Milwaukee Laboratory System Improvement Program (L-SIP).

The Laboratory System Improvement Program (L-SIP) of the Association of Public Health Laboratories aims to improve state public health laboratory (PHL) system performance through continuous quality improvement. We successfully applied this state assessment tool to a local PHL (LPHL) system by tailoring it to reflect local system needs and created an LPHL system definition explaining how a local system differs from, yet complements, a state system. On November 18, 2010, 75 stakeholders from 40 agencies assessed the Milwaukee, Wisconsin, PHL system, capturing themes, strengths and weaknesses of the system, and scores for each of the 10 Essential Public Health Services. A Laboratory Advisory Committee analyzed assessment results to identify a strategic focus of research and workforce development and define an action plan, which is now being carried out. Milwaukee's L-SIP process is effectively improving LPHL system research and workforce development while raising community awareness of the system.

Evaluation of Luminex xTAG gastrointestinal pathogen analyte-specific reagents for high-throughput, simultaneous detection of bacteria, viruses, and parasites of clinical and public health importance.

Acute diarrheal disease (ADD) can be caused by a range of pathogens, including bacteria, viruses, and parasites. Conventional diagnostic methods, such as culture, microscopy, biochemical assays, and enzyme-linked immunosorbent assays (ELISA), are laborious and time-consuming and lack sensitivity. Combined, the array of tests performed on a single specimen can increase the turnaround time (TAT) significantly. We validated a 19plex laboratory-developed gastrointestinal pathogen panel (GPP) using Luminex xTAG analyte-specific reagents (ASRs) to simultaneously screen directly in fecal specimens for diarrhea-causing pathogens, including bacteria (Campylobacter jejuni, Salmonella spp., Shigella spp., enterotoxigenic Escherichia coli [ETEC], Shiga toxin-producing E. coli [STEC], E. coli O157:H7, Vibrio cholerae, Yersinia enterocolitica, and toxigenic Clostridium difficile), parasites (Giardia lamblia, Cryptosporidium spp., and Entamoeba histolytica), and viruses (norovirus GI and GII, adenovirus 40/41, and rotavirus A). Performance characteristics of GPP ASRs were determined using 48 reference isolates and 254 clinical specimens. Stool specimens from individuals with diarrhea were tested for pathogens using conventional and molecular methods. Using the predictive methods as standards, the sensitivities of the GPP ASRs were 100% for adenovirus 40/41, norovirus, rotavirus A, Vibrio cholerae, Yersinia enterocolitica, Entamoeba histolytica, Cryptosporidium spp., and E. coli O157:H7; 95% for Giardia lamblia; 94% for ETEC and STEC; 93% for Shigella spp.; 92% for Salmonella spp.; 91% for C. difficile A/B toxins; and 90% for Campylobacter jejuni. The overall comparative performance of the GPP ASRs with conventional methods in clinical samples was 94.5% (range, 90% to 97%), with 99% (99.0% to 99.9%) specificity. Implementation of the GPP ASRs enables our public health laboratory to offer highly sensitive and specific screening and identification of the major ADD-causing pathogens.

Decision analysis: point-of-care Chlamydia testing vs. laboratory-based methods.

OBJECTIVE: To evaluate and compare the performance of several different methods available for detection of Chlamydia trachomatis (Ct) infection, and to explore possible testing and treatment strategies incorporating point-of-care testing versus laboratory-based tests. DESIGN: Prospective trial and decision analysis. SETTING: Large, urban, publicly funded sexually transmitted disease clinic. PARTICIPANTS: 1,384 female patients. METHODS: Each subject was tested for Ct infection by direct fluorescent antibody (DFA, Sanofi/Kallestad, Chaska, MN), optical immunoassay (OIA, Thermo Electron, Point of Care and Rapid Diagnostics, Louisville CO), McCoy cell culture (in-house method), and polymerase chain reaction (microwell PCR, microwell assay, Roche, Branchburg NJ). RESULTS: Performing a rapid in-clinic test on women who did not meet empiric treatment criteria would have increased the overall proportion of infected persons receiving same-day treatment from 48.6% to 79.1% using DFA or 78.4% using OIA. CONCLUSIONS: Use of empiric treatment criteria and same-day point-of-care testing for patients not meeting the empiric treatment threshold appears to be an appropriate, useful, and cost-effective strategy for increasing same-day treatment of Ct infections in this population.