappa) and area under the ROC curve (AUC) of RT-PCR/CRISPPR-Cas12a assay were calculated. RESULTS: This assay was capable of rapid and specific detection of SARS- CoV-2 Omicron BA.4/5 variant within 30 min with the lowest detection limit of 10 copies/μL, and no cross-reaction was observed in SARS-CoV-2-negative clinical samples infected with 11 common respiratory pathogens. The two Omicron BA.4/5 specific crRNAs (crRNA-1 and crRNA-2) allowed the assay to accurately distinguish Omicron BA.4/5 from BA.1 sublineage and other major SARS-CoV-2 variants of concern. For detection of SARS-CoV-2 Omicron BA.4/5 variants, the sensitivity of the established assay using crRNA-1 and crRNA-2 was 97.83% and 100% with specificity of 100% and AUC of 0.998 and 1.000, respectively, and their concordance rate with Sanger sequencing method was 92.83% and 96.41%, respectively. CONCLUSION By combining RT-PCR and CRISPPR-Cas12a gene editing technology, we successfully developed a new method for rapid detection and identification of SARS-CoV-2 Omicron BA.4/5 variants with a high sensitivity, specificity and reproducibility, which allows rapid detection and genotyping of SARS- CoV-2 variants and monitoring of the emerging variants and their dissemination.
Humans ; COVID-19 ; CRISPR-Cas Systems ; Genotype ; Reproducibility of Results ; Reverse Transcriptase Polymerase Chain Reaction ; SARS-CoV-2/genetics* ; RNA ; COVID-19 Testing

After the first outbreak of corona virus disease 2019 (COVID-19) at the end of 2019, it has caused multiple rounds of transmission in many countries around the world. Cancer patients are mainly elderly people, and the immunosuppression state caused by the tumor itself and anti-tumor treatment, more accompanying underlying diseases, and more hospital environmental exposure leading to a higher incidence of COVID-19 infection. The proportion of severe cases after infection is high, and the mortality is high. Therefore, based on the domestic and foreign research and clinical practice, the Expert Committee of Geriatric Cancer Prevention and Treatment of Chinese Society of Clinical Oncology launched a discussion based on the characteristics of cancer patients, including the epidemiology, clinical manifestations, differential diagnosis, definition and risk factors of severe cases, diagnosis and treatment recommendations, recovery of anti-tumor treatment and vaccination recommendations. To provide the corresponding suggestions for the clinical diagnosis and treatment of such patients.
Humans ; Adult ; Aged ; COVID-19/diagnosis* ; Neoplasms/epidemiology* ; Incidence ; Disease Outbreaks ; Diagnosis, Differential ; COVID-19 Testing

Objective: To establish a rapid and specific quantitative real-time PCR (qPCR) method for the detection of SARS-CoV-2 subgenomic nucleocapsid RNA (SgN) in patients with COVID-19 or environmental samples. Methods: The qPCR assay was established by designing specific primers and TaqMan probe based on the SARS-CoV-2 genomic sequence in Global Initiative of Sharing All Influenza Data (GISAID) database. The reaction conditions were optimized by using different annealing temperature, different primers and probe concentrations and the standard curve was established. Further, the specificity, sensitivity and repeatability were also assessed. The established SgN and genomic RNA (gRNA) qPCR assays were both applied to detect 21 environmental samples and 351 clinical samples containing 48 recovered patients. In the specimens with both positive gRNA and positive SgN, 25 specimens were inoculated on cells. Results: The primers and probes of SgN had good specificity for SARS-CoV-2. The minimum detection limit of the preliminarily established qPCR detection method for SgN was 1.5×10² copies/ml, with a coefficient of variation less than 1%. The positive rate of gRNA in 372 samples was 97.04% (361/372). The positive rates of SgN in positive environmental samples and positive clinical samples were 36.84% (7/19) and 49.42% (169/342), respectively. The positive rate and copy number of SgN in Wild strain were lower than those of SARS-CoV-2 Delta strain. Among the 25 SgN positive samples, 12 samples within 5 days of sampling time were all isolated with virus; 13 samples sampled for more than 12 days had no cytopathic effect. Conclusion: A qPCR method for the detection of SARS-CoV-2 SgN has been successfully established. The sensitivity, specificity and repeatability of this method are good.
Humans ; SARS-CoV-2/genetics* ; COVID-19/diagnosis* ; Subgenomic RNA ; Real-Time Polymerase Chain Reaction/methods* ; RNA, Viral/genetics* ; Sensitivity and Specificity ; Nucleocapsid/chemistry* ; COVID-19 Testing

An epidemic outbreak of the corona virus disease 2019(COVID-19) Omicron variant occurred in most regions of China. Children are susceptible to COVID-19 and the vast majority of them suffer from upper respiratory tract infection. Cough is one of the most common symptoms. COVID-19 infection related cough includes acute cough, persistent cough and chronic cough, and children with original chronic cough or chronic lung disease can also induce or aggravate symptom of cough after infection, which has a great impact on children's physical and mental health. The treatment for COVID-19 infection related cough vary with the etiology. Improper treatment would delay the patient's condition and increase adverse drug reaction. Currently, there is no guideline or consensus on the diagnosis and treatment of COVID-19 infection related cough in children in China, therefore this consensus is drafted. Referring to the latest international research and the diagnostic and therapeutic strategy for COVID-19 infection (Tenth Edition For Trial Implementation), and combining with clinical diagnosis and treatment experience,the consensus elaborates the pathogenesis and etiology of COVID-19 infection related cough, the use of cough relievers and expectorants, as well as the key points of diagnosis and treatment of different etiological factors. It is expected to provide specific and feasible guidance scheme for pediatricians, general practitioners and clinical pharmacists.
Child ; Humans ; Cough/therapy* ; COVID-19/therapy* ; SARS-CoV-2 ; Consensus ; COVID-19 Testing

PURPOSE: To prepare for future possible communicable disease epidemics/pandemics, health care providers should know how the COVID-19 pandemic influenced injured patients. This study aimed to compare epidemiologic features, outcomes, and diagnostic and therapeutic procedures of trauma patients admitted to a university-affiliated hospital before and during the pandemic. METHODS: This retrospective study was performed on data from the National Trauma Registry of Iran. All injured patients admitted to the hospital from July 25, 2016 to March 10, 2021 were included in the study. The patients were excluded if they had hospital length of stay less than 24 h. The injury outcomes, trauma mechanisms, and therapeutic and diagnostic procedures of the 2 periods: before (from July 25, 2016 to February 18, 2020) and during (from February 19, 2020 to March 10, 2021) COVID-19 pandemic were compared. All analyses were performed using STATA version 14.0 software (Stata Corporation, College Station, TX). RESULTS: Totally, 5014 patients were included in the registry. Of them, 773 (15.4%) were registered after the beginning of the COVID-19 pandemic on February 19, 2020, while 4241 were registered before that. Gender, education level, and cause of injury were significantly different among the patients before and after the beginning of the pandemic (p < 0.001). In the ≤ 15 years and ≥ 65 years age groups, injuries decreased significantly during the COVID-19 pandemic (p < 0.001). The frequency of intensive care unit (ICU) admission decreased from 694 (16.4%) to 88 (11.4%) (p < 0.001). The mean length of stay at the hospital (days) and at the ICU (days) declined as follow: 8.3 (SD = 17.2) vs. 5.5 (SD = 6.1), p < 0.001 and 7.5 (SD = 11.5) vs. 4.5 (SD = 6.3), p < 0.022. The frequency of diagnostic and therapeutic procedures before and during the pandemic was as follows, respectively: ultrasonography 905 (21.3%) vs. 417 (53.9%) (p < 0.001), echocardiography 313 (7.4%) vs. 107 (13.8%) (p < 0.001), angiography 1597 (37.7%) vs. 534 (69.1%) (p < 0.001), MRI 166 (3.9%) vs. 51 (6.6%) (p < 0.001), surgery 3407 (80.3%) vs. 654 (84.6%) (p < 0.001), and internal/external fixation 1215 (28.6%) vs. 336 (43.5%) (p < 0.001). CONCLUSION The pandemic affected the epidemiology of traumatic patients in terms of gender, age, educational level, and trauma mechanism. It changed the outcomes of injured patients: ICU admission, length of stay at the hospital and ICU decreased. The patients received more diagnostic and therapeutic procedures during the pandemic. To be more precise, more research is needed on the details.
Humans ; COVID-19/epidemiology* ; Pandemics ; Retrospective Studies ; Iran/epidemiology* ; Intensive Care Units ; Registries ; Trauma Centers ; COVID-19 Testing

Objective To rapidly screen patients with novel coronavirus pneumonia (COVID-19) infection including asymptomatic ones. Method Established a rapid detection test kit, and evaluated analytical and clinical performance of it. Result The minimum limit of detection of the reagent was 9.75×10² TCID₅₀/mL; there was no cross-reaction and interference in the high-concentration samples of 29 common respiratory pathogens tested. The diagnostic sensitivity of clinical samples was 98.56%, specificity was 99.00%, and the total coincidence rate was 98.85%; the consistency test Kappa value is 0.974 5. The stratified analysis of positive samples with different Ct values showed that the coincidence rate within each stratum was greater than 95%. Conclusion This COVID-19 antigen test kit with excellent detection performance, fast detection speed, and portable operation. It can be used as a supplementary method for existing nucleic acid detection methods for early screening of new coronavirus.
Humans ; COVID-19 ; COVID-19 Testing ; Sensitivity and Specificity ; SARS-CoV-2

The corona virus disease 2019(COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2(SARS-CoV-2), has created an urgent need of scientific and effective biomarkers for the purpose of prevention and control. Currently, commonly employed viral nucleic acids, antibodies, and rapid antigen test detection technologies all exhibit a range of limitations, including restricted applicability, inadequate sensitivity and specificity. Plasma SARS-CoV-2 quantitative antigen, as an emerging biomarker, has garnered significant attention due to its potential clinical value in the diagnosis and management of COVID-19. This article comprehensively analyzes the principles and clinical applications of quantitative detection technology for plasma SARS-CoV-2 antigen. Additionally, it explores the challenges encountered in this field and provides insights into future prospects.
Humans ; COVID-19/therapy* ; SARS-CoV-2 ; Antigens, Viral ; COVID-19 Testing