Clinical, Medical & Diagnostic Products
HPV High-Risk Test Approved for Use in The Netherlands Population Cervical Screening Programme
Hologic, Inc, a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, have announced that the NVVP (Netherlands Society for Pathology) has approved the use of the Hologic Cervista HPV HR test for detecting human papillomavirus in the Dutch national cervical screening programme.
HPV is one of the most common sexually transmitted diseases (STD) and is recognised as the cause of most cervical cancers. To help prevent the onset of disease, the RIVM (National Institute for Public Health and the Environment in The Netherlands) suggests routine Pap testing and HPV HR triage for ASCUS/LSIL testing for women over the age of 30 to identify women most likely to develop cervical cancer.
"We are extremely excited to enter the Netherlands Cervical Screening Programme with our Hologic Cervista HPV HR test for detecting HPV," said Rohan Hastie, PhD, Hologic Vice President & General Manager of Diagnostics. "The Cervista HPV HR test includes an internal control intended to verify adequate cellularity for testing, thus reducing the potential for false negative results," Dr Hastie added. "Because it requires a smaller specimen volume, this test may minimise inconclusive or indeterminate results, which may lead to fewer patients being called back for repeat testing. More importantly, the test is designed to minimise false positive results due to a low-risk HPV strain being mistakenly recognised as a high-risk HPV strain, thereby potentially reducing unnecessary clinical management and patient anxiety. The test is built on redundancy and focused on the L1/E6E7 region so it protects against false negative outcomes in the event of L1 deletion."
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Rapid Test for Diabetes Management
Point of Care Testing Excellence with a Fully Connected Blood Gas Solution
Kingston Hospital NHS Trust ensures rapid and reliable results for blood gases and other critical care parameters using Roche cobas b 221 blood gas analysers. Easy to use and requiring minimal maintenance, these robust analysers are ideal for use by non-laboratory staff at the point of care, and they have the added advantage that they can be monitored remotely by using Roche POC IT solutions.
“Having the analysers at the point of care saves valuable time,“ explained Point of Care Testing (POCT) Manager, Christine Astbury. “Blood gas samples deteriorate rapidly and need to be analysed as quickly as possible. The cobas b 221 analysers allow us to do this reliably and with ease, providing a good quality result where and when it is needed.“
EKF Diagnostics, specialists in near patient analysers, has developed Quo-Test, for easy and reliable measurement of glycated haemoglobin (HbA1c) used in the detection and management of diabetes. The device, which is awaiting FDA clearance with a launch expected early in 2013, will be sold in North, Central and South America by Stanbio Laboratory, a Texas based specialist distributor of IVD products and clinical chemistry manufacturer. Stanbio was acquired by EKF Diagnostics in May 2011. Quo-Test enables clinicians to make a rapid determination of diabetes management , thereby improving patients’ experience, thanks to the fast and accurate results obtained from the machine in just four minutes from 4µl of blood from finger prick or venous sample.
The user-friendly device has a multi-lingual menu and allows for efficient data handling, with a barcode reader and storage of up to 7,000 results, which can be downloaded to a computer via a USB port.
Quo-Test uses a patented Boronate Fluorescence Quenching Technology (BFQT): a simple, fast and accurate method, based on the well-documented boronate affinity for glycated haemoglobin, which is not affected by haemoglobin variants. Although Quo-Test has been developed to be used in a point of care setting, it is a professional product providing laboratory level accuracy, reporting its results in IFCC and DCCT standards (Mono S & JDS reporting are also available). The CE marked analyser has been approved by China's SFDA for the monitoring of HbA1c in diabetes patients and is manufactured in the UK by EKF Diagnostics Group company Quotient Diagnostics Ltd.
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Kingston Hospital has seven cobas b 221 blood gas analysers located throughout the hospital (in the intensive therapy unit, accident and emergency, acute assessment unit, neonatal unit, maternity department, a medical respiratory ward and the laboratory). Connectivity with cobas®
IT 1000 (together with cobas bge Link and cobas academy e-
learning) provides Kingston with the complete POC IT solution allowing all analysers and operators to be managed efficiently from a single point of control
“cobas® bge Link can be used to check that all quality control (QC) tests have been performed satisfactorily, from a single screen in the
laboratory“ added Christine. “It is also possible to troubleshoot remotely (using the screen sharing mode in cobas bge Link), as well as request calibrations, run QC samples, prime the system with reagents, and perform other functions. This is particularly helpful out-of - hours, when it is not possible for BMS staff to visit an analyser on the ward.
“One of the reasons we chose cobas® IT 1000 is because of the ability to connect Roche and non-Roche POCT equipment. In the near
future we hope to link in further POCT equipment to cobas IT 1000 at Kingston. When we purchase any future POCT equipment one of the requirements will be that, where possible, they must be connected to cobas IT 1000. This means that one IT Solution can effectively manage POC in our hospital and provide the cost benefits. ”
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Improve Your Ketosis Detection
Stanbio Laboratory, an EKF Diagnostics company, has developed the ß-Hydroxybutyrate LiquiColor®
Reagent System to improve the detection of clinically significant ketosis. Ketosis is elevated levels of ketones in the body that occur when stored fats are broken down in response to a low supply of energy (glucose). Using the reagent system, levels of the ketone ß- Hydroxybutyrate in serum and plasma can be used to clinically diagnose and monitor diabetes mellitus, alcoholism, glycogen storage disease, high fat/low carbohydrate diets, pregnancy, alkalosis, ingestion of isopropyl alcohol, and salicylate poisoning.
As ß-Hydroxybutyrate is the main ketone produced during ketosis (~78%), the blood assay provides a better tool than the nitroprusside test strips commonly used for the detection of ketone bodies in urine, which only detect 22% of ketones present. ß-Hydroxybutyrate also demonstrates excellent stability, making it the most reliable indicator of clinically relevant ketosis and ketoacidosis.
Stanbio Laboratory’s ß-Hydroxybutyrate LiquiColor® Reagent System produces quantitative and objective results and provides an excellent
tool for differentiating metabolic acidosis and monitoring therapy. Its precise and sensitive quantitative results enable earlier detection of ketosis and faster patient treatment, thus improving Emergency Room (ER) and Critical Decision Unit (CDU) throughput and efficiency.
MORE INFO. 597
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