Rapid antigen test as a tool for the identification of SARS-CoV-2 infection and its potential as a self-testing device

ABSTRACT Background: SARS-CoV-2 virus originated in Wuhan (China) in December (2019) and quickly spread worldwide. Antigen tests are rapid diagnostic tests (RDT) that produce results in 15-30 min and are an important tool for the scale-up of COVID-19 testing. COVID-19 diagnostic tests are authorized for self-testing at home in some countries, including Brazil. Widespread COVID-19 diagnostic testing is required to guide public health policies and control the speed of transmission and economic recovery. Methods: Patients with suspected COVID-19 were recruited at the Hospital da Baleia (Belo Horizonte, Brazil). The SARS-CoV-2 antigen-detecting rapid diagnostic tests were evaluated from June 2020 to June 2021 using saliva, nasal, and nasopharyngeal swab samples from 609 patients. Patient samples were simultaneously tested using a molecular assay (RT-qPCR). Sensitivity, specificity, accuracy, and positive and negative predictive values were determined using the statistical program, MedCalc, and GraphPad Prism 8.0. Results: The antigen-detecting rapid diagnostic tests displayed 98% specificity, 60% sensitivity, 96% positive predictive value, and moderate concordance with RT-qPCR. Substantial agreement was found between the two methods for patients tested < 7 days of symptom onset. Conclusions: Our findings support the use of Ag-RDT as a valuable and safe diagnostic method. Ag-RDT was also demonstrated to be an important triage tool for suspected COVID-19 patients in emergencies. Overall, Ag-RDT is an effective strategy for reducing the spread of SARS-CoV-2 and contributing to COVID-19 control.

Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation / 中国医疗器械杂志

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.

HIV oral self-screening test among HIV/STD/TB clinic attendees: A mixed-method pilot investigation examining merit for largerevaluation

Background & objectives: Globally, several countries consider HIV self-test as an important element in the toolbox to end AIDS by 2030. Against this background, the present investigation was conducted to pilot test the performance of an indigenous HIV oral self-test (HIVOST) and explore its acceptability. The overall purpose was to examine if this kit could serve as a promising tool and merit future larger clinical evaluation. Methods: A concurrent mixed-method investigation was undertaken during March-October 2019. One hundred and thirty two consecutive HIV/sexually transmitted diseases/tuberculosis clinic attendees were invited for participation; of whom, 100 were enrolled, and among them, 40 provided consent for qualitative in-depth interviews. The HIVOST kit assessed for its performance served as the ‘index test’, which worked on the principle of lateral flow chromatography. The results of the HIVOST were interpreted independently by the study physicians and participants at 20 min. HIVOST kit performance was assessed against the HIV confirmatory blood test result based on the national algorithm (3 rapid test or 1 ELISA and 2 rapid test) serving as the ‘reference’. Sensitivity, specificity, positive predictive value, negative predictive value and inter-rater agreement were estimated. The voices and concerns of the study participants were coded followed by identification of qualitative themes and ideas. Results: The sensitivity and specificity of the index test at the end of 20 min as interpreted by the participants were 83.3 per cent [95% confidence interval (CI): 69.8 to 92.5] and 98 per cent (95% CI: 89.4 to 99.5), respectively. Study physicians and participants independently interpreted HIVOST results with substantial inter-rater agreement (kappa value 0.88; 95% CI: 0.78-0.97). All HIVOST test strips were valid. Majority of the participants preferred saliva over blood for HIV self-test. ‘Comfort’, ‘confidentiality’ and ‘convenience’ were the perceived advantages of HIVOST. Some of the participants wished the package inserts contained ‘how-to-do instructions in local languages’, ‘expiry date (if any)’ and ‘contact helpline number’. A few of them highlighted the need for a confirmatory HIV result following oral self-test. Concerns of the participants revolved around potential self-harm following HIVOST-positive result and safe disposal of kits.Interpretation & conclusions: Two major highlights of the present investigation are (i) high level of concordance in HIVOST results interpreted by participants and physicians, and (ii) encouraging level of acceptance of HIVOST. These findings and encouraging HIVOST performance statistics lend support towards large-scale clinical evaluation of this index test.

Reduzindo o GAP entre a ciência e a clínica: lições da academia e da prática profissional - parte A: julgamento perceptivo-auditivo da qualidade vocal, análise acústica do sinal vocal e autoavaliação em voz / Reducing the GAP between science and clinic: lessons from academia and professional practice - part A: perceptual-auditory judgment of vocal quality, acoustic vocal signal analysis and voice self-assessment

RESUMO No XXVIII Congresso Brasileiro da SBFa, 24 especialistas reuniram-se e, a partir de um posicionamento condutor sobre pesquisa científica como ferramenta de conexão entre laboratório e clínica, cinco frentes de conhecimento da especialidade de voz foram discutidas: 1. Julgamento perceptivo-auditivo da qualidade vocal; 2. Análise acústica do sinal vocal; 3. Autoavaliação em voz; 4. Técnicas tradicionais de terapia; 5. Técnicas modernas de eletroestimulação e fotobiomodulação em voz. A parte "a" desta publicação é a consolidação das análises dos três primeiros aspectos. A tendência no julgamento perceptivo-auditivo da qualidade vocal é o uso de protocolos padrão. A avaliação acústica do sinal vocal é acessível e pode ser feita de modo descritivo ou por extração de parâmetros, preferindo-se medidas multiparamétricas. Finalmente, a análise do próprio indivíduo fecha essa tríade de documentação fonoaudiológica, que será base para a conclusão da avaliação, referência para monitoramento do progresso e avaliação de resultado de tratamento.

ABSTRACT During the XXVIII Brazilian Congress of SBFa, 24 specialists met and, from a leading position on scientific research as a tool for connecting laboratory and clinic, five fronts of knowledge of the voice specialty were discussed as following: Perceptual-auditory judgment of vocal quality; 2. Acoustic analysis of the vocal signal; 3. Voice self-assessment; 4. Traditional techniques of therapy; 5. Modern techniques of electrostimulation and photobiomodulation (PBMT) in voice. Part "a" of this publication was associated with the consolidation of the analyses of the first three aspects. The trend in the perceptual-auditory judgment of vocal quality was related to the use of standard protocols. The acoustic evaluation of the vocal signal is accessible and can be done descriptively or by extraction of parameters, thus preferring multiparametric measures. Finally, the analysis of the individual himself closes this triad of voice documentation, which will be the basis for the conclusion of the evaluation, reference for monitoring progress, and evaluation of treatment results.

Impact of COVID-19 on income, prevention attitudes, and access to healthcare among male clients in a Sexually Transmitted Infections clinic

ABSTRACT Background Mobility restrictions and overloaded health services during the COVID-19 pandemic compromised services dedicated to the prevention and care of HIV and other sexually transmitted infections (STI). In this study, we present client's responses to standardized questionnaires applied during the COVID-19 pandemic period as part of the strategy to measure impacts on social and sexual vulnerability, access to STI prevention services, and access to STI care. Methods: The questionnaires included variables on sociodemographics, behavior, risk perception, prevention attitudes, barriers to service-based HIV rapid test, reasons for taking an HIV self-test, and access to health services for STI diagnosis and treatment. We explored demographic variables associated with income reduction, reduced access to HIV/STI testing/treatment and increased vulnerability to HIV/STI. Results: 847 participants responded to the study questionnaire between May 2020 and January 2021. Most were young, cisgender male, and 63% self-reported as men who have sex with men. Income reductions were reported by 50%, with 30% reporting a decline over 50% of total income. An increase in heavy episodic drinking (>5 doses) was reported by 18%; 7% reported more sexual partners and 6% reported using condoms less often. Difficulties in obtaining HIV tests, tests for other STI and treatment for STI were reported by 5%, 6% and 6%, respectively. Lower schooling was significantly associated with income reduction (p = 0.004) and with reduced access to HIV/STI testing or STI treatment (p = 0.024); employment status was associated with income reduction (p < 0.001) and increased vulnerability to HIV/STI (p = 0.027). Having access to an expedite test result, avoiding physical attendance in health units during the pandemic, and undertaking the test with privacy with a trusted person were reported as motivators for HIV self-test. Conclusions: Our findings are relevant to promote service improvements tailored to subgroups more likely to struggle with detrimental effects during and after the COVID-19 pandemic.

Ease of use and validity testing of a point-of-care fast test for parasitic vaginosis self-diagnosis

@#There is a demand for patients to self-diagnose their sexually transmitted infections (selftesting), particularly during the coronavirus pandemic to prevent infection spread. We enrolled a cohort of Saudi women in a single-visit prospective study, which was the first of its kind performed in the country. Our aim was to evaluate the OSOM® Trichomonas (OSOM) test, a single-use, point-of-care rapid test, for its efficacy and accessibility as a self-test for Trichomonas vaginalis (Trichomonas) infection. At a public hospital’s gynecology clinic, women received sufficient training on specimen collection and OSOM self-testing. The women’s infection status was re-evaluated using direct wet mount microscopy and clinician performed OSOM using additional swabs. Specimens with discordant results were sorted using an inhouse polymerase chain reaction (PCR). 174 women aged 18 to 35 were registered and selftested at the clinic under the supervision of a gynecologist between June and December 2020, with 84.4 percent (147/174) having a valid result on the first or repeat OSOM. Infection was detected in 12.2% (18/147) of participants, with two-thirds of them symptomatic. Young age, low education, the existence of vaginitis symptoms, and unemployment were identified as key risk factors for infection in the study population, with statistically significant differences seen among women only in terms of education level and employment status (p<0.001). The OSOM self-test performed well (83.3% sensitivity and 98.4% specificity), outperforming the wet mount microscopy (72.2% sensitivity and 100% specificity) and comparable to the clinicians’ OSOM (88.8% sensitivity and 100% specificity). The patients’ and clinicians’ OSOM tests were strongly correlated, with a kappa of 0.89 and a 97.9% agreement. Self-collection of vaginal swabs was accepted and preferred by most women (94%) over the clinician-collection. Overall, our study’s findings may have important consequences for the implementation of Trichomonas screening based on OSOM self-testing approach in the study’s population.

The constitute and maintenance of TYCO PB840 ventilator / 中国医学装备

Ventilator is the mechanism of the implementation of artificial ventilation and its function is respiratory support, respiratory therapy and oxygenation improving. It is an important life-support equipment in life-saving first aid. Mainly for emergency transporters, recovery room, emergency department, the ICU pediatric, adult ICU and other departments in the hospital. It used to support high-risk, life-sustaining equipment. The failure is mainly concentrated on the two parts of the gas line and electric circuit. The daily maintenance and preventive maintenance are an essential part for protection breathing machine to work properly.

Nivel de conocimiento de la población femenina del consultorio 6 sobre autoexámen de mama / Knowledge level of the female population from the consulting number six about the mammary gland self

La finalidad del presente trabajo fue profundizar en el conocimiento de una población femenina sobre las técnicas para realizar el autoexamen mamario. Se realizó un estudio transversal retrospectivo en el Consultorio 6, perteneciente al Policlínico Docente Pedro Fonseca del Municipio La Lisa, Ciudad de La Habana. Se encuestaron 174 mujeres en el período entre enero y abril del 2009. Se valoraron las vías de aprendizaje de estas técnicas y frecuencia con que las realizaban. También se valoraron los conocimientos sobre la naturaleza benigna o maligna de los nódulos mamarios y sobre la relación entre el cáncer de mama y la lactancia materna. Los resultados se expresaron en porcentajes y demostraron que aunque la mayoría de estas mujeres refieren conocer y se realizan el examen de mamas, sus conocimientos sobre frecuencia y calidad dista mucho de garantizar el objetivo de su aplicación, que la vía fundamental de aprendizaje fue los medios de difusión masiva. En sentido general, la población estudiada conoce la acción protectora de la lactancia materna en relación con el cáncer de mamas(AU)

This present work aims at deepen the female population knowledge about the mammary gland self-test and its techniques. A retrospective-transverse-research was done by the consulting room number six doctors. From January to April, 174 patients were asked in a survey. The ways of learning, the techniques, and the frequency of the self-test were evaluated. There were also evaluated the knowledge about the malign or benign nature of the mammary gland and the relation between the mammary gland cancer and the breast-feeding. The results were expressed by percentage and demonstrated that, although the female patients say they knew how to do their mammary gland test, their knowledge about frequency and quality of these tests was not enough for the objective application of it. The primary way of learning was media. In general the people study and know the, protect action of the breast-feeding and its relation with the mammary gland cancer. June, 2009(AU)

SACSR: A low power BIST method for sequential circuits / 西安交通大学学报·英文版

A novel built-in-self-test,(BIST) method called seeded autonomous cyclic shift register (SACSR) is presented to reduce test power of the sequential circuit. The key idea is to use a pseudorandom pattern generator and several XOR gates to generate seeds that share fewer test vectors. The generated seed is taken XOR operation with a cyclic shift register, and the single input change (SIC) sequence is generated. The proposed scheme is easily implemented and can reduce the switching activities of the circuit under-test. (CUT) greatly. Experimental results on-ISCAS89 benchmarks show that on average more than 63% power reduction can be achieved. It also demonstrates that the generated test vectors attain high fault coverage for stuck-at fault and transition fault coverage with short test length.

SACSR:a low power BIST method for sequential circuits / 药物分析学报

A novel built-in-self-test (BIST) method called seeded autonomous cyclic shift register (SACSR) is presented to reduce test power of the sequential circuit. The key idea is to use a pseudorandom pattern generator and several XOR gates to generate seeds that share fewer test vectors. The generated seed is taken XOR operation with a cyclic shift register, and the single input change (SIC) sequence is generated. The proposed scheme is easily implemented and can reduce the switching activities of the circuit under test (CUT) greatly. Experimental results on ISCAS89 benchmarks show that on average more than 63% power reduction can be achieved. It also demonstrates that the generated test vectors attain high fault coverage for stuck-at fault and transition fault coverage with short test length.