Nova Biomedical’s StatStrip Glucose Hospital Meter System now offers bidirectional wireless connectivity to the hospital’s HIS or LIS with complete security to protect patient data. The wireless connectivity can transmit patient results directly from the patient bedside, alleviating the need to bring the meter to a fixed location for meter docking and data transmission. Wireless connectivity saves time for the caregiver and allows for faster charting of results and clinical decision making to improve patient care. StatStrip Glucose’s dual-band wireless connectivity provides complete security and encryption to ensure that patient data remains uncompromised. Nova now offers a full range of StatStrip Glucose wireless connectivity capabilities, including wireless meters, wireless carrying cases, and wireless docking stations. All of the wireless devices use industry standard POCT1-A2 data format and are compatible with a choice of middleware partners. StatStrip Glucose is the only glucose meter cleared by the U.S. Food and Drug Administration (FDA) for use with all patients, in all healthcare settings, including critical care. The device received this clearance in 2014 after an extensive, nearly four-year study conducted at five major university medical centres, which included 1,698 critically ill patients with over 257 clinical conditions. Over 8,000 medications were investigated for potential interference to StatStrip Glucose measurement. The device demonstrated excellent agreement compared to central laboratory reference methods and no clinical interferences were found. In addition to the study submitted to the FDA, 138 other independent studies over the last eight years—including 53 critical care studies—have found no clinically significant interferences for StatStrip Glucose.

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Comprehensively assessing analytical performance in your laboratory has just become easier with, RIQAS the world’s largest EQA Scheme. Our impressive programme portfolio has recently expanded to comprise of 8 new programmes including:

Anti-TSH Receptor
CSF
CYFRA 21-1
Immunosuppressant
Sweat Testing
Trace Elements in Blood
Trace Elements in Serum
Trace Elements in Urine

Launching in March these programmes will allow clinical laboratories to review & monitor calibration issues, systematic errors and test system accuracy, thus ensuring the results you release are accurate and reliable.
Features of these new programmes include;

• Monthly reporting
• Rapid report turnaround of 24-72 hours
• Comprehensive reports
• Covers the full clinical decision range
• Register 5 instruments at no extra cost

Contact us today to find out how you could consolidate your EQA test menu.

For more information please click here
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BioSystems launches a new reagent for the measurement of oxalate (oxalic acid) in urine. Oxalate is an end product of metabolism, predominantly derived from the breakdown of glyoxylate and glycine. It is eliminated entirely by urine and only about 15% of urinary oxalate is derived directly from dietary sources. Hyperoxaluria is a powerful promoter of calcium oxalate stone formation. An increased excretion of oxalate in urine may occur as a result of an excessive ingestion of oxalate-rich foods, because of malabsorption due to different gastrointestinal disorders (enteric hyperoxaluria) or because of an inborn error of metabolism (primary hyperoxaluria). Low oxalate values in urine are associated with hyperglycinemia or hyperglycinuria. BioSystems introduces this method (Oxalate Oxidase/Peroxidase – differential bireagent) in dedicated presentation for A15 and A25 analysers (code 12539: 1x25mL, 20 tests). It is calibrated using its own standard included in the kit. The kit also includes 20 pretreatment tubes which are also available separately in 100-unit packs (Oxalate Pretreatments Reagents: code 11839).

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QDx Hemostat is a compact handheld POC hemoglobin meter for measuring hemoglobin from a finger prick of whole blood. This hemoglobin measuring system is intended to help people manage their hemoglobin levels. It also provides healthcare professionals with helpful information by measuring hemoglobin in fresh capillary whole blood as well as venous blood. Calibration is done by simply inserting the code key into the test meter. The virtually painless test requires only 1 μL sample volume and provides quick results in five seconds. The device features a large display, a 100-test memory and a measuring range of 5 – 26 g/dL. Battery life allows 3,000 tests to be performed. By using Hemostat, a check of both quantitative hemoglobin and hematocrit will give quick results within 5 seconds. Only 1 μL sample volume is needed which makes it nearly painless for the patient. The ergonomic design allows comfortable usage.
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NOVA View, an automated digital IFA (indirect fluorescent assay) microscope has received FDA de novo clearance. NOVA Lite DAPI ANA Kit, an IFA reagent indicated for use with NOVA View, received 510(k) clearance at the same time. Anti-nuclear antibodies (ANA) is the first line laboratory test for the diagnosis of systemic lupus erythematosus and other systemic autoimmune rheumatic diseases.  Early and accurate diagnosis and effective treatment are key to reducing the morbidity associated with these conditions. IFA is the gold standard for ANA testing according to a Position Statement issued by the American College of Rheumatology in 2009. IFA, as it is currently practiced in many laboratories, is time and labour-intensive, subject to interpretation bias and other variables, such as the type of microscope and intensity of the light source. The workflow is manual, and prone to transcription errors. NOVA View addresses many shortcomings of the manual IFA process by reducing hands-on time, providing consistent reading and interpretation conditions, and generating digital images that can be archived.  It provides patient sample traceability with positive patient identification and improves assay integrity by using NOVA Lite barcoded IFA slides. The instrument helps standardizing the ANA IFA test and provides clinicians with a reliable test result. In addition, the capability of providing an IFA test result that can be seamlessly uploaded into the patient’s electronic medical record will be a remarkable advancement in prompt and accurate reporting. NOVA View Automated Fluorescence Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyses, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescence technology. The device can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device. A trained operator must confirm results generated with the device. NOVA View determines the result (positive or negative), and performs ANA pattern interpretation. After pattern confirmation by the operator, the instrument is able to predict a pattern-specific endpoint titre. Results are recorded electronically in a transcription-free and paperless work environment, and all digital images are archived for future review. NOVA Lite DAPI ANA Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-nuclear antibodies of the IgG isotype in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of anti-nuclear antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases.  

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