Venient Fx Inflammatory Response Comprehensive
Test Description
Venient Fx Inflammatory Response Comprehensive is a disruptive, non-invasive test that provides comprehensive information on systemic inflammatory response and autoimmune activity status.
It is based on a routine blood test and is powered by both proprietary machine learning and public algorithms, and provides highly accurate broad diagnostic information, including the likelihood of having different types of inflammatory and autoimmune disorders, such as Sjögren's disease, rheumatoid arthritis (RA), mixed connective tissue disease, scleroderma, or systemic lupus erythematosus (SLE), among others.
It is based on the determination of autoimmune antibodies in blood and also includes the determination of some acute phase proteins.
It is an Evidence Based Laboratory Medicine (EBML) test developed not only in accordance with the guidelines of the American College of Rheumatology (ACR), but also incorporating the latest scientific findings.
Screening recommendations
The United States Preventative Services Task Force (USPSTF) does not include any recommendations for screening for inflammatory and autoimmune diseases.
However, Kience Inc. recommends the Venient Fx Inflammatory Response Comprehensive test for patients with symptoms, signs or suspicion of disease: rheumatoid arthritis, Sjögren's disease, reactive arthritis, arthritis due to systemic lupus erythematosus and psoriasis, or infectious arthritis, among others.
Intended Use
The target population for the Venient Fx Inflammatory Response Comprehensive test are patients with symptoms, signs or suspected disease: rheumatoid arthritis, arthritis reactive to Sjögren's disease, arthritis due to systemic lupus erythematosus and psoriasis, or infectious arthritis, among others.
Sample Clinical Vignette
A 40-year-old female presented to the clinic for medical evaluation after a two year history of pain, edema and wrist redness. Her knees have morning stiffness and some mobility limitations. Physical exam revealed arthritis, swelling and Heberden's nodes in the distal interphalangeal joints with ulnar deviation. Her left knee and right wrist were swollen as well. Serum is submitted to detect for autoimmune inflammatory connective tissue-related diseases, such as rheumatoid arthritis.
Required Laboratory Determinations
Hemogram —Red Blood Cell Count, Hemoglobin, Hematocrit, Erythrocyte Sedimentation Rate (ESR)—; Red Blood Cell Indices —Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Red Cell Blood Distribution Width (RDW)—; Leukocyte Count —Total Leukocytes Absolute, Total Neutrophil Absolute, Total Lymphocyte Absolute, Total Monocyte Absolute, Total Eosinophil Absolute, Total Basophil Absolute—; Platelets —Total Platelet Count, Mean Platelet Volume (MPV), Platelet Distribution Width (PDW)—; Serum Antibodies —Antinuclear Antibody (ANA), Cyclic Citrullinated Peptides Antibodies (Anti-CCP), Anti-Histidyl Transfer RNA Synthase Antibodies (Anti-Jo-1), Anti-Ribonucleoprotein Antibodies (Anti-RNP), Scleroderma Antibodies (Anti-Scl-70), Smith Antibodies (Anti-Sm), Sjögren Syndrome A Antibodies (Anti-SS-A), Sjögren Syndrome B Antibodies (Anti-SS-B), Rheumatoid Factor (RF)—; Serum Proteins —High Sensitivity C-Reactive Protein (hs-CRP), Ferritin—; Serum Hepatic Enzymes —Creatine Kinase (CK)—.