DRUL for school: Opening Pre-K with safe, simple, sensitive saliva testing for SARS-CoV-2.

To address the need for simple, safe, sensitive, and scalable SARS-CoV-2 tests, we validated and implemented a PCR test that uses a saliva collection kit use at home. Individuals self-collected 300 µl saliva in vials containing Darnell Rockefeller University Laboratory (DRUL) buffer and extracted RNA was assayed by RT-PCR (the DRUL saliva assay). The limit of detection was confirmed to be 1 viral copy/µl in 20 of 20 replicate extractions. Viral RNA was stable in DRUL buffer at room temperature up to seven days after sample collection, and safety studies demonstrated that DRUL buffer immediately inactivated virus at concentrations up to 2.75x106 PFU/ml. Results from SARS-CoV-2 positive nasopharyngeal (NP) swab samples collected in viral transport media and assayed with a standard FDA Emergency Use Authorization (EUA) test were highly correlated with samples placed in DRUL buffer. Direct comparison of results from 162 individuals tested by FDA EUA oropharyngeal (OP) or NP swabs with co-collected saliva samples identified four otherwise unidentified positive cases in DRUL buffer. Over six months, we collected 3,724 samples from individuals ranging from 3 months to 92 years of age. This included collecting weekly samples over 10 weeks from teachers, children, and parents from a pre-school program, which allowed its safe reopening while at-risk pods were quarantined. In sum, we validated a simple, sensitive, stable, and safe PCR-based test using a self-collected saliva sample as a valuable tool for clinical diagnosis and screening at workplaces and schools.

Disorders of glucose metabolism in the context of human immunodeficiency virus infection.

PURPOSE: To discuss the pathophysiology and the current treatment approaches for the dysregulation of glucose metabolism in the context of human immunodeficiency virus (HIV) infection. DATA SOURCES: Selected research, clinical studies, clinical guidelines, and review articles. CONCLUSIONS: In HIV infection, multiple factors are associated with the pathogenesis of glucose dysregulation. Studies suggest that protease inhibitors, a class of antiretroviral agent, as well as viral factors, lipodystrophy, hepatitis C infection, injection drug use, and second-generation antipsychotics have been implicated in the development of glucose disorders and diabetes. Current treatment recommendations are based on extrapolated data from non-HIV diabetic patients. More research is needed to establish the most appropriate management for the disorders of glucose metabolism in the context of HIV infection. IMPLICATIONS FOR PRACTICE: If left untreated, patients are at increased risk for cardiovascular disease and complications associated with untreated diabetes.

Cardiovascular considerations in patients treated with HIV protease inhibitors.

Highly active antiretroviral therapy (HAART) has dramatically reduced mortality from HIV infection, transforming it in many cases to a chronic condition. However, protease inhibitors (PIs), which are integral components of most HAART regimens, are commonly associated with a host of metabolic disturbances that may increase the risk of cardiovascular disease in patients with HIV infection, potentially counteracting some of the positive health effects of PIs. Dyslipidemia is of particular concern. The Adult AIDS Clinical Trials Group has established preliminary guidelines to evaluate and treat PI-associated dyslipidemia. A number of strategies exist for the management of PI-based dyslipidemia in HAART recipients; their advantages and disadvantages should be considered when treating patients with HIV infection.

Simplified regimens for treating HIV infection and AIDS.

PURPOSE: To review the variables that greatly affect adherence to the complex treatment regimens used in HIV disease and to examine available options that could improve patient outcomes. DATA SOURCES: Comprehensive review of current medical and scientific literature, drug-prescribing literature, and randomized clinical trials of drug treatments. CONCLUSIONS: Effective treatment of HIV infection is dependent on consistent adherence to prescribed antiretroviral medications. A large pill burden, multiple daily doses, and adverse events are some of the complexities that negatively impact patient adherence. For example, lipodystrophy and hyperlipidemia are two serious side effects associated with some agents. Once-daily antiretroviral agents offer many advantages over historical treatment options but are associated with possible drawbacks. IMPLICATIONS FOR PRACTICE: Currently, four single agents are available for once-daily administration, and a few others are under investigation. In addition, combination therapy with either dual or boosted protease inhibitor regimens is becoming a popular way of overcoming the poor pharmacokinetic characteristics of individual protease inhibitors.