Universal screening of potential organ donors and recipients for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is now recommended prior to transplantation in the United States during the coronavirus disease 19 (COVID-19) pandemic. Challenges have included limited testing capacity, short windows of organ viability, brief lead time for notification of potential organ recipients, and the need to test lower respiratory donor specimens to optimize sensitivity. In an early U.S. epicenter of the outbreak, we designed and implemented a system to expedite this testing and the results here from the first 3 weeks. The process included a Laboratory Medicine designee for communication with organ recovery and transplant clinical staff, specialized sample labeling and handoff, and priority processing. Thirty-two organs recovered from 14 of 17 screened donors were transplanted vs 70 recovered from 23 donors during the same period in 2019. No pretransplant or organ donors tested positive for SARS-CoV-2. Median turnaround time from specimen receipt was 6.8 hours (donors), 6.5 hours (recipients): 4.5 hours faster than daily inpatient median. No organ recoveries or transplantations were disrupted by a lack of SARS-CoV-2 testing. Waitlist inactivations for COVID-19 precautions were reduced in our region. Systems that include specialized ordering pathways and adequate testing capacity can support continued organ transplantation, even in a SARS-CoV-2 hyperendemic area.

To optimize transportation processes, we present herein a contingency plan that coordinates interim measures used to ensure continued and timely services when climate based events might cause an interruption of the usual specimen transportation processes. As an example, we outline the implementation and effectiveness of a contingency plan for network laboratory courier automobile transportation during times of mountain pass highway closure. Data available from an approximately 3-year period from October 10, 2010 through August 29, 2013 revealed a total of 690 complete closures in the eastbound or westbound lanes of the Interstate-90 highway in the Snoqualmie Pass area in the state of Washington. Despite the frequency of closures, the Washington State Department of Transportation was effective in limiting the duration of closures. Road closures of less than 1 hour accounted for 58.7% of the total closures. No recorded closures prevented dispatched couriers from completing a prescheduled Snoqualmie Pass route. We identified no delays as being clinically significant, despite that there were 5 instances of delays greater than 4 hours. We implemented a contingency plan of aiding courier logistics during all times of pass closure. The plan includes an easy to interpret Condition Dashboard as a status indicator and a Decision Tree that references and summarizes information. Overall, the contingency plan allows for an objective, robust, proactive decision support system that has enabled operational flexibility and has contributed to continued safe, on-time specimen transportation; clients and courier and reference laboratory staff have appreciated these features and associated outcomes.

BACKGROUND:Chemiluminescence immunoassay (CIA) is used to detect hepatitis C virus (HCV) antibody status on the basis of signal-to-cutoff (S/Co) ratios. Positive results of antibody to HCV (anti-HCV) are followed by either recombinant immunoblot assay (RIBA) to confirm anti-HCV positivity or reverse transcription (RT)-PCR to detect viremia. We hypothesized that by analyzing S/Co ratios, we could determine a strategy to reduce unnecessary supplementary testing in our population.METHODS:CIA was performed to screen for anti-HCV, and positive results were followed up with RT-PCR testing. Negative RT-PCR results were followed up with RIBA, whereas positive RT-PCR results were assumed to be RIBA positive. ROC curves were analyzed to determine the optimal S/Co ratios to predict HCV infection.RESULTS:We determined the S/Co ratios on 34 243 veteran patient samples. We found that with the CIA method 9.0% of patients had positive test results for anti-HCV. An S/Co ratio <3.0 ruled out active HCV infection and exposure with 100% negative predictive value. When the S/Co ratio was ≥20.0, positive predictive values were 98.5% compared with RIBA results, and 81.0% compared with RT-PCR results.CONCLUSIONS:RIBA is not necessary to confirm negative or positive CIA anti-HCV if the S/Co ratio is <3.0 or ≥20.0, respectively. To confirm HCV exposure, samples with an S/Co ratio between 3.0 and 19.9 should be followed up with RIBA unless PCR testing has been performed and the result is positive. Samples with an S/Co ratio ≥20.0 or positive RIBA results should be further tested by RT-PCR to determine HCV viremia status.

Free testosterone (FT) measurement by equilibrium dialysis and liquid chromatography-tandem mass spectroscopy (LCMS/MS) is the "gold standard." We hypothesized that calculated FT values could substitute for measured values; compared FT results reported by Walter Reed Army Medical Center (WRAMC), Washington, DC, with results reported by the Seattle Veterans Affairs Health Care System, Seattle, WA, for 3 patient groups; and evaluated the calculated FT values by gold-standard measurements. Groups 1 and 2 included samples from 54 patients evaluated in Seattle and 94 evaluated at a primary care clinic in Alaska whose samples were analyzed in Seattle, respectively, whose care resulted in ordering an FT measurement. Group 3 included samples from 64 patients evaluated in endocrine WRAMC clinics. Calculated FT values between the 2 facilities demonstrated a strong correlation (R-2 = 0.98) for all 212 patients. In a comparison of calculated FT values with measured levels, group 3 had an R-2 = 0.93; however, samples with FT values less than 50 pg/mL had a poorer correlation (R-2 = 0.45). Calculated FT values may accurately reflect and be substituted in the clinical setting for gold-standard values when levels are more than 50 pg/mL.

Observational studies have suggested that low serum β-carotene concentrations may influence HIV-1 disease progression. However, randomized trials have not demonstrated beneficial effects of β-carotene supplementation. To understand this discrepancy, we conducted a cross-sectional study among 400 HIV-1-seropositive women in Mombasa, Kenya, to correlate serum β-carotene concentrations with several measures of HIV-1 disease severity. β-Carotene concentrations were significantly associated with biologic markers of HIV-1 disease progression (CD4 count, HIV-1 plasma viral load, serum C-reactive protein [CRP] concentration, and serum albumin level). In multivariate analysis, β-carotene concentrations below the median were associated with elevated CRP (>10mg/l, adjusted odds ratio [aOR] 3.32, 95% confidence interval [CI] 1.99–5.53, P <0.001) and higher HIV-1 plasma viral load (for each log10 copies/mL increase, aOR 1.38, 95% CI 1.01–1.88, P = 0.04). In the context of negative findings from randomized trials of β-carotene supplementation in HIV-1-seropositive individuals, these results suggest that low β-carotene concentrations primarily reflect more active HIV-1 infection rather than a deficiency amenable to intervention.

OBJECTIVE— The purpose of this study was to determine the relationship between plasma liver enzyme concentrations, insulin sensitivity, and intra-abdominal fat (IAF) distribution. RESEARCH DESIGN AND METHODS— Plasma γ-glutamyl transferase (GGT), aspartate transaminase (AST), alanine transaminase (ALT) levels, insulin sensitivity (insulin sensitivity index [SI]), IAF area, and subcutaneous fat (SCF) area were measured in 177 nondiabetic subjects (75 men and 102 women, aged 31–75 years) with no history of liver disease. On the basis of BMI (< or ≥27.5 kg/m2) and SI (< or ≥7.0 × 10−5 min/pmol) subjects were divided into lean insulin sensitive (LIS, n = 53), lean insulin resistant (LIR, n = 60), and obese insulin resistant (OIR, n = 56) groups. RESULTS— Levels of all three liver enzymes were higher in men than in women (P < 0.0001 for each). In men, GGT levels were higher in insulin-resistant than in insulin-sensitive subjects (P < 0.01). In women, GGT levels were higher in the OIR than in the LIS group (P < 0.01) but no different in the LIR group. There was no difference in ALT and AST levels among the LIS, LIR, and OIR groups. GGT was associated with SI (r = −0.26, P < 0.0001), IAF area (r = 0.22, P < 0.01), waist-to-hip ratio (WHR) (r = 0.25, P = 0.001), BMI (r = 0.17, P < 0.05), and SCF area (r = 0.16, P < 0.05) after adjustments for age and sex. In men, only SI (r = −0.29, P < 0.05) remained independently correlated with GGT in multiple regression analysis. In women, IAF area (r = 0.29, P < 0.01) and WHR (r = 0.29, P < 0.01) were independently associated with GGT, but SI was not. CONCLUSIONS— In nondiabetic men GGT but not AST or ALT levels, are inversely related to insulin sensitivity independent of IAF area. However in women, GGT is related to measures of central body fat rather than to insulin sensitivity.

Low vitamin E levels are often found in HIV-1 infection, and studies have suggested that higher levels may decrease the risk of disease progression. However, vitamin E supplementation has also been reported to increase CCR5 expression, which could increase HIV-1 replication. We hypothesized that vitamin E levels at HIV-1 acquisition may influence disease progression.

Background Low serum selenium has been associated with lower CD4 counts and greater mortality among HIV-1-seropositive individuals, but most studies have not controlled for serum albumin and the presence of an acute phase response. Methods A cross-sectional study was conducted to evaluate relationships between serum selenium concentrations and CD4 count, plasma viral load, serum albumin, and acute phase response markers among 400 HIV-1-seropositive women. Results In univariate analyses, lower CD4 count, higher plasma viral load, lower albumin, and the presence of an acute phase response were each significantly associated with lower serum selenium concentrations. In multivariate analyses including all four of these covariates, only albumin remained significantly associated with serum selenium. For each 0.1 g/dl increase in serum albumin, serum selenium increased by 0.8 μg/l (p < 0.001). Women with an acute phase response also had lower serum selenium (by 5.6 μg/l, p = 0.06). Conclusion Serum selenium was independently associated with serum albumin, but not with CD4 count or plasma viral load, in HIV-1-seropositive women. Our findings suggest that associations between lower serum selenium, lower CD4 count, and higher plasma viral load may be related to the frequent occurrence of low serum albumin and the acute phase response among individuals with more advanced HIV-1 infection.

Introduction and Methods: The purpose of this study was to evaluate the serum free light chain (FLC) assay in its ability to improve performance of protocols designed to screen for plasma cell disorders. We measured M-protein levels using serum protein electrophoresis (SPEP) in 312 consecutive patients being screened for plasma cell disorders at the Veterans Administration Medical Center - Puget Sound. The serum kappa and lambda free light chain levels were quantitated using the serum FLC assay in these same patients. The kappa/lambda ratio was calculated using the free kappa and free lambda results from the serum FLC assay.

Study objectives: The purpose of this study is to validate the Albumin Cobalt Binding (ACB) test at the Veterans Affairs (VA) Puget Sound Health Care System. This study measures the distribution of ACB values for our normal VA population and determines an initial ACB rule-out value for acute coronary syndrome. Methods: ACB values were determined photometrically with Ischemia Technologies reagents on the P-module of a Roche Modular Analytical System. We retrospectively measured serum ACB levels in 21 first-draw troponin samples obtained from patients presenting to the emergency department with chest pain. Specifically, we chose these samples only if the patient's initial troponin was negative and subsequent troponin levels became elevated. According to the correlations between the initial negative and subsequently elevated troponin, we constructed a receiver operating characteristic (ROC) curve to identify the highest ACB rule-out value. Furthermore, using 30 patients not experiencing chest pain, we established an initial normal range for our population. Results: There was a statistically significant difference between ACB values in the 30 apparently healthy individuals (85.5±10.3 U/mL; 95% confidence interval [CI] 81.7 to 89.4) compared with the 21 patients whose troponin became positive (123.8±17.2 U/mL; 95% CI 115.9 to 131.6; P<.0001). The area under the ROC curve was 99.1% (P<.0001), and there was almost complete discrimination between the 2 groups when a 96 U/mL decision level was used. Conclusion: This preliminary study suggests that the ACB test has a strong negative predictive value and sensitivity in the initial study group for predicting positive troponin results 6 to 24 hours after presentation. The ACB test, when used in conjunction with cardiac injury markers, holds promise in reducing inappropriate low-risk admissions. Study objectives: The purpose of this study is to validate the Albumin Cobalt Binding (ACB) test at the Veterans Affairs (VA) Puget Sound Health Care System. This study measures the distribution of ACB values for our normal VA population and determines an initial ACB rule-out value for acute coronary syndrome. Methods: ACB values were determined photometrically with Ischemia Technologies reagents on the P-module of a Roche Modular Analytical System. We retrospectively measured serum ACB levels in 21 first-draw troponin samples obtained from patients presenting to the emergency department with chest pain. Specifically, we chose these samples only if the patient's initial troponin was negative and subsequent troponin levels became elevated. According to the correlations between the initial negative and subsequently elevated troponin, we constructed a receiver operating characteristic (ROC) curve to identify the highest ACB rule-out value. Furthermore, using 30 patients not experiencing chest pain, we established an initial normal range for our population. Results: There was a statistically significant difference between ACB values in the 30 apparently healthy individuals (85.5±10.3 U/mL; 95% confidence interval [CI] 81.7 to 89.4) compared with the 21 patients whose troponin became positive (123.8±17.2 U/mL; 95% CI 115.9 to 131.6; P<.0001). The area under the ROC curve was 99.1% (P<.0001), and there was almost complete discrimination between the 2 groups when a 96 U/mL decision level was used. Conclusion: This preliminary study suggests that the ACB test has a strong negative predictive value and sensitivity in the initial study group for predicting positive troponin results 6 to 24 hours after presentation. The ACB test, when used in conjunction with cardiac injury markers, holds promise in reducing inappropriate low-risk admissions.

Preeclampsia is an important cause of maternal and perinatal mortality worldwide. The etiology of this relatively common medical complication of pregnancy, however, remains unknown. We studied the relationship between maternal leukocyte selenium, zinc, and copper concentrations and the risk of preeclampsia in a large hospital-based case-control study. One hundred seventy-one women with proteinuric pregnancy-induced hypertension (with or without seizures) comprised the case group. Controls were 184 normotensive pregnant women. Leukocytes were separated from blood samples collected during the patients’ postpartum labor and delivery admission. Leukocyte concentrations for the three cations were measured by inductively coupled plasma-mass spectrometry (ICP-MS). Concentrations for each cation were reported as micrograms per gram of total protein. Women with preeclampsia had significantly higher median leukocyte selenium concentrations than normotensive controls (3.23 vs 2.80 µg/g total protein, p <0.0001). Median leukocyte zinc concentrations were 31% higher in preeclamptics as compared with controls (179.15 vs 136.44 µg/g total protein, p <0.0001). Although median leukocyte copper concentrations were slightly higher for cases than controls, this difference did not reach statistical significance (17.72 vs 17.00 µg/g total protein, p =0.468). There was evidence of a linear increase in risk of preeclampsia with increasing concentrations of selenium and zinc. The relative risk for preeclampsia was 3.38 (adjusted odds ratio [OR]=3.38, 95% confidence interval [CI]=1.53–7.54) among women in the highest quartile of the control selenium distribution compared with women in the lowest quartile. The corresponding relative risk and 95% CI for preeclampsia was 5.30 (2.45–11.44) for women in the highest quartile of the control zinc distribution compared with women in the lowest quartile. There was no clear pattern of a linear trend in risk with increasing concentration of leukocyte copper concentrations (adjusted for linear trend in risk =0.299). Our results are consistent with some previous reports. Prospective studies are needed to determine whether observed alterations in selenium and zinc concentrations precede preeclampsia or whether the differences may be attributed to preeclampsia-related alterations in maternal and fetal-placental trace metal metabolism.