Qualification of the Geenius HIV 1/2 supplemental assay for use in the HIV blood donation screening algorithm.

BACKGROUND: A single, simplified approach for human immunodeficiency virus (HIV)-1/HIV-2 antibody confirmation/differentiation is needed for the HIV blood donation supplemental algorithm used in the United States. A clinical evaluation of the Geenius assay was performed-the same assay used for HIV diagnostic confirmation/differentiation in the United States since 2014. STUDY DESIGN AND METHODS: Well-characterized unlinked donation samples classified as HIV negative, false positive, or confirmed positive were included in the study: 200 antibody-nonreactive, 200 HIV-1 immunofluorescence assay (IFA) confirmed-positive, and 100 antibody-screen false-positive donations, equally divided between serum and plasma. Samples were retrieved from a repository, relabeled, and tested by an immunochromatographic test (Geenius HIV 1/2 Supplemental Assay, Bio-Rad). Comparator testing involved parallel US Food and Drug Administration (FDA)-licensed HIV-1 IFA or HIV-2 enzyme immunoassay (EIA) supplemental testing for any sample missing those results as part of routine testing (otherwise test-of-record results were used). Samples with discordant results were further tested with a rapid test (Multispot HIV-1/HIV-2 Rapid Test, Bio-Rad) to provide final sample interpretations. Testing volume reductions with the Geenius were estimated from screening performed by the American Red Cross from September 2016 to April 2019. RESULTS: Clinical results were 100% sensitivity and specificity with an indeterminate rate of 4.0% to 5.0%. From 2016 to 2019, sole use of the Geenius would reduce testing complexity for 5265 antibody repeat-reactive donations including 95.7% (5028) false positives, eliminating approximately 5000 unnecessary tests. CONCLUSION: Geenius FDA licensure (August 26, 2019) adding the HIV-1/HIV-2 differentiation/confirmation donation supplemental claim will enable replacement of previously used FDA-licensed supplemental assays while maintaining comparable sensitivity, avoiding thousands of unnecessary HIV-1-IFA, western blot, and HIV-2-EIA tests.

Is environmental tobacco smoke exposure a risk factor for acute gastroenteritis in young children?

Because passive smoke exposure has not been previously linked to diarrhea diseases in children, it was hypothesized that very young children exposed to environmental tobacco smoke (ETS) exposure at home would also be more likely to develop infectious gastroenteritis (GE) than their unexposed counterparts. During 1-year period, 260 children 36 months and younger were prospectively followed up in a private pediatric practice in a southern community in the United States. Multiple logistic regression analysis showed that ETS was strongly predictive of acute GE in the univariate analysis (P = .003). Even after controlling for the various confounders, ETS exposure was still significantly associated with acute GE (relative risk = 2.55; 95% CI = 1.26-5.18). It is speculated that, similar to acute respiratory infections, the same mechanisms may explain why ETS may also be associated with acute infectious GE.

Black/white differential use of health services by young children in a rural Mississippi community.

BACKGROUND AND OBJECTIVES: Use of health services in rural communities has not been well studied. We explored how black and white children used health services in a rural Mississippi community. METHODS: Data were prospectively collected for 396 children attending a private practice to determine if race was associated with the use of health services in this community. RESULTS: White children made more sick contacts than black children (P < 0.001). Black children (36%) were more likely to be treated in the emergency room than white children (24%; P = 0.013). There was no black-white difference in the hospitalization rates, although white children were more likely to undergo ear-nose-throat (ENT) surgery for pressure equalizing tube (PET) placement, and/or tonsillectomy and adenoidectomy (T and A; P < 0.001). Even after controlling for various confounders, the frequency of all physician sick contacts was twice as high for white children than for black children (RR = 2.17; 95% C.I. = 1.32-3.58). CONCLUSION: Overall, black children used disproportionately fewer health services than their white counterparts, but used significantly higher emergency room services. Private insurance coverage was the single most significant variable that accounted for the black-white differential use of the emergency room.