Track topics on Twitter Track topics that are important to you
Part 1 (POC Precision):
Demonstrate that the Minicare BNP (im)precision in hands of the user is within the expected range of the Minicare BNP (im)precision. Part 2 (sample comparison)
Primary objective :
Compare Minicare BNP values from capillary whole blood from finger stick with EDTA whole blood from venous puncture.
Secondary objective :
Compare Minicare BNP values from EDTA whole blood and plasma with Li- Heparin whole blood and plasma from venous puncture.
Study Design Part 1 (POC precision) Two levels of BNP control samples (Thermofisher) will be tested during 5 days, with 5 replicates per day by three different users to assess precision of the Minicare BNP. The two different levels need to be tested on the same analyzer by the same user. For this study, six analyzers are made available, meaning that each user will test 2 analyzers. In parallel this testing will be done at Philips to establish the expected POC (im)precision. The two (im)precision values will be compared to each other. The precision study will also be used as a proficiency study that is normally requested prior to starting enrolment. Study Design Part 2 (sample comparison)
Part 2 (Sample comparison):
This study will be a prospective European single site study with at least 100 patient samples, taken from patients presenting at the cardiology ward and coronary care unit with suspected/ diagnosed heart failure (HF) or other cardiac diseases and thus suspected elevated BNP values. The blood sample will be collected near the patient by a trained healthcare professional of the study site.
When testing capillary whole blood, the blood will be collected by a finger stick according to the local SOP's of the study site. Directly (within 1 minute) after finger stick, the blood will be transferred with capillary transfer devices, one without ant-coagulant and one containing EDTA as anti-coagulant, to the BNP cartridge that is positioned in the Minicare I-20 analyzer. Testing will be done near the bedside of the patient. Two venous whole blood tubes will be collected; one containing Li-Heparin and the other containing EDTA as anti-coagulant. The venous whole blood will be collected in the specific tubes by a venous puncture according to the local SOP's of the study site. The EDTA venous whole blood will be transferred to the Minicare BNP by using a pipet and a transfer device. The Li-Heparin and EDTA venous whole blood sample should be tested within 2 hours (keep at room temperature) after the blood is taken (preferably as soon as possible after blood taking). Li-Heparin and EDTA venous whole blood can be tested at the ward by a trained healthcare professional or in the lab by a trained lab technician. The Li-Heparin and EDTA whole blood sample will be transferred to the lab and centrifuged and tested within 2 hours after the blood is taken. The Li-Heparin and EDTA plasma should be tested within 2 hours (keep at room temperature) after the blood is taken (preferably as soon as possible after blood taking). Li- Heparin and EDTA plasma samples might be tested in the lab, dependent on local routine.
All patient samples will be tested in singleton. The time that the blood is taken and tested will be recorded for each sample. Study will continue until at least 100 patient samples covering the predefined concentration range have valid measurements. Due to experience from previous sample comparison studies (Lab2Go) the site expects the necessity to test up to 200 patients to find 100 patients within the required BNP ranges. The Minicare BNP test results will not be used as part of the patient diagnosis but only for sample comparison purposes. Testing for both Part 1 and Part 2 will be done according to the Clinical Brochure for Minicare BNP.
standard blood draw as part of routine and fingerprick for capillary sample
Medical University of Innsbruck
Philips Handheld Diagnostics
Published on BioPortfolio: 2017-04-11T03:38:22-0400
Patients with kidney transplant have blood tests very often. This is normally done in hospital and using a needle inserted into the vein. Two tests are important for kidney transplant pati...
Dry eye disease remains one of the most common complaints seen in ophthalmic clinics. Causes of dry eye are multifactorial, with the most common cause of evaporative dry eye disease being ...
Cross-sectional diagnostic accuracy study with up to 250 patient participants with a goal of obtaining 20 deficient and 20 intermediate samples. The clinic will recruit and consent study p...
The objective of the present project is to study the accuracy of capillary blood level measured by handheld lactate analyzers when compared with the reference methods e.g.venepuncture bloo...
A prospective trial conducted at Shock Trauma of patients between 18 years of age and older who have sustained a fracture with metal implanted. The investigators will be collecting between...
The application of a new calculation strategy for the psychotropic drug concentration in blood and bone marrow samples in the form of dried blood spots (DBS) was the main aim of the study. The standar...
Background Monitoring of immunosuppressive drugs such as everolimus and sirolimus is important in allograft rejection prevention in transplant patients. Dried blood spots (DBS) sampling gives patients...
Obtaining plasma from a blood sample and preparing it for subsequent analysis is currently a laborious process involving experienced health-care professionals and centrifugation. We circumvent this by...
From April to October 2018, we implemented a blood pressure measurement quality improvement project at our Hypertension Center. We aimed to compare blood pressure measured using routine, non-standardi...
Congenital disorders of glycosylation (CDG) are a growing group of inherited diseases causing manifold symptoms. Routine diagnostic procedures are high performance liquid chromatography (HPLC) or isoe...
The property of blood capillary ENDOTHELIUM that allows for the selective exchange of substances between the blood and surrounding tissues and through membranous barriers such as the BLOOD-AIR BARRIER; BLOOD-AQUEOUS BARRIER; BLOOD-BRAIN BARRIER; BLOOD-NERVE BARRIER; BLOOD-RETINAL BARRIER; and BLOOD-TESTIS BARRIER. Small lipid-soluble molecules such as carbon dioxide and oxygen move freely by diffusion. Water and water-soluble molecules cannot pass through the endothelial walls and are dependent on microscopic pores. These pores show narrow areas (TIGHT JUNCTIONS) which may limit large molecule movement.
The techniques used to draw blood from a vein for diagnostic purposes or for treatment of certain blood disorders such as erythrocytosis, hemochromatosis, polycythemia vera, and porphyria cutanea tarda.
The barrier between capillary blood and alveolar air comprising the alveolar EPITHELIUM and capillary ENDOTHELIUM with their adherent BASEMENT MEMBRANE and EPITHELIAL CELL cytoplasm. PULMONARY GAS EXCHANGE occurs across this membrane.
A type of oropharyngeal airway that provides an alternative to endotracheal intubation and standard mask anesthesia in certain patients. It is introduced into the hypopharynx to form a seal around the larynx thus permitting spontaneous or positive pressure ventilation without penetration of the larynx or esophagus. It is used in place of a facemask in routine anesthesia. The advantages over standard mask anesthesia are better airway control, minimal anesthetic gas leakage, a secure airway during patient transport to the recovery area, and minimal postoperative problems.
The fraction of a blood sample, following CENTRIFUGATION, that is distinguished as a thin light-colored layer between the RED BLOOD CELLS, underneath it, and the PLASMA, above it. It is composed mostly of WHITE BLOOD CELLS and PLATELETS.
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...
Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...