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1.
Open Forum Infect Dis ; 8(8): ofab374, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34381848

ABSTRACT

BACKGROUND: We describe the initial results of an adult academic emergency department (ED) nontargeted hepatitis C virus (HCV) screening program serving Appalachia, which is disproportionately affected by the opioid epidemic. METHODS: The study was a retrospective screening study of ED systematic, nontargeted, opt-out HCV testing outcomes from July 2018 through September 2020. Eligibility requirements for "nontargeted" HCV testing included age ≥18 years, verbally able to communicate, receiving bloodwork already as part of routine clinical care, and not opting out of testing. For eligible individuals who did not opt out of testing, an HCV antibody (Ab) test was performed. Reactive Ab tests were confirmed with reflexive HCV RNA testing. The primary study outcome was the characterization of HCV Ab and RNA prevalence. RESULTS: There were 75 722 unique adult visitors during the period studied. Of these, 54 931 individuals were verbally engaged regarding testing and did not opt out. A total of 34 848 individuals received HCV Ab testing, with 3665 patients (10.5%) having reactive results. RNA confirmatory testing was reflexively performed in all Ab-positive patients, with 1601 (50.3%) positive. The majority of HCV Ab- and RNA-positive patients were young, born after 1965, and were more likely to be White, male, Medicaid insured, and report a history of injection drug use. CONCLUSIONS: ED nontargeted, opt-out testing can identify a high prevalence of HCV infection among adult visitors. HCV infection was disproportionately high among younger, White individuals, likely reflecting the escalating syndemic of opioid injection and HCV transmission in Appalachia.

2.
J Appl Lab Med ; 1(1): 67-76, 2016 Jul 01.
Article in English | MEDLINE | ID: mdl-33626807

ABSTRACT

BACKGROUND: Point-of-care (POC) urine qualitative human chorionic gonadotropin (hCG) devices are used to rapidly assess pregnancy status, but many of these devices are susceptible to false-negative results caused by increased concentrations of hCG ß core fragment (hCGßcf) that does not contain hCGßcf. METHODS: Purified hCG was added to hCG-negative heparinized whole blood to generate samples with known hCG concentrations, and the resulting samples were used to evaluate device sensitivity, low-end reproducibility, high-dose hook effect, intermediate range performance, acceptable sample volume, acceptable hematocrit range, and lot-to-lot variation. Device performance was also prospectively evaluated in 40 pregnant and 40 nonpregnant women aged 18-44 years in a hospital-based clinic or an academic hospital emergency department. RESULTS: All device observations were positive using a whole blood sample containing a plasma hCG concentration of 2.2 × 106 IU/L, and all device observations were positive from18 IU/L to 1.2 × 103 IU/L and from 2.5 × 104 IU/L to 2.2 × 106 IU/L. Three invalid results were observed in the intermediate range because of decreased control line intensity. The minimum sample volume was 30 µL, and maximum hematocrit was 46%. In 40 pregnant and 40 nonpregnant women aged 18-44 years, the device generated 100% concordance with urine qualitative and plasma quantitative test results. CONCLUSIONS: The ADEXUSDx™ hCG test demonstrates acceptable performance for the determination of pregnancy status using capillary fingerstick samples.

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