Comparison of the time required for manual (visually read) and semi-automated POCT urinalysis and pregnancy testing with associated electronic medical record (EMR) transcription errors.

BACKGROUND: POCT urinalysis (UA) and urine pregnancy tests (UPT) are routinely performed in obstetrics and gynecology (Ob/Gyn) clinics by dipstick and pregnancy test kit methods respectively. In this study, we compared the time, efficiency and accuracy of these tests using manual, visually read methods and a semi-automated analyzer that was not interfaced to the EMR. METHODS: We prospectively enrolled 2525 patients at five Ob/Gyn clinics. Urine samples were tested using three different dipsticks for UA (2, 7 and 10 test pads) and the Sure-Vue™ urine pregnancy test kit. The samples were analyzed on the CLINITEK Status® Connect System and results compared for time taken and errors in results' transcription. RESULTS: Using the CLINITEK Status Connect System, average test time and average total test time for UA dipsticks 7 and 10 test pads was significantly less than the manual, visually read method (0.77 and 0.64 min, respectively; p < 0.001). The average test time for manual, visually read Chem 2 was significantly less than the CLINITEK Status Connect System (0.09 min; p = 0.005), but not the average total test time (0.08 min; p = 0.33). Average test time for a negative UPT using the CLINITEK Status Connect System was significantly greater (0.87 min; p < 0.001). We found a transcription error rate of 0.3-1.7% for UA results and none for UPT. About 8% of UA and 12% of UPT results were not documented in EMR. CONCLUSION: The CLINITEK Status Connect System was more efficient than the manual, visually read process and if interfaced with the EMR would eliminate errors and non-documentation of results.

What's a Lab to Do During and After a Hurricane?

Although laboratories may be able to rely on a comprehensive Hurricane Plan during a hurricane, alarming and unanticipated events frequently occur. To minimize disruption of lab operations, it is important to try to mitigate the impact of these unexpected events as quickly as possible, in the quest to minimize negative outcomes. In this article, we discuss approaches to dealing with unanticipated events during and after hurricanes, based on our personal experiences.

Hurricanes: Are You Prepared?

Severe weather events such as hurricanes have the potential to cause significant disruption of laboratory operations. Comprehensive planning is essential to mitigate the impact of such events. The essential elements of a Hurricane Plan, based on our personal experiences, are detailed in this article.

Data documenting the performance of the PT/INR line correction method for reconciling INR discrepancies between central laboratory coagulation analyzers using different thromboplastins during the evaluation of a portable Coagulometer.

The data presented here was produced as part of an evaluation of the performance of the CoaguChek XS point-of-care coagulation analyzer, which is discussed in the research article "POCT PT INR - Is it adequate for Patient Care? A Comparison of the Roche Coaguchek XS vs. Stago Star vs. Siemens BCS in Patients Routinely Seen in an Anticoagulation Clinic" (Baker et al., in press) [1]. An effort to reconcile discrepancies in the patient INR result distributions from different central lab instruments (Stago Star and Siemens BCS) with the PT/INR line method is described (Poller et al., 2010, 2011; Ibrahim et al., 2011) [2], [3], [4]. While regression analysis of the ECAA Poller calibrant data provided a linear PT/INR line for all methods, Pearson's chi-squared and one-way repeated measures ANOVA analyses showed that central lab INR measurements continued to exhibit measurement site dependence after the PT/INR line correction was applied. According to paired t-test analysis, only the human thromboplastin dependent methods (CoaguChek XS and Siemens BCS both before and after PT/INR line correction) showed statistically significant agreement (p-value >0.05).

POCT PT INR - Is it adequate for patient care? A comparison of the Roche Coaguchek XS vs. Stago Star vs. Siemens BCS in patients routinely seen in an anticoagulation clinic.

BACKGROUND: In this study we examined the difference in patient INR values as measured by the POCT CoaguChek XS device and central laboratory Stago Evolution and Siemens BCS XP analyzers. METHODS: This study composed of 100 warfarin therapy patients and 20 coagulation normal subjects, showed that the difference between the POCT and clinical laboratory values increased with increasing INR and was exacerbated by the use of different thromboplastin reagents by the POCT and central lab. RESULTS: The CoaguChek XS and on-site Stago analyzers which used human recombinant (ISI=1.01) and rabbit brain thromboplastin (ISI=1.25), respectively, showed reasonable agreement for INR<3.0 (k=0.62) but significant difference for INR≥3.0 (k=0.10). In contrast, the CoaguChek XS and Siemens BCS XP, which both employed human recombinant thromboplastin (BCS ISI=1.02), showed greater agreement for the complete range INR values (INR<3.0 k=0.84; INR≥3.0 k=0.70). ECAA Poller calibrant data showed the automated instruments were performing as expected, indicating that ISI calibrations were correct but insufficient to standardize the INR values for the different thromboplastin methods across the full range of measured INRs. Central lab verification of POCT INR>5.0 with the Stago Evolution prevented adverse treatment events for the warfarin therapy patients in the six months preceding and following this investigation.

Increased vaccine efficacy against tuberculosis of recombinant Mycobacterium bovis bacille Calmette-Guérin mutants that secrete listeriolysin.

The tuberculosis vaccine Mycobacterium bovis bacille Calmette-Guérin (BCG) was equipped with the membrane-perforating listeriolysin (Hly) of Listeria monocytogenes, which was shown to improve protection against Mycobacterium tuberculosis. Following aerosol challenge, the Hly-secreting recombinant BCG (hly+ rBCG) vaccine was shown to protect significantly better against aerosol infection with M. tuberculosis than did the parental BCG strain. The isogenic, urease C-deficient hly+ rBCG (DeltaureC hly+ rBCG) vaccine, providing an intraphagosomal pH closer to the acidic pH optimum for Hly activity, exhibited still higher vaccine efficacy than parental BCG. DeltaureC hly+ rBCG also induced profound protection against a member of the M. tuberculosis Beijing/W genotype family while parental BCG failed to do so consistently. Hly not only promoted antigen translocation into the cytoplasm but also apoptosis of infected macrophages. We concluded that superior vaccine efficacy of DeltaureC hly+ rBCG as compared with parental BCG is primarily based on improved cross-priming, which causes enhanced T cell-mediated immunity.

Application of mycobacterial proteomics to vaccine design: improved protection by Mycobacterium bovis BCG prime-Rv3407 DNA boost vaccination against tuberculosis.

Information from comparative proteome analysis of Mycobacterium tuberculosis and Mycobacterium bovis bacillus Calmette-Guerin (BCG) principally allows prediction of potential vaccine candidates. Thirty-six M. tuberculosis DNA vaccine candidates identified by comparative proteome analysis were evaluated in the mouse model for protection against low-dose aerosol M. tuberculosis infection. We identified the DNA vaccine candidate Rv3407 as a protective antigen and analyzed putative major histocompatibility complex class I epitopes by computational predictions and gamma interferon Elispot assays. Importantly, we discovered that the DNA vaccine Rv3407 improved the efficacy of BCG vaccination in a heterologous prime-boost vaccination protocol. Our data demonstrate the rationale of a combination of proteomics, epitope prediction, and broad screening of putative antigens for identification of novel DNA vaccine candidates. Furthermore, our experiments show that heterologous prime-boost vaccination with a defined antigen boost "on top" of a BCG primer provides superior protection against tuberculosis over vaccination with BCG alone.