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Over the past 20 years, there has been a continuous shift in decentralizing clinical laboratory testing in the US. Historically, testing was conducted almost exclusively in centralized laboratories in hospitals. However, at present, approximately 53% of testing is performed in hospitals (including some near-patient testing in settings such as critical care and emergency rooms), 34% in commercial clinical laboratories (50% of which is done in Quest Diagnostics and LabCorp), and the remaining in physician office laboratories and other settings as well as directly by consumers using over-the-counter devices. These numbers vary depending on the state. For example, in New York State 368 million tests in chemistry were performed in 2014, 73% of which were processed in hospital laboratories and 23% in independent (commercial) laboratories (data courtesy of Dr. Robert Rej). There are many drivers for this triangulating dynamic shift, including cost reduction, convenience to patients and clinicians, quality improvement (when the frequency of performing a particular test in the hospital laboratory is low), and the use of novel technologies such as nanotechnology, microfluidics, electrical impedance, reflectance, and time-resolved fluorescence, which enabled the miniaturization of devices and the proliferation of point-of-care (POC)8 testing. Improvement in information technology has been instrumental in the process of decentralizing testing and providing clinicians with patient results; this is, however, not a trivial matter and the cost of the interface is not always justifiable. Regulatory requirements in terms of assuring competency of those performing testing, getting patient laboratory results into the medical records, billing appropriately, and providing patients with their test findings are only few of the challenges of decentralized testing. How is the testing dynamic shift in this $56 billion industry going to evolve over the next 5 and 10 years? What will be the impact of technology, reimbursement, and confidentiality in shaping this …

Introduction: To maximize organ utilization, the United Network for Organ Sharing (UNOS) encourages use of Expanded Criteria Donors (ECD). However, Standard Criteria Donors (SCD) may also be under-utilized, some centers discarding kidneys with serum creatinine (S.Cr) >2.0 at nephrectomy. Our experience with the use of such ``impaired’’ kidneys was reviewed retrospectively. Results: From January 1, 2003 to October 1, 2006, of 130 DD kidneys transplanted at our center, 26 were ECD. Also, 22 kidneys were from Impaired SCD (ISCD), with mean S.Cr 3.2 (2.1–4.4) at nephrectomy; eight of these had S.Cr >4.0. For these 22 ISCD, mean age was 22 yrs (11–42), sex: 16 Males; race:12 Caucasians/10 African-Americans; All had evidence of rhabdomyolysis (Mean peak CPK 11,924 u/l). Thirty-seven percent came from outside OPOs. Recipient demographics: age 45 years; sex 50% male, 45% African-American. Mean HLA match was 1; dialysis was required in 28% within the first week. Mean length of stay was 10.7 days. Average discharge S.Cr was 4.2. All kidneys are currently functioning (S.Cr at 3 months, 6 months and 1 year 1.6, 1.7 and 1.7 respectively). Conclusion: An elevated creatinine should not be the only cause for discarding deceased donor kidneys.

We examine institutions’ revealed preferences towards default risk in publicly traded savings and loan institutions (S&Ls or thrifts). We test whether institutions consider default risks to be fairly priced, and therefore do not mind holding thrifts exposed to it. Our tests avoid the problems associated with measuring risks and returns ex-ante versus ex-post. An important underlying assumption of the distress anomaly is that financially distressed firms tend to cluster, preventing investors from diversifying away their risks. During the two financial crises, thrifts clearly met this criteria. We find statistically significant evidence for an inverse relationship between institutional ownership and thrift default risk. We also find statistically significant evidence that institutions increase ownership during financial crises. Our results hold for fixed effects and three stage least squares (3SLS) regressions as robustness tests to deal with missing variable bias and endogeneity between default risk and institutional ownership.

Current methodologies for the diagnosis of legionellosis are time-consuming and labor-intensive, which dissuades many doctors from ordering the tests. To make the urinary rapid diagnostic, antibody was raised to the carbohydrate portion of Legionella serogroup 1. The antibody was immobilized on nitrocellulose and conjugated to colloidal gold particles to produce an immunochromatographic test (ICT). To evaluate the test, a retrospective study was performed in which 300 frozen archive urine samples were thawed and evaluated using the ICT device. Results were compared with culture diagnosis. A prospective study was then performed in which 93 urine samples were collected from symptomatic patients reporting to the hospital with lower respiratory symptoms or sepsis. The purpose of this study was to evaluate the test with fresh urine samples. These patients were evaluated by culture and the ICT. In these samples, the specificity of the test was 100%. No samples were positive either by culture or ICT for Legionella pneumophila. Since the test can be performed rapidly with accurate results, the test is leading to more patients being properly diagnosed and treated accordingly.

Summary To our knowledge SpermCheck I represents the first immunodiagnostic device that has been developed to rapidly measure sperm in a platform suitable for both physician office and over-the-counter testing. At the time of this writing, the prototype device is poised to undergo clinical testing to gain the necessary performance data for the FDA approval process. The successful development of the working prototype establishes the proof of concept that immunodiagnostic devices of sufficient sensitivity can be developed to create products useful for male infertility as well as contraception and post-asectomy cases. The impact of these devices on the practice of urology and infertility may be wide. Significant cost saving will occur in shifting the paradigm for sperm testing from laboratory microscope to a handheld immunodiagnostic device for home use. When infertility is suspected in a couple, these devices may well reduce unnecessary testing of women by provid- ing privacy to men and encouragement to them to assess male fertility status early in the diagnostic process. Further, follow- ing vasectomy, the SpermCheck I test will indicate when to discontinue other methods of contraception and prevent unanticipated pregnancy. The development of the SpermCheck I immunodiagnostic test parallels efforts underway by several organizations to develop a male “pill.” By virtue of its ability to determine when sperm counts have fallen to very low levels, SpermCheck I provides a companion test for men considering using a male contraceptive. Eventual availability of SpermCheck devices may help to hasten the general acceptance of male methods of contraception and contribute to equitable contraceptive responsibility between men and women.

A solid-phase enzyme-linked immunosorbent assay (ELISA) has been developed to detect and quantify the K88 fimbrial adhesin antigen. The assay was used to detect cell-bound antigen present in bacterial suspensions and cell-free K88 antigen present in extracts. Comparable amounts of K88 antigen were detected with whole bacteria and in the equivalent extracts. The assay was used to compare the expression of the K88 antigen by one laboratory strain (K12: K88ab) and three wild-type strains (O8 : K87 : K88ab : H19, O8 : K87 : K88ac : H19 and K88ad) of enterotoxigenic Escherichia coli (ETEC) during cultivation with eight medium types and two medium forms. Determination of the expression of K88 during unshaken batch culture revealed a correlation between growth phase and expression, with maximal concentrations being detected during late log to early stationary phase. Colony blotting experiments demonstrated that expression of the K88 antigen was under quantitative and not qualitative control.

To maximize organ utilization, the United Network for Organ Sharing (UNOS) encourages use of Expanded Criteria Donors (ECD). However, Standard Criteria Donors (SCD) may also be under-utilized, some centers discarding kidneys with serum creatinine (S.Cr)2.0 at nephrectomy. Our experience with the use of such "impaired'' kidneys was reviewed retrospectively.From January 1, 2003 to October 1, 2006, of 130 DD kidneys transplanted at our center, 26 were ECD. Also, 22 kidneys were from Impaired SCD (ISCD), with mean S.Cr 3.2 (2.1-4.4) at nephrectomy; eight of these had S.Cr4.0. For these 22 ISCD, mean age was 22 yrs (11-42), sex: 16 Males; race:12 Caucasians/10 African-Americans; All had evidence of rhabdomyolysis (Mean peak CPK 11,924 u/l). Thirty-seven percent came from outside OPOs. Recipient demographics: age 45 years; sex 50% male, 45% African-American. Mean HLA match was 1; dialysis was required in 28% within the first week. Mean length of stay was 10.7 days. Average discharge S.Cr was 4.2. All kidneys are currently functioning (S.Cr at 3 months, 6 months and 1 year 1.6, 1.7 and 1.7 respectively).An elevated creatinine should not be the only cause for discarding deceased donor kidneys.