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Internal and External/peer group Quality Control Program
Improve your trueness
Make decision according to sigma
Multiple analytes on one instrument
Multiple sample types
All-in-one test cartridge
Automatic self-check system
No additional calibration necessary
Throughput: 480 tests/hour 580 tests/hour with ISE
Test items on board: 36 items + ISE 3 items
Reaction volume: 120– 300 micro-liter
Patient samples on board: 72 patient samples, 30 STAT samples
Reaction volume: 140– 300 micro-liter
Test items on board: 24 items + ISE 3 items / 36 items + ISE 3 items
Patient samples on board: 30 patient samples
Throughput: 270 tests/hour 450 tests/hour with ISE
R1: 140 ～ 300μl (1μl step）
R2: 20 ～ 260μl (1μl step）
News and Announcements
There is an urgent need for new, accurate, and rapid non-sputum-based tuberculosis (TB) diagnostics that have high sensitivity in patients with human immunodeficiency virus (HIV/TB) co-infection with advanced immunosuppression.
Early morning urine (EMU) is accepted as a useful method for improving the concentrations of a number of antigens and analytes found in human urine. The strategy has been shown to improve the yield of urine culture for TB diagnosis. Scientists at the University of Cape Town prospectively recruited HIV-infected adults, all over the age of 18 years, between June 2012 and February 2014 from four hospitals in South Africa. The reference standard for TB was single sputum sample positive liquid TB culture and/or Xpert MTB/RIF assay. Paired samples of EMU and random urine were collected from each patient.
The lateral flow lipoarabinomannan assay (LF-LAM) was done on random urine samples at the bedside and additionally on matched fresh bedside EMU samples the following day. All samples were tested using the Alere Determine-TB LAM Ag lateral flow assay. LF-LAM was graded using the pre-January 2014, with grade 1 and 2 manufacturer-designated cut-off-points (the latter designated grade 1 after January 2014).
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Nonalcoholic fatty liver disease is a condition characterized by a buildup of fat in the liver and the condition is often not detected until it is well advanced, and a definitive diagnosis requires an invasive biopsy of the liver. The presence of advanced fibrosis in nonalcoholic fatty liver disease (NAFLD) is the most important predictor of liver mortality, but there are limited data on the diagnostic accuracy of gut microbiota-derived signature for predicting the presence of advanced fibrosis. Scientists at the University of California-San Diego examined 86 patients with NAFLD diagnosed by biopsy, including 72 with mild or moderate disease and 14 with advanced disease. They characterized the gut microbiome compositions using whole-genome shotgun sequencing of DNA extracted from stool samples.
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It has been recognized that beta-cell dysfunction and progressive beta-cell loss is a key pathophysiologic factor in type 2 diabetes. Indeed, there has been a call for a beta-cell centric approach to classifying diabetes. At a research symposium “The Differentiation of Diabetes by Pathophysiology, Natural History and Prognosis” convened by the American Diabetes Association, JDRF, the European Association for the Study of Diabetes, and the American Association of Clinical Endocrinologists in October 2015, it was concluded by strong consensus that the primary defect resulting in hyperglycaemia is insufficient beta-cell number and/or beta-cell function, and that biomarkers and imaging tools are needed to assess beta-cell mass and loss of functional mass and to monitor progression and response to therapeutic nterventions.
In research settings, methods for assessing beta-cell secretory function include the hyperglycaemic clamp, and intravenous or oral glucose tolerance tests with application of minimal models. These protocols are labour intensive to perform or technically challenging, and are thus not practical to carry out in routine clinical practice.
It should also be noted that the assessment of insulin secretion should be differentiated from the assessment of beta cell function, as the latter requires the rate of insulin secretion to be interpreted in relation to the prevailing glucose concentration and the insulin sensitivity of the individual.
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By Tony Badrick, Chief Executive, The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) , 3 May 2017
External quality assessment (EQA) is the challenge of the effectiveness of a laboratorys quality management system, which is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. The primary customers of the laboratory are the referring clinicians and their patients, although there are many other stakeholders. This is a broad definition, yet laboratories tend to be focused on very narrow concepts of EQA, even though the significance of pre and post laboratory errors is now recognized. This can be partly attributed to the fact that laboratories are largely sample, as opposed to patient, oriented.
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