Pandemic Demand for SARS-CoV-2 Testing Led to Critical Supply and Workforce Shortages in U.S. Clinical and Public Health Laboratories.

COVID-19 has brought unprecedented challenges to clinical and public health laboratories. While U.S. laboratories have continued striving to provide quality test results during the pandemic, the uncertainty and lack of supplies became a significant hurdle, hindering day-to-day laboratory operations and the ability to increase testing capacity for both SARS-CoV-2 and non-COVID-19 testing. In addition, long-standing laboratory workforce shortages became apparent, hindering the ability of clinical and public health laboratories to rapidly increase testing. The American Society for Microbiology, the College of American Pathologists, the National Coalition of STD Directors, and the Emerging Infections Network independently conducted surveys in 2020 and early 2021 to assess the capacity of the nation's clinical laboratories to respond to the increase in demand for testing during the COVID-19 pandemic. The results of these surveys highlighted the shortages of crucial supplies for SARS-CoV-2 testing and supplies for other routine laboratory diagnostics, as well as a shortage of trained personnel to perform testing. The conclusions are based on communications, observations, and the survey results of the clinical laboratory, public health, and professional organizations represented here. While the results of each survey considered separately may not be representative of the entire community, when considered together they provide remarkably similar results, further validating the findings and highlighting the importance of laboratory supply chains and the personnel capable of performing these tests for any response to a large-scale public health emergency.

Engaging Latino Families About COVID-19 Vaccines: A Qualitative Study Conducted in Oregon, USA.

OBJECTIVES: Latinos are disproportionately vulnerable to severe COVID-19 due to workplace exposure, multigenerational households, and existing health disparities. Rolling out COVID-19 vaccines among vulnerable Latinos is critical to address disparities. This study explores vaccine perceptions of Latino families to inform culturally centered strategies for vaccine dissemination. METHOD: Semistructured telephone interviews with Latino families (22 mothers and 24 youth, 13-18 years old) explored COVID-19 vaccine perceptions including (1) sources of information, (2) trust of vaccine effectiveness and willingness to get vaccinated, and (3) access to the vaccine distribution. We identified thematic patterns using immersion-crystallization. RESULTS: We found that (1) 41% expressed optimism and willingness to receive the vaccine coupled with concerns about side effects; (2) 45% expressed hesitancy or would refuse vaccination based on mistrust, myths, fear of being used as "guinea pigs," and the perceived role of politics in vaccine development; (3) families "digested" information gathered from social media, the news, and radio through intergenerational communication; and (4) participants called for community-led advocacy and "leading by example" to dispel fear and misinformation. Optimistic participants saw the vaccine as a way to protect their families, allowing youth to return to schools and providing safer conditions for frontline essential workers. CONCLUSIONS: Culturally centered vaccine promotion campaigns may consider the Latino family unit as their target audience by providing information that can be discussed among parents and youth, engaging a range of health providers and advocates that includes traditional practitioners and community health workers, and disseminating information at key venues, such as schools, churches, and supermarkets.

The COVID-19 Mirage: A Young Biologist With an Atypical Presentation of a Zoonotic Disease During the COVID-19 Pandemic.

COVID-19 has become one of the main causes of febrile illness among emergency department patients and is always a differential diagnosis to keep in mind. Nonetheless, some patients with a history of exposure, persistent fever, and suspicion of COVID-19 end up having entirely different etiologies. Here, we present the case of a 29-year-old male biologist with an uncommon presentation of a zoonotic disease, characterized by unspecific signs and symptoms, which led to a delayed diagnosis, causing significant emotional distress in the patient. We also coin the term "COVID-19 Mirage," to serve as a constant reminder for clinicians of the effect that COVID-19 has caused on the differential diagnosis of fever of unknown etiology.

Smartphone Biosensor With App Meets FDA/ISO Standards for Clinical Pulse Oximetry and Can Be Reliably Used by a Wide Range of Patients.

BACKGROUND: Millions of smartphones contain a photoplethysmography (PPG) biosensor (Maxim Integrated) that accurately measures pulse oximetry. No clinical use of these embedded sensors is currently being made, despite the relevance of remote clinical pulse oximetry to the management of chronic cardiopulmonary disease, and the triage, initial management, and remote monitoring of people affected by respiratory viral pandemics, such as severe acute respiratory syndrome coronavirus 2 or influenza. To be used for clinical pulse oximetry the embedded PPG system must be paired with an application (app) and meet US Food and Drug Administration (FDA) and International Organization for Standardization (ISO) requirements. RESEARCH QUESTION: Does this smartphone sensor with app meet FDA/ISO requirements? Are measurements obtained using this system comparable to those of hospital reference devices, across a wide range of people? STUDY DESIGN AND METHODS: We performed laboratory testing addressing ISO and FDA requirements in 10 participants using the smartphone sensor with app. Subsequently, we performed an open-label clinical study on 320 participants with widely varying characteristics, to compare the accuracy and precision of readings obtained by patients with those of hospital reference devices, using rigorous statistical methodology. RESULTS: "Breathe down" testing in the laboratory showed that the total root-mean-square deviation of oxygen saturation (Spo2) measurement was 2.2%, meeting FDA/ISO standards. Clinical comparison of the smartphone sensor with app vs hospital reference devices determined that Spo2 and heart rate accuracy were 0.48% points (95% CI, 0.38-0.58; P < .001) and 0.73 bpm (95% CI, 0.33-1.14; P < .001), respectively; Spo2 and heart rate precision were 1.25 vs reference 0.95% points (P < .001) and 5.99 vs reference 3.80 bpm (P < .001), respectively. These small differences were similar to the variation found between two FDA-approved reference instruments for Spo2: accuracy, 0.52% points (95% CI, 0.41-0.64; P < .001) and precision, 1.01 vs 0.86% points (P < .001). INTERPRETATION: Our findings support the application for full FDA/ISO approval of the smartphone sensor with app tested for use in clinical pulse oximetry. Given the immense and immediate practical medical importance of remote intermittent clinical pulse oximetry to both chronic disease management and the global ability to respond to respiratory viral pandemics, the smartphone sensor with app should be prioritized and fast-tracked for FDA/ISO approval to allow clinical use. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT04233827; URL: www.clinicaltrials.gov.