Automated digital IFA microscope
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.
