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Concept: Becton Dickinson

169

BACKGROUND: Tuberculosis (TB) in children is rarely confirmed due to the lack of effective diagnostic tools; only 10 to 15% of pediatric TB is smear positive due to paucibacillary samples and the difficulty of obtaining high-quality specimens from children. We evaluate here the accuracy of Xpert MTB/RIF in comparison with the Micoroscopic observation drug susceptibility (MODS) assay for diagnosis of TB in children using samples stored during a previously reported evaluation of the MODS assay METHODS: Ninety-six eligible children presenting with suspected TB were recruited consecutively at Pham Ngoc Thach Hospital in Ho Chi Minh City Viet Nam between May to December 2008 and tested by Ziehl-Neelsen smear, MODS and Mycobacterial growth Indicator (MGIT, Becton Dickinson) culture. All samples sent by the treating clinician for testing were included in the analysis. An aliquot of processed sample deposit was stored at -20 [degree sign]C and tested in the present study by Xpert MTB/RIF test. 183 samples from 73 children were available for analysis by Xpert. Accuracy measures of MODS and Xpert were summarized. RESULTS: The sensitivity (%) in detecting children with a clinical diagnosis of TB for smear, MODS and Xpert were 37.9 [95% CI 25.5; 51.6], 51.7 [38.2; 65.0] and 50.0 [36.6; 63.4], respectively (per patient analysis). Xpert was significantly more sensitive than smear (P=0.046). Testing of additional samples did not increase case detection for MODS while testing of a second sputum sample by Xpert detected only two additional cases. The positive and negative predictive values (%) of Xpert were 100.0 [88.0; 100.0] and 34.1 [20.5; 49.9], respectively, while those of MODS were 96.8 [83.3; 99.9] and 33.3 [19.6; 49.5]. CONCLUSION: MODS culture and Xpert MTB/RIF test have similar sensitivities for the detection of pediatric TB. Xpert MTB RIF is able to detect tuberculosis and rifampicin resistance within two hours. MODS allows isolation of cultures for further drug susceptibility testing but requires approximately one week to become positive. Testing of multiple samples by xpert detected only two additional cases and the benefits must be considered against costs in each setting. Further research is required to evaluate the optimal integration of Xpert into pediatric testing algorithms.

Concepts: Negative predictive value, Vietnam War, Sample, Becton Dickinson, Vietnam, Tuberculosis, Ho Chi Minh City, Ho Chi Minh

149

Detection and identification of anaerobic bacteria in blood cultures (BC) is a well-recognized challenge in clinical microbiology. We studied 100 clinical anaerobic BC isolates to evaluate the performance of BacT/ALERT-FN, -FN Plus (BioMérieux), BACTEC-Plus and -Lytic (Becton Dickinson BioSciences) BC bottles in detection and time to detection (TTD) of anaerobic bacteria. BACTEC Lytic had higher detection rate (94/100, 94%) than BacT/ALERT FN Plus (80/100, 80%) (p<0.01) in the studied material. There was no significant difference in detection of anaerobic bacteria among the remaining bottle types. The 67 anaerobic bacteria that signalled positive in all four bottle types were analyzed to compare the time to detection (TTD) and isolates were directly identified by MALDI-TOF MS. There was a significant difference in TTD among the four bottle types (p<0.0001). The shortest median TTD was 18 h in BACTEC Lytic followed by BacT/ALERT FN (23.5 h), BACTEC Plus (27 h) and finally BacT/ALERT FN Plus (38 h) bottles. In contrast, MALDI-TOF MS performed similarly in all bottle types with accurate identification in 51/67 (76%) BacT/ALERT FN, 51/67 (76%) BacT/ALERT FN Plus, 53/67 (79%) BACTEC Plus and 50/67 (75%) BACTEC Lytic bottles. In conclusion, BACTEC Lytic bottles have significantly better detection rates and shorter TTD compared to the three other bottle types. The anaerobic BC bottles are equally suitable for direct MALDI-TOF MS for rapid and reliable identification of common anaerobic bacteria. Further clinical studies are warranted to investigate the performance of anaerobic BC bottles in detection of anaerobic bacteria and identification by direct MALDI-TOF MS.

Concepts: Pneumonia, Becton Dickinson, Blood culture, Microbiology

146

The BD-FACSPresto™ CD4 is a new, point-of-care (POC) instrument utilising finger-stick capillary blood sampling. This study evaluated its performance against predicate CD4 testing in South Africa.

Concepts: Fairleigh Dickinson, Jr., International AIDS Vaccine Initiative, Fairleigh S. Dickinson, Franklin Lakes, New Jersey, Maxwell Becton, Capillary, Becton Dickinson

143

We evaluated the performance of the Becton Dickinson Veritor™ System Flu A + B rapid influenza diagnostic test (RIDT) to detect influenza viruses in respiratory specimens from patients enrolled at five surveillance sites in Kenya, a tropical country where influenza seasonality is variable.

Concepts: Antiviral drug, Mucus, Maxwell Becton, Influenza pandemic, Influenza vaccine, Influenzavirus A, Becton Dickinson, Influenza

27

Abstract Background: Many diabetes patients who require insulin perform multiple subcutaneous injections every day that often cause pain, discomfort, and anxiety. We compared efficacy (glycemic control) and patient preference for two types of needle: a shorter straight needle (32 gauge×4 mm, straight wall; Nippon Becton Dickinson Co., Ltd., Tokyo, Japan; hereafter referred to as BD32S4) and a thinner microtapered needle (33-gauge tip and 28-gauge base×5 mm, double-tapered wall; Terumo Corp., Tokyo, Japan; hereafter referred to as TR33T5) in a single-center study. Patients and Methods: Eighty-four patients with diabetes were enrolled in a randomized, open-label crossover trial. The patients injected their usual insulin dosage with one type of needle for 4 weeks and then switched to the other type for the next 4 weeks. The serum glycated albumin level was measured before and after each 4-week period. Each patient assessed pain during injection on a 150-mm visual analog scale (VAS). Needle preference, perceptions of handling, and acceptance were assessed by the patients, who completed a questionnaire after using each type of needle for 4 weeks. Results: In total, 79 patients completed the study. There was no difference of glycemic control between the two needles. The mean VAS score was -14.5 mm (95% confidence interval, -20.9, -8.0 mm), indicating that the patients perceived less pain with the BD32S4 needle. In the overall evaluation, a significantly higher percentage of patients selected the BD32S4 as the better needle compared with the TR33T5 (60.3% vs. 19.2%; P<0.0001). Conclusions: The BD32S4 needle was more highly evaluated and was preferred by the patients with respect to pain during injection, usability, and visual impression, without having a negative impact on glycemic control. The overall preference of patients for the shorter needle in this study suggests that needle length may be one of the major contributing factors for patients' comfort in insulin injection, although the other relevant factors of needles still need to be considered.

Concepts: Insulin resistance, Subcutaneous injection, Insulin, Diabetes, Albumin, Becton Dickinson, Diabetes mellitus, Hypodermic needle

25

Background: A new “ready-to-use” triple-chamber container, Numeta (Baxter, Deerfield, IL), is available for preterm parenteral nutrition (PN) to provide nutrients according to the recommendations of the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the European Society for Clinical Nutrition and Metabolism (ESPEN) Guidelines for Pediatric Parenteral Nutrition. We investigated the clinical application of Numeta compared with individualized PN in preterm infants (≤1.500 g) and evaluated the effects on nutrient intake, costs, and preparation time. Materials and Methods: In a clinical observational study, prescriptions for preterm infants were performed with the new prescription software catoPAN (Cato Software Solutions, Becton Dickinson, Vienna, Austria). Individualized PN and Numeta prescriptions were mirrored, and nutrition content of the PNs was compared with each other and with ESPGHAN/ESPEN recommendations. Furthermore, costs and preparation time were assessed. Results: In total, 374 PN solutions (>1000 g [n = 333]/≤1000 g [n = 41]) were analyzed. Protein intake with Numeta was significantly lower compared with individualized PN and did not meet the recommendations for infants <1500 g during the first day and the period of transition after birth. Energy intake was significantly higher with Numeta. The costs for Numeta preparations were €18 (about US$20) higher than for individualized PN. However, the preparation time/solution was 2 minutes faster with Numeta. Conclusion: Numeta is an alternative to individualized PN for infants >1000 g in the period of stable growth when enteral feedings have already started. Protein intake is significantly lower than in individualized PN solutions. Numeta is more expensive in comparison to individualized PN but saves human resources.

Concepts: Protein, Vitamin, Essential nutrient, Medicine, Metabolism, Nutrient, Becton Dickinson, Nutrition

4

In 2006, a new variant of Chlamydia trachomatis (nvCT) was discovered in Sweden. It has a deletion in the plasmid resulting in failed detection by the single target systems from Abbott and Roche used at that time, whereas the third system used, from Becton Dickinson (BD), detects nvCT. The proportion of nvCT was initially up to 65% in counties using Abbott/Roche systems. This study analysed the proportion of nvCT from 2007 to 2015 in four selected counties and its impact on chlamydia-associated complications.

Concepts: Chlamydia trachomatis, Becton Dickinson

1

A disproportional increase of circulating GAD65 within hours from an intraportal islet allotransplantation has been validated as biomarker of beta cell loss and poor functional outcome. More sensitive assays are, however, needed to allow detection of episodes of subtle beta cell loss during late-stage graft rejection or in the peri-onset period of type 1 diabetes. We applied the same sandwich monoclonal antibody couple reactive towards the C- and N-terminus of GAD65 on three advanced immunoassay platforms-the Cytometric Bead Array (CBA, Becton, Dickinson and Company), ElectroChemiLuminescence ImmunoAssay (ECLIA, Meso Scale Discovery) and digital ELISA technology (Single Molecule Array-SIMOA, Quanterix. We then compared analytical performance (linearity, imprecision, limit of detection and functional sensitivity), correlation of results, and practicality. All evaluated techniques showed linearity up to at least 500 ng/dL (76.9 pmol/L). SIMOA achieved the lowest imprecision. The 3 platforms correlate well with each other and could all detect subpicomolar concentrations of GAD65 in plasma, but only SIMOA and CBA could quantify down to that range. SIMOA can achieve the highest sample throughput. The three methods tested allow sensitive detection of GAD65, but SIMOA appears best suited for automated quantification of subpicomolar concentrations.

Concepts: Correlation and dependence, Becton Dickinson, Islets of Langerhans, Assay, Insulin, Immune system, Protein, ELISA

0

Selection and verification of blood collection tubes is an important preanalytical issue in clinical laboratories. Today, gel tubes are commonly used with many advantages, although they are known to cause interference in immunoassay methods. In this study, we aimed to compare SSTs of two different suppliers (Ayset clot activator & Gel and Becton Dickinson (BD) Vacutainer SST II advance) with reference tubes and evaluate the effect of storage time in terms of commonly used endocrine tests such as thyroid-stimulating hormone (TSH), free thyroxine (fT4), and free triiodothyronine (fT3).

Concepts: Endocrine system, Becton Dickinson, Hyperthyroidism, Tyrosine, Triiodothyronine, Thyroxine, Thyroid, Thyroid hormone

0

In patients with invasive fungal infections, the accurate and rapid identification of the genus Candida is of utmost importance since antimycotic sensitivity is closely related to the species. The aim of the present study was to compare the identification results of species of the genus Candida obtained by BD Phoenix™ (Becton Dickinson [BD]) and Maldi-TOF MS (Bruker Microflex LT Biotyper 3.1). A total of 192 isolates from the strain collection belonging to the Mycology Network of the Autonomous City of Buenos Aires, Argentina, were analyzed. The observed concordance was 95%. Only 10 strains (5%) were not correctly identified by the BD Phoenix™ system. The average identification time with the Yeast ID panels was 8h 22min. The BD Phoenix™ system proved to be a simple, reliable and effective method for identifying the main species of the genus Candida.

Concepts: Argentina, Time, Maxwell Becton, Buenos Aires, Yeast, Fungus, Biology, Becton Dickinson