RESUMO
BACKGROUND: Accurate same-day sexually transmitted infection (STI) diagnostic testing is generally unavailable, leading to syndromic management with high rates of overtreatment and undertreatment. We analyzed the ease of integration of the Visby STI Panel into clinical practice, studied acceptance by patients and clinic personnel, and assessed the potential to inform accurate treatment decisions. METHODS: In a cross-sectional single-visit study of 55 women aged 18 to 56 years, women self-collected vaginal swab samples that were analyzed using the Visby STI Panel for Chlamydia trachomatis, Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Results were compared with standard-of-care clinic results from send-out laboratory polymerase chain reaction tests. Surveys assessed patient and device operator experiences with the Visby STI Panel and clinicians' perceived need for and acceptance of the device. Time parameters were measured to evaluate the impact on clinical workflow, and syndromic treatment decisions were compared with anticipated treatment based on the Visby STI Panel results. RESULTS: Patients strongly agreed that sample self-collection was easy, and operators reported the device easy to use. Clinicians valued the rapid return of results, and patients were comfortable waiting up to 30 minutes to receive them. In 13 of 15 cases, the Visby STI Panel correctly identified undertreated patients as infected and correctly identified all 33 incidences of overtreatment. CONCLUSIONS: Clinical adoption of the Visby STI Panel into primary care clinics and doctors' offices could reduce overtreatment and undertreatment of STIs. If integrated efficiently into the clinical workflow, the test would have minimal impact on staff time and visit duration for patients.
Assuntos
Infecções por Chlamydia , Gonorreia , Infecções Sexualmente Transmissíveis , Tricomoníase , Trichomonas vaginalis , Trichomonas , Infecções por Chlamydia/diagnóstico , Infecções por Chlamydia/tratamento farmacológico , Infecções por Chlamydia/epidemiologia , Chlamydia trachomatis/genética , Estudos Transversais , Feminino , Gonorreia/diagnóstico , Gonorreia/tratamento farmacológico , Gonorreia/epidemiologia , Humanos , Masculino , Neisseria gonorrhoeae/genética , Testes Imediatos , Reação em Cadeia da Polimerase , Infecções Sexualmente Transmissíveis/diagnóstico , Infecções Sexualmente Transmissíveis/tratamento farmacológico , Infecções Sexualmente Transmissíveis/epidemiologia , Tricomoníase/diagnóstico , Tricomoníase/tratamento farmacológico , Tricomoníase/epidemiologia , Trichomonas vaginalis/genéticaRESUMO
The Xpert Flu+RSV Xpress Assay is a fast, automated in vitro diagnostic test for qualitative detection and differentiation of influenza A and B viruses and respiratory syncytial virus (RSV) performed on the Cepheid GeneXpert Xpress System. The objective of this study was to establish performance characteristics of the Xpert Flu+RSV Xpress Assay compared to those of the Prodesse ProFlu+ real-time reverse transcription-PCR (RT-PCR) assay (ProFlu+) for the detection of influenza A and B viruses as well as RSV in a Clinical Laboratory Improvement Amendments (CLIA)-waived (CW) setting. Overall, the assay, using fresh and frozen nasopharyngeal (NP) swabs, demonstrated high concordance with results of the ProFlu+ assay in the combined CW and non-CW settings with positive percent agreements (PPA) (100%, 100%, and 97.1%) and negative percent agreements (NPA) (95.2%, 99.5%, and 99.6%) for influenza A and B viruses and RSV, respectively. In conclusion, this multicenter study using the Cepheid Xpert Flu+RSV Xpress Assay demonstrated high sensitivities and specificities for influenza A and B viruses and RSV in â¼60 min for use at the point-of-care in the CW setting.
Assuntos
Vírus da Influenza A/isolamento & purificação , Vírus da Influenza B/isolamento & purificação , Técnicas de Diagnóstico Molecular/métodos , Sistemas Automatizados de Assistência Junto ao Leito , Reação em Cadeia da Polimerase em Tempo Real , Vírus Sincicial Respiratório Humano/isolamento & purificação , Automação Laboratorial , DNA Viral/genética , Humanos , Vírus da Influenza A/genética , Vírus da Influenza B/genética , Influenza Humana/diagnóstico , Influenza Humana/virologia , Técnicas de Diagnóstico Molecular/normas , Nasofaringe/virologia , Infecções por Vírus Respiratório Sincicial/diagnóstico , Infecções por Vírus Respiratório Sincicial/virologia , Vírus Sincicial Respiratório Humano/genética , Sensibilidade e Especificidade , Fatores de TempoRESUMO
BACKGROUND: Molecular tests (ie, real-time polymerase chain reaction [RT-PCR]) and antigen tests are used to detect SARS-CoV-2. RT-PCR tests are generally considered to be the standard for clinical diagnosis of SARS-CoV-2 due to accuracy and reliability but can take longer to return results than antigen tests. Our aim was to examine if point-of-care (POC) testing for SARS-CoV-2 infection would provide a flexible resource to help achieve workplace safety. We compared test results and time-to-test results between a POC RT-PCR test and a send-out PCR test in a program implemented in summer 2020. RESULTS: POC testing shortened the time to results to 110 minutes in the POC setting from the 754 minutes for send-out tests. The specificity of POC RT-PCR single POC testing was 98.7% compared with send-out RT-PCR testing and was confirmed at 99.8% in a validation analysis. The sensitivity of the POC testing was 100% compared with send-out RT-PCR, although in a validation analysis, sensitivity appeared as 0% because only the 12 positive or indeterminate samples on the first analysis were retested and the majority were false-positives that were correctly ruled out. CONCLUSIONS: POC testing for SARS-CoV-2 with RT-PCR technology is possible at reduced time compared with send-out PCR testing.
Assuntos
COVID-19 , SARS-CoV-2 , Teste para COVID-19 , Humanos , Reação em Cadeia da Polimerase em Tempo Real , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Local de TrabalhoRESUMO
Antibiotic-resistant pathogens cause over 35,000 preventable deaths in the United States every year, and multiple strategies could decrease morbidity and mortality. As antibiotic stewardship requirements are being deployed for the outpatient setting, community providers are facing systematic challenges in implementing stewardship programs. Given that the vast majority of antibiotics are prescribed in the outpatient setting, there are endless opportunities to make a smart and informed choice when prescribing and to move the needle on antibiotic stewardship. Antibiotic stewardship in the community, or "smart prescribing" as we suggest, should factor in antibiotic efficacy, safety, local resistance rates, and overall cost, in addition to patient-specific factors and disease presentation, to arrive at an appropriate therapy. Here, we discuss some of the challenges, such as patient/parent pressure to prescribe, lack of data or resources for implementation, and a disconnect between guidelines and real-world practice, among others. We have assembled an easy-to-use best practice guide for providers in the outpatient setting who lack the time or resources to develop a plan or consult lengthy guidelines. We provide specific suggestions for antibiotic prescribing that align real-world clinical practice with best practices for antibiotic stewardship for two of the most common bacterial infections seen in the outpatient setting: community-acquired pneumonia and skin and soft-tissue infection. In addition, we discuss many ways that community providers, payors, and regulatory bodies can make antibiotic stewardship easier to implement and more streamlined in the outpatient setting.
RESUMO
The COVID-19 pandemic highlighted the significance of readily available and easily performed viral testing for surveillance during future infectious pandemics. The objectives of this study were: to assess the performance of the Xpert Xpress Flu and/or RSV test, a multiplex PCR assay for detecting influenza A and B virus and respiratory syncytial virus nucleic acids in respiratory tract specimens, relative to the Quidel Lyra Influenza A+B assay and the Prodesse ProFlu+ assay, and the system's ease of use by minimally trained operators. Overall, the Xpert Xpress Flu/RSV test demonstrated a high positive and negative percent agreement with the comparator assays, and was easy to use and interpret results, based on the operators' feedback. We concluded that the Xpert Xpress Flu/RSV test is sensitive, specific, and easy to use for the diagnosis of influenza and RSV by minimally trained operators and can be a valuable tool in future infectious clusters or pandemics.
Assuntos
COVID-19 , Vírus da Influenza A , Influenza Humana , Infecções por Vírus Respiratório Sincicial , Vírus Sincicial Respiratório Humano , COVID-19/diagnóstico , Humanos , Vírus da Influenza A/genética , Vírus da Influenza B/genética , Influenza Humana/diagnóstico , Técnicas de Diagnóstico Molecular/métodos , Nasofaringe , Pandemias , Reação em Cadeia da Polimerase em Tempo Real/métodos , Infecções por Vírus Respiratório Sincicial/diagnóstico , Vírus Sincicial Respiratório Humano/genética , Sensibilidade e EspecificidadeRESUMO
Resistance to macrolides is rising in the USA and warrants careful consideration when confronted with a patient with suspected pneumonia in the urgent care clinic. This case study exemplifies the potentially serious consequences of treatment failure following prescription of a macrolide for community-acquired bacterial pneumonia. Furthermore, the consequential treatment dilemmas currently faced by physicians are briefly discussed.