CD4 enumeration technologies: a systematic review of test performance for determining eligibility for antiretroviral therapy.

BACKGROUND: Measurement of CD4+ T-lymphocytes (CD4) is a crucial parameter in the management of HIV patients, particularly in determining eligibility to initiate antiretroviral treatment (ART). A number of technologies exist for CD4 enumeration, with considerable variation in cost, complexity, and operational requirements. We conducted a systematic review of the performance of technologies for CD4 enumeration. METHODS AND FINDINGS: Studies were identified by searching electronic databases MEDLINE and EMBASE using a pre-defined search strategy. Data on test accuracy and precision included bias and limits of agreement with a reference standard, and misclassification probabilities around CD4 thresholds of 200 and 350 cells/μl over a clinically relevant range. The secondary outcome measure was test imprecision, expressed as % coefficient of variation. Thirty-two studies evaluating 15 CD4 technologies were included, of which less than half presented data on bias and misclassification compared to the same reference technology. At CD4 counts <350 cells/μl, bias ranged from -35.2 to +13.1 cells/μl while at counts >350 cells/μl, bias ranged from -70.7 to +47 cells/μl, compared to the BD FACSCount as a reference technology. Misclassification around the threshold of 350 cells/μl ranged from 1-29% for upward classification, resulting in under-treatment, and 7-68% for downward classification resulting in overtreatment. Less than half of these studies reported within laboratory precision or reproducibility of the CD4 values obtained. CONCLUSIONS: A wide range of bias and percent misclassification around treatment thresholds were reported on the CD4 enumeration technologies included in this review, with few studies reporting assay precision. The lack of standardised methodology on test evaluation, including the use of different reference standards, is a barrier to assessing relative assay performance and could hinder the introduction of new point-of-care assays in countries where they are most needed.

Site Report for Phase III Archaeological Investigations at Reynolds Tavern (18AP23), 4 Church Circle, Annapolis, Maryland. 1982-1984

This report details the archaeology completed at Reynolds Tavern in the years 1982,1983, and 1984. It was completed in 2013, nearly 30 years after the excavation took place, using archival materials such as the draft interim reports, unit summary forms, original notes and photographs which are currently stored in the University Archives at Hornbake Library, at the University of Maryland, College Park. This report has been a collaboration across time and space, drawing from preliminary reports written by Anne Yenstch and Susan Mira in 1982 and Joe Dent and Beth Ford in 1983, as well as original notes from students of the field schools held there during those years, various analyses by scholars from many universities (including the University of Maryland, University of Georgia, and the College of William and Mary), and historical research by Nancy Baker. Thomas Cuddy began the writing of this report in 2002, completing the first three chapters in addition to the artifact analysis that led to the postexcavation identification of the African bundles in the Reynolds Tavern basement. This remarkable discovery was made along with Mark Leone of the University of Maryland, founder and director of Archaeology in Annapolis, who also served as the Principle Investigator during all three years of the Reynolds Tavern excavations. Dr. Leone contributed the fifth and final chapter to this report, the Conclusions and Recommendations, during its final compilation in 2013. The final report, including the fourth chapter on the archaeology itself, was written in part and compiled by Patricia Markert of the University of Maryland in the spring of 2013. Reynolds Tavern has been part of the landscape of Annapolis for two-hundred and fifty five years (at the time of the publication of this report). It sits on Church Circle facing St. Anne’s Church, and is a beautiful example of 18th century Georgian architecture as well one of the defining features of Historic Annapolis today. It currently operates as a popular restaurant and pub, but has served variously as a hat shop, a tavern, an inn, a library and a bank over time, among other things. Its long history contributes to its significance as an archaeological site, and also as a historic marker in present day Annapolis. The archaeology conducted at Reynolds Tavern shed light on life in 18th and 19th century Annapolis, illuminating details of the occupants’ lives through the material traces they left behind. These include an 18th century cobblestone road that ran diagonally through the Tavern’s yard, telling of the movement through early Annapolis; a large and intact well, which was found ii to contain a 19 foot wooden pipe; a large, ovular privy containing many of the objects used on a day to day basis at the Tavern or the structures around it; a subterranean brick storage feature in the basement of the Tavern, which may have been used by Reynolds during his days operating a hat shop; and also in the basement, two African caches of objects, providing a glimpse into West African spiritual practices alive in historic Annapolis and the presence of African American individuals at the Tavern in the 18th and 19th centuries. The purpose of this report is to detail these archaeological investigations and their findings, so that a public record will be available and the archaeology completed at Reynolds Tavern can continue to contribute to the history of Annapolis.