RESUMO
Direct access testing (DAT) is an emerging care model that provides on-demand laboratory services for certain preventative, diagnostic, and monitoring indications. Unlike conventional testing models where health care providers order tests and where sample collection is performed onsite at the clinic or laboratory, most interactions between DAT consumers and the laboratory are virtual. Tests are ordered and results delivered online, and specimens are frequently self-collected at home with virtual support. Thus, DAT depends on high-quality information technology (IT) tools and optimized data utilization to a greater degree than conventional laboratory testing. This review critically discusses the United States DAT landscape in relation to IT to highlight digital challenges and opportunities for consumers, health care systems, providers, and laboratories. DAT offers consumers increased autonomy over the testing experience, cost, and data sharing, but the current capacity to integrate DAT as a care option into the conventional patient-provider model is lacking and will require innovative approaches to accommodate. Likewise, both consumers and health care providers need transparent information about the quality of DAT laboratories and clinical decision support to optimize appropriate use of DAT as a part of comprehensive care. Interoperability barriers will require intentional approaches to integrating DAT-derived data into the electronic health records of health systems nationally. This includes ensuring the laboratory results are appropriately captured for downstream data analytic pipelines that are used to satisfy population health and research needs. Despite the data- and IT-related challenges for widespread incorporation of DAT into routine health care, DAT has the potential to improve health equity by providing versatile, discreet, and affordable testing options for patients who have been marginalized by the current limitations of health care delivery in the United States.
Assuntos
Atenção à Saúde , Tecnologia da Informação , Humanos , Estados UnidosRESUMO
Human papillomavirus (HPV) primary screening is an effective approach to assessing cervical cancer risk. Self-collected vaginal swabs can expand testing access, but the data defining analytical performance criteria necessary for adoption of self-collected specimens are limited, especially for those occurring outside the clinic, where the swab remains dry during transport. Here, we evaluated the performance of self-collected vaginal swabs for HPV detection using the Cobas 6800. There was insignificant variability between swabs self-collected by the same individual (n = 15 participants collecting 5 swabs per participant), measured by amplification of HPV and human ß-globin control DNA. Comparison of self-collected vaginal swab and provider-collected cervical samples (n = 144 pairs) proved highly concordant for HPV detection (total agreement = 90.3%; positive percentage agreement = 84.2%). There was no relationship between the number of dry storage days and amplification of HPV (n = 68; range, 4 to 41 days). Exposure of self-collected dry swabs to extreme summer and winter temperatures did not affect testing outcomes. A second internal control (RNase P) demonstrated that lack of amplification for ß-globin from self-collected specimens was consistent with poor, but not absent, cellularity. These data suggest that self-collected vaginal samples enable accurate clinical HPV testing, and that extended ambient dry storage or exposure to extreme temperatures does not influence HPV detection. Furthermore, lack of ß-globin amplification in HPV-negative samples accurately identified participants who required recollection.
Assuntos
Papillomavirus Humano , Infecções por Papillomavirus , Manejo de Espécimes , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , DNA Viral/análise , Detecção Precoce de Câncer/métodos , Papillomavirus Humano/isolamento & purificação , Programas de Rastreamento/métodos , Infecções por Papillomavirus/diagnóstico , Infecções por Papillomavirus/virologia , Manejo de Espécimes/métodos , Neoplasias do Colo do Útero/diagnóstico , Neoplasias do Colo do Útero/virologia , Vagina/virologia , Esfregaço Vaginal/métodosRESUMO
BACKGROUND: Urine albumin-to-creatinine ratio (uACR) is a screening assay for chronic kidney disease (CKD). A value of >30â mg/g is flagged abnormal, but lower ratios have prognostic implications. Thus, to maximize diagnostic utility, urine albumin (uAlb) should be measurable to 3â mg/L to match the lowest creatinine concentration generally utilized (10â mg/dL). Most uAlb assays have lower limits of quantitation (LLOQs) 2- to 4-fold higher. We sought to determine the performance characteristics of a commonly used uAlb assay at 3â mg/L and to evaluate the clinical screening impact of reducing the LLOQ. METHODS: Urine was serially diluted to assess uAlb linearity and precision for concentrations near the claimed LLOQ (12â mg/L). Samples (n = 30) with uAlb <12â mg/L were compared between laboratories. Sequential samples (n = 1239) were evaluated for clinical impact of reducing the measuring range to 3â mg/L. RESULTS: The assay was linear to 1.6â mg/L. Interday precision at 3.7â mg/L and 4.3â mg/L was 7.7% and 8.6%, respectively. Minimal bias was observed between labs (y = 1.091x - 0.75; average bias = -0.13â mg/L). Clinical validation demonstrated 501 of 1239 samples (40.4%) had uAlb <12â mg/L. Using 11.9â mg/L as the numerator for samples with uAlb <12â mg/dL and urine creatinine >10â mg/L, 107 of 499 (21.4%) would have a ratio flagged abnormal at >30â mg/g. Using the numeric value for these samples to 3â mg/L reduced alarm to <1%. CONCLUSIONS: A uAlb LLOQ of 3â mg/L improves screening utility of uACR by simplifying reporting and clinical interpretation when uAlb is low and provides clinical information for prognostic tools developed for people at risk of CKD.
Assuntos
Albuminúria , Insuficiência Renal Crônica , Albuminas/análise , Albuminúria/diagnóstico , Albuminúria/urina , Creatinina/urina , Humanos , Insuficiência Renal Crônica/diagnóstico , UrináliseRESUMO
BACKGROUND: Isoflurane at subhypnotic doses is known to affect cellular and network activity in the auditory pathway, but the behavioral effects of these concentrations of isoflurane on auditory processing have not been tested previously. The authors tested the hypothesis that subhypnotic doses of isoflurane would impair auditory discrimination in rats. METHODS: Rats were tested on their ability to discriminate up versus down frequency-modulated sweeps using three different pairs of sweeps ("Long," "Med," "Short"), whose frequency range and duration were varied systematically to make the discrimination more difficult. Rats were tested daily in the absence and presence of isoflurane at 0.2% or 0.4%. The effects of isoflurane (0%, 0.2%, and 0.4%) on performance (= % correct) and efficiency (= time/trial) were assessed using regression analysis. RESULTS: The effect of isoflurane was stimulus-dependent: performance for the Long stimulus pair was unaffected by isoflurane, performance on the Med stimulus pair was impaired only by 0.4% isoflurane, and performance on the Short stimulus pair was impaired by both 0.2% and 0.4% isoflurane. In contrast, isoflurane decreased efficiency equally for all stimulus pairs at 0.4% and had no effect at 0.2%. CONCLUSIONS: The stimulus dependence of the effect of isoflurane on performance suggests that it is unlikely this effect was secondary to effects on memory, motivation, or motor function. These data indicate that doses of isoflurane known to produce modest effects on neural responses alter cortical sensory processing.